CASE: COST-CONSCIOUS LAPAROSCOPIC HYSTERECTOMY
A 43-year-old woman undergoes laparoscopic hysterectomy for treatment of uterine fibroids and menorrhagia. Once she is prepped with ChloraPrep, a RUMI II uterine manipulator is placed. Laparoscopic ports include a Structural Balloon Trocar, a VersaStep Plus trocar, and two Versaport trocars. The surgeon uses an Olympus Thunderbeat device—a combination of ultrasonic and bipolar energy—to perform the majority of the procedure. The uterus is morcellated using the disposable Gynecare Morcellex, and the vaginal cuff is closed using a series of 2-0 PDS II sutures. The skin ­incisions are closed using Dermabond skin adhesive.

The total cost of the products used in this case: $1,705.60.

Could different product choices have reduced this figure?

As health-care costs continue to rise faster than inflation, with total health-care expenditures accounting for about 18% of the US gross domestic product, we face increasing pressure to take cost into account in the management of our patients.¹ Not surprisingly, cost-effectiveness and outcome quality have become measures in many clinical trials that compare standard and alternative therapies. The field of women’s health—and, specifically, minimally invasive gynecologic surgery—is not immune to such comparisons.

Overall, conventional laparoscopic gynecologic procedures tend to have lower costs than laparotomy, due to shorter hospital stays, faster recovery, and fewer complications.^2–4 What is not fully appreciated is how the choice of laparoscopic instrumentation and associated products affects surgical costs. In this article, we review these costs with the goal of raising awareness among minimally invasive gynecologic surgeons.

In the sections that follow, we highlight several aspects of laparoscopic gynecologic surgery that may affect your selection of instruments and products, describing the difference in cost as well as some unique characteristics of the products. Please note that our comparison focuses solely on cost, not ease of utility, effectiveness, surgical technique, risk of complications, or any other assessment. We’d also like to point out that numerous other instruments and devices are commercially available besides those listed in this article.

A few variables to keep in mind
Even when taking cost into consideration, tailor the selection of instruments and supplies to your capabilities and comfort, as well as characteristics particular to the patient and the planned procedure. Also keep in mind that your institution may have arrangements with companies that supply minimally invasive instruments, and such arrangements may limit your options to some degree. Be aware that reprocessed ports and instruments are now available at a reduced cost.

We believe it is crucial for surgeons to be cognizant of all products potentially available to them prior to attending a surgical case.

Related article: Update on Technology Barbara S. Levy, MD (September 2013)

Skin preparation and other preoperative considerations
Multiple preoperative skin preparations are available (TABLE 1). Traditionally, a povidone-iodine topical ­antiseptic such as Betadine has been used for skin and vaginal preparation prior to gynecologic surgery. Hibaclens and ChloraPrep are different combinations of chlorhexidine gluconate and isopropyl alcohol that act as broad-spectrum antiseptics. ChloraPrep is applied with a wand-like applicator and contains a much higher concentration of isopropyl alcohol than Hibaclens (70% vs 4%), rendering it more flammable. It also requires more drying time before the case is started. Clear and tinted ChloraPrep formulations are available.

It makes good sense to have instruments and devices readily available in the operating room (OR) at the start of a case, to avoid unnecessary surgical delays, but we recommend that you refrain from opening these tools until they are required intraoperatively. It is possible that the case will require conversion to laparotomy or that, after direct visualization of the pathology, different ports or instruments will be required.

Uterine manipulators
Cannulation of the cervical canal allows for uterine manipulation, increasing ­intraoperative traction and exposure and visualization of the adnexae and peritoneal surfaces.

The Hulka and Pelosi reusable uterine manipulators are fairly standard and easy to apply. Specialized, single-use manipulators also are available, including the VCare uterine manipulator/elevator, which consists of two opposing cups. One cup (available in four sizes, from small to extra-large) fits around the cervix and defines the site for colpotomy, and the other cup helps maintain pneumoperitoneum once a colpotomy is created.

The Zinnanti Uterine Manipulator Injector (ZUMI) is a rigid, curved shaft with an intrauterine balloon to help prevent expulsion. It also has an integrated injection channel to allow for intraoperative chromotubation.

The RUMI System fits individual patient anatomy with various tip lengths and colpotomy cup sizes (TABLE 2).

Related article: Tips and techniques for robot-assisted laparoscopic myomectomy Arnold P. Advincula, MD, and Bich-Van Tran, MD (August 2013)

Entry style and ports
The peritoneal cavity can be entered using either a closed (Veress needle) or open (Hasson) technique.⁵ Closed entry may allow for quicker access to the peritoneal cavity. A recent Cochrane review of 28 randomized, controlled trials, including 4,860 patients undergoing laparoscopy, compared outcomes between laparoscopic entry techniques.⁶ It found no difference in major vascular or visceral injury between closed and open techniques at the umbilicus. However, open entry was associated with greater successful entry into the peritoneal cavity, as well as less extraperitoneal insufflation and a lower omental injury rate, compared with closed entry.⁶ 

Left-upper-quadrant entry is another option when adhesions are anticipated or abnormal anatomy is encountered at the umbilicus.

In general, complications related to laparoscopic entry are quite rare in gynecologic surgery, ranging from 0.18% to 0.5%.^7,8 A minimally invasive surgeon may prefer one entry technique over the other, but should be able to perform both methods competently and recognize when a particular technique is warranted.

Choosing a port
Laparoscopic ports usually range from 5 mm to 12 mm and can be fixed or variable in size. The primary port, usually placed through the umbilicus, can be a standard, blunt, 10-mm (Hasson) port, or it can be specialized to ease entry of the port or stabilize the port once it is introduced through the skin incision.

Optical trocars have a transparent tip that allows the surgeon to visualize the abdominal-wall entry layer by layer using a 0° laparoscope, usually after pneumoperitoneum is created with a Veress needle. Other specialized ports include those that have balloons or foam collars, or both, to secure the port without traditional stay sutures on the fascia and minimize leakage of pneumoperitoneum.

Accessory ports
When choosing an accessory port type and size, it is important to anticipate what instruments and devices, such as an Endo Catch bag, suture, needle, or morcellator, will need to pass through it. Also know whether 5-mm and 10-mm laparoscopes are available, and anticipate whether a second port with insufflation capabilities will be required.

Related article: Update on Minimally Invasive Surgery Amy Garcia, MD (April 2011)

Pediport trocars are user-friendly 5-mm bladed ports that deploy a mushroom-shaped stabilizer to prevent ­dislodgement. A ­Versaport bladed trocar has a spring-loaded entry shield, which slides over to protect the blade once the peritoneal cavity is entered.

VersaStep bladeless trocars are introduced after a Step insufflation needle has been inserted. These trocars create a smaller fascial defect than conventional bladed trocars for an equivalent cannula size (TABLE 3).

Cutting and coagulating
Both monopolar and bipolar electrosurgical techniques are commonly employed in gynecologic laparoscopy. A wide variety of disposable and reusable instruments are available for monopolar energy, such as scissors, a hook, and a spatula.

Bipolar devices also can be disposable or reusable. Although bipolar electrosurgery minimizes injury to surrounding tissues by containing the current within the jaws of the forceps, it cannot cut or seal large vessels. As a result, several advanced bipolar devices with sealing and transecting capabilities have emerged (LigaSure, ENSEAL). Ultrasonic devices also can coagulate and cut at lower temperatures by converting electrical energy to mechanical energy (TABLE 4).

Sutures
Aspects of minimally invasive gynecologic surgery that require the use of suture include, but are not limited to, closure of the vaginal cuff, oophoropexy, and reapproximation of the ovarian cortex after cystectomy. Syntheticand delayed absorbable sutures, such as PDS II, are used frequently.

Recently, a new class of suture emerged and continues to gain popularity: barbed suture. This type of suture anchors to the tissue without the need for intra- or extracorporeal knots (TABLE 5).

Related article: Ins and outs of straight-stick laparoscopic myomectomy James Robinson, MD, MS, and Gaby Moawad, MD (September 2012)

Tissue removal
Adnexae and pathologic tissue, such as dermoid cysts, can be removed intact from the peritoneal cavity using an Endo Catch Single-Use Specimen Pouch, a polyurethane sac. Careful use, with placement of the ovary with the cyst into the pouch prior to cystectomy, can prevent spillage beyond the bag.

Large uteri that cannot be extracted through a colpotomy can be morcellated into smaller pieces to ease removal through a small laparoscopic incision or the colpotomy. Both reusable and disposable morcellator hand pieces are available (TABLE 6).

Skin closure
Final subcuticular closure can be accomplished using sutures or skin adhesive. Sutures may be synthetic, absorbable monofilament (eg, Caprosyn), or synthetic, absorbable, braided multifilament (eg, PolySorb).

Related article: 10 practical, evidence-based recommendations for improving maternal outcomes of cesarean delivery Baha M. Sibai, MD (March 2012)

Skin adhesives close incisions quickly, avoid inflammation related to foreign bodies, and ease patient concerns that sometimes arise when absorbable suture persists postoperatively (TABLE 5).

Take-home points
As health-care third-party payers and hospitals continue to evaluate surgeons individually and compare procedures between surgeons, reimbursements may be stratified, favoring physicians who demonstrate both quality outcomes and cost-containment.   

There are many ways a minimally invasive surgeon can implement cost-conscious choices that have little to no impact on the quality of the outcome.

Surgeons who are familiar with the instruments and models available for use at their institution are better prepared to make wise cost-conscious decisions.

Cost is not the only indicator of value, however. The surgeon must know how to apply tools correctly and be familiar with their limitations, and should choose instruments and products for their safety and ease of use. More often than not, a surgeon’s training and personal experience define—and sometimes restrict—the choice of devices.

CASE: SAME OUTCOME, LOWER COST
The patient undergoes laparoscopic hysterectomy for treatment of uterine fibroids and menorrhagia. However, in this scenario, the surgeon makes the following product choices: The patient is prepped with Betadine, and a reusable Pelosi uterine manipulator is placed. Laparoscopic ports include a Kii Balloon Blunt Tip, a reprocessed VersaStep Plus trocar, and two Pediport trocars. The surgeon uses the PKS Lyons Dissecting Forceps and reprocessed EndoShears to perform the hysterectomy, incorporating the Karl Storz Rotocut G1 Morcellator, a reusable system with single-use blades, to morcellate the uterus. The vaginal cuff is closed using V-Loc barbed suture, and skin incisions are closed with 4-0 Polysorb, a polyglycolic acid, absorbable suture.

The cost of these products: $1,005.68, or roughly $700 less than the set-up described at the beginning of this article (TABLE 7).

Acknowledgment
The authors thank Susan Wykoop, BSN, RN, and Anna Emery, MSN, RN, for their assistance in gathering specific cost-related information.

We want to hear from you! Tell us what you think.

CASE: COST-CONSCIOUS LAPAROSCOPIC HYSTERECTOMY
A 43-year-old woman undergoes laparoscopic hysterectomy for treatment of uterine fibroids and menorrhagia. Once she is prepped with ChloraPrep, a RUMI II uterine manipulator is placed. Laparoscopic ports include a Structural Balloon Trocar, a VersaStep Plus trocar, and two Versaport trocars. The surgeon uses an Olympus Thunderbeat device—a combination of ultrasonic and bipolar energy—to perform the majority of the procedure. The uterus is morcellated using the disposable Gynecare Morcellex, and the vaginal cuff is closed using a series of 2-0 PDS II sutures. The skin ­incisions are closed using Dermabond skin adhesive.

The total cost of the products used in this case: $1,705.60.

Could different product choices have reduced this figure?

As health-care costs continue to rise faster than inflation, with total health-care expenditures accounting for about 18% of the US gross domestic product, we face increasing pressure to take cost into account in the management of our patients.¹ Not surprisingly, cost-effectiveness and outcome quality have become measures in many clinical trials that compare standard and alternative therapies. The field of women’s health—and, specifically, minimally invasive gynecologic surgery—is not immune to such comparisons.

Overall, conventional laparoscopic gynecologic procedures tend to have lower costs than laparotomy, due to shorter hospital stays, faster recovery, and fewer complications.^2–4 What is not fully appreciated is how the choice of laparoscopic instrumentation and associated products affects surgical costs. In this article, we review these costs with the goal of raising awareness among minimally invasive gynecologic surgeons.

In the sections that follow, we highlight several aspects of laparoscopic gynecologic surgery that may affect your selection of instruments and products, describing the difference in cost as well as some unique characteristics of the products. Please note that our comparison focuses solely on cost, not ease of utility, effectiveness, surgical technique, risk of complications, or any other assessment. We’d also like to point out that numerous other instruments and devices are commercially available besides those listed in this article.

A few variables to keep in mind
Even when taking cost into consideration, tailor the selection of instruments and supplies to your capabilities and comfort, as well as characteristics particular to the patient and the planned procedure. Also keep in mind that your institution may have arrangements with companies that supply minimally invasive instruments, and such arrangements may limit your options to some degree. Be aware that reprocessed ports and instruments are now available at a reduced cost.

We believe it is crucial for surgeons to be cognizant of all products potentially available to them prior to attending a surgical case.

Related article: Update on Technology Barbara S. Levy, MD (September 2013)

Skin preparation and other preoperative considerations
Multiple preoperative skin preparations are available (TABLE 1). Traditionally, a povidone-iodine topical ­antiseptic such as Betadine has been used for skin and vaginal preparation prior to gynecologic surgery. Hibaclens and ChloraPrep are different combinations of chlorhexidine gluconate and isopropyl alcohol that act as broad-spectrum antiseptics. ChloraPrep is applied with a wand-like applicator and contains a much higher concentration of isopropyl alcohol than Hibaclens (70% vs 4%), rendering it more flammable. It also requires more drying time before the case is started. Clear and tinted ChloraPrep formulations are available.

It makes good sense to have instruments and devices readily available in the operating room (OR) at the start of a case, to avoid unnecessary surgical delays, but we recommend that you refrain from opening these tools until they are required intraoperatively. It is possible that the case will require conversion to laparotomy or that, after direct visualization of the pathology, different ports or instruments will be required.

Uterine manipulators
Cannulation of the cervical canal allows for uterine manipulation, increasing ­intraoperative traction and exposure and visualization of the adnexae and peritoneal surfaces.

The Hulka and Pelosi reusable uterine manipulators are fairly standard and easy to apply. Specialized, single-use manipulators also are available, including the VCare uterine manipulator/elevator, which consists of two opposing cups. One cup (available in four sizes, from small to extra-large) fits around the cervix and defines the site for colpotomy, and the other cup helps maintain pneumoperitoneum once a colpotomy is created.

The Zinnanti Uterine Manipulator Injector (ZUMI) is a rigid, curved shaft with an intrauterine balloon to help prevent expulsion. It also has an integrated injection channel to allow for intraoperative chromotubation.

The RUMI System fits individual patient anatomy with various tip lengths and colpotomy cup sizes (TABLE 2).

Related article: Tips and techniques for robot-assisted laparoscopic myomectomy Arnold P. Advincula, MD, and Bich-Van Tran, MD (August 2013)

Entry style and ports
The peritoneal cavity can be entered using either a closed (Veress needle) or open (Hasson) technique.⁵ Closed entry may allow for quicker access to the peritoneal cavity. A recent Cochrane review of 28 randomized, controlled trials, including 4,860 patients undergoing laparoscopy, compared outcomes between laparoscopic entry techniques.⁶ It found no difference in major vascular or visceral injury between closed and open techniques at the umbilicus. However, open entry was associated with greater successful entry into the peritoneal cavity, as well as less extraperitoneal insufflation and a lower omental injury rate, compared with closed entry.⁶ 

Left-upper-quadrant entry is another option when adhesions are anticipated or abnormal anatomy is encountered at the umbilicus.

In general, complications related to laparoscopic entry are quite rare in gynecologic surgery, ranging from 0.18% to 0.5%.^7,8 A minimally invasive surgeon may prefer one entry technique over the other, but should be able to perform both methods competently and recognize when a particular technique is warranted.

Choosing a port
Laparoscopic ports usually range from 5 mm to 12 mm and can be fixed or variable in size. The primary port, usually placed through the umbilicus, can be a standard, blunt, 10-mm (Hasson) port, or it can be specialized to ease entry of the port or stabilize the port once it is introduced through the skin incision.

Optical trocars have a transparent tip that allows the surgeon to visualize the abdominal-wall entry layer by layer using a 0° laparoscope, usually after pneumoperitoneum is created with a Veress needle. Other specialized ports include those that have balloons or foam collars, or both, to secure the port without traditional stay sutures on the fascia and minimize leakage of pneumoperitoneum.

Accessory ports
When choosing an accessory port type and size, it is important to anticipate what instruments and devices, such as an Endo Catch bag, suture, needle, or morcellator, will need to pass through it. Also know whether 5-mm and 10-mm laparoscopes are available, and anticipate whether a second port with insufflation capabilities will be required.

Related article: Update on Minimally Invasive Surgery Amy Garcia, MD (April 2011)

Pediport trocars are user-friendly 5-mm bladed ports that deploy a mushroom-shaped stabilizer to prevent ­dislodgement. A ­Versaport bladed trocar has a spring-loaded entry shield, which slides over to protect the blade once the peritoneal cavity is entered.

VersaStep bladeless trocars are introduced after a Step insufflation needle has been inserted. These trocars create a smaller fascial defect than conventional bladed trocars for an equivalent cannula size (TABLE 3).

Cutting and coagulating
Both monopolar and bipolar electrosurgical techniques are commonly employed in gynecologic laparoscopy. A wide variety of disposable and reusable instruments are available for monopolar energy, such as scissors, a hook, and a spatula.

Bipolar devices also can be disposable or reusable. Although bipolar electrosurgery minimizes injury to surrounding tissues by containing the current within the jaws of the forceps, it cannot cut or seal large vessels. As a result, several advanced bipolar devices with sealing and transecting capabilities have emerged (LigaSure, ENSEAL). Ultrasonic devices also can coagulate and cut at lower temperatures by converting electrical energy to mechanical energy (TABLE 4).

Sutures
Aspects of minimally invasive gynecologic surgery that require the use of suture include, but are not limited to, closure of the vaginal cuff, oophoropexy, and reapproximation of the ovarian cortex after cystectomy. Syntheticand delayed absorbable sutures, such as PDS II, are used frequently.

Recently, a new class of suture emerged and continues to gain popularity: barbed suture. This type of suture anchors to the tissue without the need for intra- or extracorporeal knots (TABLE 5).

Related article: Ins and outs of straight-stick laparoscopic myomectomy James Robinson, MD, MS, and Gaby Moawad, MD (September 2012)

Tissue removal
Adnexae and pathologic tissue, such as dermoid cysts, can be removed intact from the peritoneal cavity using an Endo Catch Single-Use Specimen Pouch, a polyurethane sac. Careful use, with placement of the ovary with the cyst into the pouch prior to cystectomy, can prevent spillage beyond the bag.

Large uteri that cannot be extracted through a colpotomy can be morcellated into smaller pieces to ease removal through a small laparoscopic incision or the colpotomy. Both reusable and disposable morcellator hand pieces are available (TABLE 6).

Skin closure
Final subcuticular closure can be accomplished using sutures or skin adhesive. Sutures may be synthetic, absorbable monofilament (eg, Caprosyn), or synthetic, absorbable, braided multifilament (eg, PolySorb).

Related article: 10 practical, evidence-based recommendations for improving maternal outcomes of cesarean delivery Baha M. Sibai, MD (March 2012)

Skin adhesives close incisions quickly, avoid inflammation related to foreign bodies, and ease patient concerns that sometimes arise when absorbable suture persists postoperatively (TABLE 5).

Take-home points
As health-care third-party payers and hospitals continue to evaluate surgeons individually and compare procedures between surgeons, reimbursements may be stratified, favoring physicians who demonstrate both quality outcomes and cost-containment.   

There are many ways a minimally invasive surgeon can implement cost-conscious choices that have little to no impact on the quality of the outcome.

Surgeons who are familiar with the instruments and models available for use at their institution are better prepared to make wise cost-conscious decisions.

Cost is not the only indicator of value, however. The surgeon must know how to apply tools correctly and be familiar with their limitations, and should choose instruments and products for their safety and ease of use. More often than not, a surgeon’s training and personal experience define—and sometimes restrict—the choice of devices.

CASE: SAME OUTCOME, LOWER COST
The patient undergoes laparoscopic hysterectomy for treatment of uterine fibroids and menorrhagia. However, in this scenario, the surgeon makes the following product choices: The patient is prepped with Betadine, and a reusable Pelosi uterine manipulator is placed. Laparoscopic ports include a Kii Balloon Blunt Tip, a reprocessed VersaStep Plus trocar, and two Pediport trocars. The surgeon uses the PKS Lyons Dissecting Forceps and reprocessed EndoShears to perform the hysterectomy, incorporating the Karl Storz Rotocut G1 Morcellator, a reusable system with single-use blades, to morcellate the uterus. The vaginal cuff is closed using V-Loc barbed suture, and skin incisions are closed with 4-0 Polysorb, a polyglycolic acid, absorbable suture.

The cost of these products: $1,005.68, or roughly $700 less than the set-up described at the beginning of this article (TABLE 7).

Acknowledgment
The authors thank Susan Wykoop, BSN, RN, and Anna Emery, MSN, RN, for their assistance in gathering specific cost-related information.

We want to hear from you! Tell us what you think.

CASE: COST-CONSCIOUS LAPAROSCOPIC HYSTERECTOMY
A 43-year-old woman undergoes laparoscopic hysterectomy for treatment of uterine fibroids and menorrhagia. Once she is prepped with ChloraPrep, a RUMI II uterine manipulator is placed. Laparoscopic ports include a Structural Balloon Trocar, a VersaStep Plus trocar, and two Versaport trocars. The surgeon uses an Olympus Thunderbeat device—a combination of ultrasonic and bipolar energy—to perform the majority of the procedure. The uterus is morcellated using the disposable Gynecare Morcellex, and the vaginal cuff is closed using a series of 2-0 PDS II sutures. The skin ­incisions are closed using Dermabond skin adhesive.

The total cost of the products used in this case: $1,705.60.

Could different product choices have reduced this figure?

As health-care costs continue to rise faster than inflation, with total health-care expenditures accounting for about 18% of the US gross domestic product, we face increasing pressure to take cost into account in the management of our patients.¹ Not surprisingly, cost-effectiveness and outcome quality have become measures in many clinical trials that compare standard and alternative therapies. The field of women’s health—and, specifically, minimally invasive gynecologic surgery—is not immune to such comparisons.

Overall, conventional laparoscopic gynecologic procedures tend to have lower costs than laparotomy, due to shorter hospital stays, faster recovery, and fewer complications.^2–4 What is not fully appreciated is how the choice of laparoscopic instrumentation and associated products affects surgical costs. In this article, we review these costs with the goal of raising awareness among minimally invasive gynecologic surgeons.

In the sections that follow, we highlight several aspects of laparoscopic gynecologic surgery that may affect your selection of instruments and products, describing the difference in cost as well as some unique characteristics of the products. Please note that our comparison focuses solely on cost, not ease of utility, effectiveness, surgical technique, risk of complications, or any other assessment. We’d also like to point out that numerous other instruments and devices are commercially available besides those listed in this article.

A few variables to keep in mind
Even when taking cost into consideration, tailor the selection of instruments and supplies to your capabilities and comfort, as well as characteristics particular to the patient and the planned procedure. Also keep in mind that your institution may have arrangements with companies that supply minimally invasive instruments, and such arrangements may limit your options to some degree. Be aware that reprocessed ports and instruments are now available at a reduced cost.

We believe it is crucial for surgeons to be cognizant of all products potentially available to them prior to attending a surgical case.

Related article: Update on Technology Barbara S. Levy, MD (September 2013)

Skin preparation and other preoperative considerations
Multiple preoperative skin preparations are available (TABLE 1). Traditionally, a povidone-iodine topical ­antiseptic such as Betadine has been used for skin and vaginal preparation prior to gynecologic surgery. Hibaclens and ChloraPrep are different combinations of chlorhexidine gluconate and isopropyl alcohol that act as broad-spectrum antiseptics. ChloraPrep is applied with a wand-like applicator and contains a much higher concentration of isopropyl alcohol than Hibaclens (70% vs 4%), rendering it more flammable. It also requires more drying time before the case is started. Clear and tinted ChloraPrep formulations are available.

It makes good sense to have instruments and devices readily available in the operating room (OR) at the start of a case, to avoid unnecessary surgical delays, but we recommend that you refrain from opening these tools until they are required intraoperatively. It is possible that the case will require conversion to laparotomy or that, after direct visualization of the pathology, different ports or instruments will be required.

Uterine manipulators
Cannulation of the cervical canal allows for uterine manipulation, increasing ­intraoperative traction and exposure and visualization of the adnexae and peritoneal surfaces.

The Hulka and Pelosi reusable uterine manipulators are fairly standard and easy to apply. Specialized, single-use manipulators also are available, including the VCare uterine manipulator/elevator, which consists of two opposing cups. One cup (available in four sizes, from small to extra-large) fits around the cervix and defines the site for colpotomy, and the other cup helps maintain pneumoperitoneum once a colpotomy is created.

The Zinnanti Uterine Manipulator Injector (ZUMI) is a rigid, curved shaft with an intrauterine balloon to help prevent expulsion. It also has an integrated injection channel to allow for intraoperative chromotubation.

The RUMI System fits individual patient anatomy with various tip lengths and colpotomy cup sizes (TABLE 2).

Related article: Tips and techniques for robot-assisted laparoscopic myomectomy Arnold P. Advincula, MD, and Bich-Van Tran, MD (August 2013)

Entry style and ports
The peritoneal cavity can be entered using either a closed (Veress needle) or open (Hasson) technique.⁵ Closed entry may allow for quicker access to the peritoneal cavity. A recent Cochrane review of 28 randomized, controlled trials, including 4,860 patients undergoing laparoscopy, compared outcomes between laparoscopic entry techniques.⁶ It found no difference in major vascular or visceral injury between closed and open techniques at the umbilicus. However, open entry was associated with greater successful entry into the peritoneal cavity, as well as less extraperitoneal insufflation and a lower omental injury rate, compared with closed entry.⁶ 

Left-upper-quadrant entry is another option when adhesions are anticipated or abnormal anatomy is encountered at the umbilicus.

In general, complications related to laparoscopic entry are quite rare in gynecologic surgery, ranging from 0.18% to 0.5%.^7,8 A minimally invasive surgeon may prefer one entry technique over the other, but should be able to perform both methods competently and recognize when a particular technique is warranted.

Choosing a port
Laparoscopic ports usually range from 5 mm to 12 mm and can be fixed or variable in size. The primary port, usually placed through the umbilicus, can be a standard, blunt, 10-mm (Hasson) port, or it can be specialized to ease entry of the port or stabilize the port once it is introduced through the skin incision.

Optical trocars have a transparent tip that allows the surgeon to visualize the abdominal-wall entry layer by layer using a 0° laparoscope, usually after pneumoperitoneum is created with a Veress needle. Other specialized ports include those that have balloons or foam collars, or both, to secure the port without traditional stay sutures on the fascia and minimize leakage of pneumoperitoneum.

