OBG Management

The use of minimally invasive gynecologic surgery (MIGS) has grown rapidly over the past 20 years. MIGS, which includes vaginal hysterectomy and laparoscopic hysterectomy, is safe and has fewer complications and a more rapid recovery period than open abdominal surgery.^1,2 In 2005, the role of MIGS was expanded further when the US Food and Drug Administration (FDA) approved robot-assisted surgery for the performance of gynecologic procedures.³ As knowledge and experience in the safe performance of MIGS progresses, the rates for MIGS procedures have skyrocketed and continue to grow. Between 2007 and 2010, laparoscopic hysterectomy rates rose from 23.5% to 30.5%, while robot-assisted laparoscopic hysterectomy rates increased from 0.5% to 9.5%, representing 40% of all hysterectomies.⁴ Due to the benefits of minimally invasive surgery over open abdominal surgery, patient and physician preference for minimally invasive procedures has grown significantly in popularity.^1,5

Because incisions are small in minimally invasive surgery, surgeons have been challenged with removing large specimens through incisions that are much smaller than the presenting pathology. One approach is to use a specimen retrieval bag for specimen extraction. Once the dissection is completed, the specimen is placed within the retrieval bag for removal, thus minimizing exposure of the specimen and its contents to the abdominopelvic cavity and incision.

The use of specimen retrieval devices has been advocated to prevent infection, avoid spillage into the peritoneal cavity, and minimize the risk of port-site metastases in cases of potentially cancerous specimens. Devices include affordable and readily available products, such as nonpowdered gloves, and commercially produced bags.⁶

While the use of specimen containment systems for tissue extraction has been well described in gynecology, the available systems vary widely in construction, size, durability, and shape, potentially leading to confusion and suboptimal bag selection during surgery.⁷ In this article, we review the most common laparoscopic bags available in the United States, provide an overview of bag characteristics, offer practice guidelines for bag selection, and review bag terminology to highlight important concepts for bag selection.

Controversy spurs change

In April 2014, the FDA warned against the use of power morcellation for specimen removal during minimally invasive surgery, citing a prevalence of 1 in 352 unsuspected uterine sarcomas and 1 in 498 unsuspected uterine leiomyosarcomas among women undergoing hysterectomy or myomectomy for presumed benign leiomyoma.⁸ Since then, the risk of occult uterine sarcomas, including leiomyosarcoma, in women undergoing surgery for benign gynecologic indications has been determined to be much lower.

Nonetheless, the clinical importance of contained specimen removal was clearly highlighted and the role of specimen retrieval bags soared to the forefront. Open power morcellation is no longer commonly practiced, and national societies such as the American Association of Gynecologic Laparoscopists (AAGL), the Society of Gynecologic Oncology (SGO), and the American College of Obstetricians and Gynecologists (ACOG) recommend that containment systems be used for safer specimen retrieval during gynecologic surgery.^9-11 After the specimen is placed inside the containment system (typically a specimen bag), the surgeon may deliver the bag through a vaginal colpotomy or through a slightly extended laparoscopic incision to remove bulky specimens using cold-cutting extraction techniques.^12-15

Continue to: Know the pathology’s characteristics...

In most cases, based on imaging studies and physical examination, surgeons have a good idea of what to expect before proceeding with surgery. The 2 most common characteristics used for surgical planning are the specimen size (dimensions) and the tissue type (solid, cystic, soft tissue, or mixed). The mass size can range from less than 1 cm to larger than a 20-week sized fibroid uterus. Assessing the specimen in 3 dimensions is important. Tissue type also is a consideration, as soft and squishy masses, such as ovarian cysts, are easier to deflate and manipulate within the bag compared with solid or calcified tumors, such as a large fibroid uterus or a large dermoid with solid components.

Specimen shape also is a critical determinant for bag selection. Most specimen retrieval bags are tapered to varying degrees, and some have an irregular shape. Long tubular structures, such as fallopian tubes that are composed of soft tissue, fit easily into most bags regardless of bag shape or extent of bag taper, whereas the round shape of a bulky myoma may render certain bags ineffective even if the bag’s entrance accommodates the greatest diameter of the myoma. Often, a round mass will not fully fit into a bag because there is a poor fit between the mass’s shape and the bag’s shape and taper. (We discuss the concept of a poor “fit” below.) Knowing the pathology before starting a procedure can help optimize bag selection, streamline operative flow, and reduce waste.

Overview of laparoscopic bag characteristics and clinical applications

The TABLE lists the most common laparoscopic bags available for purchase in the United States. Details include the trocar size, manufacturer, product name, mouth diameter, volume, bag shape, construction material, and best clinical application.

The following are terms used to refer to the components of a laparoscopic retrieval bag:

• Mouth diameter: diameter at the entrance of a fully opened bag (FIGURE 1)
• Bag volume: the total volume a bag can accommodate when completely full
• Bag rim: characteristics of the rim of the bag when opened (that is, rigid vs soft rim, complete vs partial rim mechanism to hold the bag open) (FIGURE 2)
• Bag shape: the shape of the bag when it is fully opened (square shaped vs cone shaped vs curved bag shape) (FIGURE 2)
• Bag taper (severity and type): extent the bag is tapered from the rim of the bag’s entrance to the base of the bag; categorized by taper severity (minimal, gradual, or steep taper) and type (continuous taper or curved taper) (FIGURE 3)
• Ball fit: the maximum spherical specimen size that completely fits into a bag and allows it to cinch closed (FIGURE 4)
• Bag strength: durability of a bag when placed on tension during specimen extraction (weak, moderate, or extremely durable).

Continue to: Mouth diameter...

Mouth diameter

Bag manufacturers often differentiate bag sizes by indicating “volume” in milliliters. Bag volume, however, offers little clinical value to surgeons, as pelvic mass dimensions are usually measured in centimeters on imaging. Rather, an important characteristic for bag selection is the diameter of the rim of the bag when it is fully opened—the so-called bag mouth diameter. For a specimen to fit, the 2 dimensions of the specimen must be smaller than the dimensions of the bag entrance.

Notably, the number often linked to the specimen bag—as, for example, in the 10-mm Endo Catch bag (Covidien/Medtronic)— describes the width of the shaft of the bag before it is opened rather than the mouth diameter of the opened bag. The number actually correlates with the trocar size necessary for bag insertion rather than with the specimen size that can fit into the bag. Therefore, a 10-mm Endo Catch bag cannot fit a 10-cm mass, but rather requires a trocar size of 10 mm or greater for insertion of the bag. Fully opened, the mouth diameters of the 10-mm Endo Catch bag are roughly 6 cm x 7 cm, which allows for delivery of a 6-cm mass.

Because 2 bags that use the same trocar size for insertion may have vastly differing bag dimensions, the surgeon must know the bag mouth diameters when selecting a bag to remove the presenting pathology. For example, the Inzii 12 (Applied Medical) laparoscopic bag has mouth diameters of 9.7 cm × 13.0 cm, whereas the Anchor TRSROBO-12 (ConMed) has mouth diameters of 6.7 cm × 7.6 cm (TABLE). Although both bags can be inserted through a 12-mm trocar, both bags cannot fit the same size mass for removal.

Shape and taper

Laparoscopic bags come in various shapes (curved, cone, or square shaped), with varying levels of bag taper (steep, gradual, or no taper) (FIGURES 2 and 3). While taper has little impact on long and skinny specimens, taper may hinder successful bagging of bulky or spherical specimens.

Each bag has different grades of taper regardless of mouth diameter or trocar size. For round masses, the steeper the taper, the smaller the mass that can comfortably fit within the bag. This concept is connected to the idea of “ball fit,” explained below.

In addition, bag shape may affect what mass size can fit into the bag. An irregularly shaped curved bag or a bag with a steep taper may be well suited for removal of multiple specimens of varying sizes or soft masses that are malleable enough to conform to the bag’s shape (such as a ruptured ovarian cyst). Alternatively, a square-shaped bag or a bag with minimal taper would better accommodate a round mass.

Ball fit

When thinking about large circular masses, such as myomas or ovarian cysts, one must consider the ball fit. This refers to the maximum spherical size of the specimen that fits completely within a bag while allowing the bag to cinch closed. Generally, this is an estimation that factors in the bag shape, extent of the bag taper, bag mouth diameter, and specimen shape and tissue type. At times, although a mass can fit through the bag’s mouth diameter, a steep taper may prevent the mass from being fully bagged and limit closure of the bag (FIGURE 4).

Curved bags like the Anchor TRSVATS-15 (ConMed), which have a very narrow bottom, are prone to a limited ball fit, and thus the bag mouth diameter will not correlate with the largest mass size that can be fitted within the bag. Therefore, if using a steeply tapered bag for removal of large round masses, do not rely on the bag’s mouth diameter for bag selection. The surgeon must visualize the ball fit within the bag, taking into account the specimen size and shape, bag shape, and bag taper. In these scenarios, using the diameter of the midportion of the opened bag may better reflect the mass size that can fit into that bag.

Bag strength

Bag strength depends on the material used for bag construction. Most laparoscopic bags in the United States are made of 3 different materials: polyurethane, polypropylene, and ripstop nylon.

Polyurethane and polypropylene are synthetic plastic polymers; in bag form they are stretchy and, under extreme force, may tear. They are best used for bagging fluid-filled cysts or soft pliable masses that will not require extensive bag or tissue handling, such as extraction of large leiomyomas. Polyurethane and polypropylene bags are more susceptible to puncture with sharp laparoscopic instruments or scalpels, and care must be taken to avoid accidentally cutting the bag during tissue extraction.

Alternatively, bags made of ripstop nylon are favored for their bag strength. Ripstop nylon is a synthetic fabric that is woven together in a crosshatch pattern that makes it resistant to tearing and ripping. It was developed originally during World War II as a replacement for silk parachutes. Modern applications include its use in sails, kites, and high-quality camping equipment. This material has a favorable strength-to-weight ratio, and, in case of a tear, it is less prone to extension of the tear. For surgical applications, these bags are best used for bagging specimens that will require a lot of bag manipulation and tissue extraction. However, the ripstop fabric takes up more space in the incision than polyurethane or polypropylene, leaving the surgeon with less space for tissue extraction. Thus, as a tradeoff for bag strength, the surgeon may need to extend the incision a little, and a small self-retracting wound retractor may be necessary to allow visibility for safe tissue extraction when using a ripstop nylon bag compared with others.

Continue to: Trocar selection is important...

Trocar selection is important

While considering bag selection, the surgeon also must consider trocar selection to allow for laparoscopic insertion of the bag. Trocar size for bag selection refers to the minimum trocar diameter needed to insert the laparoscopic bag. Most bags are designed to fit into a laparoscopic trocar or into the skin incision that previously housed the trocar. Trocar size does not directly correlate with bag mouth diameter; for example, a 10-mm laparoscopic bag that can be inserted through a 10- or 12-mm trocar size cannot fit a 10-cm mass (see the mouth diameter section above).

A tip to maximize operating room (OR) efficiency is to start off with a larger trocar, such as a 12-mm trocar, if it is known that a laparoscopic bag with a 12-mm trocar size will be used, rather than starting with a 5-mm trocar and upsizing the port site incision. This saves time and offers intraoperative flexibility, allowing for the use of larger instruments and quicker insufflation.

Furthermore, if the specimen has a solid component and tissue extraction is anticipated, consider starting off with a large trocar, one that is larger than the bag’s trocar size since the incision likely will be extended. For example, even if a myoma will fit within a 10-mm laparoscopic bag made of ripstop nylon, using a 15-mm trocar rather than a 10-mm trocar may be considered since the skin and fascial incisions will need to be extended to allow for cold-cut tissue extraction. Starting with the larger 15-mm trocar may offer surgical advantages, such as direct needle delivery of larger needles for myometrial closure after myomectomy or direct removal of smaller myomas through the trocar to avoid bagging multiple specimens.

Putting it all together

To optimize efficiency in the OR for specimen removal, we recommend streamlining OR flow and reducing waste by first considering the specimen size, tissue type, bag shape, and trocar selection. Choose a bag by taking into account the bag mouth diameter and the amount of taper you will need to obtain an appropriate ball fit. If the tissue type is soft and pliable, consider a polyurethane or polypropylene bag and the smallest bag size possible, even if it has a narrow bag shape and taper.

However, if the tissue type is solid, the shape is round, and the mass is large (requiring extensive tissue extraction for removal), consider a bag made of ripstop nylon and factor in the bag shape as well as the bag taper. Using a bag without a steep taper may allow a better fit.

After choosing a laparoscopic bag, select the appropriate trocars necessary for completion of the surgery. Consider starting off with a larger trocar rather than spending the time to upsize a trocar if you plan to use a large bag or intend to extend the trocar incision for a contained tissue extraction. These tips will help optimize efficiency, reduce equipment wastage, and prevent intra-abdominal spillage.

Keep in mind that all procedures, including specimen removal using containment systems, have inherent risks. For example, visualization of the mass within the bag and visualization of vital structures may be hindered by bulkiness of the bag or specimen. There is also a risk of bag compromise and leakage, whether through manipulation of the bag or puncture during specimen extraction. Lastly, even though removing a specimen within a containment system minimizes spillage and reports of in-bag cold-knife tissue extraction in women with histologically proven endometrial cancer have suggested that it is safe, laparoscopic bags have not been proven to prevent the dissemination of malignant tissue fragments.^16,17

Overall, the inherent risks of specimen extraction during minimally invasive surgery are far outweighed by the well-established advantages of laparoscopic surgery, which carries lower risks of surgical complications such as bleeding and infection, shorter hospital stay, and quicker recovery time compared to laparotomy. There is no doubt minimally invasive surgery offers many benefits.

In summary, for best bag selection, it is equally important to know the characteristics of the pathology as it is to know the features of the specimen retrieval systems available at your institution. Understanding both the pathology and the equipment available will allow the surgeon to make the best surgical decisions for the case. ●

The use of minimally invasive gynecologic surgery (MIGS) has grown rapidly over the past 20 years. MIGS, which includes vaginal hysterectomy and laparoscopic hysterectomy, is safe and has fewer complications and a more rapid recovery period than open abdominal surgery.^1,2 In 2005, the role of MIGS was expanded further when the US Food and Drug Administration (FDA) approved robot-assisted surgery for the performance of gynecologic procedures.³ As knowledge and experience in the safe performance of MIGS progresses, the rates for MIGS procedures have skyrocketed and continue to grow. Between 2007 and 2010, laparoscopic hysterectomy rates rose from 23.5% to 30.5%, while robot-assisted laparoscopic hysterectomy rates increased from 0.5% to 9.5%, representing 40% of all hysterectomies.⁴ Due to the benefits of minimally invasive surgery over open abdominal surgery, patient and physician preference for minimally invasive procedures has grown significantly in popularity.^1,5

Because incisions are small in minimally invasive surgery, surgeons have been challenged with removing large specimens through incisions that are much smaller than the presenting pathology. One approach is to use a specimen retrieval bag for specimen extraction. Once the dissection is completed, the specimen is placed within the retrieval bag for removal, thus minimizing exposure of the specimen and its contents to the abdominopelvic cavity and incision.

The use of specimen retrieval devices has been advocated to prevent infection, avoid spillage into the peritoneal cavity, and minimize the risk of port-site metastases in cases of potentially cancerous specimens. Devices include affordable and readily available products, such as nonpowdered gloves, and commercially produced bags.⁶

While the use of specimen containment systems for tissue extraction has been well described in gynecology, the available systems vary widely in construction, size, durability, and shape, potentially leading to confusion and suboptimal bag selection during surgery.⁷ In this article, we review the most common laparoscopic bags available in the United States, provide an overview of bag characteristics, offer practice guidelines for bag selection, and review bag terminology to highlight important concepts for bag selection.

Controversy spurs change

In April 2014, the FDA warned against the use of power morcellation for specimen removal during minimally invasive surgery, citing a prevalence of 1 in 352 unsuspected uterine sarcomas and 1 in 498 unsuspected uterine leiomyosarcomas among women undergoing hysterectomy or myomectomy for presumed benign leiomyoma.⁸ Since then, the risk of occult uterine sarcomas, including leiomyosarcoma, in women undergoing surgery for benign gynecologic indications has been determined to be much lower.

Nonetheless, the clinical importance of contained specimen removal was clearly highlighted and the role of specimen retrieval bags soared to the forefront. Open power morcellation is no longer commonly practiced, and national societies such as the American Association of Gynecologic Laparoscopists (AAGL), the Society of Gynecologic Oncology (SGO), and the American College of Obstetricians and Gynecologists (ACOG) recommend that containment systems be used for safer specimen retrieval during gynecologic surgery.^9-11 After the specimen is placed inside the containment system (typically a specimen bag), the surgeon may deliver the bag through a vaginal colpotomy or through a slightly extended laparoscopic incision to remove bulky specimens using cold-cutting extraction techniques.^12-15

Continue to: Know the pathology’s characteristics...

In most cases, based on imaging studies and physical examination, surgeons have a good idea of what to expect before proceeding with surgery. The 2 most common characteristics used for surgical planning are the specimen size (dimensions) and the tissue type (solid, cystic, soft tissue, or mixed). The mass size can range from less than 1 cm to larger than a 20-week sized fibroid uterus. Assessing the specimen in 3 dimensions is important. Tissue type also is a consideration, as soft and squishy masses, such as ovarian cysts, are easier to deflate and manipulate within the bag compared with solid or calcified tumors, such as a large fibroid uterus or a large dermoid with solid components.

Specimen shape also is a critical determinant for bag selection. Most specimen retrieval bags are tapered to varying degrees, and some have an irregular shape. Long tubular structures, such as fallopian tubes that are composed of soft tissue, fit easily into most bags regardless of bag shape or extent of bag taper, whereas the round shape of a bulky myoma may render certain bags ineffective even if the bag’s entrance accommodates the greatest diameter of the myoma. Often, a round mass will not fully fit into a bag because there is a poor fit between the mass’s shape and the bag’s shape and taper. (We discuss the concept of a poor “fit” below.) Knowing the pathology before starting a procedure can help optimize bag selection, streamline operative flow, and reduce waste.

Overview of laparoscopic bag characteristics and clinical applications

The TABLE lists the most common laparoscopic bags available for purchase in the United States. Details include the trocar size, manufacturer, product name, mouth diameter, volume, bag shape, construction material, and best clinical application.

The following are terms used to refer to the components of a laparoscopic retrieval bag:

• Mouth diameter: diameter at the entrance of a fully opened bag (FIGURE 1)
• Bag volume: the total volume a bag can accommodate when completely full
• Bag rim: characteristics of the rim of the bag when opened (that is, rigid vs soft rim, complete vs partial rim mechanism to hold the bag open) (FIGURE 2)
• Bag shape: the shape of the bag when it is fully opened (square shaped vs cone shaped vs curved bag shape) (FIGURE 2)
• Bag taper (severity and type): extent the bag is tapered from the rim of the bag’s entrance to the base of the bag; categorized by taper severity (minimal, gradual, or steep taper) and type (continuous taper or curved taper) (FIGURE 3)
• Ball fit: the maximum spherical specimen size that completely fits into a bag and allows it to cinch closed (FIGURE 4)
• Bag strength: durability of a bag when placed on tension during specimen extraction (weak, moderate, or extremely durable).

Continue to: Mouth diameter...

Mouth diameter

Bag manufacturers often differentiate bag sizes by indicating “volume” in milliliters. Bag volume, however, offers little clinical value to surgeons, as pelvic mass dimensions are usually measured in centimeters on imaging. Rather, an important characteristic for bag selection is the diameter of the rim of the bag when it is fully opened—the so-called bag mouth diameter. For a specimen to fit, the 2 dimensions of the specimen must be smaller than the dimensions of the bag entrance.

Notably, the number often linked to the specimen bag—as, for example, in the 10-mm Endo Catch bag (Covidien/Medtronic)— describes the width of the shaft of the bag before it is opened rather than the mouth diameter of the opened bag. The number actually correlates with the trocar size necessary for bag insertion rather than with the specimen size that can fit into the bag. Therefore, a 10-mm Endo Catch bag cannot fit a 10-cm mass, but rather requires a trocar size of 10 mm or greater for insertion of the bag. Fully opened, the mouth diameters of the 10-mm Endo Catch bag are roughly 6 cm x 7 cm, which allows for delivery of a 6-cm mass.