Accessory ports
When choosing an accessory port type and size, it is important to anticipate what instruments and devices, such as an Endo Catch bag, suture, needle, or morcellator, will need to pass through it. Also know whether 5-mm and 10-mm laparoscopes are available, and anticipate whether a second port with insufflation capabilities will be required.

Related article: Update on Minimally Invasive Surgery Amy Garcia, MD (April 2011)

Pediport trocars are user-friendly 5-mm bladed ports that deploy a mushroom-shaped stabilizer to prevent ­dislodgement. A ­Versaport bladed trocar has a spring-loaded entry shield, which slides over to protect the blade once the peritoneal cavity is entered.

VersaStep bladeless trocars are introduced after a Step insufflation needle has been inserted. These trocars create a smaller fascial defect than conventional bladed trocars for an equivalent cannula size (TABLE 3).

Cutting and coagulating
Both monopolar and bipolar electrosurgical techniques are commonly employed in gynecologic laparoscopy. A wide variety of disposable and reusable instruments are available for monopolar energy, such as scissors, a hook, and a spatula.

Bipolar devices also can be disposable or reusable. Although bipolar electrosurgery minimizes injury to surrounding tissues by containing the current within the jaws of the forceps, it cannot cut or seal large vessels. As a result, several advanced bipolar devices with sealing and transecting capabilities have emerged (LigaSure, ENSEAL). Ultrasonic devices also can coagulate and cut at lower temperatures by converting electrical energy to mechanical energy (TABLE 4).

Sutures
Aspects of minimally invasive gynecologic surgery that require the use of suture include, but are not limited to, closure of the vaginal cuff, oophoropexy, and reapproximation of the ovarian cortex after cystectomy. Syntheticand delayed absorbable sutures, such as PDS II, are used frequently.

Recently, a new class of suture emerged and continues to gain popularity: barbed suture. This type of suture anchors to the tissue without the need for intra- or extracorporeal knots (TABLE 5).

Related article: Ins and outs of straight-stick laparoscopic myomectomy James Robinson, MD, MS, and Gaby Moawad, MD (September 2012)

Tissue removal
Adnexae and pathologic tissue, such as dermoid cysts, can be removed intact from the peritoneal cavity using an Endo Catch Single-Use Specimen Pouch, a polyurethane sac. Careful use, with placement of the ovary with the cyst into the pouch prior to cystectomy, can prevent spillage beyond the bag.

Large uteri that cannot be extracted through a colpotomy can be morcellated into smaller pieces to ease removal through a small laparoscopic incision or the colpotomy. Both reusable and disposable morcellator hand pieces are available (TABLE 6).

Skin closure
Final subcuticular closure can be accomplished using sutures or skin adhesive. Sutures may be synthetic, absorbable monofilament (eg, Caprosyn), or synthetic, absorbable, braided multifilament (eg, PolySorb).

Related article: 10 practical, evidence-based recommendations for improving maternal outcomes of cesarean delivery Baha M. Sibai, MD (March 2012)

Skin adhesives close incisions quickly, avoid inflammation related to foreign bodies, and ease patient concerns that sometimes arise when absorbable suture persists postoperatively (TABLE 5).

Take-home points
As health-care third-party payers and hospitals continue to evaluate surgeons individually and compare procedures between surgeons, reimbursements may be stratified, favoring physicians who demonstrate both quality outcomes and cost-containment.   

There are many ways a minimally invasive surgeon can implement cost-conscious choices that have little to no impact on the quality of the outcome.

Surgeons who are familiar with the instruments and models available for use at their institution are better prepared to make wise cost-conscious decisions.

Cost is not the only indicator of value, however. The surgeon must know how to apply tools correctly and be familiar with their limitations, and should choose instruments and products for their safety and ease of use. More often than not, a surgeon’s training and personal experience define—and sometimes restrict—the choice of devices.

CASE: SAME OUTCOME, LOWER COST
The patient undergoes laparoscopic hysterectomy for treatment of uterine fibroids and menorrhagia. However, in this scenario, the surgeon makes the following product choices: The patient is prepped with Betadine, and a reusable Pelosi uterine manipulator is placed. Laparoscopic ports include a Kii Balloon Blunt Tip, a reprocessed VersaStep Plus trocar, and two Pediport trocars. The surgeon uses the PKS Lyons Dissecting Forceps and reprocessed EndoShears to perform the hysterectomy, incorporating the Karl Storz Rotocut G1 Morcellator, a reusable system with single-use blades, to morcellate the uterus. The vaginal cuff is closed using V-Loc barbed suture, and skin incisions are closed with 4-0 Polysorb, a polyglycolic acid, absorbable suture.

The cost of these products: $1,005.68, or roughly $700 less than the set-up described at the beginning of this article (TABLE 7).

Acknowledgment
The authors thank Susan Wykoop, BSN, RN, and Anna Emery, MSN, RN, for their assistance in gathering specific cost-related information.

We want to hear from you! Tell us what you think.

CASE: WOMAN WITH HEAVY BLEEDING HOPES TO AVOID HYSTERECTOMY
L.W. is a 44-year-old woman (G2P2) with a 2-year history of menorrhagia and severe dysmenorrhea but no intermenstrual spotting or bleeding. She reports that she has tried to control her symptoms using hormonal methods, without success.

Examination reveals that she has an irregular, nontender uterus 8 weeks in size. Transvaginal ultrasonography shows two deep, prominent, intramural fibroids. The first is 2 cm by 3 cm in size in the left lateral uterus, adjacent to the endometrial stripe. The second fibroid is 3 cm by 4 cm in the fundal region. Sonohysterography reveals no intracavitary fibroids, although the left lateral myoma has distorted the endometrial cavity.

The patient is seeking removal of her fibroids but would like to preserve her uterus, if at all possible.

What options would you offer her?

Uterine fibroids are common in premenopausal women, affecting 70% to 80% of the population, especially women of African descent.¹ Although the majority of women with fibroids are asymptomatic, approximately 30% report pelvic pressure, dyspareunia, dysmenorrhea, or abnormal uterine bleeding.²

Our patients are increasingly aware of uterine-sparing treatments for symptomatic fibroids.^3,4 Women seek conservative procedures to avoid the risks and extended recovery times commonly associated with major surgery. Current laparoscopic techniques for removal of uterine fibroids can be complex and require advanced surgical skills. Deep intramural fibroids may not always be visible or readily accessible, making laparoscopic removal a more invasive and challenging approach for many gynecologic surgeons.

A significant recent advancement in minimally invasive gynecologic treatment of fibroids is the Acessa System (Halt Medical, Brentwood, California). This laparoscopic system involves the outpatient use of ultrasound-guided radiofrequency volumetric thermal ablation, or RFVTA.

In this article, I outline the development of this option and step you through its technique. I also review the outcomes data that have been published to date.

How the procedure evolved
In the 1980s, Donnez and Nisolle developed a method of laparoscopic Nd:YAG laser treatment of uterine fibroids, commonly referred to as myolysis.⁵ Later, Goldfarb developed a laparoscopic bipolar needle technique that coagulated and occluded blood vessels at the periphery of the fibroid.⁶ However, myolysis led to the formation of significant adhesions to the small bowel or omentum, or both, and was abandoned by the surgical community.

Other fibroid treatments have been developed, such as laparoscopic myomectomy, uterine artery ligation, uterine artery embolization (alone or as adjuvant treatment), and high-intensity focused ultrasound. Although these procedures have made a significant contribution to the minimally invasive treatment of fibroids, the need for reintervention can be substantial, as high as 29% at 1 to 10  years of follow-up in some reports.^7–17

Related article: Ins and outs of straight-stick myomectomy James Robinson, MD, MD, and Gaby Moawad, MD (September 2012)

Radiofrequency needle ablation has been used successfully in the treatment and destruction of liver and kidney tumors for years. Lee envisioned use of the technology to treat uterine fibroids. He developed a technique using a retractable multiarray radiofrequency needle (Starburst XL, RITA Medical Systems, Fremont, California) that is inserted directly into the fibroid. In 2002, he reported the first use of intraperitoneal ultrasound for needle guidance in the laparoscopic ablation of 197 myomas in 52 symptomatic women who had declined hysterectomy and myomectomy.¹⁸ He found that a significant proportion of women experienced resolution of their symptoms, including heavy menstrual bleeding, dysmenorrhea, dyspareunia, and pelvic pressure, by 3 months, with continued improvement at 12 months.

Because he was unhappy with aspects of the RITA needle that prevented accurate and consistent ablation of fibroids, he developed other devices that would lead to RFVTA and the Acessa System. This system allows the gynecologic surgeon to target and treat deep intramural fibroids that may not be readily visible via conventional laparoscopy.

Between the time of Lee’s first report and his subsequent refinement of the device and procedure, several international fibroid radiofrequency ablation procedures emerged, including those of Bergamini, Milic, Ghezzi, and Carrafiello.^19–22 These investigators published results in small cohorts and described significant improvement in patient-reported Uterine Fibroid Symptom and Quality-of-Life (UFS-QOL) scores as well as a reduction in myoma volume.²³ Their studies provided evidence that RFA is a safe and effective uterine-sparing treatment of symptomatic ­uterine fibroids for selected patients.

Related article: Update on Minimally Invasive Surgery Amy Garcia, MD (April 2011)

How it works
RFVTA uses laparoscopy and laparoscopic ultrasound to guide placement of a needle electrode with a deployable array. Earlier international studies of radiofrequency ablation^18–22 and ongoing studies of RFVTA^23–26 have demonstrated the procedure’s therapeutic potential. Acessa was recently cleared (November 2012) by the US Food and Drug Administration (FDA).

RFVTA technique, step by step
1. Begin with a standard 5-mm laparoscopic infraumbilical port for the camera and video laparoscope (See VIDEO).

2. Place a 12-mm port in the midline, suprapubically at the level of the uterus, for insertion of the laparoscopic ultrasound probe. Now it is possible to map the uterus and plan an approach to destroy the ­fibroids.

3. Once you have determined your approach, insert the handpiece containing the radiofrequency needle through the abdominal wall under laparoscopic visualization.

4. Place the needle into the targeted fibroid using both laparoscopic and ultrasound guidance. Depending on the size of the fibroid, the needle array can be deployed to the maximum diameter necessary to effect destruction.

5. Engage the radiofrequency generator (FIGURE 1), utilizing the timing function for optimal destruction of the fibroid, based on the appropriate ­algorithm. The fibroid then will be ablated and destroyed without damage to the surrounding healthy myometrium.

The Acessa radiofrequency generator and accessories are designed to deliver monopolar radiofrequency energy to tissue through the handheld electrical probe. The procedure is monitored by real-time feedback to and from the generator via each of the thermocouples at the tips of the seven-needle array (FIGURE 1). In addition, laparoscopic ultrasound-guided visualization permits monitoring of needle placement within the fibroid capsule (FIGURES 2A and 2B) and confirmation of hemostasis upon removal of the probe tip (FIGURE 2C).

RFVTA treats a wide range of fibroids
The Acessa System is used to treat fibroids of any location and type, with the exception of pedunculated or Type 0 myomas, in which case laparoscopic or hysteroscopic myomectomy is recommended. Calcified fibroids pose no challenges. A single radiofrequency needle generally is used to treat multiple fibroids, with ablation zones ranging in diameter from 1.0 to 6.7 cm. Large, irregularly shaped fibroids may require multiple ablation zones during the same procedure.

Final steps
6. Once the treatment is complete, as confirmed by informatics transmitted by the generator, retract the needle array, set the generator to coagulation mode to coagulate the needle track during withdrawal of the probe, and confirm hemostasis (FIGURE 2C).

7. After completion of all fibroid destruction, remove the disposable radiofrequency probe and close the laparoscopic and ultrasound port sites using standard procedures.

The patient can be discharged the same day and generally is able to return to normal activities within 3 to 5 days.

Postoperative analgesia usually consists solely of nonsteroidal anti-inflammatory agents.

A look at outcomes data
Garza and colleagues published the first feasibility report in 2011.²⁴ They described the results of laparoscopic, ultrasound-guided RFVTA for the treatment of symptomatic uterine fibroids in Mexico using an Acessa predecessor. The 31 women enrolled in the study desired uterine preservation. Of these participants, 19 had completed 12 months of follow-up by the time the report was submitted for publication. Their responses to the UFS-QOL questionnaire indicated that their symptoms had decreased significantly in severity from baseline to 12 months, and their quality-of-life scores also improved significantly (P <.001). Mean uterine volume also declined significantly.

Robles and colleagues set out to confirm these findings using the investigational Halt Ablation System. They conducted a prospective, single-center, open-label clinical trial in Guatemala.²⁵ They found dramatic improvement in symptom severity and health-related quality of life from baseline to 12 months. Mean uterine volume also decreased by 23.6% during this period. In addition, the severity and duration of menses declined.

Acessa is currently not approved for women seeking future childbearing. However, several successful pregnancies have been reported following the procedure.^24,26–28 Theoretically, because it causes less damage to and disruption of healthy myometrium, Acessa may prove to be preferable to myomectomy. Head-to-head studies to evaluate this premise are ongoing.

Latest findings confirm widespread improvement of symptoms
The most recent and detailed reports of safety and efficacy of laparoscopic, ultrasound-guided RFVTA at 12 and 24 months were published by teams led by Chudnoff²⁶ and Guido²⁷ earlier this year. These investigations involved 135 women who reported moderate to severe heavy menstrual bleeding (160 mL–500 mL by alkaline hematin analysis). Clinically significant reduction in menstrual blood loss was achieved in 67.7% of participants at 12 months of follow-up.²⁹

Related article: Tips and techniques for robot-assisted laparoscopic myomectomy Arnold P. Advincula, MD, and Bich-Van Tran, MD (August 2013)

Galen and colleagues performed a retrospective analysis of these same patients, demonstrating that RFVTA of intramural fibroids without submucosal components leads to a clinically and statistically significant reduction in menstrual blood loss.³⁰

Patients generally began these trials with high symptom-severity scores and low health-related quality of life, yet all achieved significant improvement over time, as their UFS-QOL scores indicate (TABLE). The majority of patients (96%) were treated on an outpatient basis. As measured by contrast-enhanced magnetic resonance imaging, total mean uterine volume decreased by 24.3% at 12 months, and total mean fibroid volume decreased by 45.1% during the same interval. Ninety-four percent of the women reported that the treatment was effective in eliminating their symptoms at 12 months, and 98% said they would recommend the procedure to a friend having the same health ­problems.

Complication rates were low
Complications included a postoperative pelvic abscess and four other minor events. The latter were treated at the time of RFVTA or resolved without additional procedures. The reintervention rate was 0.7% (1/135 patients).²⁶

Guido and colleagues reported 24-month outcomes for the 124 women entering the second year of the Halt study and affirmed the findings of Chudnoff’s team.²⁷ The 112 patient-reported UFS-QOL scores at 24 months were virtually identical to those reported at 12 months. Six surgical reinterventions (6 of 124 patients, or 4.8%) for fibroid-related bleeding were reported between 12 and 24 months.

280 women have been treated so far
As of September 2013, 280 women have been treated under five international study protocols using the Halt Acessa System, and approximately two-thirds have been followed for more than 12 months, with excellent results. Two of the five clinical trials are under way in Germany and Canada:

• The Laparoscopic Uterine-Sparing Techniques Outcomes and Reinterventions (LUSTOR) trial in Germany is a prospective, randomized, single-center study comparing outcomes of RFVTA and laparoscopic myomectomy. Fifty women were enrolled and treated and will be followed for as long as 60 months.
• The Treatment Results of Uterine-Sparing Technologies (TRUST) trial is a prospective, multicenter, randomized study in Canada that compares direct and indirect costs associated with RFVTA, laparoscopic and abdominal myomectomy, and uterine artery embolization. Some US sites also will participate. As many as 200 women will be treated and followed for as long as 60 months.

RFVTA offers several benefits
Although hysterectomy provides a definitive “cure” to fibroid-related symptoms, it is not preferred by many patients and generally is more costly, with an increased risk of complications, a longer hospital stay, longer recovery (6–8 weeks), longer disability and more time off from work, and potential long-term sequelae.

The Acessa procedure not only is an outpatient, minimally invasive, uterine-sparing fibroid treatment option, it permits access to and ablation of almost all fibroids (with the exception of penduculated or Type 0 myomas). The data to date suggest that RFVTA provides many benefits, including a decline in symptom severity and improved health-related quality of life, as well as good cosmesis, quick recovery, and a rapid return to full activity.

There is a learning curve for ­RFVTA with Acessa—as with any new procedure. If physicians already perform ultrasound imaging, the learning process is shorter. Physicians interested in Acessa and furthering their education and training in laparoscopic RFVTA should consult the manufacturer’s professional education division through the company Web site at http://www.haltmedical.com.

CASE: RESOLVED
After she is counseled about the various uterine-sparing options for treatment, L.W. chooses to undergo laparoscopic, ultrasound-guided RFVTA using the Acessa System. The procedure is performed successfully, with the two fibroids destroyed using the appropriate algorithms, which took into account the size of the fibroids and the deployed needle array. Two additional 1-cm fibroids were found during the procedure and ablated. The patient was discharged home shortly after the procedure, with a nonsteroidal anti-inflammatory drug given for pain relief.

We want to hear from you! Tell us what you think.

CASE: WOMAN WITH HEAVY BLEEDING HOPES TO AVOID HYSTERECTOMY
L.W. is a 44-year-old woman (G2P2) with a 2-year history of menorrhagia and severe dysmenorrhea but no intermenstrual spotting or bleeding. She reports that she has tried to control her symptoms using hormonal methods, without success.

Examination reveals that she has an irregular, nontender uterus 8 weeks in size. Transvaginal ultrasonography shows two deep, prominent, intramural fibroids. The first is 2 cm by 3 cm in size in the left lateral uterus, adjacent to the endometrial stripe. The second fibroid is 3 cm by 4 cm in the fundal region. Sonohysterography reveals no intracavitary fibroids, although the left lateral myoma has distorted the endometrial cavity.

The patient is seeking removal of her fibroids but would like to preserve her uterus, if at all possible.

What options would you offer her?

Uterine fibroids are common in premenopausal women, affecting 70% to 80% of the population, especially women of African descent.¹ Although the majority of women with fibroids are asymptomatic, approximately 30% report pelvic pressure, dyspareunia, dysmenorrhea, or abnormal uterine bleeding.²

Our patients are increasingly aware of uterine-sparing treatments for symptomatic fibroids.^3,4 Women seek conservative procedures to avoid the risks and extended recovery times commonly associated with major surgery. Current laparoscopic techniques for removal of uterine fibroids can be complex and require advanced surgical skills. Deep intramural fibroids may not always be visible or readily accessible, making laparoscopic removal a more invasive and challenging approach for many gynecologic surgeons.

A significant recent advancement in minimally invasive gynecologic treatment of fibroids is the Acessa System (Halt Medical, Brentwood, California). This laparoscopic system involves the outpatient use of ultrasound-guided radiofrequency volumetric thermal ablation, or RFVTA.

In this article, I outline the development of this option and step you through its technique. I also review the outcomes data that have been published to date.

How the procedure evolved
In the 1980s, Donnez and Nisolle developed a method of laparoscopic Nd:YAG laser treatment of uterine fibroids, commonly referred to as myolysis.⁵ Later, Goldfarb developed a laparoscopic bipolar needle technique that coagulated and occluded blood vessels at the periphery of the fibroid.⁶ However, myolysis led to the formation of significant adhesions to the small bowel or omentum, or both, and was abandoned by the surgical community.

Other fibroid treatments have been developed, such as laparoscopic myomectomy, uterine artery ligation, uterine artery embolization (alone or as adjuvant treatment), and high-intensity focused ultrasound. Although these procedures have made a significant contribution to the minimally invasive treatment of fibroids, the need for reintervention can be substantial, as high as 29% at 1 to 10  years of follow-up in some reports.^7–17

Related article: Ins and outs of straight-stick myomectomy James Robinson, MD, MD, and Gaby Moawad, MD (September 2012)

Radiofrequency needle ablation has been used successfully in the treatment and destruction of liver and kidney tumors for years. Lee envisioned use of the technology to treat uterine fibroids. He developed a technique using a retractable multiarray radiofrequency needle (Starburst XL, RITA Medical Systems, Fremont, California) that is inserted directly into the fibroid. In 2002, he reported the first use of intraperitoneal ultrasound for needle guidance in the laparoscopic ablation of 197 myomas in 52 symptomatic women who had declined hysterectomy and myomectomy.¹⁸ He found that a significant proportion of women experienced resolution of their symptoms, including heavy menstrual bleeding, dysmenorrhea, dyspareunia, and pelvic pressure, by 3 months, with continued improvement at 12 months.

Because he was unhappy with aspects of the RITA needle that prevented accurate and consistent ablation of fibroids, he developed other devices that would lead to RFVTA and the Acessa System. This system allows the gynecologic surgeon to target and treat deep intramural fibroids that may not be readily visible via conventional laparoscopy.

Between the time of Lee’s first report and his subsequent refinement of the device and procedure, several international fibroid radiofrequency ablation procedures emerged, including those of Bergamini, Milic, Ghezzi, and Carrafiello.^19–22 These investigators published results in small cohorts and described significant improvement in patient-reported Uterine Fibroid Symptom and Quality-of-Life (UFS-QOL) scores as well as a reduction in myoma volume.²³ Their studies provided evidence that RFA is a safe and effective uterine-sparing treatment of symptomatic ­uterine fibroids for selected patients.

Related article: Update on Minimally Invasive Surgery Amy Garcia, MD (April 2011)

How it works
RFVTA uses laparoscopy and laparoscopic ultrasound to guide placement of a needle electrode with a deployable array. Earlier international studies of radiofrequency ablation^18–22 and ongoing studies of RFVTA^23–26 have demonstrated the procedure’s therapeutic potential. Acessa was recently cleared (November 2012) by the US Food and Drug Administration (FDA).

RFVTA technique, step by step
1. Begin with a standard 5-mm laparoscopic infraumbilical port for the camera and video laparoscope (See VIDEO).

2. Place a 12-mm port in the midline, suprapubically at the level of the uterus, for insertion of the laparoscopic ultrasound probe. Now it is possible to map the uterus and plan an approach to destroy the ­fibroids.

3. Once you have determined your approach, insert the handpiece containing the radiofrequency needle through the abdominal wall under laparoscopic visualization.

4. Place the needle into the targeted fibroid using both laparoscopic and ultrasound guidance. Depending on the size of the fibroid, the needle array can be deployed to the maximum diameter necessary to effect destruction.

5. Engage the radiofrequency generator (FIGURE 1), utilizing the timing function for optimal destruction of the fibroid, based on the appropriate ­algorithm. The fibroid then will be ablated and destroyed without damage to the surrounding healthy myometrium.

The Acessa radiofrequency generator and accessories are designed to deliver monopolar radiofrequency energy to tissue through the handheld electrical probe. The procedure is monitored by real-time feedback to and from the generator via each of the thermocouples at the tips of the seven-needle array (FIGURE 1). In addition, laparoscopic ultrasound-guided visualization permits monitoring of needle placement within the fibroid capsule (FIGURES 2A and 2B) and confirmation of hemostasis upon removal of the probe tip (FIGURE 2C).

RFVTA treats a wide range of fibroids
The Acessa System is used to treat fibroids of any location and type, with the exception of pedunculated or Type 0 myomas, in which case laparoscopic or hysteroscopic myomectomy is recommended. Calcified fibroids pose no challenges. A single radiofrequency needle generally is used to treat multiple fibroids, with ablation zones ranging in diameter from 1.0 to 6.7 cm. Large, irregularly shaped fibroids may require multiple ablation zones during the same procedure.

Final steps
6. Once the treatment is complete, as confirmed by informatics transmitted by the generator, retract the needle array, set the generator to coagulation mode to coagulate the needle track during withdrawal of the probe, and confirm hemostasis (FIGURE 2C).

7. After completion of all fibroid destruction, remove the disposable radiofrequency probe and close the laparoscopic and ultrasound port sites using standard procedures.

The patient can be discharged the same day and generally is able to return to normal activities within 3 to 5 days.

Postoperative analgesia usually consists solely of nonsteroidal anti-inflammatory agents.

A look at outcomes data
Garza and colleagues published the first feasibility report in 2011.²⁴ They described the results of laparoscopic, ultrasound-guided RFVTA for the treatment of symptomatic uterine fibroids in Mexico using an Acessa predecessor. The 31 women enrolled in the study desired uterine preservation. Of these participants, 19 had completed 12 months of follow-up by the time the report was submitted for publication. Their responses to the UFS-QOL questionnaire indicated that their symptoms had decreased significantly in severity from baseline to 12 months, and their quality-of-life scores also improved significantly (P <.001). Mean uterine volume also declined significantly.

Robles and colleagues set out to confirm these findings using the investigational Halt Ablation System. They conducted a prospective, single-center, open-label clinical trial in Guatemala.²⁵ They found dramatic improvement in symptom severity and health-related quality of life from baseline to 12 months. Mean uterine volume also decreased by 23.6% during this period. In addition, the severity and duration of menses declined.

Acessa is currently not approved for women seeking future childbearing. However, several successful pregnancies have been reported following the procedure.^24,26–28 Theoretically, because it causes less damage to and disruption of healthy myometrium, Acessa may prove to be preferable to myomectomy. Head-to-head studies to evaluate this premise are ongoing.

Latest findings confirm widespread improvement of symptoms
The most recent and detailed reports of safety and efficacy of laparoscopic, ultrasound-guided RFVTA at 12 and 24 months were published by teams led by Chudnoff²⁶ and Guido²⁷ earlier this year. These investigations involved 135 women who reported moderate to severe heavy menstrual bleeding (160 mL–500 mL by alkaline hematin analysis). Clinically significant reduction in menstrual blood loss was achieved in 67.7% of participants at 12 months of follow-up.²⁹

Related article: Tips and techniques for robot-assisted laparoscopic myomectomy Arnold P. Advincula, MD, and Bich-Van Tran, MD (August 2013)

Galen and colleagues performed a retrospective analysis of these same patients, demonstrating that RFVTA of intramural fibroids without submucosal components leads to a clinically and statistically significant reduction in menstrual blood loss.³⁰

Patients generally began these trials with high symptom-severity scores and low health-related quality of life, yet all achieved significant improvement over time, as their UFS-QOL scores indicate (TABLE). The majority of patients (96%) were treated on an outpatient basis. As measured by contrast-enhanced magnetic resonance imaging, total mean uterine volume decreased by 24.3% at 12 months, and total mean fibroid volume decreased by 45.1% during the same interval. Ninety-four percent of the women reported that the treatment was effective in eliminating their symptoms at 12 months, and 98% said they would recommend the procedure to a friend having the same health ­problems.

Complication rates were low
Complications included a postoperative pelvic abscess and four other minor events. The latter were treated at the time of RFVTA or resolved without additional procedures. The reintervention rate was 0.7% (1/135 patients).²⁶

Guido and colleagues reported 24-month outcomes for the 124 women entering the second year of the Halt study and affirmed the findings of Chudnoff’s team.²⁷ The 112 patient-reported UFS-QOL scores at 24 months were virtually identical to those reported at 12 months. Six surgical reinterventions (6 of 124 patients, or 4.8%) for fibroid-related bleeding were reported between 12 and 24 months.

280 women have been treated so far
As of September 2013, 280 women have been treated under five international study protocols using the Halt Acessa System, and approximately two-thirds have been followed for more than 12 months, with excellent results. Two of the five clinical trials are under way in Germany and Canada:

• The Laparoscopic Uterine-Sparing Techniques Outcomes and Reinterventions (LUSTOR) trial in Germany is a prospective, randomized, single-center study comparing outcomes of RFVTA and laparoscopic myomectomy. Fifty women were enrolled and treated and will be followed for as long as 60 months.
• The Treatment Results of Uterine-Sparing Technologies (TRUST) trial is a prospective, multicenter, randomized study in Canada that compares direct and indirect costs associated with RFVTA, laparoscopic and abdominal myomectomy, and uterine artery embolization. Some US sites also will participate. As many as 200 women will be treated and followed for as long as 60 months.

RFVTA offers several benefits
Although hysterectomy provides a definitive “cure” to fibroid-related symptoms, it is not preferred by many patients and generally is more costly, with an increased risk of complications, a longer hospital stay, longer recovery (6–8 weeks), longer disability and more time off from work, and potential long-term sequelae.

The Acessa procedure not only is an outpatient, minimally invasive, uterine-sparing fibroid treatment option, it permits access to and ablation of almost all fibroids (with the exception of penduculated or Type 0 myomas). The data to date suggest that RFVTA provides many benefits, including a decline in symptom severity and improved health-related quality of life, as well as good cosmesis, quick recovery, and a rapid return to full activity.

There is a learning curve for ­RFVTA with Acessa—as with any new procedure. If physicians already perform ultrasound imaging, the learning process is shorter. Physicians interested in Acessa and furthering their education and training in laparoscopic RFVTA should consult the manufacturer’s professional education division through the company Web site at http://www.haltmedical.com.

CASE: RESOLVED
After she is counseled about the various uterine-sparing options for treatment, L.W. chooses to undergo laparoscopic, ultrasound-guided RFVTA using the Acessa System. The procedure is performed successfully, with the two fibroids destroyed using the appropriate algorithms, which took into account the size of the fibroids and the deployed needle array. Two additional 1-cm fibroids were found during the procedure and ablated. The patient was discharged home shortly after the procedure, with a nonsteroidal anti-inflammatory drug given for pain relief.

We want to hear from you! Tell us what you think.

CASE: WOMAN WITH HEAVY BLEEDING HOPES TO AVOID HYSTERECTOMY
L.W. is a 44-year-old woman (G2P2) with a 2-year history of menorrhagia and severe dysmenorrhea but no intermenstrual spotting or bleeding. She reports that she has tried to control her symptoms using hormonal methods, without success.

Examination reveals that she has an irregular, nontender uterus 8 weeks in size. Transvaginal ultrasonography shows two deep, prominent, intramural fibroids. The first is 2 cm by 3 cm in size in the left lateral uterus, adjacent to the endometrial stripe. The second fibroid is 3 cm by 4 cm in the fundal region. Sonohysterography reveals no intracavitary fibroids, although the left lateral myoma has distorted the endometrial cavity.

The patient is seeking removal of her fibroids but would like to preserve her uterus, if at all possible.

What options would you offer her?

Uterine fibroids are common in premenopausal women, affecting 70% to 80% of the population, especially women of African descent.¹ Although the majority of women with fibroids are asymptomatic, approximately 30% report pelvic pressure, dyspareunia, dysmenorrhea, or abnormal uterine bleeding.²

Our patients are increasingly aware of uterine-sparing treatments for symptomatic fibroids.^3,4 Women seek conservative procedures to avoid the risks and extended recovery times commonly associated with major surgery. Current laparoscopic techniques for removal of uterine fibroids can be complex and require advanced surgical skills. Deep intramural fibroids may not always be visible or readily accessible, making laparoscopic removal a more invasive and challenging approach for many gynecologic surgeons.

A significant recent advancement in minimally invasive gynecologic treatment of fibroids is the Acessa System (Halt Medical, Brentwood, California). This laparoscopic system involves the outpatient use of ultrasound-guided radiofrequency volumetric thermal ablation, or RFVTA.

In this article, I outline the development of this option and step you through its technique. I also review the outcomes data that have been published to date.

How the procedure evolved
In the 1980s, Donnez and Nisolle developed a method of laparoscopic Nd:YAG laser treatment of uterine fibroids, commonly referred to as myolysis.⁵ Later, Goldfarb developed a laparoscopic bipolar needle technique that coagulated and occluded blood vessels at the periphery of the fibroid.⁶ However, myolysis led to the formation of significant adhesions to the small bowel or omentum, or both, and was abandoned by the surgical community.

Other fibroid treatments have been developed, such as laparoscopic myomectomy, uterine artery ligation, uterine artery embolization (alone or as adjuvant treatment), and high-intensity focused ultrasound. Although these procedures have made a significant contribution to the minimally invasive treatment of fibroids, the need for reintervention can be substantial, as high as 29% at 1 to 10  years of follow-up in some reports.^7–17

Related article: Ins and outs of straight-stick myomectomy James Robinson, MD, MD, and Gaby Moawad, MD (September 2012)

Radiofrequency needle ablation has been used successfully in the treatment and destruction of liver and kidney tumors for years. Lee envisioned use of the technology to treat uterine fibroids. He developed a technique using a retractable multiarray radiofrequency needle (Starburst XL, RITA Medical Systems, Fremont, California) that is inserted directly into the fibroid. In 2002, he reported the first use of intraperitoneal ultrasound for needle guidance in the laparoscopic ablation of 197 myomas in 52 symptomatic women who had declined hysterectomy and myomectomy.¹⁸ He found that a significant proportion of women experienced resolution of their symptoms, including heavy menstrual bleeding, dysmenorrhea, dyspareunia, and pelvic pressure, by 3 months, with continued improvement at 12 months.

Because he was unhappy with aspects of the RITA needle that prevented accurate and consistent ablation of fibroids, he developed other devices that would lead to RFVTA and the Acessa System. This system allows the gynecologic surgeon to target and treat deep intramural fibroids that may not be readily visible via conventional laparoscopy.

Between the time of Lee’s first report and his subsequent refinement of the device and procedure, several international fibroid radiofrequency ablation procedures emerged, including those of Bergamini, Milic, Ghezzi, and Carrafiello.^19–22 These investigators published results in small cohorts and described significant improvement in patient-reported Uterine Fibroid Symptom and Quality-of-Life (UFS-QOL) scores as well as a reduction in myoma volume.²³ Their studies provided evidence that RFA is a safe and effective uterine-sparing treatment of symptomatic ­uterine fibroids for selected patients.

Related article: Update on Minimally Invasive Surgery Amy Garcia, MD (April 2011)

How it works
RFVTA uses laparoscopy and laparoscopic ultrasound to guide placement of a needle electrode with a deployable array. Earlier international studies of radiofrequency ablation^18–22 and ongoing studies of RFVTA^23–26 have demonstrated the procedure’s therapeutic potential. Acessa was recently cleared (November 2012) by the US Food and Drug Administration (FDA).

RFVTA technique, step by step
1. Begin with a standard 5-mm laparoscopic infraumbilical port for the camera and video laparoscope (See VIDEO).

2. Place a 12-mm port in the midline, suprapubically at the level of the uterus, for insertion of the laparoscopic ultrasound probe. Now it is possible to map the uterus and plan an approach to destroy the ­fibroids.

3. Once you have determined your approach, insert the handpiece containing the radiofrequency needle through the abdominal wall under laparoscopic visualization.

4. Place the needle into the targeted fibroid using both laparoscopic and ultrasound guidance. Depending on the size of the fibroid, the needle array can be deployed to the maximum diameter necessary to effect destruction.

5. Engage the radiofrequency generator (FIGURE 1), utilizing the timing function for optimal destruction of the fibroid, based on the appropriate ­algorithm. The fibroid then will be ablated and destroyed without damage to the surrounding healthy myometrium.

The Acessa radiofrequency generator and accessories are designed to deliver monopolar radiofrequency energy to tissue through the handheld electrical probe. The procedure is monitored by real-time feedback to and from the generator via each of the thermocouples at the tips of the seven-needle array (FIGURE 1). In addition, laparoscopic ultrasound-guided visualization permits monitoring of needle placement within the fibroid capsule (FIGURES 2A and 2B) and confirmation of hemostasis upon removal of the probe tip (FIGURE 2C).

RFVTA treats a wide range of fibroids
The Acessa System is used to treat fibroids of any location and type, with the exception of pedunculated or Type 0 myomas, in which case laparoscopic or hysteroscopic myomectomy is recommended. Calcified fibroids pose no challenges. A single radiofrequency needle generally is used to treat multiple fibroids, with ablation zones ranging in diameter from 1.0 to 6.7 cm. Large, irregularly shaped fibroids may require multiple ablation zones during the same procedure.

Final steps
6. Once the treatment is complete, as confirmed by informatics transmitted by the generator, retract the needle array, set the generator to coagulation mode to coagulate the needle track during withdrawal of the probe, and confirm hemostasis (FIGURE 2C).

7. After completion of all fibroid destruction, remove the disposable radiofrequency probe and close the laparoscopic and ultrasound port sites using standard procedures.

The patient can be discharged the same day and generally is able to return to normal activities within 3 to 5 days.

Postoperative analgesia usually consists solely of nonsteroidal anti-inflammatory agents.

A look at outcomes data
Garza and colleagues published the first feasibility report in 2011.²⁴ They described the results of laparoscopic, ultrasound-guided RFVTA for the treatment of symptomatic uterine fibroids in Mexico using an Acessa predecessor. The 31 women enrolled in the study desired uterine preservation. Of these participants, 19 had completed 12 months of follow-up by the time the report was submitted for publication. Their responses to the UFS-QOL questionnaire indicated that their symptoms had decreased significantly in severity from baseline to 12 months, and their quality-of-life scores also improved significantly (P <.001). Mean uterine volume also declined significantly.

Robles and colleagues set out to confirm these findings using the investigational Halt Ablation System. They conducted a prospective, single-center, open-label clinical trial in Guatemala.²⁵ They found dramatic improvement in symptom severity and health-related quality of life from baseline to 12 months. Mean uterine volume also decreased by 23.6% during this period. In addition, the severity and duration of menses declined.

Acessa is currently not approved for women seeking future childbearing. However, several successful pregnancies have been reported following the procedure.^24,26–28 Theoretically, because it causes less damage to and disruption of healthy myometrium, Acessa may prove to be preferable to myomectomy. Head-to-head studies to evaluate this premise are ongoing.

Latest findings confirm widespread improvement of symptoms
The most recent and detailed reports of safety and efficacy of laparoscopic, ultrasound-guided RFVTA at 12 and 24 months were published by teams led by Chudnoff²⁶ and Guido²⁷ earlier this year. These investigations involved 135 women who reported moderate to severe heavy menstrual bleeding (160 mL–500 mL by alkaline hematin analysis). Clinically significant reduction in menstrual blood loss was achieved in 67.7% of participants at 12 months of follow-up.²⁹

Related article: Tips and techniques for robot-assisted laparoscopic myomectomy Arnold P. Advincula, MD, and Bich-Van Tran, MD (August 2013)

Galen and colleagues performed a retrospective analysis of these same patients, demonstrating that RFVTA of intramural fibroids without submucosal components leads to a clinically and statistically significant reduction in menstrual blood loss.³⁰

Patients generally began these trials with high symptom-severity scores and low health-related quality of life, yet all achieved significant improvement over time, as their UFS-QOL scores indicate (TABLE). The majority of patients (96%) were treated on an outpatient basis. As measured by contrast-enhanced magnetic resonance imaging, total mean uterine volume decreased by 24.3% at 12 months, and total mean fibroid volume decreased by 45.1% during the same interval. Ninety-four percent of the women reported that the treatment was effective in eliminating their symptoms at 12 months, and 98% said they would recommend the procedure to a friend having the same health ­problems.

Complication rates were low
Complications included a postoperative pelvic abscess and four other minor events. The latter were treated at the time of RFVTA or resolved without additional procedures. The reintervention rate was 0.7% (1/135 patients).²⁶

Guido and colleagues reported 24-month outcomes for the 124 women entering the second year of the Halt study and affirmed the findings of Chudnoff’s team.²⁷ The 112 patient-reported UFS-QOL scores at 24 months were virtually identical to those reported at 12 months. Six surgical reinterventions (6 of 124 patients, or 4.8%) for fibroid-related bleeding were reported between 12 and 24 months.

280 women have been treated so far
As of September 2013, 280 women have been treated under five international study protocols using the Halt Acessa System, and approximately two-thirds have been followed for more than 12 months, with excellent results. Two of the five clinical trials are under way in Germany and Canada:

• The Laparoscopic Uterine-Sparing Techniques Outcomes and Reinterventions (LUSTOR) trial in Germany is a prospective, randomized, single-center study comparing outcomes of RFVTA and laparoscopic myomectomy. Fifty women were enrolled and treated and will be followed for as long as 60 months.
• The Treatment Results of Uterine-Sparing Technologies (TRUST) trial is a prospective, multicenter, randomized study in Canada that compares direct and indirect costs associated with RFVTA, laparoscopic and abdominal myomectomy, and uterine artery embolization. Some US sites also will participate. As many as 200 women will be treated and followed for as long as 60 months.

RFVTA offers several benefits
Although hysterectomy provides a definitive “cure” to fibroid-related symptoms, it is not preferred by many patients and generally is more costly, with an increased risk of complications, a longer hospital stay, longer recovery (6–8 weeks), longer disability and more time off from work, and potential long-term sequelae.

The Acessa procedure not only is an outpatient, minimally invasive, uterine-sparing fibroid treatment option, it permits access to and ablation of almost all fibroids (with the exception of penduculated or Type 0 myomas). The data to date suggest that RFVTA provides many benefits, including a decline in symptom severity and improved health-related quality of life, as well as good cosmesis, quick recovery, and a rapid return to full activity.

There is a learning curve for ­RFVTA with Acessa—as with any new procedure. If physicians already perform ultrasound imaging, the learning process is shorter. Physicians interested in Acessa and furthering their education and training in laparoscopic RFVTA should consult the manufacturer’s professional education division through the company Web site at http://www.haltmedical.com.

CASE: RESOLVED
After she is counseled about the various uterine-sparing options for treatment, L.W. chooses to undergo laparoscopic, ultrasound-guided RFVTA using the Acessa System. The procedure is performed successfully, with the two fibroids destroyed using the appropriate algorithms, which took into account the size of the fibroids and the deployed needle array. Two additional 1-cm fibroids were found during the procedure and ablated. The patient was discharged home shortly after the procedure, with a nonsteroidal anti-inflammatory drug given for pain relief.

We want to hear from you! Tell us what you think.

Delayed Dx leads to blindness

A WOMAN WITH DISABLING RHEUMATOID ARTHRITIS visited her long-time internist with pulmonary symptoms. Shortly thereafter the 59-year-old patient was diagnosed with lung cancer with a moderate prognosis and underwent surgery.

The following month, the woman complained of jaw pain to her internist. She also reported an “achy” temple to the nurse who saw her initially. The internist surmised that the cause of the pain might be an allergic reaction to dye used in a CT scan the patient had undergone because the patient said the pain had begun immediately after the scan. She was treated with methylprednisolone and the symptoms improved temporarily.

Within a few weeks, the patient complained of vision problems in her left eye. An ophthalmologist to whom she was referred thought the cause might be metastasis of the lung cancer. After an MRI of the optic area, a neuroradiologist reported to the ophthalmologist that the findings were consistent with metastatic cancer.

Before the patient could keep a follow-up appointment with the ophthalmologist, she lost all vision in her left eye. When she called the internist’s office for the results of the MRI, she told the person who answered the phone about the vision loss. Her call wasn’t returned.

The patient also told the ophthalmologist’s office about her loss of vision when she received a call to remind her of her follow-up appointment. The person she spoke to claimed the patient was offered an appointment that same day with another doctor, but declined it.

On the day before the follow-up appointment, the patient lost all sight in her right eye, as well. She received emergency treatment with corticosteroids the next day, but her vision didn’t return, leaving her completely blind. A temporal artery biopsy confirmed giant cell arteritis.

PLAINTIFF'S CLAIM The patient had classic symptoms of giant cell arteritis when she saw both the internist and ophthalmologist.

THE DEFENSE No negligence occurred because the patient had additional medical conditions; the patient didn’t describe her symptoms effectively and was negligent in failing to seek emergency medical care when she lost vision in her left eye.

VERDICT $1.4 million Washington settlement.

COMMENT This is a tough case with plenty of blame to go around, but it provides a good reminder to think of temporal arteritis whenever an older patient complains of jaw pain. Sedimentation rate measurements are cheap.

Lack of vigilance ends badly

SHORTNESS OF BREATH, FATIGUE, AND DIARRHEA prompted a 36-year-old man with diabetes and hypothyroidism to consult his primary care physician. The doctor prescribed levofloxacin and told the patient to return in 4 weeks.

Three days later, the man went back to the physician, reporting weakness, diarrhea, and a fever of 103°F. The physician diagnosed bronchitis and prescribed extended-release amoxicillin tablets. Two days later, the patient went to the emergency department; a chest radiograph showed advanced bilateral pneumonia. He died about 2 weeks later.

PLAINTIFF'S CLAIM The physician was negligent in failing to order a radiograph, admit the patient to the hospital, and prescribe proper medication.

THE DEFENSE No information about the defense is available.

VERDICT $1 million New Jersey settlement.

COMMENT Shortness of breath, fatigue, and diarrhea in a 36-year-old patient with diabetes sounds potentially serious to me. Presumably the physician diagnosed pneumonia on the initial exam, and one cannot fault him for that diagnosis or the treatment he prescribed. But return in 4 weeks? No way. Such patients require close follow-up and escalation of evaluation and treatment if they’re not doing well.

Delayed Dx leads to blindness

A WOMAN WITH DISABLING RHEUMATOID ARTHRITIS visited her long-time internist with pulmonary symptoms. Shortly thereafter the 59-year-old patient was diagnosed with lung cancer with a moderate prognosis and underwent surgery.

The following month, the woman complained of jaw pain to her internist. She also reported an “achy” temple to the nurse who saw her initially. The internist surmised that the cause of the pain might be an allergic reaction to dye used in a CT scan the patient had undergone because the patient said the pain had begun immediately after the scan. She was treated with methylprednisolone and the symptoms improved temporarily.

Within a few weeks, the patient complained of vision problems in her left eye. An ophthalmologist to whom she was referred thought the cause might be metastasis of the lung cancer. After an MRI of the optic area, a neuroradiologist reported to the ophthalmologist that the findings were consistent with metastatic cancer.

Before the patient could keep a follow-up appointment with the ophthalmologist, she lost all vision in her left eye. When she called the internist’s office for the results of the MRI, she told the person who answered the phone about the vision loss. Her call wasn’t returned.

The patient also told the ophthalmologist’s office about her loss of vision when she received a call to remind her of her follow-up appointment. The person she spoke to claimed the patient was offered an appointment that same day with another doctor, but declined it.

On the day before the follow-up appointment, the patient lost all sight in her right eye, as well. She received emergency treatment with corticosteroids the next day, but her vision didn’t return, leaving her completely blind. A temporal artery biopsy confirmed giant cell arteritis.

PLAINTIFF'S CLAIM The patient had classic symptoms of giant cell arteritis when she saw both the internist and ophthalmologist.

THE DEFENSE No negligence occurred because the patient had additional medical conditions; the patient didn’t describe her symptoms effectively and was negligent in failing to seek emergency medical care when she lost vision in her left eye.

VERDICT $1.4 million Washington settlement.

COMMENT This is a tough case with plenty of blame to go around, but it provides a good reminder to think of temporal arteritis whenever an older patient complains of jaw pain. Sedimentation rate measurements are cheap.

Lack of vigilance ends badly

SHORTNESS OF BREATH, FATIGUE, AND DIARRHEA prompted a 36-year-old man with diabetes and hypothyroidism to consult his primary care physician. The doctor prescribed levofloxacin and told the patient to return in 4 weeks.

Three days later, the man went back to the physician, reporting weakness, diarrhea, and a fever of 103°F. The physician diagnosed bronchitis and prescribed extended-release amoxicillin tablets. Two days later, the patient went to the emergency department; a chest radiograph showed advanced bilateral pneumonia. He died about 2 weeks later.

PLAINTIFF'S CLAIM The physician was negligent in failing to order a radiograph, admit the patient to the hospital, and prescribe proper medication.

THE DEFENSE No information about the defense is available.

VERDICT $1 million New Jersey settlement.

COMMENT Shortness of breath, fatigue, and diarrhea in a 36-year-old patient with diabetes sounds potentially serious to me. Presumably the physician diagnosed pneumonia on the initial exam, and one cannot fault him for that diagnosis or the treatment he prescribed. But return in 4 weeks? No way. Such patients require close follow-up and escalation of evaluation and treatment if they’re not doing well.

Delayed Dx leads to blindness

A WOMAN WITH DISABLING RHEUMATOID ARTHRITIS visited her long-time internist with pulmonary symptoms. Shortly thereafter the 59-year-old patient was diagnosed with lung cancer with a moderate prognosis and underwent surgery.

The following month, the woman complained of jaw pain to her internist. She also reported an “achy” temple to the nurse who saw her initially. The internist surmised that the cause of the pain might be an allergic reaction to dye used in a CT scan the patient had undergone because the patient said the pain had begun immediately after the scan. She was treated with methylprednisolone and the symptoms improved temporarily.

Within a few weeks, the patient complained of vision problems in her left eye. An ophthalmologist to whom she was referred thought the cause might be metastasis of the lung cancer. After an MRI of the optic area, a neuroradiologist reported to the ophthalmologist that the findings were consistent with metastatic cancer.

Before the patient could keep a follow-up appointment with the ophthalmologist, she lost all vision in her left eye. When she called the internist’s office for the results of the MRI, she told the person who answered the phone about the vision loss. Her call wasn’t returned.

The patient also told the ophthalmologist’s office about her loss of vision when she received a call to remind her of her follow-up appointment. The person she spoke to claimed the patient was offered an appointment that same day with another doctor, but declined it.

On the day before the follow-up appointment, the patient lost all sight in her right eye, as well. She received emergency treatment with corticosteroids the next day, but her vision didn’t return, leaving her completely blind. A temporal artery biopsy confirmed giant cell arteritis.

PLAINTIFF'S CLAIM The patient had classic symptoms of giant cell arteritis when she saw both the internist and ophthalmologist.

THE DEFENSE No negligence occurred because the patient had additional medical conditions; the patient didn’t describe her symptoms effectively and was negligent in failing to seek emergency medical care when she lost vision in her left eye.

VERDICT $1.4 million Washington settlement.

COMMENT This is a tough case with plenty of blame to go around, but it provides a good reminder to think of temporal arteritis whenever an older patient complains of jaw pain. Sedimentation rate measurements are cheap.

Lack of vigilance ends badly

SHORTNESS OF BREATH, FATIGUE, AND DIARRHEA prompted a 36-year-old man with diabetes and hypothyroidism to consult his primary care physician. The doctor prescribed levofloxacin and told the patient to return in 4 weeks.

Three days later, the man went back to the physician, reporting weakness, diarrhea, and a fever of 103°F. The physician diagnosed bronchitis and prescribed extended-release amoxicillin tablets. Two days later, the patient went to the emergency department; a chest radiograph showed advanced bilateral pneumonia. He died about 2 weeks later.

PLAINTIFF'S CLAIM The physician was negligent in failing to order a radiograph, admit the patient to the hospital, and prescribe proper medication.

THE DEFENSE No information about the defense is available.

VERDICT $1 million New Jersey settlement.

COMMENT Shortness of breath, fatigue, and diarrhea in a 36-year-old patient with diabetes sounds potentially serious to me. Presumably the physician diagnosed pneumonia on the initial exam, and one cannot fault him for that diagnosis or the treatment he prescribed. But return in 4 weeks? No way. Such patients require close follow-up and escalation of evaluation and treatment if they’re not doing well.

A 37-year-old Caucasian man sought care at our clinic for the pruritic patches on his trunk and extremities that had developed 3 days earlier. The patient said that the lesions started on his right arm but had spread to his left arm, posterior legs, and trunk. He reported that the trunk lesions had resolved, but the extremity lesions persisted. He’d had no specific contact exposures.

Upon further questioning, the patient indicated that he had noted the pigmented patch for at least 4 years, but was not sure how long the nodular area had been there. He thought it was a birthmark. He grew up spending a lot of time at the beach in the sun and recalled at least one blistering sunburn on his back.

WHAT IS YOUR DIAGNOSIS?
HOW WOULD YOU TREAT THIS PATIENT?

The patient underwent elliptical excisional biopsy of the primary lesion after no palpable lymphadenopathy was noted. The lateral and deep margins were negative for melanoma; the mitotic rate was <1/mm². Aggregates of lymphocytes were associated with the lesion, but did not infiltrate it. There was no tumor regression or ulceration of the lesion. The Breslow depth was 1.25 mm.

A histopathologic evaluation revealed a superficial spreading melanoma (inferior lesion in the FIGURE) and a nodular lesion (the superior reddish-black lesion in the FIGURE). (For more on these and other forms of melanoma, see “The 4 main types of melanoma”^1-4 see below.) It was unclear from the patient’s history whether this represented 2 types of melanoma (superficial spreading and nodular) in the same field of skin or the development of a nodular component in a superficial spreading lesion. Important clinical information was also missing, including the evolution of the lesions and how quickly the nodule had grown.

The preferred method for biopsy is complete elliptical excision with 2- to 3-mm margins of normal skin.

Who’s affected most? More than 45,000 cases of melanoma occurred in 45 states and the District of Columbia annually between 2004 and 2006, according to a 2011 report from the Centers for Disease Control and Prevention.⁵ White, non-Hispanics have a far higher incidence of melanoma than any other race or ethnicity.⁶ Women are more likely than men to be diagnosed with melanoma early in life, while men are twice as likely as women to be diagnosed after age 60.⁶ The etiology for the malignant transformation of melanocytes has not been fully clarified, but it is likely multifactorial, including genetic susceptibility and ultraviolet (UV) radiation damage.⁴

The ABCDE mnemonic is widely taught to aid in the detection of melanomas: A = asymmetry of the lesion; B = border irregularities; C = color variegation; D = diameter >6 mm; and E = evolution. The evolution of the lesion has been shown in some studies to be the most specific finding for detecting melanomas.⁴

Regional lymph nodes should also be carefully examined for evidence of clinical spread prior to biopsy of a suspicious lesion. This is important because biopsy may cause regional lymphadenopathy, which could confound later examinations and staging of the disease.¹

The differential: Is it a worrisome lesion—or not?
The differential diagnosis of melanoma includes both benign and malignant lesions. Malignant and potentially malignant diagnoses to consider include pigmented basal cell carcinoma, pigmented squamous cell carcinoma, carcinoma metastatic to the skin, and dysplastic nevi.^2,3

Benign diagnoses to consider include pigmented seborrheic keratoses, lentigo, pyogenic granuloma, Kaposi sarcoma, cherry angioma, subungual traumatic hematoma, dermatofibroma, and nevi (including blue nevi).^2,3

The biopsy is paramount
A diagnosis is established based on the microscopic evaluation of suspicious lesions. Studies suggest that one-third to one-half of melanomas arise from existing nevi, with the remainder developing from previously normal-appearing skin.^1,2 Patients with increased numbers of either common or dysplastic nevi are at increased risk of melanoma compared with the general population.⁴ Historical clues include changes in a lesion’s size, color, or symmetry; new growths; personal or family history of melanoma; and bleeding.