Because 2 bags that use the same trocar size for insertion may have vastly differing bag dimensions, the surgeon must know the bag mouth diameters when selecting a bag to remove the presenting pathology. For example, the Inzii 12 (Applied Medical) laparoscopic bag has mouth diameters of 9.7 cm × 13.0 cm, whereas the Anchor TRSROBO-12 (ConMed) has mouth diameters of 6.7 cm × 7.6 cm (TABLE). Although both bags can be inserted through a 12-mm trocar, both bags cannot fit the same size mass for removal.

Shape and taper

Laparoscopic bags come in various shapes (curved, cone, or square shaped), with varying levels of bag taper (steep, gradual, or no taper) (FIGURES 2 and 3). While taper has little impact on long and skinny specimens, taper may hinder successful bagging of bulky or spherical specimens.

Each bag has different grades of taper regardless of mouth diameter or trocar size. For round masses, the steeper the taper, the smaller the mass that can comfortably fit within the bag. This concept is connected to the idea of “ball fit,” explained below.

In addition, bag shape may affect what mass size can fit into the bag. An irregularly shaped curved bag or a bag with a steep taper may be well suited for removal of multiple specimens of varying sizes or soft masses that are malleable enough to conform to the bag’s shape (such as a ruptured ovarian cyst). Alternatively, a square-shaped bag or a bag with minimal taper would better accommodate a round mass.

Ball fit

When thinking about large circular masses, such as myomas or ovarian cysts, one must consider the ball fit. This refers to the maximum spherical size of the specimen that fits completely within a bag while allowing the bag to cinch closed. Generally, this is an estimation that factors in the bag shape, extent of the bag taper, bag mouth diameter, and specimen shape and tissue type. At times, although a mass can fit through the bag’s mouth diameter, a steep taper may prevent the mass from being fully bagged and limit closure of the bag (FIGURE 4).

Curved bags like the Anchor TRSVATS-15 (ConMed), which have a very narrow bottom, are prone to a limited ball fit, and thus the bag mouth diameter will not correlate with the largest mass size that can be fitted within the bag. Therefore, if using a steeply tapered bag for removal of large round masses, do not rely on the bag’s mouth diameter for bag selection. The surgeon must visualize the ball fit within the bag, taking into account the specimen size and shape, bag shape, and bag taper. In these scenarios, using the diameter of the midportion of the opened bag may better reflect the mass size that can fit into that bag.

Bag strength

Bag strength depends on the material used for bag construction. Most laparoscopic bags in the United States are made of 3 different materials: polyurethane, polypropylene, and ripstop nylon.

Polyurethane and polypropylene are synthetic plastic polymers; in bag form they are stretchy and, under extreme force, may tear. They are best used for bagging fluid-filled cysts or soft pliable masses that will not require extensive bag or tissue handling, such as extraction of large leiomyomas. Polyurethane and polypropylene bags are more susceptible to puncture with sharp laparoscopic instruments or scalpels, and care must be taken to avoid accidentally cutting the bag during tissue extraction.

Alternatively, bags made of ripstop nylon are favored for their bag strength. Ripstop nylon is a synthetic fabric that is woven together in a crosshatch pattern that makes it resistant to tearing and ripping. It was developed originally during World War II as a replacement for silk parachutes. Modern applications include its use in sails, kites, and high-quality camping equipment. This material has a favorable strength-to-weight ratio, and, in case of a tear, it is less prone to extension of the tear. For surgical applications, these bags are best used for bagging specimens that will require a lot of bag manipulation and tissue extraction. However, the ripstop fabric takes up more space in the incision than polyurethane or polypropylene, leaving the surgeon with less space for tissue extraction. Thus, as a tradeoff for bag strength, the surgeon may need to extend the incision a little, and a small self-retracting wound retractor may be necessary to allow visibility for safe tissue extraction when using a ripstop nylon bag compared with others.

Continue to: Trocar selection is important...

Trocar selection is important

While considering bag selection, the surgeon also must consider trocar selection to allow for laparoscopic insertion of the bag. Trocar size for bag selection refers to the minimum trocar diameter needed to insert the laparoscopic bag. Most bags are designed to fit into a laparoscopic trocar or into the skin incision that previously housed the trocar. Trocar size does not directly correlate with bag mouth diameter; for example, a 10-mm laparoscopic bag that can be inserted through a 10- or 12-mm trocar size cannot fit a 10-cm mass (see the mouth diameter section above).

A tip to maximize operating room (OR) efficiency is to start off with a larger trocar, such as a 12-mm trocar, if it is known that a laparoscopic bag with a 12-mm trocar size will be used, rather than starting with a 5-mm trocar and upsizing the port site incision. This saves time and offers intraoperative flexibility, allowing for the use of larger instruments and quicker insufflation.

Furthermore, if the specimen has a solid component and tissue extraction is anticipated, consider starting off with a large trocar, one that is larger than the bag’s trocar size since the incision likely will be extended. For example, even if a myoma will fit within a 10-mm laparoscopic bag made of ripstop nylon, using a 15-mm trocar rather than a 10-mm trocar may be considered since the skin and fascial incisions will need to be extended to allow for cold-cut tissue extraction. Starting with the larger 15-mm trocar may offer surgical advantages, such as direct needle delivery of larger needles for myometrial closure after myomectomy or direct removal of smaller myomas through the trocar to avoid bagging multiple specimens.

Putting it all together

To optimize efficiency in the OR for specimen removal, we recommend streamlining OR flow and reducing waste by first considering the specimen size, tissue type, bag shape, and trocar selection. Choose a bag by taking into account the bag mouth diameter and the amount of taper you will need to obtain an appropriate ball fit. If the tissue type is soft and pliable, consider a polyurethane or polypropylene bag and the smallest bag size possible, even if it has a narrow bag shape and taper.

However, if the tissue type is solid, the shape is round, and the mass is large (requiring extensive tissue extraction for removal), consider a bag made of ripstop nylon and factor in the bag shape as well as the bag taper. Using a bag without a steep taper may allow a better fit.

After choosing a laparoscopic bag, select the appropriate trocars necessary for completion of the surgery. Consider starting off with a larger trocar rather than spending the time to upsize a trocar if you plan to use a large bag or intend to extend the trocar incision for a contained tissue extraction. These tips will help optimize efficiency, reduce equipment wastage, and prevent intra-abdominal spillage.

Keep in mind that all procedures, including specimen removal using containment systems, have inherent risks. For example, visualization of the mass within the bag and visualization of vital structures may be hindered by bulkiness of the bag or specimen. There is also a risk of bag compromise and leakage, whether through manipulation of the bag or puncture during specimen extraction. Lastly, even though removing a specimen within a containment system minimizes spillage and reports of in-bag cold-knife tissue extraction in women with histologically proven endometrial cancer have suggested that it is safe, laparoscopic bags have not been proven to prevent the dissemination of malignant tissue fragments.^16,17

Overall, the inherent risks of specimen extraction during minimally invasive surgery are far outweighed by the well-established advantages of laparoscopic surgery, which carries lower risks of surgical complications such as bleeding and infection, shorter hospital stay, and quicker recovery time compared to laparotomy. There is no doubt minimally invasive surgery offers many benefits.

In summary, for best bag selection, it is equally important to know the characteristics of the pathology as it is to know the features of the specimen retrieval systems available at your institution. Understanding both the pathology and the equipment available will allow the surgeon to make the best surgical decisions for the case. ●

The use of minimally invasive gynecologic surgery (MIGS) has grown rapidly over the past 20 years. MIGS, which includes vaginal hysterectomy and laparoscopic hysterectomy, is safe and has fewer complications and a more rapid recovery period than open abdominal surgery.^1,2 In 2005, the role of MIGS was expanded further when the US Food and Drug Administration (FDA) approved robot-assisted surgery for the performance of gynecologic procedures.³ As knowledge and experience in the safe performance of MIGS progresses, the rates for MIGS procedures have skyrocketed and continue to grow. Between 2007 and 2010, laparoscopic hysterectomy rates rose from 23.5% to 30.5%, while robot-assisted laparoscopic hysterectomy rates increased from 0.5% to 9.5%, representing 40% of all hysterectomies.⁴ Due to the benefits of minimally invasive surgery over open abdominal surgery, patient and physician preference for minimally invasive procedures has grown significantly in popularity.^1,5

Because incisions are small in minimally invasive surgery, surgeons have been challenged with removing large specimens through incisions that are much smaller than the presenting pathology. One approach is to use a specimen retrieval bag for specimen extraction. Once the dissection is completed, the specimen is placed within the retrieval bag for removal, thus minimizing exposure of the specimen and its contents to the abdominopelvic cavity and incision.

The use of specimen retrieval devices has been advocated to prevent infection, avoid spillage into the peritoneal cavity, and minimize the risk of port-site metastases in cases of potentially cancerous specimens. Devices include affordable and readily available products, such as nonpowdered gloves, and commercially produced bags.⁶

While the use of specimen containment systems for tissue extraction has been well described in gynecology, the available systems vary widely in construction, size, durability, and shape, potentially leading to confusion and suboptimal bag selection during surgery.⁷ In this article, we review the most common laparoscopic bags available in the United States, provide an overview of bag characteristics, offer practice guidelines for bag selection, and review bag terminology to highlight important concepts for bag selection.

Controversy spurs change

In April 2014, the FDA warned against the use of power morcellation for specimen removal during minimally invasive surgery, citing a prevalence of 1 in 352 unsuspected uterine sarcomas and 1 in 498 unsuspected uterine leiomyosarcomas among women undergoing hysterectomy or myomectomy for presumed benign leiomyoma.⁸ Since then, the risk of occult uterine sarcomas, including leiomyosarcoma, in women undergoing surgery for benign gynecologic indications has been determined to be much lower.

Nonetheless, the clinical importance of contained specimen removal was clearly highlighted and the role of specimen retrieval bags soared to the forefront. Open power morcellation is no longer commonly practiced, and national societies such as the American Association of Gynecologic Laparoscopists (AAGL), the Society of Gynecologic Oncology (SGO), and the American College of Obstetricians and Gynecologists (ACOG) recommend that containment systems be used for safer specimen retrieval during gynecologic surgery.^9-11 After the specimen is placed inside the containment system (typically a specimen bag), the surgeon may deliver the bag through a vaginal colpotomy or through a slightly extended laparoscopic incision to remove bulky specimens using cold-cutting extraction techniques.^12-15

Continue to: Know the pathology’s characteristics...

In most cases, based on imaging studies and physical examination, surgeons have a good idea of what to expect before proceeding with surgery. The 2 most common characteristics used for surgical planning are the specimen size (dimensions) and the tissue type (solid, cystic, soft tissue, or mixed). The mass size can range from less than 1 cm to larger than a 20-week sized fibroid uterus. Assessing the specimen in 3 dimensions is important. Tissue type also is a consideration, as soft and squishy masses, such as ovarian cysts, are easier to deflate and manipulate within the bag compared with solid or calcified tumors, such as a large fibroid uterus or a large dermoid with solid components.

Specimen shape also is a critical determinant for bag selection. Most specimen retrieval bags are tapered to varying degrees, and some have an irregular shape. Long tubular structures, such as fallopian tubes that are composed of soft tissue, fit easily into most bags regardless of bag shape or extent of bag taper, whereas the round shape of a bulky myoma may render certain bags ineffective even if the bag’s entrance accommodates the greatest diameter of the myoma. Often, a round mass will not fully fit into a bag because there is a poor fit between the mass’s shape and the bag’s shape and taper. (We discuss the concept of a poor “fit” below.) Knowing the pathology before starting a procedure can help optimize bag selection, streamline operative flow, and reduce waste.

Overview of laparoscopic bag characteristics and clinical applications

The TABLE lists the most common laparoscopic bags available for purchase in the United States. Details include the trocar size, manufacturer, product name, mouth diameter, volume, bag shape, construction material, and best clinical application.

The following are terms used to refer to the components of a laparoscopic retrieval bag:

• Mouth diameter: diameter at the entrance of a fully opened bag (FIGURE 1)
• Bag volume: the total volume a bag can accommodate when completely full
• Bag rim: characteristics of the rim of the bag when opened (that is, rigid vs soft rim, complete vs partial rim mechanism to hold the bag open) (FIGURE 2)
• Bag shape: the shape of the bag when it is fully opened (square shaped vs cone shaped vs curved bag shape) (FIGURE 2)
• Bag taper (severity and type): extent the bag is tapered from the rim of the bag’s entrance to the base of the bag; categorized by taper severity (minimal, gradual, or steep taper) and type (continuous taper or curved taper) (FIGURE 3)
• Ball fit: the maximum spherical specimen size that completely fits into a bag and allows it to cinch closed (FIGURE 4)
• Bag strength: durability of a bag when placed on tension during specimen extraction (weak, moderate, or extremely durable).

Continue to: Mouth diameter...

Mouth diameter

Bag manufacturers often differentiate bag sizes by indicating “volume” in milliliters. Bag volume, however, offers little clinical value to surgeons, as pelvic mass dimensions are usually measured in centimeters on imaging. Rather, an important characteristic for bag selection is the diameter of the rim of the bag when it is fully opened—the so-called bag mouth diameter. For a specimen to fit, the 2 dimensions of the specimen must be smaller than the dimensions of the bag entrance.

Notably, the number often linked to the specimen bag—as, for example, in the 10-mm Endo Catch bag (Covidien/Medtronic)— describes the width of the shaft of the bag before it is opened rather than the mouth diameter of the opened bag. The number actually correlates with the trocar size necessary for bag insertion rather than with the specimen size that can fit into the bag. Therefore, a 10-mm Endo Catch bag cannot fit a 10-cm mass, but rather requires a trocar size of 10 mm or greater for insertion of the bag. Fully opened, the mouth diameters of the 10-mm Endo Catch bag are roughly 6 cm x 7 cm, which allows for delivery of a 6-cm mass.

Because 2 bags that use the same trocar size for insertion may have vastly differing bag dimensions, the surgeon must know the bag mouth diameters when selecting a bag to remove the presenting pathology. For example, the Inzii 12 (Applied Medical) laparoscopic bag has mouth diameters of 9.7 cm × 13.0 cm, whereas the Anchor TRSROBO-12 (ConMed) has mouth diameters of 6.7 cm × 7.6 cm (TABLE). Although both bags can be inserted through a 12-mm trocar, both bags cannot fit the same size mass for removal.

Shape and taper

Laparoscopic bags come in various shapes (curved, cone, or square shaped), with varying levels of bag taper (steep, gradual, or no taper) (FIGURES 2 and 3). While taper has little impact on long and skinny specimens, taper may hinder successful bagging of bulky or spherical specimens.

Each bag has different grades of taper regardless of mouth diameter or trocar size. For round masses, the steeper the taper, the smaller the mass that can comfortably fit within the bag. This concept is connected to the idea of “ball fit,” explained below.

In addition, bag shape may affect what mass size can fit into the bag. An irregularly shaped curved bag or a bag with a steep taper may be well suited for removal of multiple specimens of varying sizes or soft masses that are malleable enough to conform to the bag’s shape (such as a ruptured ovarian cyst). Alternatively, a square-shaped bag or a bag with minimal taper would better accommodate a round mass.

Ball fit

When thinking about large circular masses, such as myomas or ovarian cysts, one must consider the ball fit. This refers to the maximum spherical size of the specimen that fits completely within a bag while allowing the bag to cinch closed. Generally, this is an estimation that factors in the bag shape, extent of the bag taper, bag mouth diameter, and specimen shape and tissue type. At times, although a mass can fit through the bag’s mouth diameter, a steep taper may prevent the mass from being fully bagged and limit closure of the bag (FIGURE 4).

Curved bags like the Anchor TRSVATS-15 (ConMed), which have a very narrow bottom, are prone to a limited ball fit, and thus the bag mouth diameter will not correlate with the largest mass size that can be fitted within the bag. Therefore, if using a steeply tapered bag for removal of large round masses, do not rely on the bag’s mouth diameter for bag selection. The surgeon must visualize the ball fit within the bag, taking into account the specimen size and shape, bag shape, and bag taper. In these scenarios, using the diameter of the midportion of the opened bag may better reflect the mass size that can fit into that bag.

Bag strength

Bag strength depends on the material used for bag construction. Most laparoscopic bags in the United States are made of 3 different materials: polyurethane, polypropylene, and ripstop nylon.

Polyurethane and polypropylene are synthetic plastic polymers; in bag form they are stretchy and, under extreme force, may tear. They are best used for bagging fluid-filled cysts or soft pliable masses that will not require extensive bag or tissue handling, such as extraction of large leiomyomas. Polyurethane and polypropylene bags are more susceptible to puncture with sharp laparoscopic instruments or scalpels, and care must be taken to avoid accidentally cutting the bag during tissue extraction.

Alternatively, bags made of ripstop nylon are favored for their bag strength. Ripstop nylon is a synthetic fabric that is woven together in a crosshatch pattern that makes it resistant to tearing and ripping. It was developed originally during World War II as a replacement for silk parachutes. Modern applications include its use in sails, kites, and high-quality camping equipment. This material has a favorable strength-to-weight ratio, and, in case of a tear, it is less prone to extension of the tear. For surgical applications, these bags are best used for bagging specimens that will require a lot of bag manipulation and tissue extraction. However, the ripstop fabric takes up more space in the incision than polyurethane or polypropylene, leaving the surgeon with less space for tissue extraction. Thus, as a tradeoff for bag strength, the surgeon may need to extend the incision a little, and a small self-retracting wound retractor may be necessary to allow visibility for safe tissue extraction when using a ripstop nylon bag compared with others.

Continue to: Trocar selection is important...

Trocar selection is important

While considering bag selection, the surgeon also must consider trocar selection to allow for laparoscopic insertion of the bag. Trocar size for bag selection refers to the minimum trocar diameter needed to insert the laparoscopic bag. Most bags are designed to fit into a laparoscopic trocar or into the skin incision that previously housed the trocar. Trocar size does not directly correlate with bag mouth diameter; for example, a 10-mm laparoscopic bag that can be inserted through a 10- or 12-mm trocar size cannot fit a 10-cm mass (see the mouth diameter section above).

A tip to maximize operating room (OR) efficiency is to start off with a larger trocar, such as a 12-mm trocar, if it is known that a laparoscopic bag with a 12-mm trocar size will be used, rather than starting with a 5-mm trocar and upsizing the port site incision. This saves time and offers intraoperative flexibility, allowing for the use of larger instruments and quicker insufflation.

Furthermore, if the specimen has a solid component and tissue extraction is anticipated, consider starting off with a large trocar, one that is larger than the bag’s trocar size since the incision likely will be extended. For example, even if a myoma will fit within a 10-mm laparoscopic bag made of ripstop nylon, using a 15-mm trocar rather than a 10-mm trocar may be considered since the skin and fascial incisions will need to be extended to allow for cold-cut tissue extraction. Starting with the larger 15-mm trocar may offer surgical advantages, such as direct needle delivery of larger needles for myometrial closure after myomectomy or direct removal of smaller myomas through the trocar to avoid bagging multiple specimens.

Putting it all together

To optimize efficiency in the OR for specimen removal, we recommend streamlining OR flow and reducing waste by first considering the specimen size, tissue type, bag shape, and trocar selection. Choose a bag by taking into account the bag mouth diameter and the amount of taper you will need to obtain an appropriate ball fit. If the tissue type is soft and pliable, consider a polyurethane or polypropylene bag and the smallest bag size possible, even if it has a narrow bag shape and taper.

However, if the tissue type is solid, the shape is round, and the mass is large (requiring extensive tissue extraction for removal), consider a bag made of ripstop nylon and factor in the bag shape as well as the bag taper. Using a bag without a steep taper may allow a better fit.

After choosing a laparoscopic bag, select the appropriate trocars necessary for completion of the surgery. Consider starting off with a larger trocar rather than spending the time to upsize a trocar if you plan to use a large bag or intend to extend the trocar incision for a contained tissue extraction. These tips will help optimize efficiency, reduce equipment wastage, and prevent intra-abdominal spillage.

Keep in mind that all procedures, including specimen removal using containment systems, have inherent risks. For example, visualization of the mass within the bag and visualization of vital structures may be hindered by bulkiness of the bag or specimen. There is also a risk of bag compromise and leakage, whether through manipulation of the bag or puncture during specimen extraction. Lastly, even though removing a specimen within a containment system minimizes spillage and reports of in-bag cold-knife tissue extraction in women with histologically proven endometrial cancer have suggested that it is safe, laparoscopic bags have not been proven to prevent the dissemination of malignant tissue fragments.^16,17

Overall, the inherent risks of specimen extraction during minimally invasive surgery are far outweighed by the well-established advantages of laparoscopic surgery, which carries lower risks of surgical complications such as bleeding and infection, shorter hospital stay, and quicker recovery time compared to laparotomy. There is no doubt minimally invasive surgery offers many benefits.