A biopsy for histopathologic evaluation is mandatory when a lesion is suspicious for melanoma. Dermoscopy, which involves a device that magnifies skin lesions, may reveal highly specific dermoscopic features for melanoma that can help in determining the need for biopsy.⁴

The preferred method for biopsy is complete elliptical excision with 2- to 3-mm margins of normal skin.^2,3 However, a deep shave biopsy may also be appropriate, depending upon the clinical situation and physician experience with the technique.⁴

A deep shave biopsy is less time consuming than elliptical excision, making it easier to perform at the time the lesion is first evaluated. Deep shave biopsy may provide several benefits, including reducing the amount of normal tissue that is removed (especially if pathology is benign) as well as, the cost, scarring, and likelihood of wound infections. Deep shave biopsy also can avoid the need for a second elliptical excision.^7,8

Determine margins, proceed with surgical excision
Early surgical excision is the primary treatment for malignant melanoma. After the diagnosis is confirmed by initial biopsy, the depth of the lesion dictates the surgical recommendations. Recommended surgical margins based on depth are: 5 mm with a layer of subcutaneous fat for melanoma in situ, 1 cm down to the fascia for lesions with a Breslow depth ≤2 mm, and 2 cm down to the fascia for lesions with a depth >2 mm.^1,4

The surgical treatment of lentigo maligna melanoma can be challenging due to indistinct borders and large size. Mohs micrographic surgery can be helpful to fully remove the lesion with sparing of healthy surrounding tissue.⁴ When surgical excision of large lentigo maligna is technically difficult, radiation therapy is another option.³

Subungual melanoma may necessitate amputation or grafting of the digit. Mohs micrographic surgery can be useful in these situations for tissue sparing.² (To learn more, see “When to consider Mohs surgery,” J Fam Pract. 2013;558-564.)

Is a sentinel lymph node biopsy needed?
Sentinel lymph node biopsy is often recommended for melanomas >1 mm in depth.^2-4 It provides guidance on who may benefit from regional lymphadenectomy and adjuvant immunotherapy.^1,3

Adjuvant therapy for patients without evidence of distant metastases can be considered in patients with positive nodes or node-negative melanoma that is 4 mm thick or Clark Level IV or V. Adjuvant high-dose interferon alpha-2b is the most commonly used agent in these situations.² Some studies suggest an increase in median overall survival of up to 11 months with high-dose interferon as compared to no treatment.³ Limitations include toxicity from these high-dose regimens.³ Treatment with interferon does not represent a cure; rather, it should be considered a palliative intervention with marginal benefit.¹

When there are distant metastases…
Once distant metastases are identified, the goal of therapy should be palliative care as this condition is generally incurable. Chemotherapy, radiation, and excision of solitary metastases are all interventions that have traditionally been employed.¹ The primary site for metastasis is the skin, but all organs are potential sites of spread. Central nervous system metastasis is the most common cause of the death.²

Novel therapies include inhibition of BRAF, an enzyme of the mitogen-activated protein kinase pathway (MAPK), and blocking of cytotoxic T lymphocyte-associated antigen-4 (CTLA-4).

Sentinel lymph node biopsy is often recommended for melanomas >1 mm in depth.

BRAF-enzyme inhibitor. Mutated BRAF contributes to uncontrolled cell growth and resistance to programmed cell death (apoptosis).^9,10 In August 2011, vemurafenib (Zelboraf ), a BRAF-enzyme inhibitor, was approved by the US Food and Drug Administration (FDA) for the treatment of late-stage melanoma. It works only in patients with the BRAF^V600E mutation, which is found in approximately 60% of melanomas.^11,12 One phase 1 study showed partial to complete regression in 80% of patients treated, but this regression lasted only 2 to 18 months.¹³

Anti-CTLA-4 monoclonal antibody. Cytotoxic T-lymphocytes can recognize and potentially destroy cancer cells.¹⁴ However, CTLA-4, which is expressed on the surface of cytotoxic T-lymphocytes, has a suppressive effect on the T-lymphocyte response after interaction with the antigen-presenting cell. Researchers deduced that blocking CTLA-4 would allow the immune system to remain responsive to abnormal antigens, including those from melanoma.⁹

Ipilimumab (Yervoy), an anti-CTLA-4 monoclonal antibody, was approved by the FDA in March 2011 for the treatment of late-stage melanoma.¹¹ Partial and complete responses have been shown in trials of ipilimumab as monotherapy and in combination with vaccines, chemotherapy, and interleukin-2, but these responses have not been sustained.⁹

Although these novel therapies represent significant advancements in the understanding of the pathogenesis of melanoma, the short duration of efficacy highlights the cancer’s ability to develop resistance to these treatments. This ability to adapt suggests that melanoma harbors multiple oncogenes and several pathways for carcinogenesis. Combination targeted therapies may be required to improve clinical results; research is ongoing.⁹ Toxicities associated with these medications are also a limiting factor.

What about vaccines? Vaccine studies are also ongoing. Although some have shown promising results, no clearly effective therapy has been produced to date.²

Factors that affect prognosis
The prognosis for melanoma is related to tumor thickness, presence or absence of melanoma in regional lymph nodes, and extent of metastases.^1-4 The TNM classification system takes these factors into account in staging melanoma.⁴ Based on this staging, a 5- and 10-year survival estimate can be discussed with the patient.

Survival estimates based on depth of invasion alone are also used. As an example, one study cited a 5-year survival rate of 95% for a tumor thickness <.75 mm; 85% (.75-1.4 mm); 66% (1.5-3.9 mm); and 46% (≥4 mm).¹

Other variables that affect prognosis include lymphocytic infiltrate (more brisk and tumor infiltrating is better prognostically), mitotic rate (less is better; >6/mm² is worse), ulceration (worse prognostically), and regression of the tumor.² Regression will appear as areas of depigmentation in a previously completely pigmented lesion; it is associated with a poorer prognosis.¹

Follow-up with patients is key
Regular skin, lymph node, and general follow-up exams are recommended to detect metastatic disease or new primary lesions. It has been estimated that approximately 5% of patients with a history of melanoma will develop a new primary lesion.³ Lab and imaging studies should be used when prompted by clinical findings.²

Some protocols recommend routine use of labs, including lactate dehydrogenase, complete blood count, and chemistries, as well as imaging such as chest x-ray, positron emission tomography (PET), or computed tomography (CT) based on the stage of the disease.⁴ No evidence has shown that routine laboratory or imaging studies affect prognosis.²

The reggae legend Bob Marley died at age 36 from metastatic subungual melanoma of the foot.

Close surveillance for my patient
My patient underwent re-excision of the tumor site with wide margins. Sentinel lymph nodes excised from the bilateral axilla were negative for melanoma. He was seen by colleagues in the oncology department, and his lab work and chest x-ray were normal. PET/CT revealed no evidence of fluorodeoxyglucose avid metastatic disease.

Based on staging, my patient’s 5-year survival was estimated at 81% and his 10-year survival at 67%. No further oncology follow-up was planned and the patient was instructed to be seen by a dermatologist for close clinical surveillance.

CORRESPONDENCE
Suresh K. Menon, MD, Hahn Medical Practices, 5078 Williamsport Pike, Martinsburg, WV 25404; [email protected]

A 37-year-old Caucasian man sought care at our clinic for the pruritic patches on his trunk and extremities that had developed 3 days earlier. The patient said that the lesions started on his right arm but had spread to his left arm, posterior legs, and trunk. He reported that the trunk lesions had resolved, but the extremity lesions persisted. He’d had no specific contact exposures.

Upon further questioning, the patient indicated that he had noted the pigmented patch for at least 4 years, but was not sure how long the nodular area had been there. He thought it was a birthmark. He grew up spending a lot of time at the beach in the sun and recalled at least one blistering sunburn on his back.

WHAT IS YOUR DIAGNOSIS?
HOW WOULD YOU TREAT THIS PATIENT?

The patient underwent elliptical excisional biopsy of the primary lesion after no palpable lymphadenopathy was noted. The lateral and deep margins were negative for melanoma; the mitotic rate was <1/mm². Aggregates of lymphocytes were associated with the lesion, but did not infiltrate it. There was no tumor regression or ulceration of the lesion. The Breslow depth was 1.25 mm.

A histopathologic evaluation revealed a superficial spreading melanoma (inferior lesion in the FIGURE) and a nodular lesion (the superior reddish-black lesion in the FIGURE). (For more on these and other forms of melanoma, see “The 4 main types of melanoma”^1-4 see below.) It was unclear from the patient’s history whether this represented 2 types of melanoma (superficial spreading and nodular) in the same field of skin or the development of a nodular component in a superficial spreading lesion. Important clinical information was also missing, including the evolution of the lesions and how quickly the nodule had grown.

The preferred method for biopsy is complete elliptical excision with 2- to 3-mm margins of normal skin.

Who’s affected most? More than 45,000 cases of melanoma occurred in 45 states and the District of Columbia annually between 2004 and 2006, according to a 2011 report from the Centers for Disease Control and Prevention.⁵ White, non-Hispanics have a far higher incidence of melanoma than any other race or ethnicity.⁶ Women are more likely than men to be diagnosed with melanoma early in life, while men are twice as likely as women to be diagnosed after age 60.⁶ The etiology for the malignant transformation of melanocytes has not been fully clarified, but it is likely multifactorial, including genetic susceptibility and ultraviolet (UV) radiation damage.⁴

The ABCDE mnemonic is widely taught to aid in the detection of melanomas: A = asymmetry of the lesion; B = border irregularities; C = color variegation; D = diameter >6 mm; and E = evolution. The evolution of the lesion has been shown in some studies to be the most specific finding for detecting melanomas.⁴

Regional lymph nodes should also be carefully examined for evidence of clinical spread prior to biopsy of a suspicious lesion. This is important because biopsy may cause regional lymphadenopathy, which could confound later examinations and staging of the disease.¹

The differential: Is it a worrisome lesion—or not?
The differential diagnosis of melanoma includes both benign and malignant lesions. Malignant and potentially malignant diagnoses to consider include pigmented basal cell carcinoma, pigmented squamous cell carcinoma, carcinoma metastatic to the skin, and dysplastic nevi.^2,3

Benign diagnoses to consider include pigmented seborrheic keratoses, lentigo, pyogenic granuloma, Kaposi sarcoma, cherry angioma, subungual traumatic hematoma, dermatofibroma, and nevi (including blue nevi).^2,3

The biopsy is paramount
A diagnosis is established based on the microscopic evaluation of suspicious lesions. Studies suggest that one-third to one-half of melanomas arise from existing nevi, with the remainder developing from previously normal-appearing skin.^1,2 Patients with increased numbers of either common or dysplastic nevi are at increased risk of melanoma compared with the general population.⁴ Historical clues include changes in a lesion’s size, color, or symmetry; new growths; personal or family history of melanoma; and bleeding.

A biopsy for histopathologic evaluation is mandatory when a lesion is suspicious for melanoma. Dermoscopy, which involves a device that magnifies skin lesions, may reveal highly specific dermoscopic features for melanoma that can help in determining the need for biopsy.⁴

The preferred method for biopsy is complete elliptical excision with 2- to 3-mm margins of normal skin.^2,3 However, a deep shave biopsy may also be appropriate, depending upon the clinical situation and physician experience with the technique.⁴

A deep shave biopsy is less time consuming than elliptical excision, making it easier to perform at the time the lesion is first evaluated. Deep shave biopsy may provide several benefits, including reducing the amount of normal tissue that is removed (especially if pathology is benign) as well as, the cost, scarring, and likelihood of wound infections. Deep shave biopsy also can avoid the need for a second elliptical excision.^7,8

Determine margins, proceed with surgical excision
Early surgical excision is the primary treatment for malignant melanoma. After the diagnosis is confirmed by initial biopsy, the depth of the lesion dictates the surgical recommendations. Recommended surgical margins based on depth are: 5 mm with a layer of subcutaneous fat for melanoma in situ, 1 cm down to the fascia for lesions with a Breslow depth ≤2 mm, and 2 cm down to the fascia for lesions with a depth >2 mm.^1,4

The surgical treatment of lentigo maligna melanoma can be challenging due to indistinct borders and large size. Mohs micrographic surgery can be helpful to fully remove the lesion with sparing of healthy surrounding tissue.⁴ When surgical excision of large lentigo maligna is technically difficult, radiation therapy is another option.³

Subungual melanoma may necessitate amputation or grafting of the digit. Mohs micrographic surgery can be useful in these situations for tissue sparing.² (To learn more, see “When to consider Mohs surgery,” J Fam Pract. 2013;558-564.)

Is a sentinel lymph node biopsy needed?
Sentinel lymph node biopsy is often recommended for melanomas >1 mm in depth.^2-4 It provides guidance on who may benefit from regional lymphadenectomy and adjuvant immunotherapy.^1,3

Adjuvant therapy for patients without evidence of distant metastases can be considered in patients with positive nodes or node-negative melanoma that is 4 mm thick or Clark Level IV or V. Adjuvant high-dose interferon alpha-2b is the most commonly used agent in these situations.² Some studies suggest an increase in median overall survival of up to 11 months with high-dose interferon as compared to no treatment.³ Limitations include toxicity from these high-dose regimens.³ Treatment with interferon does not represent a cure; rather, it should be considered a palliative intervention with marginal benefit.¹

When there are distant metastases…
Once distant metastases are identified, the goal of therapy should be palliative care as this condition is generally incurable. Chemotherapy, radiation, and excision of solitary metastases are all interventions that have traditionally been employed.¹ The primary site for metastasis is the skin, but all organs are potential sites of spread. Central nervous system metastasis is the most common cause of the death.²

Novel therapies include inhibition of BRAF, an enzyme of the mitogen-activated protein kinase pathway (MAPK), and blocking of cytotoxic T lymphocyte-associated antigen-4 (CTLA-4).

Sentinel lymph node biopsy is often recommended for melanomas >1 mm in depth.

BRAF-enzyme inhibitor. Mutated BRAF contributes to uncontrolled cell growth and resistance to programmed cell death (apoptosis).^9,10 In August 2011, vemurafenib (Zelboraf ), a BRAF-enzyme inhibitor, was approved by the US Food and Drug Administration (FDA) for the treatment of late-stage melanoma. It works only in patients with the BRAF^V600E mutation, which is found in approximately 60% of melanomas.^11,12 One phase 1 study showed partial to complete regression in 80% of patients treated, but this regression lasted only 2 to 18 months.¹³

Anti-CTLA-4 monoclonal antibody. Cytotoxic T-lymphocytes can recognize and potentially destroy cancer cells.¹⁴ However, CTLA-4, which is expressed on the surface of cytotoxic T-lymphocytes, has a suppressive effect on the T-lymphocyte response after interaction with the antigen-presenting cell. Researchers deduced that blocking CTLA-4 would allow the immune system to remain responsive to abnormal antigens, including those from melanoma.⁹

Ipilimumab (Yervoy), an anti-CTLA-4 monoclonal antibody, was approved by the FDA in March 2011 for the treatment of late-stage melanoma.¹¹ Partial and complete responses have been shown in trials of ipilimumab as monotherapy and in combination with vaccines, chemotherapy, and interleukin-2, but these responses have not been sustained.⁹

Although these novel therapies represent significant advancements in the understanding of the pathogenesis of melanoma, the short duration of efficacy highlights the cancer’s ability to develop resistance to these treatments. This ability to adapt suggests that melanoma harbors multiple oncogenes and several pathways for carcinogenesis. Combination targeted therapies may be required to improve clinical results; research is ongoing.⁹ Toxicities associated with these medications are also a limiting factor.

What about vaccines? Vaccine studies are also ongoing. Although some have shown promising results, no clearly effective therapy has been produced to date.²

Factors that affect prognosis
The prognosis for melanoma is related to tumor thickness, presence or absence of melanoma in regional lymph nodes, and extent of metastases.^1-4 The TNM classification system takes these factors into account in staging melanoma.⁴ Based on this staging, a 5- and 10-year survival estimate can be discussed with the patient.

Survival estimates based on depth of invasion alone are also used. As an example, one study cited a 5-year survival rate of 95% for a tumor thickness <.75 mm; 85% (.75-1.4 mm); 66% (1.5-3.9 mm); and 46% (≥4 mm).¹

Other variables that affect prognosis include lymphocytic infiltrate (more brisk and tumor infiltrating is better prognostically), mitotic rate (less is better; >6/mm² is worse), ulceration (worse prognostically), and regression of the tumor.² Regression will appear as areas of depigmentation in a previously completely pigmented lesion; it is associated with a poorer prognosis.¹

Follow-up with patients is key
Regular skin, lymph node, and general follow-up exams are recommended to detect metastatic disease or new primary lesions. It has been estimated that approximately 5% of patients with a history of melanoma will develop a new primary lesion.³ Lab and imaging studies should be used when prompted by clinical findings.²

Some protocols recommend routine use of labs, including lactate dehydrogenase, complete blood count, and chemistries, as well as imaging such as chest x-ray, positron emission tomography (PET), or computed tomography (CT) based on the stage of the disease.⁴ No evidence has shown that routine laboratory or imaging studies affect prognosis.²

The reggae legend Bob Marley died at age 36 from metastatic subungual melanoma of the foot.

Close surveillance for my patient
My patient underwent re-excision of the tumor site with wide margins. Sentinel lymph nodes excised from the bilateral axilla were negative for melanoma. He was seen by colleagues in the oncology department, and his lab work and chest x-ray were normal. PET/CT revealed no evidence of fluorodeoxyglucose avid metastatic disease.

Based on staging, my patient’s 5-year survival was estimated at 81% and his 10-year survival at 67%. No further oncology follow-up was planned and the patient was instructed to be seen by a dermatologist for close clinical surveillance.

CORRESPONDENCE
Suresh K. Menon, MD, Hahn Medical Practices, 5078 Williamsport Pike, Martinsburg, WV 25404; [email protected]

A 37-year-old Caucasian man sought care at our clinic for the pruritic patches on his trunk and extremities that had developed 3 days earlier. The patient said that the lesions started on his right arm but had spread to his left arm, posterior legs, and trunk. He reported that the trunk lesions had resolved, but the extremity lesions persisted. He’d had no specific contact exposures.

Upon further questioning, the patient indicated that he had noted the pigmented patch for at least 4 years, but was not sure how long the nodular area had been there. He thought it was a birthmark. He grew up spending a lot of time at the beach in the sun and recalled at least one blistering sunburn on his back.

WHAT IS YOUR DIAGNOSIS?
HOW WOULD YOU TREAT THIS PATIENT?

The patient underwent elliptical excisional biopsy of the primary lesion after no palpable lymphadenopathy was noted. The lateral and deep margins were negative for melanoma; the mitotic rate was <1/mm². Aggregates of lymphocytes were associated with the lesion, but did not infiltrate it. There was no tumor regression or ulceration of the lesion. The Breslow depth was 1.25 mm.

A histopathologic evaluation revealed a superficial spreading melanoma (inferior lesion in the FIGURE) and a nodular lesion (the superior reddish-black lesion in the FIGURE). (For more on these and other forms of melanoma, see “The 4 main types of melanoma”^1-4 see below.) It was unclear from the patient’s history whether this represented 2 types of melanoma (superficial spreading and nodular) in the same field of skin or the development of a nodular component in a superficial spreading lesion. Important clinical information was also missing, including the evolution of the lesions and how quickly the nodule had grown.

The preferred method for biopsy is complete elliptical excision with 2- to 3-mm margins of normal skin.

Who’s affected most? More than 45,000 cases of melanoma occurred in 45 states and the District of Columbia annually between 2004 and 2006, according to a 2011 report from the Centers for Disease Control and Prevention.⁵ White, non-Hispanics have a far higher incidence of melanoma than any other race or ethnicity.⁶ Women are more likely than men to be diagnosed with melanoma early in life, while men are twice as likely as women to be diagnosed after age 60.⁶ The etiology for the malignant transformation of melanocytes has not been fully clarified, but it is likely multifactorial, including genetic susceptibility and ultraviolet (UV) radiation damage.⁴

The ABCDE mnemonic is widely taught to aid in the detection of melanomas: A = asymmetry of the lesion; B = border irregularities; C = color variegation; D = diameter >6 mm; and E = evolution. The evolution of the lesion has been shown in some studies to be the most specific finding for detecting melanomas.⁴

Regional lymph nodes should also be carefully examined for evidence of clinical spread prior to biopsy of a suspicious lesion. This is important because biopsy may cause regional lymphadenopathy, which could confound later examinations and staging of the disease.¹

The differential: Is it a worrisome lesion—or not?
The differential diagnosis of melanoma includes both benign and malignant lesions. Malignant and potentially malignant diagnoses to consider include pigmented basal cell carcinoma, pigmented squamous cell carcinoma, carcinoma metastatic to the skin, and dysplastic nevi.^2,3

Benign diagnoses to consider include pigmented seborrheic keratoses, lentigo, pyogenic granuloma, Kaposi sarcoma, cherry angioma, subungual traumatic hematoma, dermatofibroma, and nevi (including blue nevi).^2,3

The biopsy is paramount
A diagnosis is established based on the microscopic evaluation of suspicious lesions. Studies suggest that one-third to one-half of melanomas arise from existing nevi, with the remainder developing from previously normal-appearing skin.^1,2 Patients with increased numbers of either common or dysplastic nevi are at increased risk of melanoma compared with the general population.⁴ Historical clues include changes in a lesion’s size, color, or symmetry; new growths; personal or family history of melanoma; and bleeding.

A biopsy for histopathologic evaluation is mandatory when a lesion is suspicious for melanoma. Dermoscopy, which involves a device that magnifies skin lesions, may reveal highly specific dermoscopic features for melanoma that can help in determining the need for biopsy.⁴

The preferred method for biopsy is complete elliptical excision with 2- to 3-mm margins of normal skin.^2,3 However, a deep shave biopsy may also be appropriate, depending upon the clinical situation and physician experience with the technique.⁴

A deep shave biopsy is less time consuming than elliptical excision, making it easier to perform at the time the lesion is first evaluated. Deep shave biopsy may provide several benefits, including reducing the amount of normal tissue that is removed (especially if pathology is benign) as well as, the cost, scarring, and likelihood of wound infections. Deep shave biopsy also can avoid the need for a second elliptical excision.^7,8

Determine margins, proceed with surgical excision
Early surgical excision is the primary treatment for malignant melanoma. After the diagnosis is confirmed by initial biopsy, the depth of the lesion dictates the surgical recommendations. Recommended surgical margins based on depth are: 5 mm with a layer of subcutaneous fat for melanoma in situ, 1 cm down to the fascia for lesions with a Breslow depth ≤2 mm, and 2 cm down to the fascia for lesions with a depth >2 mm.^1,4

The surgical treatment of lentigo maligna melanoma can be challenging due to indistinct borders and large size. Mohs micrographic surgery can be helpful to fully remove the lesion with sparing of healthy surrounding tissue.⁴ When surgical excision of large lentigo maligna is technically difficult, radiation therapy is another option.³

Subungual melanoma may necessitate amputation or grafting of the digit. Mohs micrographic surgery can be useful in these situations for tissue sparing.² (To learn more, see “When to consider Mohs surgery,” J Fam Pract. 2013;558-564.)

Is a sentinel lymph node biopsy needed?
Sentinel lymph node biopsy is often recommended for melanomas >1 mm in depth.^2-4 It provides guidance on who may benefit from regional lymphadenectomy and adjuvant immunotherapy.^1,3

Adjuvant therapy for patients without evidence of distant metastases can be considered in patients with positive nodes or node-negative melanoma that is 4 mm thick or Clark Level IV or V. Adjuvant high-dose interferon alpha-2b is the most commonly used agent in these situations.² Some studies suggest an increase in median overall survival of up to 11 months with high-dose interferon as compared to no treatment.³ Limitations include toxicity from these high-dose regimens.³ Treatment with interferon does not represent a cure; rather, it should be considered a palliative intervention with marginal benefit.¹

When there are distant metastases…
Once distant metastases are identified, the goal of therapy should be palliative care as this condition is generally incurable. Chemotherapy, radiation, and excision of solitary metastases are all interventions that have traditionally been employed.¹ The primary site for metastasis is the skin, but all organs are potential sites of spread. Central nervous system metastasis is the most common cause of the death.²

Novel therapies include inhibition of BRAF, an enzyme of the mitogen-activated protein kinase pathway (MAPK), and blocking of cytotoxic T lymphocyte-associated antigen-4 (CTLA-4).

Sentinel lymph node biopsy is often recommended for melanomas >1 mm in depth.

BRAF-enzyme inhibitor. Mutated BRAF contributes to uncontrolled cell growth and resistance to programmed cell death (apoptosis).^9,10 In August 2011, vemurafenib (Zelboraf ), a BRAF-enzyme inhibitor, was approved by the US Food and Drug Administration (FDA) for the treatment of late-stage melanoma. It works only in patients with the BRAF^V600E mutation, which is found in approximately 60% of melanomas.^11,12 One phase 1 study showed partial to complete regression in 80% of patients treated, but this regression lasted only 2 to 18 months.¹³

Anti-CTLA-4 monoclonal antibody. Cytotoxic T-lymphocytes can recognize and potentially destroy cancer cells.¹⁴ However, CTLA-4, which is expressed on the surface of cytotoxic T-lymphocytes, has a suppressive effect on the T-lymphocyte response after interaction with the antigen-presenting cell. Researchers deduced that blocking CTLA-4 would allow the immune system to remain responsive to abnormal antigens, including those from melanoma.⁹

Ipilimumab (Yervoy), an anti-CTLA-4 monoclonal antibody, was approved by the FDA in March 2011 for the treatment of late-stage melanoma.¹¹ Partial and complete responses have been shown in trials of ipilimumab as monotherapy and in combination with vaccines, chemotherapy, and interleukin-2, but these responses have not been sustained.⁹

Although these novel therapies represent significant advancements in the understanding of the pathogenesis of melanoma, the short duration of efficacy highlights the cancer’s ability to develop resistance to these treatments. This ability to adapt suggests that melanoma harbors multiple oncogenes and several pathways for carcinogenesis. Combination targeted therapies may be required to improve clinical results; research is ongoing.⁹ Toxicities associated with these medications are also a limiting factor.

What about vaccines? Vaccine studies are also ongoing. Although some have shown promising results, no clearly effective therapy has been produced to date.²

Factors that affect prognosis
The prognosis for melanoma is related to tumor thickness, presence or absence of melanoma in regional lymph nodes, and extent of metastases.^1-4 The TNM classification system takes these factors into account in staging melanoma.⁴ Based on this staging, a 5- and 10-year survival estimate can be discussed with the patient.

Survival estimates based on depth of invasion alone are also used. As an example, one study cited a 5-year survival rate of 95% for a tumor thickness <.75 mm; 85% (.75-1.4 mm); 66% (1.5-3.9 mm); and 46% (≥4 mm).¹

Other variables that affect prognosis include lymphocytic infiltrate (more brisk and tumor infiltrating is better prognostically), mitotic rate (less is better; >6/mm² is worse), ulceration (worse prognostically), and regression of the tumor.² Regression will appear as areas of depigmentation in a previously completely pigmented lesion; it is associated with a poorer prognosis.¹

Follow-up with patients is key
Regular skin, lymph node, and general follow-up exams are recommended to detect metastatic disease or new primary lesions. It has been estimated that approximately 5% of patients with a history of melanoma will develop a new primary lesion.³ Lab and imaging studies should be used when prompted by clinical findings.²

Some protocols recommend routine use of labs, including lactate dehydrogenase, complete blood count, and chemistries, as well as imaging such as chest x-ray, positron emission tomography (PET), or computed tomography (CT) based on the stage of the disease.⁴ No evidence has shown that routine laboratory or imaging studies affect prognosis.²

The reggae legend Bob Marley died at age 36 from metastatic subungual melanoma of the foot.

Close surveillance for my patient
My patient underwent re-excision of the tumor site with wide margins. Sentinel lymph nodes excised from the bilateral axilla were negative for melanoma. He was seen by colleagues in the oncology department, and his lab work and chest x-ray were normal. PET/CT revealed no evidence of fluorodeoxyglucose avid metastatic disease.

Based on staging, my patient’s 5-year survival was estimated at 81% and his 10-year survival at 67%. No further oncology follow-up was planned and the patient was instructed to be seen by a dermatologist for close clinical surveillance.

CORRESPONDENCE
Suresh K. Menon, MD, Hahn Medical Practices, 5078 Williamsport Pike, Martinsburg, WV 25404; [email protected]

My coauthors and I appreciate the comments of Drs. Mayer and Hansen. Regarding the cost effectiveness and utility of the Unna boot, we would point out that the focus of our Clinical Inquiry was on the initial management of venous stasis ulcers and how best to promote healing.

Little data exist on Unna boot application alone. But it is likely that many of the compression therapy modality studies in the Cochrane meta-analysis included in our review featured Unna boot dressings as part of some form of multilayer compression therapy being evaluated.¹

As Dr. Hansen observes, compression, the standard compression classes, and the minimal benefits of low pressure levels provided by the classic TED hose and OTC support hose should have been addressed. This information was not included in our review due to space limitations. This subject deserves a dedicated article, as there is a great deal of confusion about terminology and types of dressings.

Both the 2009 Cochrane meta-analysis¹ and a 2012 update² found that adding a component of elastic compression therapy results in faster ulcer healing compared with inelastic compression therapy alone. Venous ulcers treated with 4-layer bandages heal faster, on average, than those treated with short stretch bandages, and regular use of compression stockings lowers the risk of recurrence.³ Correcting underlying venous incompetency issues is certainly a consideration, particularly for ulcers that initially heal but later recur.

Mark Andrews, MD
Winston-Salem, NC

My coauthors and I appreciate the comments of Drs. Mayer and Hansen. Regarding the cost effectiveness and utility of the Unna boot, we would point out that the focus of our Clinical Inquiry was on the initial management of venous stasis ulcers and how best to promote healing.

Little data exist on Unna boot application alone. But it is likely that many of the compression therapy modality studies in the Cochrane meta-analysis included in our review featured Unna boot dressings as part of some form of multilayer compression therapy being evaluated.¹

As Dr. Hansen observes, compression, the standard compression classes, and the minimal benefits of low pressure levels provided by the classic TED hose and OTC support hose should have been addressed. This information was not included in our review due to space limitations. This subject deserves a dedicated article, as there is a great deal of confusion about terminology and types of dressings.

Both the 2009 Cochrane meta-analysis¹ and a 2012 update² found that adding a component of elastic compression therapy results in faster ulcer healing compared with inelastic compression therapy alone. Venous ulcers treated with 4-layer bandages heal faster, on average, than those treated with short stretch bandages, and regular use of compression stockings lowers the risk of recurrence.³ Correcting underlying venous incompetency issues is certainly a consideration, particularly for ulcers that initially heal but later recur.

Mark Andrews, MD
Winston-Salem, NC

My coauthors and I appreciate the comments of Drs. Mayer and Hansen. Regarding the cost effectiveness and utility of the Unna boot, we would point out that the focus of our Clinical Inquiry was on the initial management of venous stasis ulcers and how best to promote healing.

Little data exist on Unna boot application alone. But it is likely that many of the compression therapy modality studies in the Cochrane meta-analysis included in our review featured Unna boot dressings as part of some form of multilayer compression therapy being evaluated.¹

As Dr. Hansen observes, compression, the standard compression classes, and the minimal benefits of low pressure levels provided by the classic TED hose and OTC support hose should have been addressed. This information was not included in our review due to space limitations. This subject deserves a dedicated article, as there is a great deal of confusion about terminology and types of dressings.

Both the 2009 Cochrane meta-analysis¹ and a 2012 update² found that adding a component of elastic compression therapy results in faster ulcer healing compared with inelastic compression therapy alone. Venous ulcers treated with 4-layer bandages heal faster, on average, than those treated with short stretch bandages, and regular use of compression stockings lowers the risk of recurrence.³ Correcting underlying venous incompetency issues is certainly a consideration, particularly for ulcers that initially heal but later recur.

Mark Andrews, MD
Winston-Salem, NC

In “What is the best initial treatment for venous stasis ulcers?” (Clinical Inquiries. J Fam Pract. 2013;62:433-434), Dr. Poynter et al seemed to say that various kinds of compression stockings are suitable. What about going back to the Unna boot?

I have had great success treating venous stasis ulcers with the Unna boot. This calamine-infused gauze dressing, which can easily be applied in a primary care setting, has been replaced by wound treatments that are much more expensive—and may be less effective. Cost matters, and all things being equal, it’s time to promote the Unna boot once more.

Charles Mayer, MD, MPH
Seattle, Wash

As a family physician certified by the American Board of Venous and Lymphatic Disease, I would like to point out a couple of things.

First, while the authors discussed compression, they did not define what that meant. This is important, as many physicians prescribe TED hose for venous stasis ulcers, although it does not provide enough compression.

Secondly, fixing the underlying problem should be considered part of the initial treatment. Studies show that a combination of compression and intervention is the best way to ensure long-term healing of venous stasis ulcers.^1,2 I would recommend that such patients be referred to a phlebologist for evaluation. Compression alone has a poor long-term outcome for the healing of ulceration.

Lornell E. Hansen II, MD, FAAFP
Sioux Falls, SD

In “What is the best initial treatment for venous stasis ulcers?” (Clinical Inquiries. J Fam Pract. 2013;62:433-434), Dr. Poynter et al seemed to say that various kinds of compression stockings are suitable. What about going back to the Unna boot?

I have had great success treating venous stasis ulcers with the Unna boot. This calamine-infused gauze dressing, which can easily be applied in a primary care setting, has been replaced by wound treatments that are much more expensive—and may be less effective. Cost matters, and all things being equal, it’s time to promote the Unna boot once more.

Charles Mayer, MD, MPH
Seattle, Wash

As a family physician certified by the American Board of Venous and Lymphatic Disease, I would like to point out a couple of things.

First, while the authors discussed compression, they did not define what that meant. This is important, as many physicians prescribe TED hose for venous stasis ulcers, although it does not provide enough compression.

Secondly, fixing the underlying problem should be considered part of the initial treatment. Studies show that a combination of compression and intervention is the best way to ensure long-term healing of venous stasis ulcers.^1,2 I would recommend that such patients be referred to a phlebologist for evaluation. Compression alone has a poor long-term outcome for the healing of ulceration.

Lornell E. Hansen II, MD, FAAFP
Sioux Falls, SD

In “What is the best initial treatment for venous stasis ulcers?” (Clinical Inquiries. J Fam Pract. 2013;62:433-434), Dr. Poynter et al seemed to say that various kinds of compression stockings are suitable. What about going back to the Unna boot?

I have had great success treating venous stasis ulcers with the Unna boot. This calamine-infused gauze dressing, which can easily be applied in a primary care setting, has been replaced by wound treatments that are much more expensive—and may be less effective. Cost matters, and all things being equal, it’s time to promote the Unna boot once more.

Charles Mayer, MD, MPH
Seattle, Wash

As a family physician certified by the American Board of Venous and Lymphatic Disease, I would like to point out a couple of things.

First, while the authors discussed compression, they did not define what that meant. This is important, as many physicians prescribe TED hose for venous stasis ulcers, although it does not provide enough compression.

Secondly, fixing the underlying problem should be considered part of the initial treatment. Studies show that a combination of compression and intervention is the best way to ensure long-term healing of venous stasis ulcers.^1,2 I would recommend that such patients be referred to a phlebologist for evaluation. Compression alone has a poor long-term outcome for the healing of ulceration.

Lornell E. Hansen II, MD, FAAFP
Sioux Falls, SD

EVIDENCE SUMMARY

In a meta-analysis of 31 studies with 10,130 patients, researchers reported that the total rate of sexual dysfunction (SD) associated with selective serotonin reuptake inhibitors (SSRIs) was significantly higher than the placebo rate of 14.2% (TABLE).¹ The SSRIs citalopram, fluoxetine, paroxetine, and sertraline as well as the SNRI venlafaxine, had significantly greater rates (70%-80%) of reported total sexual dysfunction, including desire, arousal, and orgasm, than placebo.

Bupropion has sexual dysfunction rates comparable to placebo

Other SSRIs (fluvoxamine, escitalopram), the tricyclic antidepressant imipramine, and the SNRI duloxetine also had total SD rates significantly greater than placebo. However, the rates of dysfunction with these agents are often lower than the dysfunction rates of SSRIs such as sertraline and citalopram, and thus, may be viewed as falling into an intermediate risk category. The total SD rates for the NDRI bupropion were comparable to the placebo rate.¹

With few exceptions, all drugs associated with overall SD were associated with significant dysfunction affecting the sexual components of desire, arousal, and orgasm. The results of this meta-analysis should be interpreted with some degree of caution because methods of assessing SD varied within individual studies.

AHRQ weighs in

An Agency for Healthcare Research and Quality (AHRQ) review of antidepressants found that paroxetine, citalopram, and venlafaxine, when compared with other antidepressants (fluoxetine, fluvoxamine, nefazodone, sertraline), generally were associated with more reports of SD, specifically complaints of erectile dysfunction in men and decreased vaginal lubrication in women. 2 The number needed to treat one additional person with general sexual functioning satisfaction was 6 (95% CI, 4-9) with buproprion.²

RECOMMENDATIONS

The American College of Physicians’ clinical practice guidelines suggest that although SD is likely underreported, the NDRI bupropion has consistently shown lower rates of associated dysfunction than the SSRIs fluoxetine and sertraline.³ Conversely, the SSRI paroxetine has shown higher rates of adverse sexual events than other SSRIs, such as fluoxetine and fluvoxamine, and the serotonin reuptake inhibitor/antagonist nefazodone.³

EVIDENCE SUMMARY

In a meta-analysis of 31 studies with 10,130 patients, researchers reported that the total rate of sexual dysfunction (SD) associated with selective serotonin reuptake inhibitors (SSRIs) was significantly higher than the placebo rate of 14.2% (TABLE).¹ The SSRIs citalopram, fluoxetine, paroxetine, and sertraline as well as the SNRI venlafaxine, had significantly greater rates (70%-80%) of reported total sexual dysfunction, including desire, arousal, and orgasm, than placebo.

Bupropion has sexual dysfunction rates comparable to placebo

Other SSRIs (fluvoxamine, escitalopram), the tricyclic antidepressant imipramine, and the SNRI duloxetine also had total SD rates significantly greater than placebo. However, the rates of dysfunction with these agents are often lower than the dysfunction rates of SSRIs such as sertraline and citalopram, and thus, may be viewed as falling into an intermediate risk category. The total SD rates for the NDRI bupropion were comparable to the placebo rate.¹

With few exceptions, all drugs associated with overall SD were associated with significant dysfunction affecting the sexual components of desire, arousal, and orgasm. The results of this meta-analysis should be interpreted with some degree of caution because methods of assessing SD varied within individual studies.

AHRQ weighs in

An Agency for Healthcare Research and Quality (AHRQ) review of antidepressants found that paroxetine, citalopram, and venlafaxine, when compared with other antidepressants (fluoxetine, fluvoxamine, nefazodone, sertraline), generally were associated with more reports of SD, specifically complaints of erectile dysfunction in men and decreased vaginal lubrication in women. 2 The number needed to treat one additional person with general sexual functioning satisfaction was 6 (95% CI, 4-9) with buproprion.²

RECOMMENDATIONS

The American College of Physicians’ clinical practice guidelines suggest that although SD is likely underreported, the NDRI bupropion has consistently shown lower rates of associated dysfunction than the SSRIs fluoxetine and sertraline.³ Conversely, the SSRI paroxetine has shown higher rates of adverse sexual events than other SSRIs, such as fluoxetine and fluvoxamine, and the serotonin reuptake inhibitor/antagonist nefazodone.³

EVIDENCE SUMMARY

In a meta-analysis of 31 studies with 10,130 patients, researchers reported that the total rate of sexual dysfunction (SD) associated with selective serotonin reuptake inhibitors (SSRIs) was significantly higher than the placebo rate of 14.2% (TABLE).¹ The SSRIs citalopram, fluoxetine, paroxetine, and sertraline as well as the SNRI venlafaxine, had significantly greater rates (70%-80%) of reported total sexual dysfunction, including desire, arousal, and orgasm, than placebo.

Bupropion has sexual dysfunction rates comparable to placebo

Other SSRIs (fluvoxamine, escitalopram), the tricyclic antidepressant imipramine, and the SNRI duloxetine also had total SD rates significantly greater than placebo. However, the rates of dysfunction with these agents are often lower than the dysfunction rates of SSRIs such as sertraline and citalopram, and thus, may be viewed as falling into an intermediate risk category. The total SD rates for the NDRI bupropion were comparable to the placebo rate.¹

With few exceptions, all drugs associated with overall SD were associated with significant dysfunction affecting the sexual components of desire, arousal, and orgasm. The results of this meta-analysis should be interpreted with some degree of caution because methods of assessing SD varied within individual studies.

AHRQ weighs in

An Agency for Healthcare Research and Quality (AHRQ) review of antidepressants found that paroxetine, citalopram, and venlafaxine, when compared with other antidepressants (fluoxetine, fluvoxamine, nefazodone, sertraline), generally were associated with more reports of SD, specifically complaints of erectile dysfunction in men and decreased vaginal lubrication in women. 2 The number needed to treat one additional person with general sexual functioning satisfaction was 6 (95% CI, 4-9) with buproprion.²

RECOMMENDATIONS

The American College of Physicians’ clinical practice guidelines suggest that although SD is likely underreported, the NDRI bupropion has consistently shown lower rates of associated dysfunction than the SSRIs fluoxetine and sertraline.³ Conversely, the SSRI paroxetine has shown higher rates of adverse sexual events than other SSRIs, such as fluoxetine and fluvoxamine, and the serotonin reuptake inhibitor/antagonist nefazodone.³

Estimates suggest that about 18 million adults in the United States suffer from fecal incontinence.¹ But because the condition often goes unreported by patients and undetected by physicians, the actual prevalence is not known—and may be considerably higher.

What is known is that fecal incontinence carries a substantial socioeconomic burden. The average annual per patient cost is estimated at $4110.² But fecal incontinence also exacts a heavy personal toll, and is one of the main reasons elderly individuals are placed in nursing homes.³

But it’s not just the elderly who are affected. A recent study of women ages 45 years and older found that nearly one in 5 had an episode of fecal incontinence at least once a year, and for nearly half, the frequency was once a month or more.⁴ Less than 3 in 10 reported their symptoms to a clinician, but those who did were most likely to have confided in their primary care physician.⁵

Fortunately, recent developments—most notably, sacral nerve stimulation, a minimally invasive surgical technique with a high success rate—have changed the outlook for patients with fecal incontinence. Here’s what you need to know to help patients who suffer from this embarrassing condition achieve optimal outcomes.

Risk factors and key causes

Maintaining fecal continence involves a complex series of events, both voluntary and involuntary. Problems at various levels—stool consistency, anatomic and neurologic abnormalities, and psychological problems among them—can disrupt the process.

Those at high risk for fecal incontinence, in addition to the elderly, include patients who are mentally ill and institutionalized, individuals with neurologic disorders, patients who have had anorectal surgery, and women who have had vaginal deliveries.^6-8 Obstetric and operative injuries account for most cases of fecal incontinence.^9-10

Risks of vaginal delivery
As many as 25% of women report some degree of fecal incontinence—although often confined to loss of control of flatus—3 months after giving birth.¹¹ Stool incontinence is more frequent among women who sustained third- or fourth-degree perineal tears. Obstetrical risk factors include first vaginal birth, median episiotomy, forceps delivery, vacuum-assisted delivery, and a prolonged second stage of labor.

Asymptomatic sphincter defects. Studies in which women underwent endosonographic examination of the sphincter complex both before and after vaginal delivery have found sphincter defects in anywhere from 7% to 41% of new mothers.^12-14 It is important to note, however, that as many as 70% of those with defects detected by sonogram were asymptomatic.¹⁵ (Despite the risk of sphincter injury during vaginal delivery and evidence suggesting that the risk of fecal incontinence increases with additional deliveries after a previous perineal tear, prophylactic cesarean section is not recommended.)

Fistula surgery and postop incontinence
Fistula surgery is the primary cause of postoperative incontinence, typically resulting from inadvertent injury to either the internal or external sphincter muscle.¹⁶ Other relatively common causes of fecal incontinence are rectal prolapse, trauma, irradiation, neurologic and demyelinating disorders such as multiple sclerosis, neoplasms, stroke, infection (eg, of a perineal wound), and diabetes.¹⁷ As diagnostic modalities have improved, much of what was previously termed idiopathic incontinence has been found to have identifiable underlying pathology, such as pudendal and inferior hypogastric neuropathies.^18-20

Identifying fecal incontinence starts with a single question
As already noted, most patients with symptoms of bowel leakage do not voluntarily mention it to their physician. Many are likely to acknowledge the problem, however, if they’re specifically asked. While little has been written about how best to screen for fecal incontinence, simply adding it to the checklist on your medical intake form may be a good starting point.

Follow up with a targeted history and physical
When a patient checks fecal incontinence on a form or broaches the subject, it is important to question him or her about medical conditions that may be related. These include urinary incontinence, prolapsing tissue, diabetes, and a history of radiation, as well as childbirth. A medication history is also needed, as certain drugs—including some antacids and laxatives—have been implicated in fecal incontinence.²¹

Physical assessment should include a general neurologic exam as well as a perineal exam, to look for prolapsing tissue and evidence of scars from prior surgery or obstetrical trauma. Check the anocutaneous reflex by stroking the perianal skin. Absence of the anal wink in a younger patient is likely associated with nerve damage; in an older patient, it may simply indicate muscle weakness. Perform a digital rectal exam to assess for normal resting tone and augmentation with squeeze, regardless of the patient’s age. 

Absence of the anal wink in a younger patient is likely associated with nerve damage; in an older patient, it may simply indicate muscle weakness.

Use tools to assess the severity

Anal incontinence can be broadly characterized as complete or partial. Numerous other systems have been proposed for classifying severity, the simplest of which has the following 4 components:
A: Continent of solid, liquid, and flatus (complete continence)
B: Continent of solid and liquid, but not flatus
C: Continent of solid, but not liquid or flatus
D: Continued fecal leakage (complete incontinence).²²

Although this classification system may be helpful, it yields little information about the significance of the problem from the patient’s perspective.²³ Thus, scales that take into account both the frequency of incontinence episodes and the extent of both the mental and physical impact are used more frequently.

One of the most widely used scales is the Cleveland Clinic Fecal Incontinence Score (TABLE),²⁴ which quantifies both the frequency and type of incontinence and scores the level of severity. Fecal incontinence quality of life scales are available, as well, and include questions about the impact on the patient’s lifestyle, coping behavior, mood, and level of embarrassment.²⁵

Even without a quality of life scale, a couple of targeted questions—(eg, Are you ever afraid to go out? Do you worry about others smelling stool on you?)—will give you an idea of how great an impact fecal incontinence is having on your patient’s life. Asking patients to keep bowel diaries can also be helpful in assessing the extent of the problem and the effect of treatment.

Next steps: Start with modifiable risks

While there are numerous diagnostic tests for fecal incontinence (more about these in a bit), none is necessary for initial treatment, which starts with modifiable risks. Chief among them is smoking.

Smoking cessation. Nicotine is believed to have a direct effect on colonic transit and rectal compliance.²⁶ Thus, smoking is associated with an increased risk for fecal incontinence, independent of chronic cough or chronic obstructive pulmonary disease. Patients should be advised to quit smoking and referred to a smoking cessation program.

Dietary fiber. Diet may be a factor in fecal incontinence, as well. Ask patients to record everything they eat, and advise those with a low intake of dietary fiber to eat more fruits, vegetables, whole grains, and other high-fiber food. Recommend that they avoid caffeine and alcohol, as well.

Some medications may also affect stool form and frequency, and precipitate fecal incontinence. Common offenders, in addition to laxatives and antacids, include antibiotics, proton pump inhibitors, and senna-based colon cleansers.²⁷ Consider a switch to another drug class. A trial with a drug thought to improve bowel continence is recommended, as well.

Prescribe pharmacologic treatment
Kaolin, pectin, bulking agents, bismuth salts, anticholinergics, opium derivatives, diphenoxylate/atropine, and loperamide have all been used to treat fecal incontinence, with variable success. Loperamide, the drug most extensively studied for this purpose, has been found to increase resting anal pressure and improve anal sphincter function and continence by acting directly on the circular and longitudinal muscles of the bowel.²⁸

Amitriptyline has also been used empirically, with some success. It is believed to work by decreasing the frequency and amplitude of rectal motor complexes.²⁹ Clonidine in the form of a transdermal patch has been shown to increase the number of problem-free days and overall quality of life for patients with fecal incontinence.³⁰

Consider biofeedback
Biofeedback training is often the next step after pharmacologic treatment. It has been investigated for the treatment of fecal incontinence, and many patients—particularly if they are highly motivated—have reported improvement.³¹ Therapy generally has 3 components: exercising the external sphincter complex, training in the discrimination of rectal sensations, and developing synchrony of the internal and external sphincter responses during rectal distension.

The goal is for the patient to learn to contract the sphincter in response to small amounts of rectal distension.

But a significant time commitment on the part of the patient and sophisticated apparatus are necessary to carry out such therapy, and only a few randomized controlled trials (RCTs) have evaluated the effect. The largest RCT had 4 arms: a standard care group; standard care plus instruction on sphincter exercises; standard care with sphincter exercises and biofeedback; and standard care with sphincter exercises, biofeedback, and training at home.³²

All 4 groups had similar improvement in symptoms, raising questions about the therapeutic value of biofeedback.³² Long-term studies have found that 60% to 80% of patients will continue to have episodes of incontinence after undergoing biofeedback. A Cochrane review of RCTs concluded that there is not enough evidence to judge whether sphincter exercises and biofeedback are effective in reducing fecal incontinence.³³Long-term studies have found that 60% to 80% of patients will continue to have episodes of incontinence after undergoing biofeedback.

Still no relief? Order tests and consider surgery

For patients with fecal incontinence refractory to conservative management, more sophisticated diagnostic studies can provide invaluable information for guiding further treatment.

Endoanal ultrasound is considered the gold standard diagnostic test for fecal incontinence. It is superior to electromyography in terms of availability, patient tolerance, and ability to assess the internal anal sphincter, except in cases in which nerve injury is suspected.³⁴

Other tests sometimes used to pinpoint the cause of fecal incontinence include an enema challenge (which can differentiate between liquid and solid incontinence) and anal manometry (which can quantify anal sphincter tone). Defecography (which makes it possible to visualize the rectal emptying process) can be helpful if a diagnosis of rectal prolapse is being considered.

Magnetic resonance imaging is among the most costly diagnostic studies associated with fecal incontinence. But it is the only modality that can depict the morphology of the external sphincter and the presence of muscle atrophy—providing information that has been shown to significantly improve the likelihood of successful sphincter repair.³⁵

A wider range of surgical options

When medical therapy and biofeedback fail to produce adequate results, referral to a colorectal surgeon is appropriate. (Although conservative management is frequently unsuccessful, health plans typically require that they be attempted before surgical intervention is considered.)

Sphincteroplasty, or anterior anal sphincter repair, addresses the most common cause of fecal incontinence—and is still a common surgical procedure.³⁶ Sphincteroplasty generally has good to excellent results, providing there is sufficient muscle mass for a successful repair.^37,38

The procedure involves dissecting the sphincter complex from the surrounding anoderm, then overlapping the edges of the sphincter muscle and suturing them together. Continence has been reported nearly 80% of the time, although a longer duration of fecal incontinence and incontinence secondary to operative injury of the sphincter are risk factors for poorer outcomes.^39,40

Recent studies have called into question the durability of anterior sphincter repair. A systematic review of 16 studies reporting short- and long-term outcomes for more than 900 patients found that all but one of the studies showed a decline over time in the number of patients who were happy with the outcome.³⁹

Sacral nerve stimulation is first-line surgical treatment
Sacral nerve stimulation (SNS) is the most promising development in the treatment of fecal incontinence. In the last decade, SNS has become the first-line surgical treatment for patients for whom medical and behavioral therapy are unsuccessful.⁴⁰

A minimally invasive procedure that involves an implantable device, SNS is always preceded by an effectiveness trial in which a finder needle is percutaneously inserted into the third sacral foramen. Stimulation should result in immediate contraction of the pelvic floor and external sphincter and plantar flexion of the big toe.

The next step is the insertion of a temporary stimulator lead, which remains in place for a 2- to 3-week test of low-frequency stimulation. If significant reduction in the number of incontinence episodes during the trial period occurs, the device is inserted (See “Sacral nerve stimulation: A case study” above).

Improvement in fecal continence has been reported to be as high as 100% in some cases, with up to 75% of patients achieving complete continence.⁴¹ While the mechanism involved remains unclear, multiple studies have confirmed its effectiveness.^42,43

Posterior tibial nerve stimulation is another recent development, in which a small, thin lead is placed at the posterior tibial nerve, then connected to a temporary stimulator. Less data are available for this treatment, but a recent review summarized the findings of 8 published studies and found success rates ranging from 30% to 83%.⁴⁴

The Secca procedure—a relatively new therapy that delivers radiofrequency energy to the anal sphincter—is another option, believed to work by reducing compliance of the sphincter complex and the level of tolerable rectal distension.⁴⁵ Procedures using injectable bulking materials and fat grafting around the sphincter complex have demonstrated some promise, as well.⁴⁶

A number of other surgical modalities are available, and often effective under certain circumstances. Among them are rotational and free muscle transfers, used only in cases in which the bulk of the sphincter complex has been destroyed.^47,48 Implantable anal sphincters (made from human muscle and nerve cells) are occasionally used, as well, but frequently need to be removed because of infection.^49-51

Regardless of the type of treatment they receive, patients often do not achieve total continence. Anyone who continues to have occasional episodes of fecal incontinence or leakage should be advised to wear incontinence pads, as needed.