In summary, for best bag selection, it is equally important to know the characteristics of the pathology as it is to know the features of the specimen retrieval systems available at your institution. Understanding both the pathology and the equipment available will allow the surgeon to make the best surgical decisions for the case. ●

Stress urinary incontinence (SUI) is the involuntary loss of urine with increased intra-abdominal pressure, such as with physical exertion, sneezing, or coughing.¹ Currently, the gold standard treatment for SUI is surgical repair with the use of a synthetic midurethral sling (MUS), based on long-term data that support its excellent efficacy and durability. The risk-benefit balance of MUS continues to be scrutinized, however, with erosions and pain poorly studied and apparently underreported. 

The medical-legal risks associated with the MUS are a significant concern and have led many patients to reconsider this option for their condition. Many other countries (United Kingdom, Australia, New Zealand, and European Union) are now re-evaluating the use of the MUS.² In the United Kingdom, for example, the National Institute for Health and Care Excellence (NICE) Guideline advises considering the MUS only when another surgical intervention is not suitable for the patient.³ 

In light of the heightened skepticism surrounding the MUS, interest has increased in the use of urethral bulking agents. These agents consist of a material injected into the wall of the urethra to improve urethral coaptation in women with SUI.⁴ 

A brief history of bulking agents 

In 1938, Murless first reported the injection of sodium morrhuate for the management of urinary incontinence.⁴ Other early bulking agents introduced in the 1950s and 1960s included paraffin wax and sclerosing agents. Subsequently, Teflon, collagen, and autologous fat, among other agents, were found to be efficacious for augmenting urethral coaptation; however, only collagen initially demonstrated acceptable safety.⁵ 

Contigen (bovine dermal collagen cross-linked with gluteraldehyde) was approved as a bulking agent by the US Food and Drug Administration (FDA) in 1993; however, the manufacturing of bovine collagen was halted in 2011. Contigen was the only nonpermanent biodegradable urethral bulking agent, and its use required skin testing prior to use, as 2% to 5% of women experienced allergic reaction.⁴ 

Presently, 3 particle-based urethral bulking agents are FDA approved for marketing in the United States: Macroplastique (Laborie Medical Technologies), Coaptite (Boston Scientific), and Durasphere (Coloplast). In addition, Bulkamid (Contura), which was approved earlier this year, is a nonparticulate agent composed of a nonresorbable polyacrylamide hydrogel.⁵ 

Continue to: Indications for use...

According to the FDA premarket approvals (PMAs) for the particle-based urethral bulking agents, their use is indicated for adult women with SUI primarily due to intrinsic sphincter deficiency (ISD).⁶ The PMA indication for the nonparticulate agent, however, allows it to be used for SUI as well as SUI-predominant mixed urinary incontinence (MUI) due to ISD.⁷ Traditionally, ISD is defined by urodynamic criteria that includes a maximal urethral closure pressure less than 20 to 25 cm of water and/or a Valsalva leak point pressure of less than 60 cm of water.⁴ 

The American Urological Association (AUA) guideline lists bulking agents as an option for women who do not wish to pursue invasive surgical intervention for SUI, are concerned about lengthier recovery after surgery, or have previously undergone anti-incontinence procedures with suboptimal results.⁸ In general, most urologists and urogynecologists who perform urethral bulking agree with the AUA guideline. 

Perceptions of bulking agents have shifted 

Urethral bulking agents traditionally have been thought of as a "salvage therapy." Perceived indications for these agents include use in women with persistent SUI after more invasive treatment options or in women who were medically fragile and thus could not undergo a more invasive procedure.⁹ As mentioned, however, circumstances related to mesh use have shifted the current perception of indications for urethral bulking agents from salvage therapy only to use as a possible first-line treatment in the appropriately selected patient.⁹ 

Recent data that note improved durability and patient satisfaction, as well as better appreciation of the fact that, if the bulking agent fails, a synthetic sling procedure still can be performed without significant concerns, have contributed to this shift in intervention strategy.^10,11 There also has been the perception that urethral bulking agents should not be considered in women who have urethral mobility. However, studies have shown that outcomes are not significantly different in patients with urethral mobility compared with those with a fixed urethra.¹¹ 

Types of bulking agents  

The ideal bulking agent should be made of a material that is biocompatible--with low host reactivity, low carcinogenic potential, low risk of migration--and easy to administer.⁵ Currently available bulking agents are classified as particulate and nonparticulate agents. The TABLE provides summary details of the available agents FDA approved for use.

Particulate bulking agents 

Durasphere, approved by the FDA in 1999, is composed of carbon-coated zirconium oxide in a water-based and beta-glucan carrier. The first generation of this agent had particles that ranged in size from 212 to 500 µm and required an 18-gauge needle for injection.4 The second-generation preparation has a smaller particle size, ranging from 90 to 212 µm, which permits injection with a smaller needle, typically 20 gauge.⁴ Theoretically, the larger bead size reduces the risk of migration as particles larger than 80 µm cannot be engulfed by macrophages.⁴ 

Coaptite is a calcium hydroxylapatite-based product approved by the FDA in 2005. The carrier media is composed of sodium carboxymethylcellulose, sterile water, and glycerin. The particle size ranges from 75 to 125 µm, with an average of 100 µm.⁵ This synthetic material historically has been used in orthopedics and dental applications. The aqueous gel carrier dissipates over months, resulting in tissue growth; thereafter, the particulate beads slowly degrade.¹² 

Macroplastique, a polydimethylsiloxane compound, was approved by the FDA in 2006. It has a long history of use primarily in Europe where it has been used since 1991. It is composed of a nonbiodegradable silicone (polydimethylsiloxane) elastomer suspended in a water-soluble gel. The initial composition was of particles that ranged in size from 5 to 400 µm, with 25% of the particles smaller than 50 µm. Because of the large number of particles smaller than 50 µm, there were concerns for migration.⁵ The agent's current composition contains particles that range from 120 to 600 µm, with an average particle size of 140 µm.⁴ 

Nonparticulate bulking agent 

Bulkamid has been available in Europe since 2003 and was FDA approved in January 2020. It is the only available nonparticulate urethral bulking agent; it is composed uniquely of a nonresorbable polyacrylamide hydrogel made of cross-linked 2.5% polyacrylamide and water. Its bulking effect is achieved through the actual volume of hydrogel injected, which integrates with host tissue by vessel ingrowth, suggestive of a persistent durable effect. Because Bulkamid contains no particles or crystals, the theoretical risk of migration is mitigated.⁴ 

Continue to: The urethral bulking technique...

The urethral bulking technique 

The basic technique for urethral bulking is similar for all agents, with nuances in technique for each agent. 

The procedure typically begins with placement of 2% lidocaine gel in the urethra for 5 to 10 minutes. The disposable needle is primed with the agent.⁴ For Durasphere, an 18- or 21-gauge rigid needle is used; for Coaptite, a 21-gauge rigid side injecting needle called the SideKick is used; and for Macroplastique, an 18- or 20-gauge rigid needle is used.⁴ Bulkamid administration requires the use of a special 23-gauge needle. Durasphere and Coaptite are delivered via a standard cystoscope.⁴ Macroplastique requires a proprietary delivery system4 (FIGURE 1). Bulkamid has a proprietary urethroscope and rotatable sheath to guide accuracy of injection (FIGURE 2).⁴ 

After the needle is primed and the delivery device placed into the urethra, the injection site is selected, approximately 1.5 to 2 cm from the bladder neck. The needle is introduced into the suburethral tissue at a 30- to 45-degree angle.  

The injection site varies by agent. The 4 and 8 o'clock positions are recommended for Coaptite and Durasphere, while the 2, 6, and 10 o'clock positions are recommended for Macroplastique. For Bulkamid, the recommendation is to create 3 cushions at the 2, 6, and 10 o'clock positions.¹³ Regardless of the agent used, the bulking is easily visualized and should result in the various sites meeting in the midline (FIGURE 3). 

Continue to: Evidence-based outcomes...

Evidence-based outcomes 

The published data on outcomes of urethral bulking treatments have used inconsistent measures of efficacy. Most of the FDA trials used subjective success calculated with use of the Stamey Urinary Incontinence Scale (Stamey Grade) and validated questionnaires as well as objective data collected via voiding diaries and pad tests.⁴ 

In 2007, a multicenter prospective randomized controlled trial (RCT) compared Coaptite with Contigen treatment and found that 63.4% versus 57.0% of patients, respectively, experienced an improvement on the Stamey Urinary Incontinence Scale at 12-month follow-up.¹⁴ 

A prospective multicenter RCT in 2009 was conducted to test the durability and efficacy of Macroplastique treatment at 12-month follow-up.¹⁵ The authors noted that at 12 months, 62% of treated women reported significant improvement.¹⁵ Further, a systematic review and meta-analysis of the literature (1990-2010) on Macroplastique use was published in 2013.¹⁶ Data from 958 patients from 23 cohorts were analyzed in a random-effects model for 3 time periods: short term (less than 6 months), mid term (6-12 months), and long term (>18 months). Cure/dry rates were reported for short, mid, and long-term follow-up as 43% (95% confidence interval [CI], 33%-54%), 37% (95% CI, 28%-46%), and 36% (95% CI, 27%-46%), respectively.¹⁶ 

The newest bulking product in the United States, Bulkamid, has been available for use in Europe since 2003.¹⁷ In a 3-year follow-up of a prospective nonrandomized single-site study, 212 of 256 (82.8%) participants were subjectively cured or had significant improvement in SUI or MUI, and this result was maintained until the end of the study period (a median of 38 months).¹⁰ In 2014, an 8-year follow-up of 24 women was published.¹⁸ Subjectively, 44% of the women reported cure or significant improvement, and 11 women who presented for objective evaluation all had polyacrylamide hydrogel visible on vaginal ultrasound.¹⁸ 

In addition, an RCT published in 2020 compared surgery with tension-free vaginal tape (TVT) and Bulkamid use in 224 women with SUI. At the 12-month follow-up, TVT was found to be more effective than Bulkamid; the median visual analog scale score for satisfaction was 99 for the TVT-treated group and 85 for the Bulkamid-treated patients.¹¹ Additionally, a cough stress test was negative in 95.0% and 66.4% of participants, respectively, but reoperations occurred only in patients who received the TVT procedure (n = 6). The authors concluded that while TVT treatment provided higher satisfaction rates than did Bulkamid, all major perioperative and follow-up complications were associated with TVT use. The study is ongoing and will eventually report 3-year outcomes.¹¹ 

According to a 2017 Cochrane Review on urethral bulking, treatments with all 3 of the particulate bulking agents resulted in improvements that were no more or less effective than Contigen treatment. The review failed to include publications on Bulkamid treatment.¹⁹ 

Continue to: Complications and safety issues...

Adverse events. Reported adverse effects associated with urethral bulking include mild pain, transient urinary retention (typically resolving within 1-2 days after injection), dysuria, hematuria, and urinary tract infection (UTI).^4,12 

In a 12-month RCT involving 355 women treated with Durasphere or bovine collagen, adverse events were reported in 178 Durasphere-treated women; dysuria (24.7%) and temporary urinary retention (16.9%) were the most commonly reported adverse events.²⁰ 

An RCT of Coaptite injection (n = 296) found that temporary urinary retention (41%) was the most common adverse event.¹⁴ 

In a 12-month comparative study of Macroplastique versus Contigen (n = 122), UTI was reported as the most common adverse event (23.8%), followed by dysuria (9%) and urgency (9%).¹⁵ In addition, in a meta-analysis involving 958 patients in 23 cohorts, Ghoniem and Miller reported that the median rates for adverse events were temporary dysuria, 50%; hematuria, 45%; urge incontinence, 7%; temporary urinary retention, 7%; and UTI, 3%.¹⁶ 

A 3-year summary outcome of 256 patients who received Bulkamid injection reported that only 1 patient developed infection, abscess, or allergic reaction at the injection site and 1 patient had a UTI.¹⁰ In an 8-year follow-up of patients who received Bulkamid injection, 1 patient experienced stranguria and 7 patients had recurrent cystitis.¹⁸ 

It appears that transient dysuria, urgency, and urinary retention occur more frequently after urethral bulking with particulate agents.¹² 

Complications. Few delayed but serious complications after urethral bulking have been reported, including suburethral abscess, urethral prolapse, and particle migration.⁴ Cases of urethral prolapse have been reported with both Coaptite and Durasphere. Notably, all cases of urethral prolapse occurred in patients with a history of pelvic surgery and/or previous urethral bulking.^21,22 Cases also have been reported of Durasphere carbon bead particles migrating to regional and distant lymph nodes, and pseudoabscess also has been reported.^12,23 A single case of periurethral abscess was reported after Bulkamid injection in a patient who had prior vaginal hysterectomy and a transobturator tape procedure after a total vaginal mesh repair.²⁴ 

Bulking agent use: Time to go mainstream? 

Historically, urethral bulking agents have had limited utility, largely due to the inaccurate and unsubstantiated perceptions of them being indicated only in women with ISD and a well-supported urethra. More recently, urethral bulking agents are commonly being used in patients who: have recurrent SUI after a surgical intervention, have infrequent but bothersome SUI symptoms, are not ideal candidates to undergo anesthesia, or wish to avoid mesh. 

Some data suggest that objective and subjective success rates are lower with bulking agent treatment compared with the gold standard MUS procedure. However, in the appropriately selected patient, urethral bulking agents may be considered primary treatment due to their associated low morbidity and, as recently reported with newer nonparticulate agents, high subjective success rates. If the patient is not satisfied with the results of bulking treatment, surgical repair with any type of sling remains a subsequent option. This feature adds to the potential viability and appropriateness of considering a bulking agent as a primary treatment. ●

Stress urinary incontinence (SUI) is the involuntary loss of urine with increased intra-abdominal pressure, such as with physical exertion, sneezing, or coughing.¹ Currently, the gold standard treatment for SUI is surgical repair with the use of a synthetic midurethral sling (MUS), based on long-term data that support its excellent efficacy and durability. The risk-benefit balance of MUS continues to be scrutinized, however, with erosions and pain poorly studied and apparently underreported. 

The medical-legal risks associated with the MUS are a significant concern and have led many patients to reconsider this option for their condition. Many other countries (United Kingdom, Australia, New Zealand, and European Union) are now re-evaluating the use of the MUS.² In the United Kingdom, for example, the National Institute for Health and Care Excellence (NICE) Guideline advises considering the MUS only when another surgical intervention is not suitable for the patient.³ 

In light of the heightened skepticism surrounding the MUS, interest has increased in the use of urethral bulking agents. These agents consist of a material injected into the wall of the urethra to improve urethral coaptation in women with SUI.⁴ 

A brief history of bulking agents 

In 1938, Murless first reported the injection of sodium morrhuate for the management of urinary incontinence.⁴ Other early bulking agents introduced in the 1950s and 1960s included paraffin wax and sclerosing agents. Subsequently, Teflon, collagen, and autologous fat, among other agents, were found to be efficacious for augmenting urethral coaptation; however, only collagen initially demonstrated acceptable safety.⁵ 

Contigen (bovine dermal collagen cross-linked with gluteraldehyde) was approved as a bulking agent by the US Food and Drug Administration (FDA) in 1993; however, the manufacturing of bovine collagen was halted in 2011. Contigen was the only nonpermanent biodegradable urethral bulking agent, and its use required skin testing prior to use, as 2% to 5% of women experienced allergic reaction.⁴ 

Presently, 3 particle-based urethral bulking agents are FDA approved for marketing in the United States: Macroplastique (Laborie Medical Technologies), Coaptite (Boston Scientific), and Durasphere (Coloplast). In addition, Bulkamid (Contura), which was approved earlier this year, is a nonparticulate agent composed of a nonresorbable polyacrylamide hydrogel.⁵ 

Continue to: Indications for use...

According to the FDA premarket approvals (PMAs) for the particle-based urethral bulking agents, their use is indicated for adult women with SUI primarily due to intrinsic sphincter deficiency (ISD).⁶ The PMA indication for the nonparticulate agent, however, allows it to be used for SUI as well as SUI-predominant mixed urinary incontinence (MUI) due to ISD.⁷ Traditionally, ISD is defined by urodynamic criteria that includes a maximal urethral closure pressure less than 20 to 25 cm of water and/or a Valsalva leak point pressure of less than 60 cm of water.⁴ 

The American Urological Association (AUA) guideline lists bulking agents as an option for women who do not wish to pursue invasive surgical intervention for SUI, are concerned about lengthier recovery after surgery, or have previously undergone anti-incontinence procedures with suboptimal results.⁸ In general, most urologists and urogynecologists who perform urethral bulking agree with the AUA guideline. 

Perceptions of bulking agents have shifted 

Urethral bulking agents traditionally have been thought of as a "salvage therapy." Perceived indications for these agents include use in women with persistent SUI after more invasive treatment options or in women who were medically fragile and thus could not undergo a more invasive procedure.⁹ As mentioned, however, circumstances related to mesh use have shifted the current perception of indications for urethral bulking agents from salvage therapy only to use as a possible first-line treatment in the appropriately selected patient.⁹ 

Recent data that note improved durability and patient satisfaction, as well as better appreciation of the fact that, if the bulking agent fails, a synthetic sling procedure still can be performed without significant concerns, have contributed to this shift in intervention strategy.^10,11 There also has been the perception that urethral bulking agents should not be considered in women who have urethral mobility. However, studies have shown that outcomes are not significantly different in patients with urethral mobility compared with those with a fixed urethra.¹¹ 

Types of bulking agents  

The ideal bulking agent should be made of a material that is biocompatible--with low host reactivity, low carcinogenic potential, low risk of migration--and easy to administer.⁵ Currently available bulking agents are classified as particulate and nonparticulate agents. The TABLE provides summary details of the available agents FDA approved for use.

Particulate bulking agents 

Durasphere, approved by the FDA in 1999, is composed of carbon-coated zirconium oxide in a water-based and beta-glucan carrier. The first generation of this agent had particles that ranged in size from 212 to 500 µm and required an 18-gauge needle for injection.4 The second-generation preparation has a smaller particle size, ranging from 90 to 212 µm, which permits injection with a smaller needle, typically 20 gauge.⁴ Theoretically, the larger bead size reduces the risk of migration as particles larger than 80 µm cannot be engulfed by macrophages.⁴ 

Coaptite is a calcium hydroxylapatite-based product approved by the FDA in 2005. The carrier media is composed of sodium carboxymethylcellulose, sterile water, and glycerin. The particle size ranges from 75 to 125 µm, with an average of 100 µm.⁵ This synthetic material historically has been used in orthopedics and dental applications. The aqueous gel carrier dissipates over months, resulting in tissue growth; thereafter, the particulate beads slowly degrade.¹² 

Macroplastique, a polydimethylsiloxane compound, was approved by the FDA in 2006. It has a long history of use primarily in Europe where it has been used since 1991. It is composed of a nonbiodegradable silicone (polydimethylsiloxane) elastomer suspended in a water-soluble gel. The initial composition was of particles that ranged in size from 5 to 400 µm, with 25% of the particles smaller than 50 µm. Because of the large number of particles smaller than 50 µm, there were concerns for migration.⁵ The agent's current composition contains particles that range from 120 to 600 µm, with an average particle size of 140 µm.⁴ 

Nonparticulate bulking agent 

Bulkamid has been available in Europe since 2003 and was FDA approved in January 2020. It is the only available nonparticulate urethral bulking agent; it is composed uniquely of a nonresorbable polyacrylamide hydrogel made of cross-linked 2.5% polyacrylamide and water. Its bulking effect is achieved through the actual volume of hydrogel injected, which integrates with host tissue by vessel ingrowth, suggestive of a persistent durable effect. Because Bulkamid contains no particles or crystals, the theoretical risk of migration is mitigated.⁴ 

Continue to: The urethral bulking technique...

The urethral bulking technique 

The basic technique for urethral bulking is similar for all agents, with nuances in technique for each agent. 

The procedure typically begins with placement of 2% lidocaine gel in the urethra for 5 to 10 minutes. The disposable needle is primed with the agent.⁴ For Durasphere, an 18- or 21-gauge rigid needle is used; for Coaptite, a 21-gauge rigid side injecting needle called the SideKick is used; and for Macroplastique, an 18- or 20-gauge rigid needle is used.⁴ Bulkamid administration requires the use of a special 23-gauge needle. Durasphere and Coaptite are delivered via a standard cystoscope.⁴ Macroplastique requires a proprietary delivery system4 (FIGURE 1). Bulkamid has a proprietary urethroscope and rotatable sheath to guide accuracy of injection (FIGURE 2).⁴ 

After the needle is primed and the delivery device placed into the urethra, the injection site is selected, approximately 1.5 to 2 cm from the bladder neck. The needle is introduced into the suburethral tissue at a 30- to 45-degree angle.  

The injection site varies by agent. The 4 and 8 o'clock positions are recommended for Coaptite and Durasphere, while the 2, 6, and 10 o'clock positions are recommended for Macroplastique. For Bulkamid, the recommendation is to create 3 cushions at the 2, 6, and 10 o'clock positions.¹³ Regardless of the agent used, the bulking is easily visualized and should result in the various sites meeting in the midline (FIGURE 3). 

Continue to: Evidence-based outcomes...

Evidence-based outcomes 

The published data on outcomes of urethral bulking treatments have used inconsistent measures of efficacy. Most of the FDA trials used subjective success calculated with use of the Stamey Urinary Incontinence Scale (Stamey Grade) and validated questionnaires as well as objective data collected via voiding diaries and pad tests.⁴ 

In 2007, a multicenter prospective randomized controlled trial (RCT) compared Coaptite with Contigen treatment and found that 63.4% versus 57.0% of patients, respectively, experienced an improvement on the Stamey Urinary Incontinence Scale at 12-month follow-up.¹⁴ 

A prospective multicenter RCT in 2009 was conducted to test the durability and efficacy of Macroplastique treatment at 12-month follow-up.¹⁵ The authors noted that at 12 months, 62% of treated women reported significant improvement.¹⁵ Further, a systematic review and meta-analysis of the literature (1990-2010) on Macroplastique use was published in 2013.¹⁶ Data from 958 patients from 23 cohorts were analyzed in a random-effects model for 3 time periods: short term (less than 6 months), mid term (6-12 months), and long term (>18 months). Cure/dry rates were reported for short, mid, and long-term follow-up as 43% (95% confidence interval [CI], 33%-54%), 37% (95% CI, 28%-46%), and 36% (95% CI, 27%-46%), respectively.¹⁶ 

The newest bulking product in the United States, Bulkamid, has been available for use in Europe since 2003.¹⁷ In a 3-year follow-up of a prospective nonrandomized single-site study, 212 of 256 (82.8%) participants were subjectively cured or had significant improvement in SUI or MUI, and this result was maintained until the end of the study period (a median of 38 months).¹⁰ In 2014, an 8-year follow-up of 24 women was published.¹⁸ Subjectively, 44% of the women reported cure or significant improvement, and 11 women who presented for objective evaluation all had polyacrylamide hydrogel visible on vaginal ultrasound.¹⁸ 

In addition, an RCT published in 2020 compared surgery with tension-free vaginal tape (TVT) and Bulkamid use in 224 women with SUI. At the 12-month follow-up, TVT was found to be more effective than Bulkamid; the median visual analog scale score for satisfaction was 99 for the TVT-treated group and 85 for the Bulkamid-treated patients.¹¹ Additionally, a cough stress test was negative in 95.0% and 66.4% of participants, respectively, but reoperations occurred only in patients who received the TVT procedure (n = 6). The authors concluded that while TVT treatment provided higher satisfaction rates than did Bulkamid, all major perioperative and follow-up complications were associated with TVT use. The study is ongoing and will eventually report 3-year outcomes.¹¹ 

According to a 2017 Cochrane Review on urethral bulking, treatments with all 3 of the particulate bulking agents resulted in improvements that were no more or less effective than Contigen treatment. The review failed to include publications on Bulkamid treatment.¹⁹ 

Continue to: Complications and safety issues...

Adverse events. Reported adverse effects associated with urethral bulking include mild pain, transient urinary retention (typically resolving within 1-2 days after injection), dysuria, hematuria, and urinary tract infection (UTI).^4,12 

In a 12-month RCT involving 355 women treated with Durasphere or bovine collagen, adverse events were reported in 178 Durasphere-treated women; dysuria (24.7%) and temporary urinary retention (16.9%) were the most commonly reported adverse events.²⁰ 

An RCT of Coaptite injection (n = 296) found that temporary urinary retention (41%) was the most common adverse event.¹⁴ 

In a 12-month comparative study of Macroplastique versus Contigen (n = 122), UTI was reported as the most common adverse event (23.8%), followed by dysuria (9%) and urgency (9%).¹⁵ In addition, in a meta-analysis involving 958 patients in 23 cohorts, Ghoniem and Miller reported that the median rates for adverse events were temporary dysuria, 50%; hematuria, 45%; urge incontinence, 7%; temporary urinary retention, 7%; and UTI, 3%.¹⁶ 

A 3-year summary outcome of 256 patients who received Bulkamid injection reported that only 1 patient developed infection, abscess, or allergic reaction at the injection site and 1 patient had a UTI.¹⁰ In an 8-year follow-up of patients who received Bulkamid injection, 1 patient experienced stranguria and 7 patients had recurrent cystitis.¹⁸ 

It appears that transient dysuria, urgency, and urinary retention occur more frequently after urethral bulking with particulate agents.¹² 

Complications. Few delayed but serious complications after urethral bulking have been reported, including suburethral abscess, urethral prolapse, and particle migration.⁴ Cases of urethral prolapse have been reported with both Coaptite and Durasphere. Notably, all cases of urethral prolapse occurred in patients with a history of pelvic surgery and/or previous urethral bulking.^21,22 Cases also have been reported of Durasphere carbon bead particles migrating to regional and distant lymph nodes, and pseudoabscess also has been reported.^12,23 A single case of periurethral abscess was reported after Bulkamid injection in a patient who had prior vaginal hysterectomy and a transobturator tape procedure after a total vaginal mesh repair.²⁴ 

Bulking agent use: Time to go mainstream? 

Historically, urethral bulking agents have had limited utility, largely due to the inaccurate and unsubstantiated perceptions of them being indicated only in women with ISD and a well-supported urethra. More recently, urethral bulking agents are commonly being used in patients who: have recurrent SUI after a surgical intervention, have infrequent but bothersome SUI symptoms, are not ideal candidates to undergo anesthesia, or wish to avoid mesh. 

Some data suggest that objective and subjective success rates are lower with bulking agent treatment compared with the gold standard MUS procedure. However, in the appropriately selected patient, urethral bulking agents may be considered primary treatment due to their associated low morbidity and, as recently reported with newer nonparticulate agents, high subjective success rates. If the patient is not satisfied with the results of bulking treatment, surgical repair with any type of sling remains a subsequent option. This feature adds to the potential viability and appropriateness of considering a bulking agent as a primary treatment. ●

Stress urinary incontinence (SUI) is the involuntary loss of urine with increased intra-abdominal pressure, such as with physical exertion, sneezing, or coughing.¹ Currently, the gold standard treatment for SUI is surgical repair with the use of a synthetic midurethral sling (MUS), based on long-term data that support its excellent efficacy and durability. The risk-benefit balance of MUS continues to be scrutinized, however, with erosions and pain poorly studied and apparently underreported. 

The medical-legal risks associated with the MUS are a significant concern and have led many patients to reconsider this option for their condition. Many other countries (United Kingdom, Australia, New Zealand, and European Union) are now re-evaluating the use of the MUS.² In the United Kingdom, for example, the National Institute for Health and Care Excellence (NICE) Guideline advises considering the MUS only when another surgical intervention is not suitable for the patient.³ 

In light of the heightened skepticism surrounding the MUS, interest has increased in the use of urethral bulking agents. These agents consist of a material injected into the wall of the urethra to improve urethral coaptation in women with SUI.⁴ 

A brief history of bulking agents 

In 1938, Murless first reported the injection of sodium morrhuate for the management of urinary incontinence.⁴ Other early bulking agents introduced in the 1950s and 1960s included paraffin wax and sclerosing agents. Subsequently, Teflon, collagen, and autologous fat, among other agents, were found to be efficacious for augmenting urethral coaptation; however, only collagen initially demonstrated acceptable safety.⁵ 

Contigen (bovine dermal collagen cross-linked with gluteraldehyde) was approved as a bulking agent by the US Food and Drug Administration (FDA) in 1993; however, the manufacturing of bovine collagen was halted in 2011. Contigen was the only nonpermanent biodegradable urethral bulking agent, and its use required skin testing prior to use, as 2% to 5% of women experienced allergic reaction.⁴ 

Presently, 3 particle-based urethral bulking agents are FDA approved for marketing in the United States: Macroplastique (Laborie Medical Technologies), Coaptite (Boston Scientific), and Durasphere (Coloplast). In addition, Bulkamid (Contura), which was approved earlier this year, is a nonparticulate agent composed of a nonresorbable polyacrylamide hydrogel.⁵ 

Continue to: Indications for use...

According to the FDA premarket approvals (PMAs) for the particle-based urethral bulking agents, their use is indicated for adult women with SUI primarily due to intrinsic sphincter deficiency (ISD).⁶ The PMA indication for the nonparticulate agent, however, allows it to be used for SUI as well as SUI-predominant mixed urinary incontinence (MUI) due to ISD.⁷ Traditionally, ISD is defined by urodynamic criteria that includes a maximal urethral closure pressure less than 20 to 25 cm of water and/or a Valsalva leak point pressure of less than 60 cm of water.⁴ 

The American Urological Association (AUA) guideline lists bulking agents as an option for women who do not wish to pursue invasive surgical intervention for SUI, are concerned about lengthier recovery after surgery, or have previously undergone anti-incontinence procedures with suboptimal results.⁸ In general, most urologists and urogynecologists who perform urethral bulking agree with the AUA guideline. 

Perceptions of bulking agents have shifted 

Urethral bulking agents traditionally have been thought of as a "salvage therapy." Perceived indications for these agents include use in women with persistent SUI after more invasive treatment options or in women who were medically fragile and thus could not undergo a more invasive procedure.⁹ As mentioned, however, circumstances related to mesh use have shifted the current perception of indications for urethral bulking agents from salvage therapy only to use as a possible first-line treatment in the appropriately selected patient.⁹ 

Recent data that note improved durability and patient satisfaction, as well as better appreciation of the fact that, if the bulking agent fails, a synthetic sling procedure still can be performed without significant concerns, have contributed to this shift in intervention strategy.^10,11 There also has been the perception that urethral bulking agents should not be considered in women who have urethral mobility. However, studies have shown that outcomes are not significantly different in patients with urethral mobility compared with those with a fixed urethra.¹¹ 

Types of bulking agents  

The ideal bulking agent should be made of a material that is biocompatible--with low host reactivity, low carcinogenic potential, low risk of migration--and easy to administer.⁵ Currently available bulking agents are classified as particulate and nonparticulate agents. The TABLE provides summary details of the available agents FDA approved for use.

Particulate bulking agents 

Durasphere, approved by the FDA in 1999, is composed of carbon-coated zirconium oxide in a water-based and beta-glucan carrier. The first generation of this agent had particles that ranged in size from 212 to 500 µm and required an 18-gauge needle for injection.4 The second-generation preparation has a smaller particle size, ranging from 90 to 212 µm, which permits injection with a smaller needle, typically 20 gauge.⁴ Theoretically, the larger bead size reduces the risk of migration as particles larger than 80 µm cannot be engulfed by macrophages.⁴ 

Coaptite is a calcium hydroxylapatite-based product approved by the FDA in 2005. The carrier media is composed of sodium carboxymethylcellulose, sterile water, and glycerin. The particle size ranges from 75 to 125 µm, with an average of 100 µm.⁵ This synthetic material historically has been used in orthopedics and dental applications. The aqueous gel carrier dissipates over months, resulting in tissue growth; thereafter, the particulate beads slowly degrade.¹² 

Macroplastique, a polydimethylsiloxane compound, was approved by the FDA in 2006. It has a long history of use primarily in Europe where it has been used since 1991. It is composed of a nonbiodegradable silicone (polydimethylsiloxane) elastomer suspended in a water-soluble gel. The initial composition was of particles that ranged in size from 5 to 400 µm, with 25% of the particles smaller than 50 µm. Because of the large number of particles smaller than 50 µm, there were concerns for migration.⁵ The agent's current composition contains particles that range from 120 to 600 µm, with an average particle size of 140 µm.⁴ 

Nonparticulate bulking agent 

Bulkamid has been available in Europe since 2003 and was FDA approved in January 2020. It is the only available nonparticulate urethral bulking agent; it is composed uniquely of a nonresorbable polyacrylamide hydrogel made of cross-linked 2.5% polyacrylamide and water. Its bulking effect is achieved through the actual volume of hydrogel injected, which integrates with host tissue by vessel ingrowth, suggestive of a persistent durable effect. Because Bulkamid contains no particles or crystals, the theoretical risk of migration is mitigated.⁴ 

Continue to: The urethral bulking technique...

The urethral bulking technique 

The basic technique for urethral bulking is similar for all agents, with nuances in technique for each agent. 

The procedure typically begins with placement of 2% lidocaine gel in the urethra for 5 to 10 minutes. The disposable needle is primed with the agent.⁴ For Durasphere, an 18- or 21-gauge rigid needle is used; for Coaptite, a 21-gauge rigid side injecting needle called the SideKick is used; and for Macroplastique, an 18- or 20-gauge rigid needle is used.⁴ Bulkamid administration requires the use of a special 23-gauge needle. Durasphere and Coaptite are delivered via a standard cystoscope.⁴ Macroplastique requires a proprietary delivery system4 (FIGURE 1). Bulkamid has a proprietary urethroscope and rotatable sheath to guide accuracy of injection (FIGURE 2).⁴ 

After the needle is primed and the delivery device placed into the urethra, the injection site is selected, approximately 1.5 to 2 cm from the bladder neck. The needle is introduced into the suburethral tissue at a 30- to 45-degree angle.  

The injection site varies by agent. The 4 and 8 o'clock positions are recommended for Coaptite and Durasphere, while the 2, 6, and 10 o'clock positions are recommended for Macroplastique. For Bulkamid, the recommendation is to create 3 cushions at the 2, 6, and 10 o'clock positions.¹³ Regardless of the agent used, the bulking is easily visualized and should result in the various sites meeting in the midline (FIGURE 3). 

Continue to: Evidence-based outcomes...

Evidence-based outcomes 

The published data on outcomes of urethral bulking treatments have used inconsistent measures of efficacy. Most of the FDA trials used subjective success calculated with use of the Stamey Urinary Incontinence Scale (Stamey Grade) and validated questionnaires as well as objective data collected via voiding diaries and pad tests.⁴ 

In 2007, a multicenter prospective randomized controlled trial (RCT) compared Coaptite with Contigen treatment and found that 63.4% versus 57.0% of patients, respectively, experienced an improvement on the Stamey Urinary Incontinence Scale at 12-month follow-up.¹⁴ 

A prospective multicenter RCT in 2009 was conducted to test the durability and efficacy of Macroplastique treatment at 12-month follow-up.¹⁵ The authors noted that at 12 months, 62% of treated women reported significant improvement.¹⁵ Further, a systematic review and meta-analysis of the literature (1990-2010) on Macroplastique use was published in 2013.¹⁶ Data from 958 patients from 23 cohorts were analyzed in a random-effects model for 3 time periods: short term (less than 6 months), mid term (6-12 months), and long term (>18 months). Cure/dry rates were reported for short, mid, and long-term follow-up as 43% (95% confidence interval [CI], 33%-54%), 37% (95% CI, 28%-46%), and 36% (95% CI, 27%-46%), respectively.¹⁶ 

The newest bulking product in the United States, Bulkamid, has been available for use in Europe since 2003.¹⁷ In a 3-year follow-up of a prospective nonrandomized single-site study, 212 of 256 (82.8%) participants were subjectively cured or had significant improvement in SUI or MUI, and this result was maintained until the end of the study period (a median of 38 months).¹⁰ In 2014, an 8-year follow-up of 24 women was published.¹⁸ Subjectively, 44% of the women reported cure or significant improvement, and 11 women who presented for objective evaluation all had polyacrylamide hydrogel visible on vaginal ultrasound.¹⁸ 

In addition, an RCT published in 2020 compared surgery with tension-free vaginal tape (TVT) and Bulkamid use in 224 women with SUI. At the 12-month follow-up, TVT was found to be more effective than Bulkamid; the median visual analog scale score for satisfaction was 99 for the TVT-treated group and 85 for the Bulkamid-treated patients.¹¹ Additionally, a cough stress test was negative in 95.0% and 66.4% of participants, respectively, but reoperations occurred only in patients who received the TVT procedure (n = 6). The authors concluded that while TVT treatment provided higher satisfaction rates than did Bulkamid, all major perioperative and follow-up complications were associated with TVT use. The study is ongoing and will eventually report 3-year outcomes.¹¹ 

According to a 2017 Cochrane Review on urethral bulking, treatments with all 3 of the particulate bulking agents resulted in improvements that were no more or less effective than Contigen treatment. The review failed to include publications on Bulkamid treatment.¹⁹ 

Continue to: Complications and safety issues...

Adverse events. Reported adverse effects associated with urethral bulking include mild pain, transient urinary retention (typically resolving within 1-2 days after injection), dysuria, hematuria, and urinary tract infection (UTI).^4,12 

In a 12-month RCT involving 355 women treated with Durasphere or bovine collagen, adverse events were reported in 178 Durasphere-treated women; dysuria (24.7%) and temporary urinary retention (16.9%) were the most commonly reported adverse events.²⁰ 

An RCT of Coaptite injection (n = 296) found that temporary urinary retention (41%) was the most common adverse event.¹⁴ 

In a 12-month comparative study of Macroplastique versus Contigen (n = 122), UTI was reported as the most common adverse event (23.8%), followed by dysuria (9%) and urgency (9%).¹⁵ In addition, in a meta-analysis involving 958 patients in 23 cohorts, Ghoniem and Miller reported that the median rates for adverse events were temporary dysuria, 50%; hematuria, 45%; urge incontinence, 7%; temporary urinary retention, 7%; and UTI, 3%.¹⁶ 

A 3-year summary outcome of 256 patients who received Bulkamid injection reported that only 1 patient developed infection, abscess, or allergic reaction at the injection site and 1 patient had a UTI.¹⁰ In an 8-year follow-up of patients who received Bulkamid injection, 1 patient experienced stranguria and 7 patients had recurrent cystitis.¹⁸ 

It appears that transient dysuria, urgency, and urinary retention occur more frequently after urethral bulking with particulate agents.¹² 

Complications. Few delayed but serious complications after urethral bulking have been reported, including suburethral abscess, urethral prolapse, and particle migration.⁴ Cases of urethral prolapse have been reported with both Coaptite and Durasphere. Notably, all cases of urethral prolapse occurred in patients with a history of pelvic surgery and/or previous urethral bulking.^21,22 Cases also have been reported of Durasphere carbon bead particles migrating to regional and distant lymph nodes, and pseudoabscess also has been reported.^12,23 A single case of periurethral abscess was reported after Bulkamid injection in a patient who had prior vaginal hysterectomy and a transobturator tape procedure after a total vaginal mesh repair.²⁴ 

Bulking agent use: Time to go mainstream? 

Historically, urethral bulking agents have had limited utility, largely due to the inaccurate and unsubstantiated perceptions of them being indicated only in women with ISD and a well-supported urethra. More recently, urethral bulking agents are commonly being used in patients who: have recurrent SUI after a surgical intervention, have infrequent but bothersome SUI symptoms, are not ideal candidates to undergo anesthesia, or wish to avoid mesh. 

Some data suggest that objective and subjective success rates are lower with bulking agent treatment compared with the gold standard MUS procedure. However, in the appropriately selected patient, urethral bulking agents may be considered primary treatment due to their associated low morbidity and, as recently reported with newer nonparticulate agents, high subjective success rates. If the patient is not satisfied with the results of bulking treatment, surgical repair with any type of sling remains a subsequent option. This feature adds to the potential viability and appropriateness of considering a bulking agent as a primary treatment. ●

A vaginal ring that can be reused for up to 1 year and a progestin-only pill (POP) with a wider window for missed pills are 2 of the novel contraceptive products introduced to the market this year. In addition, an ongoing study of the levonorgestrel 52-mg intrauterine system (IUS) continues to provide evidence on its extended duration of use, now approved through 6 years.