Consider colostomy when incontinence is severe

For patients with fecal incontinence severe enough to be disabling—often as a result of irradiation—colostomy remains a tried and true treatment. The rectum can either be left intact or a proctectomy performed in concert with ostomy creation. Most studies evaluating colostomy for the treatment of incontinence have found that it significantly improves the quality of life and that most patients say they would choose to undergo the procedure again.⁵²

Estimates suggest that about 18 million adults in the United States suffer from fecal incontinence.¹ But because the condition often goes unreported by patients and undetected by physicians, the actual prevalence is not known—and may be considerably higher.

What is known is that fecal incontinence carries a substantial socioeconomic burden. The average annual per patient cost is estimated at $4110.² But fecal incontinence also exacts a heavy personal toll, and is one of the main reasons elderly individuals are placed in nursing homes.³

But it’s not just the elderly who are affected. A recent study of women ages 45 years and older found that nearly one in 5 had an episode of fecal incontinence at least once a year, and for nearly half, the frequency was once a month or more.⁴ Less than 3 in 10 reported their symptoms to a clinician, but those who did were most likely to have confided in their primary care physician.⁵

Fortunately, recent developments—most notably, sacral nerve stimulation, a minimally invasive surgical technique with a high success rate—have changed the outlook for patients with fecal incontinence. Here’s what you need to know to help patients who suffer from this embarrassing condition achieve optimal outcomes.

Risk factors and key causes

Maintaining fecal continence involves a complex series of events, both voluntary and involuntary. Problems at various levels—stool consistency, anatomic and neurologic abnormalities, and psychological problems among them—can disrupt the process.

Those at high risk for fecal incontinence, in addition to the elderly, include patients who are mentally ill and institutionalized, individuals with neurologic disorders, patients who have had anorectal surgery, and women who have had vaginal deliveries.^6-8 Obstetric and operative injuries account for most cases of fecal incontinence.^9-10

Risks of vaginal delivery
As many as 25% of women report some degree of fecal incontinence—although often confined to loss of control of flatus—3 months after giving birth.¹¹ Stool incontinence is more frequent among women who sustained third- or fourth-degree perineal tears. Obstetrical risk factors include first vaginal birth, median episiotomy, forceps delivery, vacuum-assisted delivery, and a prolonged second stage of labor.

Asymptomatic sphincter defects. Studies in which women underwent endosonographic examination of the sphincter complex both before and after vaginal delivery have found sphincter defects in anywhere from 7% to 41% of new mothers.^12-14 It is important to note, however, that as many as 70% of those with defects detected by sonogram were asymptomatic.¹⁵ (Despite the risk of sphincter injury during vaginal delivery and evidence suggesting that the risk of fecal incontinence increases with additional deliveries after a previous perineal tear, prophylactic cesarean section is not recommended.)

Fistula surgery and postop incontinence
Fistula surgery is the primary cause of postoperative incontinence, typically resulting from inadvertent injury to either the internal or external sphincter muscle.¹⁶ Other relatively common causes of fecal incontinence are rectal prolapse, trauma, irradiation, neurologic and demyelinating disorders such as multiple sclerosis, neoplasms, stroke, infection (eg, of a perineal wound), and diabetes.¹⁷ As diagnostic modalities have improved, much of what was previously termed idiopathic incontinence has been found to have identifiable underlying pathology, such as pudendal and inferior hypogastric neuropathies.^18-20

Identifying fecal incontinence starts with a single question
As already noted, most patients with symptoms of bowel leakage do not voluntarily mention it to their physician. Many are likely to acknowledge the problem, however, if they’re specifically asked. While little has been written about how best to screen for fecal incontinence, simply adding it to the checklist on your medical intake form may be a good starting point.

Follow up with a targeted history and physical
When a patient checks fecal incontinence on a form or broaches the subject, it is important to question him or her about medical conditions that may be related. These include urinary incontinence, prolapsing tissue, diabetes, and a history of radiation, as well as childbirth. A medication history is also needed, as certain drugs—including some antacids and laxatives—have been implicated in fecal incontinence.²¹

Physical assessment should include a general neurologic exam as well as a perineal exam, to look for prolapsing tissue and evidence of scars from prior surgery or obstetrical trauma. Check the anocutaneous reflex by stroking the perianal skin. Absence of the anal wink in a younger patient is likely associated with nerve damage; in an older patient, it may simply indicate muscle weakness. Perform a digital rectal exam to assess for normal resting tone and augmentation with squeeze, regardless of the patient’s age. 

Absence of the anal wink in a younger patient is likely associated with nerve damage; in an older patient, it may simply indicate muscle weakness.

Use tools to assess the severity

Anal incontinence can be broadly characterized as complete or partial. Numerous other systems have been proposed for classifying severity, the simplest of which has the following 4 components:
A: Continent of solid, liquid, and flatus (complete continence)
B: Continent of solid and liquid, but not flatus
C: Continent of solid, but not liquid or flatus
D: Continued fecal leakage (complete incontinence).²²

Although this classification system may be helpful, it yields little information about the significance of the problem from the patient’s perspective.²³ Thus, scales that take into account both the frequency of incontinence episodes and the extent of both the mental and physical impact are used more frequently.

One of the most widely used scales is the Cleveland Clinic Fecal Incontinence Score (TABLE),²⁴ which quantifies both the frequency and type of incontinence and scores the level of severity. Fecal incontinence quality of life scales are available, as well, and include questions about the impact on the patient’s lifestyle, coping behavior, mood, and level of embarrassment.²⁵

Even without a quality of life scale, a couple of targeted questions—(eg, Are you ever afraid to go out? Do you worry about others smelling stool on you?)—will give you an idea of how great an impact fecal incontinence is having on your patient’s life. Asking patients to keep bowel diaries can also be helpful in assessing the extent of the problem and the effect of treatment.

Next steps: Start with modifiable risks

While there are numerous diagnostic tests for fecal incontinence (more about these in a bit), none is necessary for initial treatment, which starts with modifiable risks. Chief among them is smoking.

Smoking cessation. Nicotine is believed to have a direct effect on colonic transit and rectal compliance.²⁶ Thus, smoking is associated with an increased risk for fecal incontinence, independent of chronic cough or chronic obstructive pulmonary disease. Patients should be advised to quit smoking and referred to a smoking cessation program.

Dietary fiber. Diet may be a factor in fecal incontinence, as well. Ask patients to record everything they eat, and advise those with a low intake of dietary fiber to eat more fruits, vegetables, whole grains, and other high-fiber food. Recommend that they avoid caffeine and alcohol, as well.

Some medications may also affect stool form and frequency, and precipitate fecal incontinence. Common offenders, in addition to laxatives and antacids, include antibiotics, proton pump inhibitors, and senna-based colon cleansers.²⁷ Consider a switch to another drug class. A trial with a drug thought to improve bowel continence is recommended, as well.

Prescribe pharmacologic treatment
Kaolin, pectin, bulking agents, bismuth salts, anticholinergics, opium derivatives, diphenoxylate/atropine, and loperamide have all been used to treat fecal incontinence, with variable success. Loperamide, the drug most extensively studied for this purpose, has been found to increase resting anal pressure and improve anal sphincter function and continence by acting directly on the circular and longitudinal muscles of the bowel.²⁸

Amitriptyline has also been used empirically, with some success. It is believed to work by decreasing the frequency and amplitude of rectal motor complexes.²⁹ Clonidine in the form of a transdermal patch has been shown to increase the number of problem-free days and overall quality of life for patients with fecal incontinence.³⁰

Consider biofeedback
Biofeedback training is often the next step after pharmacologic treatment. It has been investigated for the treatment of fecal incontinence, and many patients—particularly if they are highly motivated—have reported improvement.³¹ Therapy generally has 3 components: exercising the external sphincter complex, training in the discrimination of rectal sensations, and developing synchrony of the internal and external sphincter responses during rectal distension.

The goal is for the patient to learn to contract the sphincter in response to small amounts of rectal distension.

But a significant time commitment on the part of the patient and sophisticated apparatus are necessary to carry out such therapy, and only a few randomized controlled trials (RCTs) have evaluated the effect. The largest RCT had 4 arms: a standard care group; standard care plus instruction on sphincter exercises; standard care with sphincter exercises and biofeedback; and standard care with sphincter exercises, biofeedback, and training at home.³²

All 4 groups had similar improvement in symptoms, raising questions about the therapeutic value of biofeedback.³² Long-term studies have found that 60% to 80% of patients will continue to have episodes of incontinence after undergoing biofeedback. A Cochrane review of RCTs concluded that there is not enough evidence to judge whether sphincter exercises and biofeedback are effective in reducing fecal incontinence.³³Long-term studies have found that 60% to 80% of patients will continue to have episodes of incontinence after undergoing biofeedback.

Still no relief? Order tests and consider surgery

For patients with fecal incontinence refractory to conservative management, more sophisticated diagnostic studies can provide invaluable information for guiding further treatment.

Endoanal ultrasound is considered the gold standard diagnostic test for fecal incontinence. It is superior to electromyography in terms of availability, patient tolerance, and ability to assess the internal anal sphincter, except in cases in which nerve injury is suspected.³⁴

Other tests sometimes used to pinpoint the cause of fecal incontinence include an enema challenge (which can differentiate between liquid and solid incontinence) and anal manometry (which can quantify anal sphincter tone). Defecography (which makes it possible to visualize the rectal emptying process) can be helpful if a diagnosis of rectal prolapse is being considered.

Magnetic resonance imaging is among the most costly diagnostic studies associated with fecal incontinence. But it is the only modality that can depict the morphology of the external sphincter and the presence of muscle atrophy—providing information that has been shown to significantly improve the likelihood of successful sphincter repair.³⁵

A wider range of surgical options

When medical therapy and biofeedback fail to produce adequate results, referral to a colorectal surgeon is appropriate. (Although conservative management is frequently unsuccessful, health plans typically require that they be attempted before surgical intervention is considered.)

Sphincteroplasty, or anterior anal sphincter repair, addresses the most common cause of fecal incontinence—and is still a common surgical procedure.³⁶ Sphincteroplasty generally has good to excellent results, providing there is sufficient muscle mass for a successful repair.^37,38

The procedure involves dissecting the sphincter complex from the surrounding anoderm, then overlapping the edges of the sphincter muscle and suturing them together. Continence has been reported nearly 80% of the time, although a longer duration of fecal incontinence and incontinence secondary to operative injury of the sphincter are risk factors for poorer outcomes.^39,40

Recent studies have called into question the durability of anterior sphincter repair. A systematic review of 16 studies reporting short- and long-term outcomes for more than 900 patients found that all but one of the studies showed a decline over time in the number of patients who were happy with the outcome.³⁹

Sacral nerve stimulation is first-line surgical treatment
Sacral nerve stimulation (SNS) is the most promising development in the treatment of fecal incontinence. In the last decade, SNS has become the first-line surgical treatment for patients for whom medical and behavioral therapy are unsuccessful.⁴⁰

A minimally invasive procedure that involves an implantable device, SNS is always preceded by an effectiveness trial in which a finder needle is percutaneously inserted into the third sacral foramen. Stimulation should result in immediate contraction of the pelvic floor and external sphincter and plantar flexion of the big toe.

The next step is the insertion of a temporary stimulator lead, which remains in place for a 2- to 3-week test of low-frequency stimulation. If significant reduction in the number of incontinence episodes during the trial period occurs, the device is inserted (See “Sacral nerve stimulation: A case study” above).

Improvement in fecal continence has been reported to be as high as 100% in some cases, with up to 75% of patients achieving complete continence.⁴¹ While the mechanism involved remains unclear, multiple studies have confirmed its effectiveness.^42,43

Posterior tibial nerve stimulation is another recent development, in which a small, thin lead is placed at the posterior tibial nerve, then connected to a temporary stimulator. Less data are available for this treatment, but a recent review summarized the findings of 8 published studies and found success rates ranging from 30% to 83%.⁴⁴

The Secca procedure—a relatively new therapy that delivers radiofrequency energy to the anal sphincter—is another option, believed to work by reducing compliance of the sphincter complex and the level of tolerable rectal distension.⁴⁵ Procedures using injectable bulking materials and fat grafting around the sphincter complex have demonstrated some promise, as well.⁴⁶

A number of other surgical modalities are available, and often effective under certain circumstances. Among them are rotational and free muscle transfers, used only in cases in which the bulk of the sphincter complex has been destroyed.^47,48 Implantable anal sphincters (made from human muscle and nerve cells) are occasionally used, as well, but frequently need to be removed because of infection.^49-51

Regardless of the type of treatment they receive, patients often do not achieve total continence. Anyone who continues to have occasional episodes of fecal incontinence or leakage should be advised to wear incontinence pads, as needed.

Consider colostomy when incontinence is severe

For patients with fecal incontinence severe enough to be disabling—often as a result of irradiation—colostomy remains a tried and true treatment. The rectum can either be left intact or a proctectomy performed in concert with ostomy creation. Most studies evaluating colostomy for the treatment of incontinence have found that it significantly improves the quality of life and that most patients say they would choose to undergo the procedure again.⁵²

Estimates suggest that about 18 million adults in the United States suffer from fecal incontinence.¹ But because the condition often goes unreported by patients and undetected by physicians, the actual prevalence is not known—and may be considerably higher.

What is known is that fecal incontinence carries a substantial socioeconomic burden. The average annual per patient cost is estimated at $4110.² But fecal incontinence also exacts a heavy personal toll, and is one of the main reasons elderly individuals are placed in nursing homes.³

But it’s not just the elderly who are affected. A recent study of women ages 45 years and older found that nearly one in 5 had an episode of fecal incontinence at least once a year, and for nearly half, the frequency was once a month or more.⁴ Less than 3 in 10 reported their symptoms to a clinician, but those who did were most likely to have confided in their primary care physician.⁵

Fortunately, recent developments—most notably, sacral nerve stimulation, a minimally invasive surgical technique with a high success rate—have changed the outlook for patients with fecal incontinence. Here’s what you need to know to help patients who suffer from this embarrassing condition achieve optimal outcomes.

Risk factors and key causes

Maintaining fecal continence involves a complex series of events, both voluntary and involuntary. Problems at various levels—stool consistency, anatomic and neurologic abnormalities, and psychological problems among them—can disrupt the process.

Those at high risk for fecal incontinence, in addition to the elderly, include patients who are mentally ill and institutionalized, individuals with neurologic disorders, patients who have had anorectal surgery, and women who have had vaginal deliveries.^6-8 Obstetric and operative injuries account for most cases of fecal incontinence.^9-10

Risks of vaginal delivery
As many as 25% of women report some degree of fecal incontinence—although often confined to loss of control of flatus—3 months after giving birth.¹¹ Stool incontinence is more frequent among women who sustained third- or fourth-degree perineal tears. Obstetrical risk factors include first vaginal birth, median episiotomy, forceps delivery, vacuum-assisted delivery, and a prolonged second stage of labor.

Asymptomatic sphincter defects. Studies in which women underwent endosonographic examination of the sphincter complex both before and after vaginal delivery have found sphincter defects in anywhere from 7% to 41% of new mothers.^12-14 It is important to note, however, that as many as 70% of those with defects detected by sonogram were asymptomatic.¹⁵ (Despite the risk of sphincter injury during vaginal delivery and evidence suggesting that the risk of fecal incontinence increases with additional deliveries after a previous perineal tear, prophylactic cesarean section is not recommended.)

Fistula surgery and postop incontinence
Fistula surgery is the primary cause of postoperative incontinence, typically resulting from inadvertent injury to either the internal or external sphincter muscle.¹⁶ Other relatively common causes of fecal incontinence are rectal prolapse, trauma, irradiation, neurologic and demyelinating disorders such as multiple sclerosis, neoplasms, stroke, infection (eg, of a perineal wound), and diabetes.¹⁷ As diagnostic modalities have improved, much of what was previously termed idiopathic incontinence has been found to have identifiable underlying pathology, such as pudendal and inferior hypogastric neuropathies.^18-20

Identifying fecal incontinence starts with a single question
As already noted, most patients with symptoms of bowel leakage do not voluntarily mention it to their physician. Many are likely to acknowledge the problem, however, if they’re specifically asked. While little has been written about how best to screen for fecal incontinence, simply adding it to the checklist on your medical intake form may be a good starting point.

Follow up with a targeted history and physical
When a patient checks fecal incontinence on a form or broaches the subject, it is important to question him or her about medical conditions that may be related. These include urinary incontinence, prolapsing tissue, diabetes, and a history of radiation, as well as childbirth. A medication history is also needed, as certain drugs—including some antacids and laxatives—have been implicated in fecal incontinence.²¹

Physical assessment should include a general neurologic exam as well as a perineal exam, to look for prolapsing tissue and evidence of scars from prior surgery or obstetrical trauma. Check the anocutaneous reflex by stroking the perianal skin. Absence of the anal wink in a younger patient is likely associated with nerve damage; in an older patient, it may simply indicate muscle weakness. Perform a digital rectal exam to assess for normal resting tone and augmentation with squeeze, regardless of the patient’s age. 

Absence of the anal wink in a younger patient is likely associated with nerve damage; in an older patient, it may simply indicate muscle weakness.

Use tools to assess the severity

Anal incontinence can be broadly characterized as complete or partial. Numerous other systems have been proposed for classifying severity, the simplest of which has the following 4 components:
A: Continent of solid, liquid, and flatus (complete continence)
B: Continent of solid and liquid, but not flatus
C: Continent of solid, but not liquid or flatus
D: Continued fecal leakage (complete incontinence).²²

Although this classification system may be helpful, it yields little information about the significance of the problem from the patient’s perspective.²³ Thus, scales that take into account both the frequency of incontinence episodes and the extent of both the mental and physical impact are used more frequently.

One of the most widely used scales is the Cleveland Clinic Fecal Incontinence Score (TABLE),²⁴ which quantifies both the frequency and type of incontinence and scores the level of severity. Fecal incontinence quality of life scales are available, as well, and include questions about the impact on the patient’s lifestyle, coping behavior, mood, and level of embarrassment.²⁵

Even without a quality of life scale, a couple of targeted questions—(eg, Are you ever afraid to go out? Do you worry about others smelling stool on you?)—will give you an idea of how great an impact fecal incontinence is having on your patient’s life. Asking patients to keep bowel diaries can also be helpful in assessing the extent of the problem and the effect of treatment.

Next steps: Start with modifiable risks

While there are numerous diagnostic tests for fecal incontinence (more about these in a bit), none is necessary for initial treatment, which starts with modifiable risks. Chief among them is smoking.

Smoking cessation. Nicotine is believed to have a direct effect on colonic transit and rectal compliance.²⁶ Thus, smoking is associated with an increased risk for fecal incontinence, independent of chronic cough or chronic obstructive pulmonary disease. Patients should be advised to quit smoking and referred to a smoking cessation program.

Dietary fiber. Diet may be a factor in fecal incontinence, as well. Ask patients to record everything they eat, and advise those with a low intake of dietary fiber to eat more fruits, vegetables, whole grains, and other high-fiber food. Recommend that they avoid caffeine and alcohol, as well.

Some medications may also affect stool form and frequency, and precipitate fecal incontinence. Common offenders, in addition to laxatives and antacids, include antibiotics, proton pump inhibitors, and senna-based colon cleansers.²⁷ Consider a switch to another drug class. A trial with a drug thought to improve bowel continence is recommended, as well.

Prescribe pharmacologic treatment
Kaolin, pectin, bulking agents, bismuth salts, anticholinergics, opium derivatives, diphenoxylate/atropine, and loperamide have all been used to treat fecal incontinence, with variable success. Loperamide, the drug most extensively studied for this purpose, has been found to increase resting anal pressure and improve anal sphincter function and continence by acting directly on the circular and longitudinal muscles of the bowel.²⁸

Amitriptyline has also been used empirically, with some success. It is believed to work by decreasing the frequency and amplitude of rectal motor complexes.²⁹ Clonidine in the form of a transdermal patch has been shown to increase the number of problem-free days and overall quality of life for patients with fecal incontinence.³⁰

Consider biofeedback
Biofeedback training is often the next step after pharmacologic treatment. It has been investigated for the treatment of fecal incontinence, and many patients—particularly if they are highly motivated—have reported improvement.³¹ Therapy generally has 3 components: exercising the external sphincter complex, training in the discrimination of rectal sensations, and developing synchrony of the internal and external sphincter responses during rectal distension.

The goal is for the patient to learn to contract the sphincter in response to small amounts of rectal distension.

But a significant time commitment on the part of the patient and sophisticated apparatus are necessary to carry out such therapy, and only a few randomized controlled trials (RCTs) have evaluated the effect. The largest RCT had 4 arms: a standard care group; standard care plus instruction on sphincter exercises; standard care with sphincter exercises and biofeedback; and standard care with sphincter exercises, biofeedback, and training at home.³²

All 4 groups had similar improvement in symptoms, raising questions about the therapeutic value of biofeedback.³² Long-term studies have found that 60% to 80% of patients will continue to have episodes of incontinence after undergoing biofeedback. A Cochrane review of RCTs concluded that there is not enough evidence to judge whether sphincter exercises and biofeedback are effective in reducing fecal incontinence.³³Long-term studies have found that 60% to 80% of patients will continue to have episodes of incontinence after undergoing biofeedback.

Still no relief? Order tests and consider surgery

For patients with fecal incontinence refractory to conservative management, more sophisticated diagnostic studies can provide invaluable information for guiding further treatment.

Endoanal ultrasound is considered the gold standard diagnostic test for fecal incontinence. It is superior to electromyography in terms of availability, patient tolerance, and ability to assess the internal anal sphincter, except in cases in which nerve injury is suspected.³⁴

Other tests sometimes used to pinpoint the cause of fecal incontinence include an enema challenge (which can differentiate between liquid and solid incontinence) and anal manometry (which can quantify anal sphincter tone). Defecography (which makes it possible to visualize the rectal emptying process) can be helpful if a diagnosis of rectal prolapse is being considered.

Magnetic resonance imaging is among the most costly diagnostic studies associated with fecal incontinence. But it is the only modality that can depict the morphology of the external sphincter and the presence of muscle atrophy—providing information that has been shown to significantly improve the likelihood of successful sphincter repair.³⁵

A wider range of surgical options

When medical therapy and biofeedback fail to produce adequate results, referral to a colorectal surgeon is appropriate. (Although conservative management is frequently unsuccessful, health plans typically require that they be attempted before surgical intervention is considered.)

Sphincteroplasty, or anterior anal sphincter repair, addresses the most common cause of fecal incontinence—and is still a common surgical procedure.³⁶ Sphincteroplasty generally has good to excellent results, providing there is sufficient muscle mass for a successful repair.^37,38

The procedure involves dissecting the sphincter complex from the surrounding anoderm, then overlapping the edges of the sphincter muscle and suturing them together. Continence has been reported nearly 80% of the time, although a longer duration of fecal incontinence and incontinence secondary to operative injury of the sphincter are risk factors for poorer outcomes.^39,40

Recent studies have called into question the durability of anterior sphincter repair. A systematic review of 16 studies reporting short- and long-term outcomes for more than 900 patients found that all but one of the studies showed a decline over time in the number of patients who were happy with the outcome.³⁹

Sacral nerve stimulation is first-line surgical treatment
Sacral nerve stimulation (SNS) is the most promising development in the treatment of fecal incontinence. In the last decade, SNS has become the first-line surgical treatment for patients for whom medical and behavioral therapy are unsuccessful.⁴⁰

A minimally invasive procedure that involves an implantable device, SNS is always preceded by an effectiveness trial in which a finder needle is percutaneously inserted into the third sacral foramen. Stimulation should result in immediate contraction of the pelvic floor and external sphincter and plantar flexion of the big toe.

The next step is the insertion of a temporary stimulator lead, which remains in place for a 2- to 3-week test of low-frequency stimulation. If significant reduction in the number of incontinence episodes during the trial period occurs, the device is inserted (See “Sacral nerve stimulation: A case study” above).

Improvement in fecal continence has been reported to be as high as 100% in some cases, with up to 75% of patients achieving complete continence.⁴¹ While the mechanism involved remains unclear, multiple studies have confirmed its effectiveness.^42,43

Posterior tibial nerve stimulation is another recent development, in which a small, thin lead is placed at the posterior tibial nerve, then connected to a temporary stimulator. Less data are available for this treatment, but a recent review summarized the findings of 8 published studies and found success rates ranging from 30% to 83%.⁴⁴

The Secca procedure—a relatively new therapy that delivers radiofrequency energy to the anal sphincter—is another option, believed to work by reducing compliance of the sphincter complex and the level of tolerable rectal distension.⁴⁵ Procedures using injectable bulking materials and fat grafting around the sphincter complex have demonstrated some promise, as well.⁴⁶

A number of other surgical modalities are available, and often effective under certain circumstances. Among them are rotational and free muscle transfers, used only in cases in which the bulk of the sphincter complex has been destroyed.^47,48 Implantable anal sphincters (made from human muscle and nerve cells) are occasionally used, as well, but frequently need to be removed because of infection.^49-51

Regardless of the type of treatment they receive, patients often do not achieve total continence. Anyone who continues to have occasional episodes of fecal incontinence or leakage should be advised to wear incontinence pads, as needed.

Consider colostomy when incontinence is severe

For patients with fecal incontinence severe enough to be disabling—often as a result of irradiation—colostomy remains a tried and true treatment. The rectum can either be left intact or a proctectomy performed in concert with ostomy creation. Most studies evaluating colostomy for the treatment of incontinence have found that it significantly improves the quality of life and that most patients say they would choose to undergo the procedure again.⁵²

A woman in her 50s underwent hysterectomy performed by a surgeon, who then assigned an ObGyn to her follow-up care. The day after surgery, the patient had severe abdominal pain with decreased blood pressure and increased heart and respiration rates. The ObGyn admitted the patient to the intensive care unit (ICU), and then designated Dr. A, the patient’s family practitioner to continue her care. Dr. A was not available, so his associate, Dr. B, took over. Over the phone, Dr. B requested pulmonary, cardiology, and infectious disease consults. In the ICU the next day, the patient suffered respiratory arrest and was intubated. When her abdomen became rigid and swollen, emergency surgery revealed that a colon perforation had allowed fecal matter to reach the abdominal cavity. The woman died the next day from complications of sepsis, peritonitis, and multiple organ failure.

ESTATE’S CLAIM None of the physicians assigned to her care ever saw the patient in the ICU. Earlier surgery could have prevented her death. The physicians involved in her care failed to communicate with each other properly.

DEFENDANTS’ DEFENSE The case was settled during the trial.

VERDICT A $3.2 million Illinois settlement was reached with the hospital.

BOTH PARENTS HAD PLATELET ANTIBODIES
When a 32-year-old woman became pregnant with her third child, she sought treatment at a clinic. The mother informed the nurse practi-tioner that her two other children had been diagnosed with low platelets at birth, but they were now healthy and had no further problems.