The segesterone acetate (SA) and ethinyl estradiol (EE) vaginal ring (Annovera) is new among contraceptive options. Segesterone acetate is a novel progestin that can be used only via nonoral routes; it binds specifically to progesterone receptors without estrogenic or antiandrogen effects.¹ Unlike the etonogestrel and ethinyl estradiol ring (NuvaRing; for which generic products became available this past year), which is used for 1 cycle and then thrown away, the SA/EE ring is effective for 13 consecutive cycles. It does not require refrigeration when not in use.² Because a single ring can be used for 13 cycles, users in locations without laws that mandate a 12-month supply of pills, patches, and rings need less frequent visits to the pharmacy or clinic.

Progestin-only contraceptive pills are an important option for patients who desire hormonal contraception and have contraindications to estrogen, such as migraines with aura, cardiovascular risk factors, and being in the early postpartum period.³ In the United States, current POPs contain norethindrone, which has a 3-hour window for missed pills⁴; a desogestrel-only pill available outside the United States has a 12-hour window.⁵ Both are provided as a 28-day pill pack for continuous use, and both result in undesirable bleeding patterns in some users.

The prolonged half-life of drospirenone, another progestin, gives it the potential to increase reliability in the setting of missed or delayed pills and improve bleeding patterns. A new POP contraceptive contains drospirenone (Slynd) and is available in a 28-day pack with a 24-day supply of hormone and a 4-day supply of placebo; it provides a window for missed pill use similar to that for combined hormonal contraception (CHC) as well as a placebo period for a timed withdrawal bleed.^6,7

Liletta is a well-known levonorgestrel 52-mg IUS that was first approved by the US Food and Drug Administration (FDA) in 2015. An ongoing clinical trial has been the basis for approval of this IUS for use in increasing durations, from 3 years initially to 4 and then 5 years. The newest data indicate efficacy up to 6 years.⁸

Continue to: Combined hormonal vaginal system provides a year's contraception with an acceptable safety profile...

Combined hormonal vaginal system provides a year's contraception with an acceptable safety profile 

Archer DF, Merkatz RB, Bahamondes L, et al. Efficacy of the 1-year (13-cycle) segesterone acetate and ethinylestradiol contraceptive vaginal system: results of two multicentre, open-label, single-arm, phase 3 trials. Lancet Glob Health. 2019;7:e1054-e1064. 

Gemzell-Danielsson K, Sitruk-Ware R, Creinin MD, et al. Segesterone acetate/ethinyl estradiol 12-month contraceptive vaginal system safety evaluation. Contraception. 2019;99:323-328. 

Archer and colleagues reported the results of 2 pivotal multicenter, open-label, phase 3 trials, which included 2,265 users, conducted to evaluate efficacy and return to menses or pregnancy after use of the 1-year (13 cycles) SA/EE contraceptive vaginal system (CVS). 

Details of the efficacy study 

The study included 1,130 women in a US-only study and 1,135 women in an international study with sites in the United States, Australia, Brazil, Chile, Dominican Republic, Finland, Hungary, and Sweden. Participants used the CVS for 21 days followed by a 7-day use-free interval for up to 13 consecutive cycles; they were instructed not to remove the CVS for more than 2 hours during the 21 days of use. 

Primary and secondary efficacy outcomes were calculated using the Pearl Index and an intention-to-treat Kaplan-Meier life table, respectively. At the end of the study, users who desired not to continue hormonal contraception or to become pregnant were followed up for 6 months to evaluate return to menses or pregnancy. 

Year-long effectiveness 

The investigators reported an overall Pearl index of 2.98 (95% confidence interval [CI], 2.13-4.06) and a Kaplan-Meier life table cumulative efficacy rate of 97.5% (FIGURE 1), consistent with other recently approved CHC methods. Women from non-European sites, who primarily were US participants, had a Pearl Index of 3.25 (95% CI, 2.35-4.37), and participants from the European sites had a Pearl Index of 0.47 (95% CI, 0.03-2.07). Importantly, CVS removal had a significant impact on efficacy, with a Pearl Index of 5.98 (95% CI, 2.46-9.27) in users reporting CVS removals for longer than 2 hours, suggesting escape ovulation with improper use. The Pearl Index was highest in users aged 18 to 19 years and was not affected by body mass index (BMI), although 91% of users had a BMI of 29.0 kg/m² or lower. 

There was no trend for a change in pregnancy risk across 13 cycles, providing evidence of CVS efficacy throughout a full year's use. The follow-up portion of the study included 290 users who were not continuing hormonal contraception at study end; all follow-up participants reported return to menses after method discontinuation. 

Clinical safety data 

To evaluate safety outcomes from clinical studies on the CVS containing SA/EE, Gemzell-Danielsson and colleagues analyzed 9 studies. Most of the data were derived from 2 phase 3, multicenter trials (as discussed above), with supporting evidence from 7 other studies. 

Adverse events reported 

Among 2,308 CVS users in the phase 3 trials, 87% reported at least 1 adverse effect, with most of mild or moderate severity. These included headache, 26%; nausea, 18%; vaginal discharge, 10%; and metrorrhagia, 7%. Overall, 12% of CVS users discontinued use due to an adverse effect. Two percent of users experienced severe adverse effects, including venous thromboembolism (VTE), allergic reaction, gallbladder disease, and spontaneous abortion. 

In the US-only phase 3 trial, 2 VTE events occurred in the first 6 months in women with baseline BMI greater than 29.0 kg/m²; therefore, enrollment of patients with a BMI greater than 29.0 kg/m² was halted and current users meeting that criteria were discontinued. Notably, no cases of VTE occurred in studies with a segesterone acetate-only CVS; this suggests that risk can be attributed to the estrogen component. Overall, 4 nonfatal VTEs occurred, all among the 1,536 women enrolled in the phase 3 trials (4 of 1,536 [0.3%]); at least 3 of these cases occurred in users with VTE risk factors (TABLE 1). The estimated VTE rate in CVS users with a BMI greater than 29.0 kg/m2 is 10.8/10,000 women-years (95% CI, 8.9-13.1). 

Complete expulsion of the CVS occurred in 7% of cycles and partial expulsion in 19.5% of cycles; users reported expulsion more frequently in the first cycle, most (about 70%) of which were partial expulsions. Of the laboratory values and vital signs studied, including weight, users had no clinically relevant changes from baseline.

Continue to: New drospirenone pill is an effective POP option...

New drospirenone pill is an effective POP option 

Kimble T, Burke AE, Barnhart KT, et al. A 1-year prospective, open-label, single-arm, multicenter, phase 3 trial of the contraceptive efficacy and safety of the oral progestin-only pill drospirenone 4 mg using a 24/4-day regimen. Contracept X. 2020;2:100020. 

Palacios S, Colli E, Regidor PA. Multicenter, phase III trials on the contraceptive efficacy, tolerability and safety of a new drospirenone-only pill. Acta Obstet Gynecol Scand. 2019;98:1549-1557. 

In a prospective, single-arm, multicenter phase 3 trial in the United States, Kimble and colleagues evaluated the efficacy and safety of an oral drospirenone POP in a cyclic 24-day hormone/4-day placebo regimen. The trial included 1,006 users. No BMI cutoff was used, and about one-third of study participants were obese (BMI >30.0 kg/m²). Women were instructed to take a missed tablet as soon as remembered if within 24 hours or with the next scheduled dose if more than 24 hours late. 

Contraceptive effectiveness 

The Pearl Index for nonbreastfeeding users aged 35 years or younger with pregnancies confirmed by a quantitative serum ß-human chorionic gonadotropin test (915 users) was 2.9 (95% CI, 1.5-5.1). Of note, 2 out of 15 on-treatment pregnancies were excluded from this calculation because of protocol site violations, as were 3 pregnancies that were unconfirmed. In the modified full analysis set of 915 users, 36% were obese (BMI≥30 kg/m²), and the Pearl Index was noted to be unaffected by BMI (TABLE 2). 

While 61% of women reported adverse effects, more than 95% of these were mild or moderate in intensity, including headache, nausea, dysmenorrhea, metrorrhagia, and breast pain. No VTE occurred. The frequency of hyperkalemia was 0.5%, and there was no evidence of hypotension, which is significant due to the antimineralocorticoid activity of drospirenone. All cases of hyperkalemia were considered mild, and all women were asymptomatic. There were no clinically relevant changes in body weight, gynecologic exam, or other laboratory values. 

With increased cycles of use, the number of days with bleeding or spotting generally decreased and amenorrhea increased. However, in cycles 11 to 13, 41.6% of users still had unscheduled bleeding (reduced from 57.0% at cycles 2-4), and 29.0% had scheduled bleeding (decreased from 44% at cycles 2-4) (FIGURE 2). With these bleeding patterns, 86.2% of users agreed or strongly agreed that they were satisfied with the product. 

European multicenter study of drospironene 

In a European investigation, Palacios and colleagues pooled and analyzed data from 2 phase 3 multicenter trials to assess the efficacy, tolerability, and safety of the same drospirenone-only pill (24 days of drospironene 4 mg and 4 days of placebo) in 1,571 users. No BMI cutoff was used, but overall only 71 participants (4.6%) were obese. One study included desogestrel 0.075 mg (in a regimen of 28 active pills) as a comparator for safety. 

The overall Pearl Index for users 35 years or younger (1,251 users) was 1.0 (95% CI, 0.4-2.0). The "method failure Pearl Index" in users 35 years or younger, which included all pregnancies during "perfect medication cycles," was 1.3 (95% CI, 0.5-2.5). 

The most common adverse effects were acne (6.6% in study 1 and 4.4% in study 2), headache (4.5% in study 1), and irregular bleeding (4.4% in study 2). No cases of VTE occurred; there was 1 case of asymptomatic hyperkalemia. Additional laboratory values and vital signs showed no significant changes. The trend in bleeding was similar to that in the US studies, but it is interesting to note that there were significantly lower rates of unscheduled bleeding or spotting in drospirenone users than in desogestrel users (67.9% vs 86.5%, respectively; P<.001).

Continue to: Evidence supports 6 years' use of a levonorgestrel 52-mg IUS...

Westhoff CL, Keder LM, Gangestad A, et al. Six-year contraceptive efficacy and continued safety of a levonorgestrel 52-mg intrauterine system. Contraception. 2020;101:159-161. 

Two levonorgestrel 52-mg IUS products are on the market, both of which were approved for 5 years of use. The ACCESS IUS study (A Comprehensive Contraceptive Efficacy and Safety Study of an IUS) is an ongoing phase 3 trial to assess the safety and efficacy of a levonorgestrel 52-mg IUS (Liletta) for up to 10 years of use in US women. Westhoff and colleagues presented the data used for this IUS to gain approval for 6 years of use as of October 2019. The report included safety information for all users, with use exceeding 8 years in 122 participants. 

In year 6 of the ongoing trial, there were no on-treatment pregnancies with a 6-year life table pregnancy rate of 0.87 (95% CI, 0.44-1.70). Forty percent of users reported amenorrhea in the 90 days preceding the end of year 6, consistent with prior data after 3 years of use (FIGURE 3). The most common adverse effects over 6 or more years of use were bacterial vulvovaginal infections and urinary tract infections. 

Long-term IUS effectiveness 

Overall, in users aged 16 to 35 years, 72% discontinued study participation, most frequently due to an adverse event (19.2%) or to seeking pregnancy (15.5%). Through 6 or more years of use, overall discontinuation rates for expulsion (4.0%) and bleeding symptoms (2.3%) were very low, with 2 expulsions occurring in year 6 and only 1 participant discontinuing in year 6 for a bleeding symptom. These findings are consistent with those found at 5 years of IUS use and are representative of continued efficacy as well as overall low frequency of new significant events with extended use.¹¹

A vaginal ring that can be reused for up to 1 year and a progestin-only pill (POP) with a wider window for missed pills are 2 of the novel contraceptive products introduced to the market this year. In addition, an ongoing study of the levonorgestrel 52-mg intrauterine system (IUS) continues to provide evidence on its extended duration of use, now approved through 6 years.

The segesterone acetate (SA) and ethinyl estradiol (EE) vaginal ring (Annovera) is new among contraceptive options. Segesterone acetate is a novel progestin that can be used only via nonoral routes; it binds specifically to progesterone receptors without estrogenic or antiandrogen effects.¹ Unlike the etonogestrel and ethinyl estradiol ring (NuvaRing; for which generic products became available this past year), which is used for 1 cycle and then thrown away, the SA/EE ring is effective for 13 consecutive cycles. It does not require refrigeration when not in use.² Because a single ring can be used for 13 cycles, users in locations without laws that mandate a 12-month supply of pills, patches, and rings need less frequent visits to the pharmacy or clinic.

Progestin-only contraceptive pills are an important option for patients who desire hormonal contraception and have contraindications to estrogen, such as migraines with aura, cardiovascular risk factors, and being in the early postpartum period.³ In the United States, current POPs contain norethindrone, which has a 3-hour window for missed pills⁴; a desogestrel-only pill available outside the United States has a 12-hour window.⁵ Both are provided as a 28-day pill pack for continuous use, and both result in undesirable bleeding patterns in some users.

The prolonged half-life of drospirenone, another progestin, gives it the potential to increase reliability in the setting of missed or delayed pills and improve bleeding patterns. A new POP contraceptive contains drospirenone (Slynd) and is available in a 28-day pack with a 24-day supply of hormone and a 4-day supply of placebo; it provides a window for missed pill use similar to that for combined hormonal contraception (CHC) as well as a placebo period for a timed withdrawal bleed.^6,7

Liletta is a well-known levonorgestrel 52-mg IUS that was first approved by the US Food and Drug Administration (FDA) in 2015. An ongoing clinical trial has been the basis for approval of this IUS for use in increasing durations, from 3 years initially to 4 and then 5 years. The newest data indicate efficacy up to 6 years.⁸

Continue to: Combined hormonal vaginal system provides a year's contraception with an acceptable safety profile...

Combined hormonal vaginal system provides a year's contraception with an acceptable safety profile 

Archer DF, Merkatz RB, Bahamondes L, et al. Efficacy of the 1-year (13-cycle) segesterone acetate and ethinylestradiol contraceptive vaginal system: results of two multicentre, open-label, single-arm, phase 3 trials. Lancet Glob Health. 2019;7:e1054-e1064. 

Gemzell-Danielsson K, Sitruk-Ware R, Creinin MD, et al. Segesterone acetate/ethinyl estradiol 12-month contraceptive vaginal system safety evaluation. Contraception. 2019;99:323-328. 

Archer and colleagues reported the results of 2 pivotal multicenter, open-label, phase 3 trials, which included 2,265 users, conducted to evaluate efficacy and return to menses or pregnancy after use of the 1-year (13 cycles) SA/EE contraceptive vaginal system (CVS). 

Details of the efficacy study 

The study included 1,130 women in a US-only study and 1,135 women in an international study with sites in the United States, Australia, Brazil, Chile, Dominican Republic, Finland, Hungary, and Sweden. Participants used the CVS for 21 days followed by a 7-day use-free interval for up to 13 consecutive cycles; they were instructed not to remove the CVS for more than 2 hours during the 21 days of use. 

Primary and secondary efficacy outcomes were calculated using the Pearl Index and an intention-to-treat Kaplan-Meier life table, respectively. At the end of the study, users who desired not to continue hormonal contraception or to become pregnant were followed up for 6 months to evaluate return to menses or pregnancy. 

Year-long effectiveness 

The investigators reported an overall Pearl index of 2.98 (95% confidence interval [CI], 2.13-4.06) and a Kaplan-Meier life table cumulative efficacy rate of 97.5% (FIGURE 1), consistent with other recently approved CHC methods. Women from non-European sites, who primarily were US participants, had a Pearl Index of 3.25 (95% CI, 2.35-4.37), and participants from the European sites had a Pearl Index of 0.47 (95% CI, 0.03-2.07). Importantly, CVS removal had a significant impact on efficacy, with a Pearl Index of 5.98 (95% CI, 2.46-9.27) in users reporting CVS removals for longer than 2 hours, suggesting escape ovulation with improper use. The Pearl Index was highest in users aged 18 to 19 years and was not affected by body mass index (BMI), although 91% of users had a BMI of 29.0 kg/m² or lower. 

There was no trend for a change in pregnancy risk across 13 cycles, providing evidence of CVS efficacy throughout a full year's use. The follow-up portion of the study included 290 users who were not continuing hormonal contraception at study end; all follow-up participants reported return to menses after method discontinuation. 

Clinical safety data 

To evaluate safety outcomes from clinical studies on the CVS containing SA/EE, Gemzell-Danielsson and colleagues analyzed 9 studies. Most of the data were derived from 2 phase 3, multicenter trials (as discussed above), with supporting evidence from 7 other studies. 

Adverse events reported 

Among 2,308 CVS users in the phase 3 trials, 87% reported at least 1 adverse effect, with most of mild or moderate severity. These included headache, 26%; nausea, 18%; vaginal discharge, 10%; and metrorrhagia, 7%. Overall, 12% of CVS users discontinued use due to an adverse effect. Two percent of users experienced severe adverse effects, including venous thromboembolism (VTE), allergic reaction, gallbladder disease, and spontaneous abortion. 

In the US-only phase 3 trial, 2 VTE events occurred in the first 6 months in women with baseline BMI greater than 29.0 kg/m²; therefore, enrollment of patients with a BMI greater than 29.0 kg/m² was halted and current users meeting that criteria were discontinued. Notably, no cases of VTE occurred in studies with a segesterone acetate-only CVS; this suggests that risk can be attributed to the estrogen component. Overall, 4 nonfatal VTEs occurred, all among the 1,536 women enrolled in the phase 3 trials (4 of 1,536 [0.3%]); at least 3 of these cases occurred in users with VTE risk factors (TABLE 1). The estimated VTE rate in CVS users with a BMI greater than 29.0 kg/m2 is 10.8/10,000 women-years (95% CI, 8.9-13.1). 

Complete expulsion of the CVS occurred in 7% of cycles and partial expulsion in 19.5% of cycles; users reported expulsion more frequently in the first cycle, most (about 70%) of which were partial expulsions. Of the laboratory values and vital signs studied, including weight, users had no clinically relevant changes from baseline.

Continue to: New drospirenone pill is an effective POP option...

New drospirenone pill is an effective POP option 

Kimble T, Burke AE, Barnhart KT, et al. A 1-year prospective, open-label, single-arm, multicenter, phase 3 trial of the contraceptive efficacy and safety of the oral progestin-only pill drospirenone 4 mg using a 24/4-day regimen. Contracept X. 2020;2:100020. 

Palacios S, Colli E, Regidor PA. Multicenter, phase III trials on the contraceptive efficacy, tolerability and safety of a new drospirenone-only pill. Acta Obstet Gynecol Scand. 2019;98:1549-1557. 

In a prospective, single-arm, multicenter phase 3 trial in the United States, Kimble and colleagues evaluated the efficacy and safety of an oral drospirenone POP in a cyclic 24-day hormone/4-day placebo regimen. The trial included 1,006 users. No BMI cutoff was used, and about one-third of study participants were obese (BMI >30.0 kg/m²). Women were instructed to take a missed tablet as soon as remembered if within 24 hours or with the next scheduled dose if more than 24 hours late. 

Contraceptive effectiveness 

The Pearl Index for nonbreastfeeding users aged 35 years or younger with pregnancies confirmed by a quantitative serum ß-human chorionic gonadotropin test (915 users) was 2.9 (95% CI, 1.5-5.1). Of note, 2 out of 15 on-treatment pregnancies were excluded from this calculation because of protocol site violations, as were 3 pregnancies that were unconfirmed. In the modified full analysis set of 915 users, 36% were obese (BMI≥30 kg/m²), and the Pearl Index was noted to be unaffected by BMI (TABLE 2). 

While 61% of women reported adverse effects, more than 95% of these were mild or moderate in intensity, including headache, nausea, dysmenorrhea, metrorrhagia, and breast pain. No VTE occurred. The frequency of hyperkalemia was 0.5%, and there was no evidence of hypotension, which is significant due to the antimineralocorticoid activity of drospirenone. All cases of hyperkalemia were considered mild, and all women were asymptomatic. There were no clinically relevant changes in body weight, gynecologic exam, or other laboratory values. 

With increased cycles of use, the number of days with bleeding or spotting generally decreased and amenorrhea increased. However, in cycles 11 to 13, 41.6% of users still had unscheduled bleeding (reduced from 57.0% at cycles 2-4), and 29.0% had scheduled bleeding (decreased from 44% at cycles 2-4) (FIGURE 2). With these bleeding patterns, 86.2% of users agreed or strongly agreed that they were satisfied with the product. 