The woman gave birth vaginally to her third child at term. The newborn had Apgar scores of 8 and 8, at 1 and 5 minutes, respectively. However, the child’s platelet level was 26 x 103/µL. The baby was transferred to another hospital the next day, where he was diagnosed with hydrocephalus and neonatal alloimmune thrombocytopenia. He suffered a massive intracranial hemorrhage, which caused severe neurologic injuries and brain damage. A shunt was placed. The child has significant cognitive deficits as well as cerebral palsy with mild developmental delays. Testing showed that each parent had a different genotype for platelet antibodies.

PARENTS’ CLAIM The parents should have been tested for platelet antibodies prior to this birth due to the family’s history. A prenatal diagnosis of neonatal alloimmune thrombocytopenia would have allowed for treatment with gamma globulin, which could have avoided the intracranial hemorrhage.

DEFENDANTS’ DEFENSE The case was settled during the trial.  

VERDICT A $4.8 million California settlement was reached.

CORD PROLAPSE NOT CARED FOR IN AMBULANCE
At 36 weeks’ gestation, a mother called an ambulance when her membranes ruptured and she noticed an umbilical cord prolapse.

The child was in a breech presentation, experienced oxygen deprivation, and sustained severe neurologic damage.

PARENTS’ CLAIM The ambulance service was negligent in its care. The ambulance service dispatcher advised the mother to stand, squat, and push before the ambulance arrived. The ambulance attendants failed to take basic actions to relieve pressure on the prolapsed umbilical cord. The ambulance did not stop at two closer hospitals, which delayed arrival for an additional 20 minutes.

DEFENDANTS’ DEFENSE The case was settled during the trial.

VERDICT A $2.7 million settlement was reached, but before it was submitted to the court for approval, the child died. The defendants then sought to revoke the settlement, but the parents claimed breach of contract. The defendants claimed that the agreement was orally negotiated independent of defense counsel and was unenforceable due to the child’s death and lack of court approval. A Texas judge issued summary judgment on breach of contract and awarded $2.7 million plus $40,000 in attorney fees to the parents.    

SECOND- AND THIRD-DEGREE BURNS TO PERINEUM
A mother received an epidural injection during vaginal delivery. Six hours later, the patient asked a nurse for a warm compress to place on her perineum. The nurse heated the compress in a microwave and then applied it to the perineal area. The compress caused second- and third-degree burns to the patient’s labia and inner left thigh. She underwent surgical repair of the burned area, and, a year later, had plastic surgery.

PATIENT’S CLAIM The nurse was negligent in overheating the compress.

DEFENDANTS’ DEFENSE The hospital agreed that the nurse who heated and applied the compress had been negligent. The hospital paid all medical expenses relating to the burns, including follow-up surgeries. 

VERDICT A $190,000 Utah verdict was returned for noneconomic damages.

DOCUMENTATION MAKES A DIFFERENCE FOR OBGYN AFTER CHILD DIES
A 30-year-old physician was pregnant with her first child. Due to a low amniotic fluid index and lagging fetal growth, she saw a maternal-fetal medicine specialist, who suggested labor induction at 39 weeks.

Labor progressed slowly. After three attempts at vacuum-assisted delivery, the ObGyn recommended cesarean delivery. The parents eventually consented to cesarean delivery after another failed vacuum-assisted attempt. Although the ObGyn had recommended cesarean 2 hours earlier, surgery was not ordered on an emergent basis.

At birth, the baby’s resuscitation took more than 20 minutes. The child lost nearly one-third of her blood volume; she had a subgaleal hemorrhage. Both parties agreed that the vacuum device probably caused the bleeding.

The child had hypoxic ischemic encephalopathy and disseminated intravascular coagulation. She suffered a myocardial infarction at 3 days of age. Without electrical brain activity, life support was removed, and the child died at 5 days of age. An autopsy found possible hypereosinophilic syndrome as the concurrent cause of death.

PARENTS’ CLAIM The mother claimed she was not informed of the risks, benefits, and alternatives to vacuum extraction; she would not have consented had she known the risks. The mother, her husband, and two family members maintained that the ObGyn offered the possibility of cesarean delivery as a question, but did not insist on it. The mother claimed she wanted what was best for the baby, and never refused a cesarean. The resuscitation efforts caused eosinophilic infiltration into several organs.

PHYSICIAN’S DEFENSE The ObGyn charted that the parents were “adamant about having a vaginal delivery,” and said she told the parents what she charted. The obstetric nurse testified that the mother delayed consent because she felt vaginal delivery was imminent. The ObGyn acted properly; eosinophilia caused the baby’s death.  

VERDICT An Illinois defense verdict was returned.

HIGH BP TO BLAME FOR DEATHS OF BOTH MOTHER AND CHILD
A 23-year-old woman’s pregnancy was at high risk because of very high blood pressure (BP). At 34 weeks’ gestation, she went to a county hospital with symptoms of high BP; she was treated and discharged 3 days later. She returned to the hospital to be checked twice more within a month. The day after the third visit, she suffered a seizure and was taken to a university hospital, where emergency cesarean delivery was performed. The mother died from an aortic rupture during delivery.

The child was born with brain injuries and died at age 4 years due to neurologic complications.

ESTATE’S CLAIM The mother was not properly treated at the county hospital, resulting in both deaths; she should not have been discharged. Under monitoring, she would have undergone delivery before the aortic rupture occurred, avoiding the baby’s brain injury.

DEFENDANTS’ DEFENSE The mother was stable when released; aortic rupture is unpredictable and unpreventable, and would have occurred under any circumstances. It is highly unusual that a woman of her age would have an aortic rupture.

VERDICT A $3,062,803 California verdict was returned. The parties then settled for $1,782,000 (with the county assuming the medical lien).

NECROTIZING FASCIITIS FROM PERFORATED COLON
A woman underwent laparoscopic-assisted vaginal hysterectomy performed by her ObGyn, and was discharged after 3 days. The next day, she went to another hospital’s emergency department (ED) with abdominal distention and rigidity, severe abdominal pain, and vomiting. She had a toxic appearance, rapid pulse rate, and hypotension. In emergency surgery, several liters of dark brown, foul-smelling fluid were found in her abdomen, and feculent peritonitis and necrotizing fasciitis were diagnosed due to a perforated sigmoid colon. She required multiple hospitalizations and operations.

PATIENT’S CLAIM Perforation occur­red during hysterectomy. The ObGyn failed to recognize the injury prior to discharge. The hospital staff did not properly assess her or communicate her symptoms to the ObGyn.

DEFENDANTS’ DEFENSE There was no negligence; proper care was given.

VERDICT A $2,922,503 Florida verdict was returned, with the jury finding the ObGyn 30% at fault and the hospital 70% at fault.

FAILURE TO REACT TO FETAL DISTRESS: $15.6M
After delivery at full term, a child suffered convulsions and seizures on her second day of life. A CT scan showed brain injuries. At age 11 years, she has severe learning and developmental delays, and requires 24-hour care.

PARENTS’ CLAIM Severe decelerations with slow return to baseline occurred several times during labor and delivery. The nurse midwife failed to recognize and react to fetal distress. A cesarean delivery should have been performed instead of a vaginal delivery. The delay in delivery caused the child’s injuries.

DEFENDANTS’ DEFENSE A prenatal neurogenetic disorder caused the child’s injuries. 

VERDICT A $15.6 million Maryland verdict was returned. It will not be automatically reduced; the awarded noneconomic damages do not exceed the state cap.

LATE DELIVERY; SEVERE INJURY TO CHILD
At 40 weeks’ gestation, a woman was admitted to the hospital in labor. When the mother’s membranes were ruptured, a small amount of meconium was noted, but the fetal monitor strips were reassuring. Two hours later, the nurse and midwife noted a pattern of decelerations, but they felt the pattern was nonrepetitive and reactive. Thirty minutes later, the nurse and midwife noted decelerations to 90 bpm with pushing, but did not call a physician.

Another midwife arrived to assist the first midwife who was new to practice. The mother was given oxygen, her position was changed, and an IV fluid bolus was administered. Thirty minutes later, the nurses recognized late decelerations and called a Code White twice while the fetal heart rate continued to decelerate. After the attending physician unsuccessfully attempted vacuum extraction, an emergency cesarean delivery was performed.

The child’s Apgar scores were 2, 3, and 3, at 1, 5, and 10 minutes, respectively. The cord blood pH was 6.66, indicating severe metabolic acidosis. She developed seizures within the first few minutes of life. Imaging studies showed global hypoxic ischemic encephalopathy. The child cannot walk, talk, or sit up unsupported at age 8, and requires a G-tube. She is cortically blind and requires antiseizure medication.

PARENTS’ CLAIM The nurse, two midwives, and physician were negligent in their care of the mother and child.

DEFENDANTS’ DEFENSE The case was settled during the trial.  

VERDICT A $5 million Massachusetts settlement was reached.

WHAT CAUSED INFECTION AFTER ABORTION?
A 20-year-old woman underwent a surgical termination of pregnancy performed by an ObGyn. After discharge, the patient developed pain and other complications requiring rehospitalization and additional surgery for a pelvic infection.

PATIENT’S CLAIM Complications were due to a uterine perforation that spontaneously sealed before it could be detected. The ObGyn was negligent in the performance of the elective abortion. The patient has a large scar on her abdomen because of the additional operation.

PHYSICIAN’S DEFENSE Perforation of the uterus is a known complication of the procedure. However, no perforation occurred; it was not found on imaging, and spontaneous sealing of a perforation cannot occur. The patient’s complications were due to a subclinical infection that was activated by the surgery.  

VERDICT A New York defense verdict was returned.

We want to hear from you. Tell us what you think!

These cases were selected by the editors of OBG Management from Medical Malpractice Verdicts, Settlements & Experts, with permission of the editor, Lewis Laska (www.verdictslaska.com). The information available to the editors about the cases presented here is sometimes incomplete. Moreover, the cases may or may not have merit. Nevertheless, these cases represent the types of clinical situations that typically result in litigation and are meant to illustrate nationwide variation in jury verdicts and awards.

A woman in her 50s underwent hysterectomy performed by a surgeon, who then assigned an ObGyn to her follow-up care. The day after surgery, the patient had severe abdominal pain with decreased blood pressure and increased heart and respiration rates. The ObGyn admitted the patient to the intensive care unit (ICU), and then designated Dr. A, the patient’s family practitioner to continue her care. Dr. A was not available, so his associate, Dr. B, took over. Over the phone, Dr. B requested pulmonary, cardiology, and infectious disease consults. In the ICU the next day, the patient suffered respiratory arrest and was intubated. When her abdomen became rigid and swollen, emergency surgery revealed that a colon perforation had allowed fecal matter to reach the abdominal cavity. The woman died the next day from complications of sepsis, peritonitis, and multiple organ failure.

ESTATE’S CLAIM None of the physicians assigned to her care ever saw the patient in the ICU. Earlier surgery could have prevented her death. The physicians involved in her care failed to communicate with each other properly.

DEFENDANTS’ DEFENSE The case was settled during the trial.

VERDICT A $3.2 million Illinois settlement was reached with the hospital.

BOTH PARENTS HAD PLATELET ANTIBODIES
When a 32-year-old woman became pregnant with her third child, she sought treatment at a clinic. The mother informed the nurse practi-tioner that her two other children had been diagnosed with low platelets at birth, but they were now healthy and had no further problems.

The woman gave birth vaginally to her third child at term. The newborn had Apgar scores of 8 and 8, at 1 and 5 minutes, respectively. However, the child’s platelet level was 26 x 103/µL. The baby was transferred to another hospital the next day, where he was diagnosed with hydrocephalus and neonatal alloimmune thrombocytopenia. He suffered a massive intracranial hemorrhage, which caused severe neurologic injuries and brain damage. A shunt was placed. The child has significant cognitive deficits as well as cerebral palsy with mild developmental delays. Testing showed that each parent had a different genotype for platelet antibodies.

PARENTS’ CLAIM The parents should have been tested for platelet antibodies prior to this birth due to the family’s history. A prenatal diagnosis of neonatal alloimmune thrombocytopenia would have allowed for treatment with gamma globulin, which could have avoided the intracranial hemorrhage.

DEFENDANTS’ DEFENSE The case was settled during the trial.  

VERDICT A $4.8 million California settlement was reached.

CORD PROLAPSE NOT CARED FOR IN AMBULANCE
At 36 weeks’ gestation, a mother called an ambulance when her membranes ruptured and she noticed an umbilical cord prolapse.

The child was in a breech presentation, experienced oxygen deprivation, and sustained severe neurologic damage.

PARENTS’ CLAIM The ambulance service was negligent in its care. The ambulance service dispatcher advised the mother to stand, squat, and push before the ambulance arrived. The ambulance attendants failed to take basic actions to relieve pressure on the prolapsed umbilical cord. The ambulance did not stop at two closer hospitals, which delayed arrival for an additional 20 minutes.

DEFENDANTS’ DEFENSE The case was settled during the trial.

VERDICT A $2.7 million settlement was reached, but before it was submitted to the court for approval, the child died. The defendants then sought to revoke the settlement, but the parents claimed breach of contract. The defendants claimed that the agreement was orally negotiated independent of defense counsel and was unenforceable due to the child’s death and lack of court approval. A Texas judge issued summary judgment on breach of contract and awarded $2.7 million plus $40,000 in attorney fees to the parents.    

SECOND- AND THIRD-DEGREE BURNS TO PERINEUM
A mother received an epidural injection during vaginal delivery. Six hours later, the patient asked a nurse for a warm compress to place on her perineum. The nurse heated the compress in a microwave and then applied it to the perineal area. The compress caused second- and third-degree burns to the patient’s labia and inner left thigh. She underwent surgical repair of the burned area, and, a year later, had plastic surgery.

PATIENT’S CLAIM The nurse was negligent in overheating the compress.

DEFENDANTS’ DEFENSE The hospital agreed that the nurse who heated and applied the compress had been negligent. The hospital paid all medical expenses relating to the burns, including follow-up surgeries. 

VERDICT A $190,000 Utah verdict was returned for noneconomic damages.

DOCUMENTATION MAKES A DIFFERENCE FOR OBGYN AFTER CHILD DIES
A 30-year-old physician was pregnant with her first child. Due to a low amniotic fluid index and lagging fetal growth, she saw a maternal-fetal medicine specialist, who suggested labor induction at 39 weeks.

Labor progressed slowly. After three attempts at vacuum-assisted delivery, the ObGyn recommended cesarean delivery. The parents eventually consented to cesarean delivery after another failed vacuum-assisted attempt. Although the ObGyn had recommended cesarean 2 hours earlier, surgery was not ordered on an emergent basis.

At birth, the baby’s resuscitation took more than 20 minutes. The child lost nearly one-third of her blood volume; she had a subgaleal hemorrhage. Both parties agreed that the vacuum device probably caused the bleeding.

The child had hypoxic ischemic encephalopathy and disseminated intravascular coagulation. She suffered a myocardial infarction at 3 days of age. Without electrical brain activity, life support was removed, and the child died at 5 days of age. An autopsy found possible hypereosinophilic syndrome as the concurrent cause of death.

PARENTS’ CLAIM The mother claimed she was not informed of the risks, benefits, and alternatives to vacuum extraction; she would not have consented had she known the risks. The mother, her husband, and two family members maintained that the ObGyn offered the possibility of cesarean delivery as a question, but did not insist on it. The mother claimed she wanted what was best for the baby, and never refused a cesarean. The resuscitation efforts caused eosinophilic infiltration into several organs.

PHYSICIAN’S DEFENSE The ObGyn charted that the parents were “adamant about having a vaginal delivery,” and said she told the parents what she charted. The obstetric nurse testified that the mother delayed consent because she felt vaginal delivery was imminent. The ObGyn acted properly; eosinophilia caused the baby’s death.  

VERDICT An Illinois defense verdict was returned.

HIGH BP TO BLAME FOR DEATHS OF BOTH MOTHER AND CHILD
A 23-year-old woman’s pregnancy was at high risk because of very high blood pressure (BP). At 34 weeks’ gestation, she went to a county hospital with symptoms of high BP; she was treated and discharged 3 days later. She returned to the hospital to be checked twice more within a month. The day after the third visit, she suffered a seizure and was taken to a university hospital, where emergency cesarean delivery was performed. The mother died from an aortic rupture during delivery.

The child was born with brain injuries and died at age 4 years due to neurologic complications.

ESTATE’S CLAIM The mother was not properly treated at the county hospital, resulting in both deaths; she should not have been discharged. Under monitoring, she would have undergone delivery before the aortic rupture occurred, avoiding the baby’s brain injury.

DEFENDANTS’ DEFENSE The mother was stable when released; aortic rupture is unpredictable and unpreventable, and would have occurred under any circumstances. It is highly unusual that a woman of her age would have an aortic rupture.

VERDICT A $3,062,803 California verdict was returned. The parties then settled for $1,782,000 (with the county assuming the medical lien).

NECROTIZING FASCIITIS FROM PERFORATED COLON
A woman underwent laparoscopic-assisted vaginal hysterectomy performed by her ObGyn, and was discharged after 3 days. The next day, she went to another hospital’s emergency department (ED) with abdominal distention and rigidity, severe abdominal pain, and vomiting. She had a toxic appearance, rapid pulse rate, and hypotension. In emergency surgery, several liters of dark brown, foul-smelling fluid were found in her abdomen, and feculent peritonitis and necrotizing fasciitis were diagnosed due to a perforated sigmoid colon. She required multiple hospitalizations and operations.

PATIENT’S CLAIM Perforation occur­red during hysterectomy. The ObGyn failed to recognize the injury prior to discharge. The hospital staff did not properly assess her or communicate her symptoms to the ObGyn.

DEFENDANTS’ DEFENSE There was no negligence; proper care was given.

VERDICT A $2,922,503 Florida verdict was returned, with the jury finding the ObGyn 30% at fault and the hospital 70% at fault.

FAILURE TO REACT TO FETAL DISTRESS: $15.6M
After delivery at full term, a child suffered convulsions and seizures on her second day of life. A CT scan showed brain injuries. At age 11 years, she has severe learning and developmental delays, and requires 24-hour care.

PARENTS’ CLAIM Severe decelerations with slow return to baseline occurred several times during labor and delivery. The nurse midwife failed to recognize and react to fetal distress. A cesarean delivery should have been performed instead of a vaginal delivery. The delay in delivery caused the child’s injuries.

DEFENDANTS’ DEFENSE A prenatal neurogenetic disorder caused the child’s injuries. 

VERDICT A $15.6 million Maryland verdict was returned. It will not be automatically reduced; the awarded noneconomic damages do not exceed the state cap.

LATE DELIVERY; SEVERE INJURY TO CHILD
At 40 weeks’ gestation, a woman was admitted to the hospital in labor. When the mother’s membranes were ruptured, a small amount of meconium was noted, but the fetal monitor strips were reassuring. Two hours later, the nurse and midwife noted a pattern of decelerations, but they felt the pattern was nonrepetitive and reactive. Thirty minutes later, the nurse and midwife noted decelerations to 90 bpm with pushing, but did not call a physician.

Another midwife arrived to assist the first midwife who was new to practice. The mother was given oxygen, her position was changed, and an IV fluid bolus was administered. Thirty minutes later, the nurses recognized late decelerations and called a Code White twice while the fetal heart rate continued to decelerate. After the attending physician unsuccessfully attempted vacuum extraction, an emergency cesarean delivery was performed.

The child’s Apgar scores were 2, 3, and 3, at 1, 5, and 10 minutes, respectively. The cord blood pH was 6.66, indicating severe metabolic acidosis. She developed seizures within the first few minutes of life. Imaging studies showed global hypoxic ischemic encephalopathy. The child cannot walk, talk, or sit up unsupported at age 8, and requires a G-tube. She is cortically blind and requires antiseizure medication.

PARENTS’ CLAIM The nurse, two midwives, and physician were negligent in their care of the mother and child.

DEFENDANTS’ DEFENSE The case was settled during the trial.  

VERDICT A $5 million Massachusetts settlement was reached.

WHAT CAUSED INFECTION AFTER ABORTION?
A 20-year-old woman underwent a surgical termination of pregnancy performed by an ObGyn. After discharge, the patient developed pain and other complications requiring rehospitalization and additional surgery for a pelvic infection.

PATIENT’S CLAIM Complications were due to a uterine perforation that spontaneously sealed before it could be detected. The ObGyn was negligent in the performance of the elective abortion. The patient has a large scar on her abdomen because of the additional operation.

PHYSICIAN’S DEFENSE Perforation of the uterus is a known complication of the procedure. However, no perforation occurred; it was not found on imaging, and spontaneous sealing of a perforation cannot occur. The patient’s complications were due to a subclinical infection that was activated by the surgery.  

VERDICT A New York defense verdict was returned.

We want to hear from you. Tell us what you think!

These cases were selected by the editors of OBG Management from Medical Malpractice Verdicts, Settlements & Experts, with permission of the editor, Lewis Laska (www.verdictslaska.com). The information available to the editors about the cases presented here is sometimes incomplete. Moreover, the cases may or may not have merit. Nevertheless, these cases represent the types of clinical situations that typically result in litigation and are meant to illustrate nationwide variation in jury verdicts and awards.

A woman in her 50s underwent hysterectomy performed by a surgeon, who then assigned an ObGyn to her follow-up care. The day after surgery, the patient had severe abdominal pain with decreased blood pressure and increased heart and respiration rates. The ObGyn admitted the patient to the intensive care unit (ICU), and then designated Dr. A, the patient’s family practitioner to continue her care. Dr. A was not available, so his associate, Dr. B, took over. Over the phone, Dr. B requested pulmonary, cardiology, and infectious disease consults. In the ICU the next day, the patient suffered respiratory arrest and was intubated. When her abdomen became rigid and swollen, emergency surgery revealed that a colon perforation had allowed fecal matter to reach the abdominal cavity. The woman died the next day from complications of sepsis, peritonitis, and multiple organ failure.

ESTATE’S CLAIM None of the physicians assigned to her care ever saw the patient in the ICU. Earlier surgery could have prevented her death. The physicians involved in her care failed to communicate with each other properly.

DEFENDANTS’ DEFENSE The case was settled during the trial.

VERDICT A $3.2 million Illinois settlement was reached with the hospital.

BOTH PARENTS HAD PLATELET ANTIBODIES
When a 32-year-old woman became pregnant with her third child, she sought treatment at a clinic. The mother informed the nurse practi-tioner that her two other children had been diagnosed with low platelets at birth, but they were now healthy and had no further problems.

The woman gave birth vaginally to her third child at term. The newborn had Apgar scores of 8 and 8, at 1 and 5 minutes, respectively. However, the child’s platelet level was 26 x 103/µL. The baby was transferred to another hospital the next day, where he was diagnosed with hydrocephalus and neonatal alloimmune thrombocytopenia. He suffered a massive intracranial hemorrhage, which caused severe neurologic injuries and brain damage. A shunt was placed. The child has significant cognitive deficits as well as cerebral palsy with mild developmental delays. Testing showed that each parent had a different genotype for platelet antibodies.

PARENTS’ CLAIM The parents should have been tested for platelet antibodies prior to this birth due to the family’s history. A prenatal diagnosis of neonatal alloimmune thrombocytopenia would have allowed for treatment with gamma globulin, which could have avoided the intracranial hemorrhage.

DEFENDANTS’ DEFENSE The case was settled during the trial.  

VERDICT A $4.8 million California settlement was reached.

CORD PROLAPSE NOT CARED FOR IN AMBULANCE
At 36 weeks’ gestation, a mother called an ambulance when her membranes ruptured and she noticed an umbilical cord prolapse.

The child was in a breech presentation, experienced oxygen deprivation, and sustained severe neurologic damage.

PARENTS’ CLAIM The ambulance service was negligent in its care. The ambulance service dispatcher advised the mother to stand, squat, and push before the ambulance arrived. The ambulance attendants failed to take basic actions to relieve pressure on the prolapsed umbilical cord. The ambulance did not stop at two closer hospitals, which delayed arrival for an additional 20 minutes.

DEFENDANTS’ DEFENSE The case was settled during the trial.

VERDICT A $2.7 million settlement was reached, but before it was submitted to the court for approval, the child died. The defendants then sought to revoke the settlement, but the parents claimed breach of contract. The defendants claimed that the agreement was orally negotiated independent of defense counsel and was unenforceable due to the child’s death and lack of court approval. A Texas judge issued summary judgment on breach of contract and awarded $2.7 million plus $40,000 in attorney fees to the parents.    

SECOND- AND THIRD-DEGREE BURNS TO PERINEUM
A mother received an epidural injection during vaginal delivery. Six hours later, the patient asked a nurse for a warm compress to place on her perineum. The nurse heated the compress in a microwave and then applied it to the perineal area. The compress caused second- and third-degree burns to the patient’s labia and inner left thigh. She underwent surgical repair of the burned area, and, a year later, had plastic surgery.

PATIENT’S CLAIM The nurse was negligent in overheating the compress.

DEFENDANTS’ DEFENSE The hospital agreed that the nurse who heated and applied the compress had been negligent. The hospital paid all medical expenses relating to the burns, including follow-up surgeries. 

VERDICT A $190,000 Utah verdict was returned for noneconomic damages.

DOCUMENTATION MAKES A DIFFERENCE FOR OBGYN AFTER CHILD DIES
A 30-year-old physician was pregnant with her first child. Due to a low amniotic fluid index and lagging fetal growth, she saw a maternal-fetal medicine specialist, who suggested labor induction at 39 weeks.

Labor progressed slowly. After three attempts at vacuum-assisted delivery, the ObGyn recommended cesarean delivery. The parents eventually consented to cesarean delivery after another failed vacuum-assisted attempt. Although the ObGyn had recommended cesarean 2 hours earlier, surgery was not ordered on an emergent basis.

At birth, the baby’s resuscitation took more than 20 minutes. The child lost nearly one-third of her blood volume; she had a subgaleal hemorrhage. Both parties agreed that the vacuum device probably caused the bleeding.

The child had hypoxic ischemic encephalopathy and disseminated intravascular coagulation. She suffered a myocardial infarction at 3 days of age. Without electrical brain activity, life support was removed, and the child died at 5 days of age. An autopsy found possible hypereosinophilic syndrome as the concurrent cause of death.

PARENTS’ CLAIM The mother claimed she was not informed of the risks, benefits, and alternatives to vacuum extraction; she would not have consented had she known the risks. The mother, her husband, and two family members maintained that the ObGyn offered the possibility of cesarean delivery as a question, but did not insist on it. The mother claimed she wanted what was best for the baby, and never refused a cesarean. The resuscitation efforts caused eosinophilic infiltration into several organs.

PHYSICIAN’S DEFENSE The ObGyn charted that the parents were “adamant about having a vaginal delivery,” and said she told the parents what she charted. The obstetric nurse testified that the mother delayed consent because she felt vaginal delivery was imminent. The ObGyn acted properly; eosinophilia caused the baby’s death.  

VERDICT An Illinois defense verdict was returned.