European multicenter study of drospironene 

In a European investigation, Palacios and colleagues pooled and analyzed data from 2 phase 3 multicenter trials to assess the efficacy, tolerability, and safety of the same drospirenone-only pill (24 days of drospironene 4 mg and 4 days of placebo) in 1,571 users. No BMI cutoff was used, but overall only 71 participants (4.6%) were obese. One study included desogestrel 0.075 mg (in a regimen of 28 active pills) as a comparator for safety. 

The overall Pearl Index for users 35 years or younger (1,251 users) was 1.0 (95% CI, 0.4-2.0). The "method failure Pearl Index" in users 35 years or younger, which included all pregnancies during "perfect medication cycles," was 1.3 (95% CI, 0.5-2.5). 

The most common adverse effects were acne (6.6% in study 1 and 4.4% in study 2), headache (4.5% in study 1), and irregular bleeding (4.4% in study 2). No cases of VTE occurred; there was 1 case of asymptomatic hyperkalemia. Additional laboratory values and vital signs showed no significant changes. The trend in bleeding was similar to that in the US studies, but it is interesting to note that there were significantly lower rates of unscheduled bleeding or spotting in drospirenone users than in desogestrel users (67.9% vs 86.5%, respectively; P<.001).

Continue to: Evidence supports 6 years' use of a levonorgestrel 52-mg IUS...

Westhoff CL, Keder LM, Gangestad A, et al. Six-year contraceptive efficacy and continued safety of a levonorgestrel 52-mg intrauterine system. Contraception. 2020;101:159-161. 

Two levonorgestrel 52-mg IUS products are on the market, both of which were approved for 5 years of use. The ACCESS IUS study (A Comprehensive Contraceptive Efficacy and Safety Study of an IUS) is an ongoing phase 3 trial to assess the safety and efficacy of a levonorgestrel 52-mg IUS (Liletta) for up to 10 years of use in US women. Westhoff and colleagues presented the data used for this IUS to gain approval for 6 years of use as of October 2019. The report included safety information for all users, with use exceeding 8 years in 122 participants. 

In year 6 of the ongoing trial, there were no on-treatment pregnancies with a 6-year life table pregnancy rate of 0.87 (95% CI, 0.44-1.70). Forty percent of users reported amenorrhea in the 90 days preceding the end of year 6, consistent with prior data after 3 years of use (FIGURE 3). The most common adverse effects over 6 or more years of use were bacterial vulvovaginal infections and urinary tract infections. 

Long-term IUS effectiveness 

Overall, in users aged 16 to 35 years, 72% discontinued study participation, most frequently due to an adverse event (19.2%) or to seeking pregnancy (15.5%). Through 6 or more years of use, overall discontinuation rates for expulsion (4.0%) and bleeding symptoms (2.3%) were very low, with 2 expulsions occurring in year 6 and only 1 participant discontinuing in year 6 for a bleeding symptom. These findings are consistent with those found at 5 years of IUS use and are representative of continued efficacy as well as overall low frequency of new significant events with extended use.¹¹

A vaginal ring that can be reused for up to 1 year and a progestin-only pill (POP) with a wider window for missed pills are 2 of the novel contraceptive products introduced to the market this year. In addition, an ongoing study of the levonorgestrel 52-mg intrauterine system (IUS) continues to provide evidence on its extended duration of use, now approved through 6 years.

The segesterone acetate (SA) and ethinyl estradiol (EE) vaginal ring (Annovera) is new among contraceptive options. Segesterone acetate is a novel progestin that can be used only via nonoral routes; it binds specifically to progesterone receptors without estrogenic or antiandrogen effects.¹ Unlike the etonogestrel and ethinyl estradiol ring (NuvaRing; for which generic products became available this past year), which is used for 1 cycle and then thrown away, the SA/EE ring is effective for 13 consecutive cycles. It does not require refrigeration when not in use.² Because a single ring can be used for 13 cycles, users in locations without laws that mandate a 12-month supply of pills, patches, and rings need less frequent visits to the pharmacy or clinic.

Progestin-only contraceptive pills are an important option for patients who desire hormonal contraception and have contraindications to estrogen, such as migraines with aura, cardiovascular risk factors, and being in the early postpartum period.³ In the United States, current POPs contain norethindrone, which has a 3-hour window for missed pills⁴; a desogestrel-only pill available outside the United States has a 12-hour window.⁵ Both are provided as a 28-day pill pack for continuous use, and both result in undesirable bleeding patterns in some users.

The prolonged half-life of drospirenone, another progestin, gives it the potential to increase reliability in the setting of missed or delayed pills and improve bleeding patterns. A new POP contraceptive contains drospirenone (Slynd) and is available in a 28-day pack with a 24-day supply of hormone and a 4-day supply of placebo; it provides a window for missed pill use similar to that for combined hormonal contraception (CHC) as well as a placebo period for a timed withdrawal bleed.^6,7

Liletta is a well-known levonorgestrel 52-mg IUS that was first approved by the US Food and Drug Administration (FDA) in 2015. An ongoing clinical trial has been the basis for approval of this IUS for use in increasing durations, from 3 years initially to 4 and then 5 years. The newest data indicate efficacy up to 6 years.⁸

Continue to: Combined hormonal vaginal system provides a year's contraception with an acceptable safety profile...

Combined hormonal vaginal system provides a year's contraception with an acceptable safety profile 

Archer DF, Merkatz RB, Bahamondes L, et al. Efficacy of the 1-year (13-cycle) segesterone acetate and ethinylestradiol contraceptive vaginal system: results of two multicentre, open-label, single-arm, phase 3 trials. Lancet Glob Health. 2019;7:e1054-e1064. 

Gemzell-Danielsson K, Sitruk-Ware R, Creinin MD, et al. Segesterone acetate/ethinyl estradiol 12-month contraceptive vaginal system safety evaluation. Contraception. 2019;99:323-328. 

Archer and colleagues reported the results of 2 pivotal multicenter, open-label, phase 3 trials, which included 2,265 users, conducted to evaluate efficacy and return to menses or pregnancy after use of the 1-year (13 cycles) SA/EE contraceptive vaginal system (CVS). 

Details of the efficacy study 

The study included 1,130 women in a US-only study and 1,135 women in an international study with sites in the United States, Australia, Brazil, Chile, Dominican Republic, Finland, Hungary, and Sweden. Participants used the CVS for 21 days followed by a 7-day use-free interval for up to 13 consecutive cycles; they were instructed not to remove the CVS for more than 2 hours during the 21 days of use. 

Primary and secondary efficacy outcomes were calculated using the Pearl Index and an intention-to-treat Kaplan-Meier life table, respectively. At the end of the study, users who desired not to continue hormonal contraception or to become pregnant were followed up for 6 months to evaluate return to menses or pregnancy. 

Year-long effectiveness 

The investigators reported an overall Pearl index of 2.98 (95% confidence interval [CI], 2.13-4.06) and a Kaplan-Meier life table cumulative efficacy rate of 97.5% (FIGURE 1), consistent with other recently approved CHC methods. Women from non-European sites, who primarily were US participants, had a Pearl Index of 3.25 (95% CI, 2.35-4.37), and participants from the European sites had a Pearl Index of 0.47 (95% CI, 0.03-2.07). Importantly, CVS removal had a significant impact on efficacy, with a Pearl Index of 5.98 (95% CI, 2.46-9.27) in users reporting CVS removals for longer than 2 hours, suggesting escape ovulation with improper use. The Pearl Index was highest in users aged 18 to 19 years and was not affected by body mass index (BMI), although 91% of users had a BMI of 29.0 kg/m² or lower. 

There was no trend for a change in pregnancy risk across 13 cycles, providing evidence of CVS efficacy throughout a full year's use. The follow-up portion of the study included 290 users who were not continuing hormonal contraception at study end; all follow-up participants reported return to menses after method discontinuation. 

Clinical safety data 

To evaluate safety outcomes from clinical studies on the CVS containing SA/EE, Gemzell-Danielsson and colleagues analyzed 9 studies. Most of the data were derived from 2 phase 3, multicenter trials (as discussed above), with supporting evidence from 7 other studies. 

Adverse events reported 

Among 2,308 CVS users in the phase 3 trials, 87% reported at least 1 adverse effect, with most of mild or moderate severity. These included headache, 26%; nausea, 18%; vaginal discharge, 10%; and metrorrhagia, 7%. Overall, 12% of CVS users discontinued use due to an adverse effect. Two percent of users experienced severe adverse effects, including venous thromboembolism (VTE), allergic reaction, gallbladder disease, and spontaneous abortion. 

In the US-only phase 3 trial, 2 VTE events occurred in the first 6 months in women with baseline BMI greater than 29.0 kg/m²; therefore, enrollment of patients with a BMI greater than 29.0 kg/m² was halted and current users meeting that criteria were discontinued. Notably, no cases of VTE occurred in studies with a segesterone acetate-only CVS; this suggests that risk can be attributed to the estrogen component. Overall, 4 nonfatal VTEs occurred, all among the 1,536 women enrolled in the phase 3 trials (4 of 1,536 [0.3%]); at least 3 of these cases occurred in users with VTE risk factors (TABLE 1). The estimated VTE rate in CVS users with a BMI greater than 29.0 kg/m2 is 10.8/10,000 women-years (95% CI, 8.9-13.1). 

Complete expulsion of the CVS occurred in 7% of cycles and partial expulsion in 19.5% of cycles; users reported expulsion more frequently in the first cycle, most (about 70%) of which were partial expulsions. Of the laboratory values and vital signs studied, including weight, users had no clinically relevant changes from baseline.

Continue to: New drospirenone pill is an effective POP option...

New drospirenone pill is an effective POP option 

Kimble T, Burke AE, Barnhart KT, et al. A 1-year prospective, open-label, single-arm, multicenter, phase 3 trial of the contraceptive efficacy and safety of the oral progestin-only pill drospirenone 4 mg using a 24/4-day regimen. Contracept X. 2020;2:100020. 

Palacios S, Colli E, Regidor PA. Multicenter, phase III trials on the contraceptive efficacy, tolerability and safety of a new drospirenone-only pill. Acta Obstet Gynecol Scand. 2019;98:1549-1557. 

In a prospective, single-arm, multicenter phase 3 trial in the United States, Kimble and colleagues evaluated the efficacy and safety of an oral drospirenone POP in a cyclic 24-day hormone/4-day placebo regimen. The trial included 1,006 users. No BMI cutoff was used, and about one-third of study participants were obese (BMI >30.0 kg/m²). Women were instructed to take a missed tablet as soon as remembered if within 24 hours or with the next scheduled dose if more than 24 hours late. 

Contraceptive effectiveness 

The Pearl Index for nonbreastfeeding users aged 35 years or younger with pregnancies confirmed by a quantitative serum ß-human chorionic gonadotropin test (915 users) was 2.9 (95% CI, 1.5-5.1). Of note, 2 out of 15 on-treatment pregnancies were excluded from this calculation because of protocol site violations, as were 3 pregnancies that were unconfirmed. In the modified full analysis set of 915 users, 36% were obese (BMI≥30 kg/m²), and the Pearl Index was noted to be unaffected by BMI (TABLE 2). 

While 61% of women reported adverse effects, more than 95% of these were mild or moderate in intensity, including headache, nausea, dysmenorrhea, metrorrhagia, and breast pain. No VTE occurred. The frequency of hyperkalemia was 0.5%, and there was no evidence of hypotension, which is significant due to the antimineralocorticoid activity of drospirenone. All cases of hyperkalemia were considered mild, and all women were asymptomatic. There were no clinically relevant changes in body weight, gynecologic exam, or other laboratory values. 

With increased cycles of use, the number of days with bleeding or spotting generally decreased and amenorrhea increased. However, in cycles 11 to 13, 41.6% of users still had unscheduled bleeding (reduced from 57.0% at cycles 2-4), and 29.0% had scheduled bleeding (decreased from 44% at cycles 2-4) (FIGURE 2). With these bleeding patterns, 86.2% of users agreed or strongly agreed that they were satisfied with the product. 

European multicenter study of drospironene 

In a European investigation, Palacios and colleagues pooled and analyzed data from 2 phase 3 multicenter trials to assess the efficacy, tolerability, and safety of the same drospirenone-only pill (24 days of drospironene 4 mg and 4 days of placebo) in 1,571 users. No BMI cutoff was used, but overall only 71 participants (4.6%) were obese. One study included desogestrel 0.075 mg (in a regimen of 28 active pills) as a comparator for safety. 

The overall Pearl Index for users 35 years or younger (1,251 users) was 1.0 (95% CI, 0.4-2.0). The "method failure Pearl Index" in users 35 years or younger, which included all pregnancies during "perfect medication cycles," was 1.3 (95% CI, 0.5-2.5). 

The most common adverse effects were acne (6.6% in study 1 and 4.4% in study 2), headache (4.5% in study 1), and irregular bleeding (4.4% in study 2). No cases of VTE occurred; there was 1 case of asymptomatic hyperkalemia. Additional laboratory values and vital signs showed no significant changes. The trend in bleeding was similar to that in the US studies, but it is interesting to note that there were significantly lower rates of unscheduled bleeding or spotting in drospirenone users than in desogestrel users (67.9% vs 86.5%, respectively; P<.001).

Continue to: Evidence supports 6 years' use of a levonorgestrel 52-mg IUS...

Westhoff CL, Keder LM, Gangestad A, et al. Six-year contraceptive efficacy and continued safety of a levonorgestrel 52-mg intrauterine system. Contraception. 2020;101:159-161. 

Two levonorgestrel 52-mg IUS products are on the market, both of which were approved for 5 years of use. The ACCESS IUS study (A Comprehensive Contraceptive Efficacy and Safety Study of an IUS) is an ongoing phase 3 trial to assess the safety and efficacy of a levonorgestrel 52-mg IUS (Liletta) for up to 10 years of use in US women. Westhoff and colleagues presented the data used for this IUS to gain approval for 6 years of use as of October 2019. The report included safety information for all users, with use exceeding 8 years in 122 participants. 

In year 6 of the ongoing trial, there were no on-treatment pregnancies with a 6-year life table pregnancy rate of 0.87 (95% CI, 0.44-1.70). Forty percent of users reported amenorrhea in the 90 days preceding the end of year 6, consistent with prior data after 3 years of use (FIGURE 3). The most common adverse effects over 6 or more years of use were bacterial vulvovaginal infections and urinary tract infections. 

Long-term IUS effectiveness 

Overall, in users aged 16 to 35 years, 72% discontinued study participation, most frequently due to an adverse event (19.2%) or to seeking pregnancy (15.5%). Through 6 or more years of use, overall discontinuation rates for expulsion (4.0%) and bleeding symptoms (2.3%) were very low, with 2 expulsions occurring in year 6 and only 1 participant discontinuing in year 6 for a bleeding symptom. These findings are consistent with those found at 5 years of IUS use and are representative of continued efficacy as well as overall low frequency of new significant events with extended use.¹¹

Patrick J. Culligan, MD: We all know that burnout is an important problem among surgeons. In fact, it seems that, in the United States, we are working longer hours than ever before, and that higher education correlates with less balance in life. This dysfunction seems to start in school, when we are encouraged to be competitive, and overwork just becomes another way to compete. It’s very easy to get swept up in the traditional model of academic medicine, the engine of which is competition and overwork.

My impression of our younger colleagues, however, is that many of them are not attracted to the traditional ivory tower research model of academic advancement to which many in previous generations aspired. They seem more concerned with work-life balance as their measure of success rather than the classic metrics of money and prestige. Everyone still needs role models and mentors, though, and that’s where all of you come in. I asked each of you to be on this panel because I admire you for your varying approaches to work-life balance while achieving success as gynecologic surgeons. I thought others in the field might be inspired by hearing your stories.

Cultivating your passions

Kristie Greene, MD: What I have come to learn and appreciate is a really simple point: you do not have to do everything. Determining who you want to be both personally and professionally is step 1.

Granted, answering the question, “Who do I want to be?” is not as simple as it sounds. Many factors figure into the decisions we make in our personal and professional lives. Also, it is not a question we often stop and ask ourselves. From early on, we are placed on an escalator moving up through medical school, residency, fellowship, good job, better job, etc. We are so accustomed to being competitive, to winning, and to wanting to be the best that we sometimes forget to ask ourselves, “What is it exactly that I want, and why? What is my endpoint? And does it make me happy?”

Multitasking is regarded as a talent. As much as we would like to believe that we can do everything at the same time and do it all well, we actually can’t. A friend of mine made me read a book a couple of years ago, called Feeling Good, by David Burns. The book encourages you to consider the different tasks you do in a day and rate how good you are at each of them on a scale of 1 to 10. It then asks you to think about how much enjoyment you derive from each of the tasks and about why you are doing the ones that bring you little to no enjoyment.

I ultimately decided that, for me professionally, the most important thing was my interest in global health. So I decided to do whatever it took to make this happen. But you don’t get something for nothing, and everything comes with sacrifices.

Continue to: Charles Rardin, MD...

Charles Rardin, MD: How exactly did you decide that you were going to focus your career toward pursuing international health? How did you know it was more important? And how did you overcome some of those obstacles?

Dr. Greene: You have to ask the hard question again about what brings you the most joy professionally and personally. That was the easy part of it for me because global health has always been that source of happiness and fulfillment for me. The more challenging parts are the sacrifices and hard choices that come with it. With global health, it can be difficult to balance the demands of a clinical practice.

All of our jobs are a business. I am still struggling with the money part of it. For my husband and I, that meant we had to start small—do what we could afford. But then it blossomed into something that was involving residents, fellows, and med students, which requires far more funding than we had. So I reached out to family. Most of our families donate to different organizations or charities every year, so why not donate to a loved one for something they are passionate about?

At the University of South Florida (USF), we set up a fund, a foundation for global health, which helps support our work abroad as well as the costs associated with involvement of our trainees. Right now, what we have is still small potatoes to a country, but we are making it happen by starting at a small level and growing it.

Beyond the money aspect, traveling abroad means less involvement in meetings, missed opportunities to teach courses that might interest me, and time away from my family. I guess my advice on this whole thing is that you can make things happen if they are important enough to you, and if you are willing to make sacrifices in other areas because you can’t have it all.

Making time for you

Dr. Culligan: So you have found what is important to you, and you have found a way to make it happen. But you are faced with more work; you have given yourself additional work on top of your regular work. How do you make time for a personal life?

Catherine Matthews, MD: In preparing for this discussion, I decided to break down my advice into 3 buckets: The first bucket is discovering and knowing your authentic self. The second is building a community, which I’ll elaborate on. And the third, which we have discussed, is to let go of the money.

Dr. Culligan: I love the concept of the authentic self, but how does that jive with a tendency to strive for perfection? We all think we can do it all. How do we narrow down to what really matters?

Dr. Matthews: We often focus on the things that bring us happiness and what we are good at, but it’s the things that make us unhappy that tend to bring us down. It’s the presence of unhappiness, not the absence of happiness, that seems to be the undoing of many, including myself.

None of us are born with dramatic insight. It is experience that leads to insight. People who are actually present are able to gain insight through observation. A person becomes a better surgeon by observing the outcome of doing a stitch this way versus that; you learn how to do it by seeing what it looks like afterward.

Finding our authentic selves happens in much the same way. Having the presence of mind to ask the right questions, such as, “How am I feeling while I’m doing this?” leads to insights into the true self.

Continue to: It takes a village...

Dr. Greene: Catherine mentioned community earlier, and that is extremely important. The people who surround us can have a huge impact on the way we perceive things, including ourselves. Having a mix of people in our lives—some who practice medicine and others who don’t—helps us stay balanced and answer some of the tough questions. Catherine, for example, has helped me in various stages of my career to ask myself meaningful questions and get real answers.

Dr. Rardin: Part of finding balance is luck, and part of it is making a choice between money and everything else. In considering my first job out of training, I knew that money had the potential to distract me from what was important to me. So I chose a position that was almost entirely salaried so that the decisions I made clinically, surgically, and regarding work-life balance would be less likely to directly impact what was important to me.

Sally Huber, MD: I am still in the “getting there” phase of my life, but one thing I have found is that getting my family involved and excited about what I do has made them much more accepting of when I have longer work days or work to do on the weekend. My spouse has become quite involved with what I have been doing with transgender health in Atlanta. It has been a great bonding experience; she shares my passions, and together we are creating something about which we both can be proud.

When work invades home life

Dr. Culligan: That is great. Sally, I think when we talked, you were just learning about the necessity of mental separation and of not taking your work home with you, which is so hard for all of us with all of our devices.