HIGH BP TO BLAME FOR DEATHS OF BOTH MOTHER AND CHILD
A 23-year-old woman’s pregnancy was at high risk because of very high blood pressure (BP). At 34 weeks’ gestation, she went to a county hospital with symptoms of high BP; she was treated and discharged 3 days later. She returned to the hospital to be checked twice more within a month. The day after the third visit, she suffered a seizure and was taken to a university hospital, where emergency cesarean delivery was performed. The mother died from an aortic rupture during delivery.

The child was born with brain injuries and died at age 4 years due to neurologic complications.

ESTATE’S CLAIM The mother was not properly treated at the county hospital, resulting in both deaths; she should not have been discharged. Under monitoring, she would have undergone delivery before the aortic rupture occurred, avoiding the baby’s brain injury.

DEFENDANTS’ DEFENSE The mother was stable when released; aortic rupture is unpredictable and unpreventable, and would have occurred under any circumstances. It is highly unusual that a woman of her age would have an aortic rupture.

VERDICT A $3,062,803 California verdict was returned. The parties then settled for $1,782,000 (with the county assuming the medical lien).

NECROTIZING FASCIITIS FROM PERFORATED COLON
A woman underwent laparoscopic-assisted vaginal hysterectomy performed by her ObGyn, and was discharged after 3 days. The next day, she went to another hospital’s emergency department (ED) with abdominal distention and rigidity, severe abdominal pain, and vomiting. She had a toxic appearance, rapid pulse rate, and hypotension. In emergency surgery, several liters of dark brown, foul-smelling fluid were found in her abdomen, and feculent peritonitis and necrotizing fasciitis were diagnosed due to a perforated sigmoid colon. She required multiple hospitalizations and operations.

PATIENT’S CLAIM Perforation occur­red during hysterectomy. The ObGyn failed to recognize the injury prior to discharge. The hospital staff did not properly assess her or communicate her symptoms to the ObGyn.

DEFENDANTS’ DEFENSE There was no negligence; proper care was given.

VERDICT A $2,922,503 Florida verdict was returned, with the jury finding the ObGyn 30% at fault and the hospital 70% at fault.

FAILURE TO REACT TO FETAL DISTRESS: $15.6M
After delivery at full term, a child suffered convulsions and seizures on her second day of life. A CT scan showed brain injuries. At age 11 years, she has severe learning and developmental delays, and requires 24-hour care.

PARENTS’ CLAIM Severe decelerations with slow return to baseline occurred several times during labor and delivery. The nurse midwife failed to recognize and react to fetal distress. A cesarean delivery should have been performed instead of a vaginal delivery. The delay in delivery caused the child’s injuries.

DEFENDANTS’ DEFENSE A prenatal neurogenetic disorder caused the child’s injuries. 

VERDICT A $15.6 million Maryland verdict was returned. It will not be automatically reduced; the awarded noneconomic damages do not exceed the state cap.

LATE DELIVERY; SEVERE INJURY TO CHILD
At 40 weeks’ gestation, a woman was admitted to the hospital in labor. When the mother’s membranes were ruptured, a small amount of meconium was noted, but the fetal monitor strips were reassuring. Two hours later, the nurse and midwife noted a pattern of decelerations, but they felt the pattern was nonrepetitive and reactive. Thirty minutes later, the nurse and midwife noted decelerations to 90 bpm with pushing, but did not call a physician.

Another midwife arrived to assist the first midwife who was new to practice. The mother was given oxygen, her position was changed, and an IV fluid bolus was administered. Thirty minutes later, the nurses recognized late decelerations and called a Code White twice while the fetal heart rate continued to decelerate. After the attending physician unsuccessfully attempted vacuum extraction, an emergency cesarean delivery was performed.

The child’s Apgar scores were 2, 3, and 3, at 1, 5, and 10 minutes, respectively. The cord blood pH was 6.66, indicating severe metabolic acidosis. She developed seizures within the first few minutes of life. Imaging studies showed global hypoxic ischemic encephalopathy. The child cannot walk, talk, or sit up unsupported at age 8, and requires a G-tube. She is cortically blind and requires antiseizure medication.

PARENTS’ CLAIM The nurse, two midwives, and physician were negligent in their care of the mother and child.

DEFENDANTS’ DEFENSE The case was settled during the trial.  

VERDICT A $5 million Massachusetts settlement was reached.

WHAT CAUSED INFECTION AFTER ABORTION?
A 20-year-old woman underwent a surgical termination of pregnancy performed by an ObGyn. After discharge, the patient developed pain and other complications requiring rehospitalization and additional surgery for a pelvic infection.

PATIENT’S CLAIM Complications were due to a uterine perforation that spontaneously sealed before it could be detected. The ObGyn was negligent in the performance of the elective abortion. The patient has a large scar on her abdomen because of the additional operation.

PHYSICIAN’S DEFENSE Perforation of the uterus is a known complication of the procedure. However, no perforation occurred; it was not found on imaging, and spontaneous sealing of a perforation cannot occur. The patient’s complications were due to a subclinical infection that was activated by the surgery.  

VERDICT A New York defense verdict was returned.

We want to hear from you. Tell us what you think!

These cases were selected by the editors of OBG Management from Medical Malpractice Verdicts, Settlements & Experts, with permission of the editor, Lewis Laska (www.verdictslaska.com). The information available to the editors about the cases presented here is sometimes incomplete. Moreover, the cases may or may not have merit. Nevertheless, these cases represent the types of clinical situations that typically result in litigation and are meant to illustrate nationwide variation in jury verdicts and awards.

Every morning before I leave for work, I kiss my three children goodbye and tell them, “I love you. Make good choices today.”

This has become my mantra—so much so that, on her way out the door to join her friends at the movies recently, my daughter turned to me and said, “I know, Dad. I know. I’ll make good decisions tonight.”

And what decision is more important than where to deliver your child and who to have in attendance at the birth?

It is said that the passage from the uterus to the outside world that each one of us was forced to negotiate at birth is the most treacherous journey we will ever undertake. Any unnecessary delay or complication can have profound, lifelong consequences.

There is no question that the past few centuries have seen a significant “medicalization” of childbirth, including the relocation of deliveries from the community to a hospital setting, the introduction of male obstetricians, the unfortunate marginalization of midwives and support personnel (doulas), the development of uterotonic drugs, and the evolution of operative vaginal (forceps, vacuum) and cesarean deliveries.

Many of the practices initially introduced by obstetric care providers (including multiple vaginal examinations in labor, induction of labor for a large baby, and active management of labor protocols) have since been shown to be unhelpful in improving pregnancy outcomes, and some practices (such as episiotomy) have even been shown to be harmful.

Related article: Difficult fetal extraction at cesarean delivery: What should you do? Robert L. Barbieri, MD (Editorial, January 2012)

In the midst of this confusion, the one voice that has been lost is that of the patient herself.

Whose birth is it anyway?
The American College of Obstetricians and Gynecologists (ACOG), the American Academy of Pediatrics (AAP), and the American College of Nurse-Midwives (ACNM) all agree that patient autonomy is paramount, and that the final decision of where to deliver and who to have in attendance should be made by the patient herself, ideally in conjunction with her family and her obstetric care provider.^1–3 But an informed decision is only as good as the available data. Regrettably, the literature on how planned home birth compares with hospital delivery in terms of pregnancy outcomes in the United States are sparse.

Related article: Lay midwives the the ObGyn: Is collaboration risky? Lucia DiVenere, MA (May 2012)

How safe is home birth in the United States?
Cheng and colleagues attempt to answer this question by reviewing newborn and maternal outcomes among planned home births versus hospital deliveries in a contemporary low-risk birth cohort. Their retrospective study included low-risk women at term with a singleton vertex live birth in 2008 in 27 of the 50 states using information from the Vital Statistics Natality Data provided by the Centers for Disease Control and Prevention.

Of these 2,081,753 women, 0.58% (n = 12,039) had planned home births, and the remainder delivered in a hospital setting. Women who had an “accidental” (unintended) home birth or who delivered in a freestanding birthing center were excluded. The primary outcome was the risk of a 5-minute Apgar score less than 4. Secondary outcomes included the risk of a 5-minute Apgar score less than 7, assisted ventilation for more than 6 hours, neonatal seizures, admission to the NICU, and a series of maternal outcome measures.

Besides the outcomes listed previously (top of page 24), women with a planned home birth had fewer obstetric interventions, including operative vaginal delivery and labor induction or augmentation. They also were less likely to be given antibiotics during labor (although the authors did not distinguish between antibiotics administered for prophylaxis against group B strep or surgical-site infection versus antibiotics to treat infections such as urinary tract infections or chorioamnionitis).

Of special interest is the fact that neither a prior vaginal delivery (multiparity) nor the absence of a prior cesarean delivery was protective against these adverse events.

The women at highest risk of an adverse event were those who delivered at home under the supervision of “other midwives.” Although these providers were not well defined, this term typically refers to community-based lay midwives whose only “training” consists of an unofficial apprenticeship of variable length. Despite the absence of formal training, the lack of certification and standardization of care, and the existence of legislation in many states banning their activity, such lay midwives continue to encourage and support home birth for both low- and high-risk women in the United States.

Related article: Update on Obstetrics John T. Repke, MD, and Jaimey M. Pauli, MD (January 2012)

Limitations of the study design
Although this dataset contains more than 2 million births, it includes only low-risk women at term and, therefore, is underpowered to measure outcomes such as fetal or neonatal death or birth injuries.

No data were presented on a number of important variables and outcome measures, such as the rate of or indications for cesarean delivery, the mode and frequency of intrapartum fetal monitoring, birth weight, intrapartum complications (uterine rupture, postpartum hemorrhage), blood transfusions, and infectious morbidity. The study also lacks long-term follow-up data on the infants.

That said, the study was well designed and very well written, and many of the limitations listed above are inherent in all retrospective cohort studies.

Putting these findings in context
These data are not novel, but they are remarkably consistent with other publications that have explored pregnancy outcomes in planned home birth versus hospital delivery from the Netherlands, the United Kingdom, Australia, and the United States, all of which show a higher rate of neonatal complications with planned home birth [see Reference 4 for review].⁴

Moreover, it is likely that the data in the current report significantly underestimate the risks of planned home birth for two reasons:

• Attempted home births that ended in transfer and, ultimately, delivery in a hospital setting (presumably for some unforeseen event such as excessive hemorrhage or uterine rupture or cord prolapse or nonreassuring fetal testing) were classified as hospital births.
• Apgar scores at 5 minutes are assigned by the attending care provider, and there is no way to independently verify their accuracy. Because of their limited training and/or concern about efforts to limit the scope of their practice, “other midwives” may be inclined to assign more favorable Apgar scores.

Who is choosing to deliver at home?
The proportion of US women who delivered outside the hospital setting increased by 29% between 2004 and 2009,⁵ although home births still constitute a minority of low-risk births (0.58% in the current study).

Related Article: Why are well-educated women more likely to choose home birth? Errol R. Norwitz, MD, PhD (Audiocast, November 2013)

One of the more interesting questions raised by this publication is the issue of who is choosing to deliver at home. In this cohort, women who planned home birth were more likely to be older, married, multiparous, white, and well educated. These aren’t exactly the women you would expect to gamble with the lives of their unborn offspring. So why are they choosing to deliver at home?

It could be that they are not well informed about the risks. Alternatively, they may have concluded that, although the relative risk of an adverse event is significantly higher with home birth, the absolute risk is low and acceptable to them. Or it could be that they are frustrated by the lack of autonomy afforded to them in the decisions surrounding antenatal care and the birthing process.

In recent years, more women are asking for minimally invasive births that are physically, emotionally, and socially supported. As hospital-based obstetric care providers, we do not always respect or meet these expectations. We can and should do better.

Women should not have to choose between a good birth experience and medical safety, between social support and hospital resources, between a sense of autonomy and access to life-saving interventions. Although every effort should be taken to make the birthing experience a positive one for the mother and her family as a whole, it should not be done at the expense of safety. I have yet to hear an asphyxiated and brain-damaged child thank his mother’s obstetric care provider for allowing a wonderful birth experience.

What this evidence means for practice
Even in countries where home births are integrated fully into the medical care system and attended by trained and certified nurse-midwives, they are associated with increased risks, including a twofold to threefold increase in the odds of neonatal death.4 In the US, where no such integration exists, home births are dangerous.

Maternity care has come a long way since the 17th Century, when a woman had a 1 in 6 chance of dying in childbirth and only one of every five children lived to enjoy a first birthday. It is appropriate in this era of Obamacare and cost containment that we explore alternative methods. The option of a safe home delivery may well be part of the solution, as it is for many European countries--but until we can be assured that such an approach is safe for both mothers and infants, let's keep home delivery where it belongs...for pizza!

--Errol R. Norwitz, MD, PHD

We want to hear from you! Tell us what you think.

Every morning before I leave for work, I kiss my three children goodbye and tell them, “I love you. Make good choices today.”

This has become my mantra—so much so that, on her way out the door to join her friends at the movies recently, my daughter turned to me and said, “I know, Dad. I know. I’ll make good decisions tonight.”

And what decision is more important than where to deliver your child and who to have in attendance at the birth?

It is said that the passage from the uterus to the outside world that each one of us was forced to negotiate at birth is the most treacherous journey we will ever undertake. Any unnecessary delay or complication can have profound, lifelong consequences.

There is no question that the past few centuries have seen a significant “medicalization” of childbirth, including the relocation of deliveries from the community to a hospital setting, the introduction of male obstetricians, the unfortunate marginalization of midwives and support personnel (doulas), the development of uterotonic drugs, and the evolution of operative vaginal (forceps, vacuum) and cesarean deliveries.

Many of the practices initially introduced by obstetric care providers (including multiple vaginal examinations in labor, induction of labor for a large baby, and active management of labor protocols) have since been shown to be unhelpful in improving pregnancy outcomes, and some practices (such as episiotomy) have even been shown to be harmful.

Related article: Difficult fetal extraction at cesarean delivery: What should you do? Robert L. Barbieri, MD (Editorial, January 2012)

In the midst of this confusion, the one voice that has been lost is that of the patient herself.

Whose birth is it anyway?
The American College of Obstetricians and Gynecologists (ACOG), the American Academy of Pediatrics (AAP), and the American College of Nurse-Midwives (ACNM) all agree that patient autonomy is paramount, and that the final decision of where to deliver and who to have in attendance should be made by the patient herself, ideally in conjunction with her family and her obstetric care provider.^1–3 But an informed decision is only as good as the available data. Regrettably, the literature on how planned home birth compares with hospital delivery in terms of pregnancy outcomes in the United States are sparse.

Related article: Lay midwives the the ObGyn: Is collaboration risky? Lucia DiVenere, MA (May 2012)

How safe is home birth in the United States?
Cheng and colleagues attempt to answer this question by reviewing newborn and maternal outcomes among planned home births versus hospital deliveries in a contemporary low-risk birth cohort. Their retrospective study included low-risk women at term with a singleton vertex live birth in 2008 in 27 of the 50 states using information from the Vital Statistics Natality Data provided by the Centers for Disease Control and Prevention.

Of these 2,081,753 women, 0.58% (n = 12,039) had planned home births, and the remainder delivered in a hospital setting. Women who had an “accidental” (unintended) home birth or who delivered in a freestanding birthing center were excluded. The primary outcome was the risk of a 5-minute Apgar score less than 4. Secondary outcomes included the risk of a 5-minute Apgar score less than 7, assisted ventilation for more than 6 hours, neonatal seizures, admission to the NICU, and a series of maternal outcome measures.

Besides the outcomes listed previously (top of page 24), women with a planned home birth had fewer obstetric interventions, including operative vaginal delivery and labor induction or augmentation. They also were less likely to be given antibiotics during labor (although the authors did not distinguish between antibiotics administered for prophylaxis against group B strep or surgical-site infection versus antibiotics to treat infections such as urinary tract infections or chorioamnionitis).

Of special interest is the fact that neither a prior vaginal delivery (multiparity) nor the absence of a prior cesarean delivery was protective against these adverse events.

The women at highest risk of an adverse event were those who delivered at home under the supervision of “other midwives.” Although these providers were not well defined, this term typically refers to community-based lay midwives whose only “training” consists of an unofficial apprenticeship of variable length. Despite the absence of formal training, the lack of certification and standardization of care, and the existence of legislation in many states banning their activity, such lay midwives continue to encourage and support home birth for both low- and high-risk women in the United States.

Related article: Update on Obstetrics John T. Repke, MD, and Jaimey M. Pauli, MD (January 2012)

Limitations of the study design
Although this dataset contains more than 2 million births, it includes only low-risk women at term and, therefore, is underpowered to measure outcomes such as fetal or neonatal death or birth injuries.

No data were presented on a number of important variables and outcome measures, such as the rate of or indications for cesarean delivery, the mode and frequency of intrapartum fetal monitoring, birth weight, intrapartum complications (uterine rupture, postpartum hemorrhage), blood transfusions, and infectious morbidity. The study also lacks long-term follow-up data on the infants.

That said, the study was well designed and very well written, and many of the limitations listed above are inherent in all retrospective cohort studies.

Putting these findings in context
These data are not novel, but they are remarkably consistent with other publications that have explored pregnancy outcomes in planned home birth versus hospital delivery from the Netherlands, the United Kingdom, Australia, and the United States, all of which show a higher rate of neonatal complications with planned home birth [see Reference 4 for review].⁴

Moreover, it is likely that the data in the current report significantly underestimate the risks of planned home birth for two reasons:

• Attempted home births that ended in transfer and, ultimately, delivery in a hospital setting (presumably for some unforeseen event such as excessive hemorrhage or uterine rupture or cord prolapse or nonreassuring fetal testing) were classified as hospital births.
• Apgar scores at 5 minutes are assigned by the attending care provider, and there is no way to independently verify their accuracy. Because of their limited training and/or concern about efforts to limit the scope of their practice, “other midwives” may be inclined to assign more favorable Apgar scores.

Who is choosing to deliver at home?
The proportion of US women who delivered outside the hospital setting increased by 29% between 2004 and 2009,⁵ although home births still constitute a minority of low-risk births (0.58% in the current study).

Related Article: Why are well-educated women more likely to choose home birth? Errol R. Norwitz, MD, PhD (Audiocast, November 2013)

One of the more interesting questions raised by this publication is the issue of who is choosing to deliver at home. In this cohort, women who planned home birth were more likely to be older, married, multiparous, white, and well educated. These aren’t exactly the women you would expect to gamble with the lives of their unborn offspring. So why are they choosing to deliver at home?

It could be that they are not well informed about the risks. Alternatively, they may have concluded that, although the relative risk of an adverse event is significantly higher with home birth, the absolute risk is low and acceptable to them. Or it could be that they are frustrated by the lack of autonomy afforded to them in the decisions surrounding antenatal care and the birthing process.

In recent years, more women are asking for minimally invasive births that are physically, emotionally, and socially supported. As hospital-based obstetric care providers, we do not always respect or meet these expectations. We can and should do better.

Women should not have to choose between a good birth experience and medical safety, between social support and hospital resources, between a sense of autonomy and access to life-saving interventions. Although every effort should be taken to make the birthing experience a positive one for the mother and her family as a whole, it should not be done at the expense of safety. I have yet to hear an asphyxiated and brain-damaged child thank his mother’s obstetric care provider for allowing a wonderful birth experience.

What this evidence means for practice
Even in countries where home births are integrated fully into the medical care system and attended by trained and certified nurse-midwives, they are associated with increased risks, including a twofold to threefold increase in the odds of neonatal death.4 In the US, where no such integration exists, home births are dangerous.

Maternity care has come a long way since the 17th Century, when a woman had a 1 in 6 chance of dying in childbirth and only one of every five children lived to enjoy a first birthday. It is appropriate in this era of Obamacare and cost containment that we explore alternative methods. The option of a safe home delivery may well be part of the solution, as it is for many European countries--but until we can be assured that such an approach is safe for both mothers and infants, let's keep home delivery where it belongs...for pizza!

--Errol R. Norwitz, MD, PHD

We want to hear from you! Tell us what you think.

Every morning before I leave for work, I kiss my three children goodbye and tell them, “I love you. Make good choices today.”

This has become my mantra—so much so that, on her way out the door to join her friends at the movies recently, my daughter turned to me and said, “I know, Dad. I know. I’ll make good decisions tonight.”

And what decision is more important than where to deliver your child and who to have in attendance at the birth?

It is said that the passage from the uterus to the outside world that each one of us was forced to negotiate at birth is the most treacherous journey we will ever undertake. Any unnecessary delay or complication can have profound, lifelong consequences.

There is no question that the past few centuries have seen a significant “medicalization” of childbirth, including the relocation of deliveries from the community to a hospital setting, the introduction of male obstetricians, the unfortunate marginalization of midwives and support personnel (doulas), the development of uterotonic drugs, and the evolution of operative vaginal (forceps, vacuum) and cesarean deliveries.

Many of the practices initially introduced by obstetric care providers (including multiple vaginal examinations in labor, induction of labor for a large baby, and active management of labor protocols) have since been shown to be unhelpful in improving pregnancy outcomes, and some practices (such as episiotomy) have even been shown to be harmful.

Related article: Difficult fetal extraction at cesarean delivery: What should you do? Robert L. Barbieri, MD (Editorial, January 2012)

In the midst of this confusion, the one voice that has been lost is that of the patient herself.

Whose birth is it anyway?
The American College of Obstetricians and Gynecologists (ACOG), the American Academy of Pediatrics (AAP), and the American College of Nurse-Midwives (ACNM) all agree that patient autonomy is paramount, and that the final decision of where to deliver and who to have in attendance should be made by the patient herself, ideally in conjunction with her family and her obstetric care provider.^1–3 But an informed decision is only as good as the available data. Regrettably, the literature on how planned home birth compares with hospital delivery in terms of pregnancy outcomes in the United States are sparse.

Related article: Lay midwives the the ObGyn: Is collaboration risky? Lucia DiVenere, MA (May 2012)

How safe is home birth in the United States?
Cheng and colleagues attempt to answer this question by reviewing newborn and maternal outcomes among planned home births versus hospital deliveries in a contemporary low-risk birth cohort. Their retrospective study included low-risk women at term with a singleton vertex live birth in 2008 in 27 of the 50 states using information from the Vital Statistics Natality Data provided by the Centers for Disease Control and Prevention.

Of these 2,081,753 women, 0.58% (n = 12,039) had planned home births, and the remainder delivered in a hospital setting. Women who had an “accidental” (unintended) home birth or who delivered in a freestanding birthing center were excluded. The primary outcome was the risk of a 5-minute Apgar score less than 4. Secondary outcomes included the risk of a 5-minute Apgar score less than 7, assisted ventilation for more than 6 hours, neonatal seizures, admission to the NICU, and a series of maternal outcome measures.

Besides the outcomes listed previously (top of page 24), women with a planned home birth had fewer obstetric interventions, including operative vaginal delivery and labor induction or augmentation. They also were less likely to be given antibiotics during labor (although the authors did not distinguish between antibiotics administered for prophylaxis against group B strep or surgical-site infection versus antibiotics to treat infections such as urinary tract infections or chorioamnionitis).

Of special interest is the fact that neither a prior vaginal delivery (multiparity) nor the absence of a prior cesarean delivery was protective against these adverse events.

The women at highest risk of an adverse event were those who delivered at home under the supervision of “other midwives.” Although these providers were not well defined, this term typically refers to community-based lay midwives whose only “training” consists of an unofficial apprenticeship of variable length. Despite the absence of formal training, the lack of certification and standardization of care, and the existence of legislation in many states banning their activity, such lay midwives continue to encourage and support home birth for both low- and high-risk women in the United States.

Related article: Update on Obstetrics John T. Repke, MD, and Jaimey M. Pauli, MD (January 2012)

Limitations of the study design
Although this dataset contains more than 2 million births, it includes only low-risk women at term and, therefore, is underpowered to measure outcomes such as fetal or neonatal death or birth injuries.

No data were presented on a number of important variables and outcome measures, such as the rate of or indications for cesarean delivery, the mode and frequency of intrapartum fetal monitoring, birth weight, intrapartum complications (uterine rupture, postpartum hemorrhage), blood transfusions, and infectious morbidity. The study also lacks long-term follow-up data on the infants.

That said, the study was well designed and very well written, and many of the limitations listed above are inherent in all retrospective cohort studies.

Putting these findings in context
These data are not novel, but they are remarkably consistent with other publications that have explored pregnancy outcomes in planned home birth versus hospital delivery from the Netherlands, the United Kingdom, Australia, and the United States, all of which show a higher rate of neonatal complications with planned home birth [see Reference 4 for review].⁴

Moreover, it is likely that the data in the current report significantly underestimate the risks of planned home birth for two reasons:

• Attempted home births that ended in transfer and, ultimately, delivery in a hospital setting (presumably for some unforeseen event such as excessive hemorrhage or uterine rupture or cord prolapse or nonreassuring fetal testing) were classified as hospital births.
• Apgar scores at 5 minutes are assigned by the attending care provider, and there is no way to independently verify their accuracy. Because of their limited training and/or concern about efforts to limit the scope of their practice, “other midwives” may be inclined to assign more favorable Apgar scores.

Who is choosing to deliver at home?
The proportion of US women who delivered outside the hospital setting increased by 29% between 2004 and 2009,⁵ although home births still constitute a minority of low-risk births (0.58% in the current study).

Related Article: Why are well-educated women more likely to choose home birth? Errol R. Norwitz, MD, PhD (Audiocast, November 2013)

One of the more interesting questions raised by this publication is the issue of who is choosing to deliver at home. In this cohort, women who planned home birth were more likely to be older, married, multiparous, white, and well educated. These aren’t exactly the women you would expect to gamble with the lives of their unborn offspring. So why are they choosing to deliver at home?

It could be that they are not well informed about the risks. Alternatively, they may have concluded that, although the relative risk of an adverse event is significantly higher with home birth, the absolute risk is low and acceptable to them. Or it could be that they are frustrated by the lack of autonomy afforded to them in the decisions surrounding antenatal care and the birthing process.

In recent years, more women are asking for minimally invasive births that are physically, emotionally, and socially supported. As hospital-based obstetric care providers, we do not always respect or meet these expectations. We can and should do better.

Women should not have to choose between a good birth experience and medical safety, between social support and hospital resources, between a sense of autonomy and access to life-saving interventions. Although every effort should be taken to make the birthing experience a positive one for the mother and her family as a whole, it should not be done at the expense of safety. I have yet to hear an asphyxiated and brain-damaged child thank his mother’s obstetric care provider for allowing a wonderful birth experience.

What this evidence means for practice
Even in countries where home births are integrated fully into the medical care system and attended by trained and certified nurse-midwives, they are associated with increased risks, including a twofold to threefold increase in the odds of neonatal death.4 In the US, where no such integration exists, home births are dangerous.

Maternity care has come a long way since the 17th Century, when a woman had a 1 in 6 chance of dying in childbirth and only one of every five children lived to enjoy a first birthday. It is appropriate in this era of Obamacare and cost containment that we explore alternative methods. The option of a safe home delivery may well be part of the solution, as it is for many European countries--but until we can be assured that such an approach is safe for both mothers and infants, let's keep home delivery where it belongs...for pizza!

--Errol R. Norwitz, MD, PHD

We want to hear from you! Tell us what you think.