Dr. Huber: Yes, this year has been about seeing what works best as far as being efficient at work and having quality time at home. At the end of every day I ask myself, “What worked well today? What didn’t work well? What else can I do to maximize time with my family?” I am slowly becoming more efficient, but it has been a challenge. During fellowship, your day is pretty set, but once you are practicing on your own, your hours and responsibilities are completely different, and you have to figure out what works best for you, your values, and your expectations of private life. It takes some time, and I am still figuring it out.

Dr. Culligan: How often would you say that you bring work home? I try hard once I am home to quit working, but sometimes on the weekends I break that rule.

Dr. Matthews: I must say that I do feel like there are certain times when I am better at that than others. Work comes in waves with pressing deadlines. If I averaged it out, probably a third of the time I have some email or some conference call or something that I have got to do at home. I do really try to limit the obligations that I have after 5:30 or 6:00 pm. I resent intrusions after that time. As far as weekends, I delegate about one weekend every 2 months to work, instead of doing a little bit every weekend.

Dr. Greene: I agree. I try hard to make 5:30 to 7:30 pm unequivocal time for a family dinner and time for my kids. During that time, I do not have my phone near me so I can’t look at email or texts. I try not to schedule conference calls. I try to be there to read books to my kids at night. Then if I need to do work, I do it later at night, which interferes with time with my spouse, and is not ideal, but that’s what happens.

Dr. Matthews: One of the things that I think is a huge part of work-life balance is work-related travel. When you are present at work on a consistent basis, the work does not pile up to the extent that it does when you are absent on a trip. When you come back, you invariably pay the price by seeing more patients and doing more surgery. Then it becomes a stressful event.

My advice to young people is to be very thoughtful about planning trips, especially distant ones. You do not want to sit on a plane all day when you could be doing something more productive. If I could have done something differently in my mid-career, I would have traveled less.

Continue to: Prioritizing “out of office” time...

Dr. Greene: How do you all mentally separate yourself from work, so that when you are on vacation with your family you are not thinking about the office, the patients, and all of the things on your to-do list?

Dr. Rardin: I don’t have a great answer for that except that it is about being present. You have to decide that now is the time when I am home, now is the time when I am a parent, now is the time when I am a boy scout leader, etc. I guess maybe it’s a skill, or maybe it’s about making something a priority. Work will always be waiting for you when you turn your attention back to it.

Dr. Matthews: Kristie, the answer to your question goes back to community. Partners in a practice cover for each other. You have to trust them to take care of things so that you can relax during your time away.

Some people recommend not scheduling challenging cases right before going away because invariably something goes wrong, and then you are asking, “Why did I schedule 3 colpopexies before getting on a plane?”

Dr. Rardin: Yes, I completely agree with all of that. Personally, I feel fortunate that I can compartmentalize pretty well. When I am home with my kids, I allow myself to shed some of the doctor/surgeon/leadership persona; I am able to be goofy and completely non–doctor-like. It works to help me leave work behind.

Dr. Matthews: Other things you can do include setting up an out-of-office notice on your email that says when you will be back and what to do in case of urgent matters. This basically says to the world, “Don’t expect to hear from me until X date.” It removes the expectation that you will respond sooner. Otherwise, we would all be on our smartphones all the time and not enjoying our time away.

What I wish I knew then

Dr. Culligan: How would you complete the sentence, “I wish they had told me X when I was embarking on my career?”

Dr. Rardin: I keep coming back to the phrase, “Don’t do anything that you can reasonably pay someone else to do.” By that I mean, if you don’t get energy from housework, consider spending some of your money to get help with the housework. Resolve to make a relatively small expenditure to maximize the quality of the time that you give to yourself and your family. Those are the sorts of things that I think can go a long way.

Dr. Culligan: Charley, your wife is an ObGyn. How do you navigate a dual medical career household? What advice do you have for others?

Dr. Rardin: When I was going into fellowship, we had a conversation about how hard it is for both people in a relationship to have an academic fire in the belly and to be truly engaged in climbing the academic ladder. We made a decision that Jane would go into private practice. There has got to be some give and take in a dual medical relationship; a lot of sacrifices and compromises need to happen. We are fortunate in that there are complementary aspects to our jobs. We both spend about the same number of nights away from the house, but my travel is more in chunks and hers is overnight calls for labor and delivery. We have different ways of (briefly) single-parenting, and you have to come up with ways to handle the domestic chores.

Dr. Matthews: I wish someone had explained to me that the people you work with are much more important than the place. The human connection is what defines your experience, much more than any ego-driven outcome.

Dr. Greene: I wish someone had explained to me the competing aspects of academic medicine. The cards are stacked in a way that make it difficult for you to win. For example, you may love to teach and may be really good at it, but if you let your students handle too many cases, your relative value units plummet and then the hospital is on your back. There are the interests of people, and there are the interests of the business. Everything is a balance, and it’s really tricky.

Dr. Huber: Luckily, Pat counselled me as I was finishing my fellowship about the importance of negotiating a good contract, of being pushy and knowing what you want out of it and knowing what your limitations are. I joined a private practice that had 3 different physical locations. If I had to drive to all of them, as they wanted, it would have meant up to a one-and-a-half-hour commute. But I pushed to stay in one location and to put that extra hour to better use. I am glad I did, but it was terrifying at the time because I didn’t want to lose the offer. I know people that did not do that and took the first thing they got. Now, they are driving all over the place or they have these crazy hours or terrible call responsibilities that if they had just been a little firmer, they probably could have gotten out of. As they start trying to find work-life balance, they are already handicapped.

Continue to: Passions outside the office...

Passions outside the office

Dr. Culligan: One thing I would like to touch on is what is going on in each of your personal lives because all of you have interesting stories to tell outside of what you do professionally. What drives you other than medicine?

Dr. Rardin: I am the father of 3 boys. The oldest one just got his Eagle Scout rank yesterday in Boy Scouts. I would be a woodworker if I wasn’t in medicine. I am a Deacon at church. And I love to spend my downtime reading with my family in front of the fireplace.

Dr. Matthews: For me, it’s music. When my husband and I first met, he asked me if I played a musical instrument. I said I played the cello in primary school. He said, “Great, go rent a cello.” I was never at all interested in playing the cello by myself, but because he plays guitar and piano we became able to play a lot of music together. Our son, Alexander, plays drums. We now have a family band.

In addition, I do yoga. I would never have labeled myself an anxious person, but I learned through this process that I am and need to manage it. It took a lot of years to figure that out. If I don’t leave myself an hour each day to go to a yoga class, I am not a happy person and neither is anyone around me. Also, I get tremendous pleasure from reading books and magazines as opposed to watching a screen.

Dr. Greene: I have found that my passions outside of work often change depending on my stage of life. Right now, I have two young babies and so my life outside of work revolves around them. Before the babies, my dad, who lives in Buffalo, was ill. So for awhile, we were flying to Buffalo almost every weekend that I was not on call. I would say, in general what fuels me is connecting with the people I love as often as I can. A typical night involves me and my husband going for a walk with our kids and dog after dinner and talking to each other. We connect with neighbors and chat on the front porch. It doesn’t really matter what we are doing; it is about being surrounded by people who matter.

Dr. Huber: It’s similar for me. Having a child completely shifts your world view. My goal every day is to give my daughter her first feeding in the morning and to get home as soon as possible at the end of the day to do her last feeding and put her to sleep. She crawled for the first time yesterday, and I was so excited that I could be there for that.

Also, I love being outdoors. I love hiking and camping. Going on a hike and being outside with nature is my way of decompressing.

Continue to: Thinking about upcoming generations...

Dr. Matthews: One other thing I would like to propose is looking at what can we do to make the profession better for the next generation. As a group, our profession is somewhat inflexible. We tend to fall into the trap of, “since this is the way we have always done it this is how we should continue doing it.” The OR still starts at 7:00 or 7:30 am, ignoring the need for school drop-offs, etc. We are not innovative about flexibility in the work week. Honestly, it does not work well for many people, patients and physicians alike. Flexible scheduling should be something that is on the table for both men and women who are trying to balance being full-time parents and full-time surgeons. We need to create an environment in which it is okay for you to spend 10 years instead of 6 as an assistant professor because you are also a young parent, and it will not count against you when you come up for promotion.

Dr. Culligan: I agree with you, Catherine. Full “Professor” is a nice title, but it means time away from family and a lot of other things. Each of us has to decide whether it is worth it, especially since it often does not come with any extra money.

Dr. Huber: A question on a recent survey of residents asked, “Do you see yourself going into private practice or academic medicine when you’ve completed your residency?” When I was a resident, everyone wanted to go into academic medicine, but now it seems like more and more residents have their sights set on private practice because that is where they see the opportunities to create work-life balance.

In the academic world, you have to try to get a promotion in X number of years, and get X number of publications, and be a great teacher, doctor, and administrator all at the same time. I am wondering if we are going to start seeing more and more residents and fellows going into private or hospital-owned practice where there aren’t those added expectations.

Dr. Rardin: I agree, and we are back to what we said in the beginning about doing an honest assessment of what is meaningful and important. We are all trained to try to reach for that shiny brass ring, but do we really want that brass ring? Will it be an asset or a hindrance once we get it? It is okay to be honest and say, “I really don’t want that promotion. I would rather spend more time with my family.” ●

Patrick J. Culligan, MD: We all know that burnout is an important problem among surgeons. In fact, it seems that, in the United States, we are working longer hours than ever before, and that higher education correlates with less balance in life. This dysfunction seems to start in school, when we are encouraged to be competitive, and overwork just becomes another way to compete. It’s very easy to get swept up in the traditional model of academic medicine, the engine of which is competition and overwork.

My impression of our younger colleagues, however, is that many of them are not attracted to the traditional ivory tower research model of academic advancement to which many in previous generations aspired. They seem more concerned with work-life balance as their measure of success rather than the classic metrics of money and prestige. Everyone still needs role models and mentors, though, and that’s where all of you come in. I asked each of you to be on this panel because I admire you for your varying approaches to work-life balance while achieving success as gynecologic surgeons. I thought others in the field might be inspired by hearing your stories.

Cultivating your passions

Kristie Greene, MD: What I have come to learn and appreciate is a really simple point: you do not have to do everything. Determining who you want to be both personally and professionally is step 1.

Granted, answering the question, “Who do I want to be?” is not as simple as it sounds. Many factors figure into the decisions we make in our personal and professional lives. Also, it is not a question we often stop and ask ourselves. From early on, we are placed on an escalator moving up through medical school, residency, fellowship, good job, better job, etc. We are so accustomed to being competitive, to winning, and to wanting to be the best that we sometimes forget to ask ourselves, “What is it exactly that I want, and why? What is my endpoint? And does it make me happy?”

Multitasking is regarded as a talent. As much as we would like to believe that we can do everything at the same time and do it all well, we actually can’t. A friend of mine made me read a book a couple of years ago, called Feeling Good, by David Burns. The book encourages you to consider the different tasks you do in a day and rate how good you are at each of them on a scale of 1 to 10. It then asks you to think about how much enjoyment you derive from each of the tasks and about why you are doing the ones that bring you little to no enjoyment.

I ultimately decided that, for me professionally, the most important thing was my interest in global health. So I decided to do whatever it took to make this happen. But you don’t get something for nothing, and everything comes with sacrifices.

Continue to: Charles Rardin, MD...

Charles Rardin, MD: How exactly did you decide that you were going to focus your career toward pursuing international health? How did you know it was more important? And how did you overcome some of those obstacles?

Dr. Greene: You have to ask the hard question again about what brings you the most joy professionally and personally. That was the easy part of it for me because global health has always been that source of happiness and fulfillment for me. The more challenging parts are the sacrifices and hard choices that come with it. With global health, it can be difficult to balance the demands of a clinical practice.

All of our jobs are a business. I am still struggling with the money part of it. For my husband and I, that meant we had to start small—do what we could afford. But then it blossomed into something that was involving residents, fellows, and med students, which requires far more funding than we had. So I reached out to family. Most of our families donate to different organizations or charities every year, so why not donate to a loved one for something they are passionate about?

At the University of South Florida (USF), we set up a fund, a foundation for global health, which helps support our work abroad as well as the costs associated with involvement of our trainees. Right now, what we have is still small potatoes to a country, but we are making it happen by starting at a small level and growing it.

Beyond the money aspect, traveling abroad means less involvement in meetings, missed opportunities to teach courses that might interest me, and time away from my family. I guess my advice on this whole thing is that you can make things happen if they are important enough to you, and if you are willing to make sacrifices in other areas because you can’t have it all.

Making time for you

Dr. Culligan: So you have found what is important to you, and you have found a way to make it happen. But you are faced with more work; you have given yourself additional work on top of your regular work. How do you make time for a personal life?

Catherine Matthews, MD: In preparing for this discussion, I decided to break down my advice into 3 buckets: The first bucket is discovering and knowing your authentic self. The second is building a community, which I’ll elaborate on. And the third, which we have discussed, is to let go of the money.

Dr. Culligan: I love the concept of the authentic self, but how does that jive with a tendency to strive for perfection? We all think we can do it all. How do we narrow down to what really matters?

Dr. Matthews: We often focus on the things that bring us happiness and what we are good at, but it’s the things that make us unhappy that tend to bring us down. It’s the presence of unhappiness, not the absence of happiness, that seems to be the undoing of many, including myself.

None of us are born with dramatic insight. It is experience that leads to insight. People who are actually present are able to gain insight through observation. A person becomes a better surgeon by observing the outcome of doing a stitch this way versus that; you learn how to do it by seeing what it looks like afterward.

Finding our authentic selves happens in much the same way. Having the presence of mind to ask the right questions, such as, “How am I feeling while I’m doing this?” leads to insights into the true self.

Continue to: It takes a village...

Dr. Greene: Catherine mentioned community earlier, and that is extremely important. The people who surround us can have a huge impact on the way we perceive things, including ourselves. Having a mix of people in our lives—some who practice medicine and others who don’t—helps us stay balanced and answer some of the tough questions. Catherine, for example, has helped me in various stages of my career to ask myself meaningful questions and get real answers.

Dr. Rardin: Part of finding balance is luck, and part of it is making a choice between money and everything else. In considering my first job out of training, I knew that money had the potential to distract me from what was important to me. So I chose a position that was almost entirely salaried so that the decisions I made clinically, surgically, and regarding work-life balance would be less likely to directly impact what was important to me.

Sally Huber, MD: I am still in the “getting there” phase of my life, but one thing I have found is that getting my family involved and excited about what I do has made them much more accepting of when I have longer work days or work to do on the weekend. My spouse has become quite involved with what I have been doing with transgender health in Atlanta. It has been a great bonding experience; she shares my passions, and together we are creating something about which we both can be proud.

When work invades home life

Dr. Culligan: That is great. Sally, I think when we talked, you were just learning about the necessity of mental separation and of not taking your work home with you, which is so hard for all of us with all of our devices.

Dr. Huber: Yes, this year has been about seeing what works best as far as being efficient at work and having quality time at home. At the end of every day I ask myself, “What worked well today? What didn’t work well? What else can I do to maximize time with my family?” I am slowly becoming more efficient, but it has been a challenge. During fellowship, your day is pretty set, but once you are practicing on your own, your hours and responsibilities are completely different, and you have to figure out what works best for you, your values, and your expectations of private life. It takes some time, and I am still figuring it out.

Dr. Culligan: How often would you say that you bring work home? I try hard once I am home to quit working, but sometimes on the weekends I break that rule.

Dr. Matthews: I must say that I do feel like there are certain times when I am better at that than others. Work comes in waves with pressing deadlines. If I averaged it out, probably a third of the time I have some email or some conference call or something that I have got to do at home. I do really try to limit the obligations that I have after 5:30 or 6:00 pm. I resent intrusions after that time. As far as weekends, I delegate about one weekend every 2 months to work, instead of doing a little bit every weekend.

Dr. Greene: I agree. I try hard to make 5:30 to 7:30 pm unequivocal time for a family dinner and time for my kids. During that time, I do not have my phone near me so I can’t look at email or texts. I try not to schedule conference calls. I try to be there to read books to my kids at night. Then if I need to do work, I do it later at night, which interferes with time with my spouse, and is not ideal, but that’s what happens.

Dr. Matthews: One of the things that I think is a huge part of work-life balance is work-related travel. When you are present at work on a consistent basis, the work does not pile up to the extent that it does when you are absent on a trip. When you come back, you invariably pay the price by seeing more patients and doing more surgery. Then it becomes a stressful event.

My advice to young people is to be very thoughtful about planning trips, especially distant ones. You do not want to sit on a plane all day when you could be doing something more productive. If I could have done something differently in my mid-career, I would have traveled less.

Continue to: Prioritizing “out of office” time...

Dr. Greene: How do you all mentally separate yourself from work, so that when you are on vacation with your family you are not thinking about the office, the patients, and all of the things on your to-do list?

Dr. Rardin: I don’t have a great answer for that except that it is about being present. You have to decide that now is the time when I am home, now is the time when I am a parent, now is the time when I am a boy scout leader, etc. I guess maybe it’s a skill, or maybe it’s about making something a priority. Work will always be waiting for you when you turn your attention back to it.

Dr. Matthews: Kristie, the answer to your question goes back to community. Partners in a practice cover for each other. You have to trust them to take care of things so that you can relax during your time away.

Some people recommend not scheduling challenging cases right before going away because invariably something goes wrong, and then you are asking, “Why did I schedule 3 colpopexies before getting on a plane?”

Dr. Rardin: Yes, I completely agree with all of that. Personally, I feel fortunate that I can compartmentalize pretty well. When I am home with my kids, I allow myself to shed some of the doctor/surgeon/leadership persona; I am able to be goofy and completely non–doctor-like. It works to help me leave work behind.

Dr. Matthews: Other things you can do include setting up an out-of-office notice on your email that says when you will be back and what to do in case of urgent matters. This basically says to the world, “Don’t expect to hear from me until X date.” It removes the expectation that you will respond sooner. Otherwise, we would all be on our smartphones all the time and not enjoying our time away.

What I wish I knew then

Dr. Culligan: How would you complete the sentence, “I wish they had told me X when I was embarking on my career?”

Dr. Rardin: I keep coming back to the phrase, “Don’t do anything that you can reasonably pay someone else to do.” By that I mean, if you don’t get energy from housework, consider spending some of your money to get help with the housework. Resolve to make a relatively small expenditure to maximize the quality of the time that you give to yourself and your family. Those are the sorts of things that I think can go a long way.

Dr. Culligan: Charley, your wife is an ObGyn. How do you navigate a dual medical career household? What advice do you have for others?

Dr. Rardin: When I was going into fellowship, we had a conversation about how hard it is for both people in a relationship to have an academic fire in the belly and to be truly engaged in climbing the academic ladder. We made a decision that Jane would go into private practice. There has got to be some give and take in a dual medical relationship; a lot of sacrifices and compromises need to happen. We are fortunate in that there are complementary aspects to our jobs. We both spend about the same number of nights away from the house, but my travel is more in chunks and hers is overnight calls for labor and delivery. We have different ways of (briefly) single-parenting, and you have to come up with ways to handle the domestic chores.

Dr. Matthews: I wish someone had explained to me that the people you work with are much more important than the place. The human connection is what defines your experience, much more than any ego-driven outcome.

Dr. Greene: I wish someone had explained to me the competing aspects of academic medicine. The cards are stacked in a way that make it difficult for you to win. For example, you may love to teach and may be really good at it, but if you let your students handle too many cases, your relative value units plummet and then the hospital is on your back. There are the interests of people, and there are the interests of the business. Everything is a balance, and it’s really tricky.

Dr. Huber: Luckily, Pat counselled me as I was finishing my fellowship about the importance of negotiating a good contract, of being pushy and knowing what you want out of it and knowing what your limitations are. I joined a private practice that had 3 different physical locations. If I had to drive to all of them, as they wanted, it would have meant up to a one-and-a-half-hour commute. But I pushed to stay in one location and to put that extra hour to better use. I am glad I did, but it was terrifying at the time because I didn’t want to lose the offer. I know people that did not do that and took the first thing they got. Now, they are driving all over the place or they have these crazy hours or terrible call responsibilities that if they had just been a little firmer, they probably could have gotten out of. As they start trying to find work-life balance, they are already handicapped.

Continue to: Passions outside the office...

Passions outside the office

Dr. Culligan: One thing I would like to touch on is what is going on in each of your personal lives because all of you have interesting stories to tell outside of what you do professionally. What drives you other than medicine?

Dr. Rardin: I am the father of 3 boys. The oldest one just got his Eagle Scout rank yesterday in Boy Scouts. I would be a woodworker if I wasn’t in medicine. I am a Deacon at church. And I love to spend my downtime reading with my family in front of the fireplace.

Dr. Matthews: For me, it’s music. When my husband and I first met, he asked me if I played a musical instrument. I said I played the cello in primary school. He said, “Great, go rent a cello.” I was never at all interested in playing the cello by myself, but because he plays guitar and piano we became able to play a lot of music together. Our son, Alexander, plays drums. We now have a family band.

In addition, I do yoga. I would never have labeled myself an anxious person, but I learned through this process that I am and need to manage it. It took a lot of years to figure that out. If I don’t leave myself an hour each day to go to a yoga class, I am not a happy person and neither is anyone around me. Also, I get tremendous pleasure from reading books and magazines as opposed to watching a screen.

Dr. Greene: I have found that my passions outside of work often change depending on my stage of life. Right now, I have two young babies and so my life outside of work revolves around them. Before the babies, my dad, who lives in Buffalo, was ill. So for awhile, we were flying to Buffalo almost every weekend that I was not on call. I would say, in general what fuels me is connecting with the people I love as often as I can. A typical night involves me and my husband going for a walk with our kids and dog after dinner and talking to each other. We connect with neighbors and chat on the front porch. It doesn’t really matter what we are doing; it is about being surrounded by people who matter.

Dr. Huber: It’s similar for me. Having a child completely shifts your world view. My goal every day is to give my daughter her first feeding in the morning and to get home as soon as possible at the end of the day to do her last feeding and put her to sleep. She crawled for the first time yesterday, and I was so excited that I could be there for that.

Also, I love being outdoors. I love hiking and camping. Going on a hike and being outside with nature is my way of decompressing.

Continue to: Thinking about upcoming generations...

Dr. Matthews: One other thing I would like to propose is looking at what can we do to make the profession better for the next generation. As a group, our profession is somewhat inflexible. We tend to fall into the trap of, “since this is the way we have always done it this is how we should continue doing it.” The OR still starts at 7:00 or 7:30 am, ignoring the need for school drop-offs, etc. We are not innovative about flexibility in the work week. Honestly, it does not work well for many people, patients and physicians alike. Flexible scheduling should be something that is on the table for both men and women who are trying to balance being full-time parents and full-time surgeons. We need to create an environment in which it is okay for you to spend 10 years instead of 6 as an assistant professor because you are also a young parent, and it will not count against you when you come up for promotion.

Dr. Culligan: I agree with you, Catherine. Full “Professor” is a nice title, but it means time away from family and a lot of other things. Each of us has to decide whether it is worth it, especially since it often does not come with any extra money.

Dr. Huber: A question on a recent survey of residents asked, “Do you see yourself going into private practice or academic medicine when you’ve completed your residency?” When I was a resident, everyone wanted to go into academic medicine, but now it seems like more and more residents have their sights set on private practice because that is where they see the opportunities to create work-life balance.

In the academic world, you have to try to get a promotion in X number of years, and get X number of publications, and be a great teacher, doctor, and administrator all at the same time. I am wondering if we are going to start seeing more and more residents and fellows going into private or hospital-owned practice where there aren’t those added expectations.

Dr. Rardin: I agree, and we are back to what we said in the beginning about doing an honest assessment of what is meaningful and important. We are all trained to try to reach for that shiny brass ring, but do we really want that brass ring? Will it be an asset or a hindrance once we get it? It is okay to be honest and say, “I really don’t want that promotion. I would rather spend more time with my family.” ●

Patrick J. Culligan, MD: We all know that burnout is an important problem among surgeons. In fact, it seems that, in the United States, we are working longer hours than ever before, and that higher education correlates with less balance in life. This dysfunction seems to start in school, when we are encouraged to be competitive, and overwork just becomes another way to compete. It’s very easy to get swept up in the traditional model of academic medicine, the engine of which is competition and overwork.

My impression of our younger colleagues, however, is that many of them are not attracted to the traditional ivory tower research model of academic advancement to which many in previous generations aspired. They seem more concerned with work-life balance as their measure of success rather than the classic metrics of money and prestige. Everyone still needs role models and mentors, though, and that’s where all of you come in. I asked each of you to be on this panel because I admire you for your varying approaches to work-life balance while achieving success as gynecologic surgeons. I thought others in the field might be inspired by hearing your stories.

Cultivating your passions

Kristie Greene, MD: What I have come to learn and appreciate is a really simple point: you do not have to do everything. Determining who you want to be both personally and professionally is step 1.

Granted, answering the question, “Who do I want to be?” is not as simple as it sounds. Many factors figure into the decisions we make in our personal and professional lives. Also, it is not a question we often stop and ask ourselves. From early on, we are placed on an escalator moving up through medical school, residency, fellowship, good job, better job, etc. We are so accustomed to being competitive, to winning, and to wanting to be the best that we sometimes forget to ask ourselves, “What is it exactly that I want, and why? What is my endpoint? And does it make me happy?”

Multitasking is regarded as a talent. As much as we would like to believe that we can do everything at the same time and do it all well, we actually can’t. A friend of mine made me read a book a couple of years ago, called Feeling Good, by David Burns. The book encourages you to consider the different tasks you do in a day and rate how good you are at each of them on a scale of 1 to 10. It then asks you to think about how much enjoyment you derive from each of the tasks and about why you are doing the ones that bring you little to no enjoyment.

I ultimately decided that, for me professionally, the most important thing was my interest in global health. So I decided to do whatever it took to make this happen. But you don’t get something for nothing, and everything comes with sacrifices.

Continue to: Charles Rardin, MD...

Charles Rardin, MD: How exactly did you decide that you were going to focus your career toward pursuing international health? How did you know it was more important? And how did you overcome some of those obstacles?

Dr. Greene: You have to ask the hard question again about what brings you the most joy professionally and personally. That was the easy part of it for me because global health has always been that source of happiness and fulfillment for me. The more challenging parts are the sacrifices and hard choices that come with it. With global health, it can be difficult to balance the demands of a clinical practice.

All of our jobs are a business. I am still struggling with the money part of it. For my husband and I, that meant we had to start small—do what we could afford. But then it blossomed into something that was involving residents, fellows, and med students, which requires far more funding than we had. So I reached out to family. Most of our families donate to different organizations or charities every year, so why not donate to a loved one for something they are passionate about?

At the University of South Florida (USF), we set up a fund, a foundation for global health, which helps support our work abroad as well as the costs associated with involvement of our trainees. Right now, what we have is still small potatoes to a country, but we are making it happen by starting at a small level and growing it.

Beyond the money aspect, traveling abroad means less involvement in meetings, missed opportunities to teach courses that might interest me, and time away from my family. I guess my advice on this whole thing is that you can make things happen if they are important enough to you, and if you are willing to make sacrifices in other areas because you can’t have it all.

Making time for you

Dr. Culligan: So you have found what is important to you, and you have found a way to make it happen. But you are faced with more work; you have given yourself additional work on top of your regular work. How do you make time for a personal life?

Catherine Matthews, MD: In preparing for this discussion, I decided to break down my advice into 3 buckets: The first bucket is discovering and knowing your authentic self. The second is building a community, which I’ll elaborate on. And the third, which we have discussed, is to let go of the money.

Dr. Culligan: I love the concept of the authentic self, but how does that jive with a tendency to strive for perfection? We all think we can do it all. How do we narrow down to what really matters?

Dr. Matthews: We often focus on the things that bring us happiness and what we are good at, but it’s the things that make us unhappy that tend to bring us down. It’s the presence of unhappiness, not the absence of happiness, that seems to be the undoing of many, including myself.

None of us are born with dramatic insight. It is experience that leads to insight. People who are actually present are able to gain insight through observation. A person becomes a better surgeon by observing the outcome of doing a stitch this way versus that; you learn how to do it by seeing what it looks like afterward.

Finding our authentic selves happens in much the same way. Having the presence of mind to ask the right questions, such as, “How am I feeling while I’m doing this?” leads to insights into the true self.

Continue to: It takes a village...

Dr. Greene: Catherine mentioned community earlier, and that is extremely important. The people who surround us can have a huge impact on the way we perceive things, including ourselves. Having a mix of people in our lives—some who practice medicine and others who don’t—helps us stay balanced and answer some of the tough questions. Catherine, for example, has helped me in various stages of my career to ask myself meaningful questions and get real answers.

Dr. Rardin: Part of finding balance is luck, and part of it is making a choice between money and everything else. In considering my first job out of training, I knew that money had the potential to distract me from what was important to me. So I chose a position that was almost entirely salaried so that the decisions I made clinically, surgically, and regarding work-life balance would be less likely to directly impact what was important to me.

Sally Huber, MD: I am still in the “getting there” phase of my life, but one thing I have found is that getting my family involved and excited about what I do has made them much more accepting of when I have longer work days or work to do on the weekend. My spouse has become quite involved with what I have been doing with transgender health in Atlanta. It has been a great bonding experience; she shares my passions, and together we are creating something about which we both can be proud.

When work invades home life

Dr. Culligan: That is great. Sally, I think when we talked, you were just learning about the necessity of mental separation and of not taking your work home with you, which is so hard for all of us with all of our devices.

Dr. Huber: Yes, this year has been about seeing what works best as far as being efficient at work and having quality time at home. At the end of every day I ask myself, “What worked well today? What didn’t work well? What else can I do to maximize time with my family?” I am slowly becoming more efficient, but it has been a challenge. During fellowship, your day is pretty set, but once you are practicing on your own, your hours and responsibilities are completely different, and you have to figure out what works best for you, your values, and your expectations of private life. It takes some time, and I am still figuring it out.

Dr. Culligan: How often would you say that you bring work home? I try hard once I am home to quit working, but sometimes on the weekends I break that rule.

Dr. Matthews: I must say that I do feel like there are certain times when I am better at that than others. Work comes in waves with pressing deadlines. If I averaged it out, probably a third of the time I have some email or some conference call or something that I have got to do at home. I do really try to limit the obligations that I have after 5:30 or 6:00 pm. I resent intrusions after that time. As far as weekends, I delegate about one weekend every 2 months to work, instead of doing a little bit every weekend.

Dr. Greene: I agree. I try hard to make 5:30 to 7:30 pm unequivocal time for a family dinner and time for my kids. During that time, I do not have my phone near me so I can’t look at email or texts. I try not to schedule conference calls. I try to be there to read books to my kids at night. Then if I need to do work, I do it later at night, which interferes with time with my spouse, and is not ideal, but that’s what happens.

Dr. Matthews: One of the things that I think is a huge part of work-life balance is work-related travel. When you are present at work on a consistent basis, the work does not pile up to the extent that it does when you are absent on a trip. When you come back, you invariably pay the price by seeing more patients and doing more surgery. Then it becomes a stressful event.

My advice to young people is to be very thoughtful about planning trips, especially distant ones. You do not want to sit on a plane all day when you could be doing something more productive. If I could have done something differently in my mid-career, I would have traveled less.

Continue to: Prioritizing “out of office” time...

Dr. Greene: How do you all mentally separate yourself from work, so that when you are on vacation with your family you are not thinking about the office, the patients, and all of the things on your to-do list?

Dr. Rardin: I don’t have a great answer for that except that it is about being present. You have to decide that now is the time when I am home, now is the time when I am a parent, now is the time when I am a boy scout leader, etc. I guess maybe it’s a skill, or maybe it’s about making something a priority. Work will always be waiting for you when you turn your attention back to it.

Dr. Matthews: Kristie, the answer to your question goes back to community. Partners in a practice cover for each other. You have to trust them to take care of things so that you can relax during your time away.

Some people recommend not scheduling challenging cases right before going away because invariably something goes wrong, and then you are asking, “Why did I schedule 3 colpopexies before getting on a plane?”

Dr. Rardin: Yes, I completely agree with all of that. Personally, I feel fortunate that I can compartmentalize pretty well. When I am home with my kids, I allow myself to shed some of the doctor/surgeon/leadership persona; I am able to be goofy and completely non–doctor-like. It works to help me leave work behind.

Dr. Matthews: Other things you can do include setting up an out-of-office notice on your email that says when you will be back and what to do in case of urgent matters. This basically says to the world, “Don’t expect to hear from me until X date.” It removes the expectation that you will respond sooner. Otherwise, we would all be on our smartphones all the time and not enjoying our time away.

What I wish I knew then

Dr. Culligan: How would you complete the sentence, “I wish they had told me X when I was embarking on my career?”

Dr. Rardin: I keep coming back to the phrase, “Don’t do anything that you can reasonably pay someone else to do.” By that I mean, if you don’t get energy from housework, consider spending some of your money to get help with the housework. Resolve to make a relatively small expenditure to maximize the quality of the time that you give to yourself and your family. Those are the sorts of things that I think can go a long way.

Dr. Culligan: Charley, your wife is an ObGyn. How do you navigate a dual medical career household? What advice do you have for others?

Dr. Rardin: When I was going into fellowship, we had a conversation about how hard it is for both people in a relationship to have an academic fire in the belly and to be truly engaged in climbing the academic ladder. We made a decision that Jane would go into private practice. There has got to be some give and take in a dual medical relationship; a lot of sacrifices and compromises need to happen. We are fortunate in that there are complementary aspects to our jobs. We both spend about the same number of nights away from the house, but my travel is more in chunks and hers is overnight calls for labor and delivery. We have different ways of (briefly) single-parenting, and you have to come up with ways to handle the domestic chores.

Dr. Matthews: I wish someone had explained to me that the people you work with are much more important than the place. The human connection is what defines your experience, much more than any ego-driven outcome.

Dr. Greene: I wish someone had explained to me the competing aspects of academic medicine. The cards are stacked in a way that make it difficult for you to win. For example, you may love to teach and may be really good at it, but if you let your students handle too many cases, your relative value units plummet and then the hospital is on your back. There are the interests of people, and there are the interests of the business. Everything is a balance, and it’s really tricky.

Dr. Huber: Luckily, Pat counselled me as I was finishing my fellowship about the importance of negotiating a good contract, of being pushy and knowing what you want out of it and knowing what your limitations are. I joined a private practice that had 3 different physical locations. If I had to drive to all of them, as they wanted, it would have meant up to a one-and-a-half-hour commute. But I pushed to stay in one location and to put that extra hour to better use. I am glad I did, but it was terrifying at the time because I didn’t want to lose the offer. I know people that did not do that and took the first thing they got. Now, they are driving all over the place or they have these crazy hours or terrible call responsibilities that if they had just been a little firmer, they probably could have gotten out of. As they start trying to find work-life balance, they are already handicapped.

Continue to: Passions outside the office...

Passions outside the office

Dr. Culligan: One thing I would like to touch on is what is going on in each of your personal lives because all of you have interesting stories to tell outside of what you do professionally. What drives you other than medicine?

Dr. Rardin: I am the father of 3 boys. The oldest one just got his Eagle Scout rank yesterday in Boy Scouts. I would be a woodworker if I wasn’t in medicine. I am a Deacon at church. And I love to spend my downtime reading with my family in front of the fireplace.

Dr. Matthews: For me, it’s music. When my husband and I first met, he asked me if I played a musical instrument. I said I played the cello in primary school. He said, “Great, go rent a cello.” I was never at all interested in playing the cello by myself, but because he plays guitar and piano we became able to play a lot of music together. Our son, Alexander, plays drums. We now have a family band.

In addition, I do yoga. I would never have labeled myself an anxious person, but I learned through this process that I am and need to manage it. It took a lot of years to figure that out. If I don’t leave myself an hour each day to go to a yoga class, I am not a happy person and neither is anyone around me. Also, I get tremendous pleasure from reading books and magazines as opposed to watching a screen.

Dr. Greene: I have found that my passions outside of work often change depending on my stage of life. Right now, I have two young babies and so my life outside of work revolves around them. Before the babies, my dad, who lives in Buffalo, was ill. So for awhile, we were flying to Buffalo almost every weekend that I was not on call. I would say, in general what fuels me is connecting with the people I love as often as I can. A typical night involves me and my husband going for a walk with our kids and dog after dinner and talking to each other. We connect with neighbors and chat on the front porch. It doesn’t really matter what we are doing; it is about being surrounded by people who matter.

Dr. Huber: It’s similar for me. Having a child completely shifts your world view. My goal every day is to give my daughter her first feeding in the morning and to get home as soon as possible at the end of the day to do her last feeding and put her to sleep. She crawled for the first time yesterday, and I was so excited that I could be there for that.

Also, I love being outdoors. I love hiking and camping. Going on a hike and being outside with nature is my way of decompressing.

Continue to: Thinking about upcoming generations...

Dr. Matthews: One other thing I would like to propose is looking at what can we do to make the profession better for the next generation. As a group, our profession is somewhat inflexible. We tend to fall into the trap of, “since this is the way we have always done it this is how we should continue doing it.” The OR still starts at 7:00 or 7:30 am, ignoring the need for school drop-offs, etc. We are not innovative about flexibility in the work week. Honestly, it does not work well for many people, patients and physicians alike. Flexible scheduling should be something that is on the table for both men and women who are trying to balance being full-time parents and full-time surgeons. We need to create an environment in which it is okay for you to spend 10 years instead of 6 as an assistant professor because you are also a young parent, and it will not count against you when you come up for promotion.

Dr. Culligan: I agree with you, Catherine. Full “Professor” is a nice title, but it means time away from family and a lot of other things. Each of us has to decide whether it is worth it, especially since it often does not come with any extra money.

Dr. Huber: A question on a recent survey of residents asked, “Do you see yourself going into private practice or academic medicine when you’ve completed your residency?” When I was a resident, everyone wanted to go into academic medicine, but now it seems like more and more residents have their sights set on private practice because that is where they see the opportunities to create work-life balance.

In the academic world, you have to try to get a promotion in X number of years, and get X number of publications, and be a great teacher, doctor, and administrator all at the same time. I am wondering if we are going to start seeing more and more residents and fellows going into private or hospital-owned practice where there aren’t those added expectations.

Dr. Rardin: I agree, and we are back to what we said in the beginning about doing an honest assessment of what is meaningful and important. We are all trained to try to reach for that shiny brass ring, but do we really want that brass ring? Will it be an asset or a hindrance once we get it? It is okay to be honest and say, “I really don’t want that promotion. I would rather spend more time with my family.” ●

© TRENDOBJECTS/SHUTTERSTOCK

I often say that there are both “guardrail” days and very good days when it comes to the ins and outs of health care builds and product launches. The process is much like starting down the path of a country road in the middle of a blizzard—unless you have dependable wipers and a good defrost system, that path can get murky very quickly. With this article I hope to offer my counsel to inventors, featuring a few of my prior launches as well as case studies of health care launches I was not involved with, and sharing the lessons learned and hurdles that were overcome. I encourage all entrepreneurs to act on their ideas because, in the world of health care startups, the only failure is not acting on an invention.

Case study 1: Cerezyme

Today, Cerezyme is indicated for patients with Gaucher, which is a lysosomal storage disorder. Cerezyme’s first-generation product, called Ceredase, was a human tissue-derived protein that we extracted from human placentas. At the time, the concept of moving this program forward was denied by the Board of Directors because they said that even if you could collect enough placentas to make the enzyme, it would be too expensive to manufacture. In fact, early scale-up modeling for manufacturing the protein demonstrated that Genzyme would need 4 tons of placentas per Gaucher patient per year.

Gaucher is a severe, early-onset disease that has a significant negative outcome for patients. Patients with Gaucher are in dire need of treatment. Genzyme went forward with the Ceredase program by financing it through the families of patients with the disease, by starting an LLC separate from the business and funding the initial clinical trial and the development of the protein through the families of Gaucher patients. That approach was a successful endeavor. A great example of a creative capital structure to advance a program.

This was in the late 1980s/early 1990s, and at the height of the AIDS challenge. Genzyme based the manufacturing in Lille, France, and we cryopreserved placentas in the United States and Europe and shipped them to Lille to be processed into therapy. Genzyme eventually received approval for Ceredase from the US Food and Drug Administration (FDA) and the European Medicines Agency. At the height of the placenta collection, we were gathering about 10% to 15% of the placentas in the United States and 30% to 40% of the placentas in Europe. Resources supply became an issue until we developed a recombinant form of the protein, accomplished by using a manufacturing system called a CHO cell line.

This is a very good success story: If this invention was not pursued, Gaucher patients would not benefit from the treatment today. In addition, there are a plethora of patients with different lysosomal storage disorders treated with additional proteins that have been aided by us going through the entire development, manufacturing, and global commercialization process. We figured out how to manufacture and deliver the treatment, working through multiple countries’ political systems, and today the therapy is paid for by insurance and government systems on a worldwide basis.

Continue to: Case study 2...