Which of these wardrobe items would you ban from the hospital?*

* FOR MEDICAL STAFF

Which of these wardrobe items would you ban from the hospital?*

* FOR MEDICAL STAFF

Which of these wardrobe items would you ban from the hospital?*

* FOR MEDICAL STAFF

Hear Dr Phillips discuss the key points of this series

Vaginal placement of mesh for the correction of pelvic organ prolapse is not an entirely benign procedure. As Mickey M. Karram, MD, and an expert panel discuss in this article—the second of a two-part series—complications secondary to mesh placement can be a challenge to correct and often make life miserable for patients who experience them. Here, these experts address mesh erosion, extrusion, and other serious complications; discuss ways to prevent them; and offer strategies for managing them when they arise.

In Part 1, which appeared in the January 2009 issue of OBG Management, the panel discussed the increasing use of mesh in prolapse repair—in particular, the proliferation of mesh kits.

How common is erosion?

DR. KARRAM: The literature seems to indicate that, even in the best of hands, there is an extrusion, or erosion, rate of between 5% and 17% when mesh is used. Would you agree with this statistic?

DR. LUCENTE: Not completely. The vaginal exposure rate can be as low as 2%, as reported by our center and others, when the mesh is properly placed below all histologic layers of the vaginal wall, as it is when it is “delivered” to the pelvis via the transabdominal route.^1,2

At the other end of the scale, an exposure rate above 17% has been reported when mesh is improperly placed within the vaginal wall—that is, just below the mucosa, as some surgeons have described in the methodology section of their abstract or article.^3,4

THE OBG MANAGEMENT EXPERT PANEL

MICKEY M. KARRAM, MD, moderator, is Director of Urogynecology at Good Samaritan Hospital and Voluntary Professor of ObGyn at the University of Cincinnati School of Medicine in Cincinnati, Ohio.

SHLOMO RAZ, MD, is Professor of Urology and Chief of Pelvic Medicine and Reconstructive Urology at UCLA School of Medicine in Los Angeles.

VINCENT LUCENTE, MD, MBA, is Founder and Director of the Institute for Female Pelvic Medicine and Reconstructive Surgery in Allentown, Pa, and Clinical Professor of ObGyn at Temple University School of Medicine in Philadelphia.

MARK D. WALTERS, MD, is Professor and Vice Chair of Gynecology, Section of Urogynecology and Reconstructive Pelvic Surgery, Department of Obstetrics and Gynecology, at the Cleveland Clinic in Cleveland, Ohio.

We have found that complete, full-thickness dissection of the vaginal wall into the true pelvic space (vesicovaginal and rectovaginal), utilizing small vaginal incisions and limiting hysterectomy and the trimming of vaginal mucosa, can promote a very low vaginal-exposure rate.

DR. WALTERS: Some surgeons tell me that their own extrusion or erosion rate is lower than the published rate of 5% to 17%, but it is impossible to be certain of the long-term outcome in any patient unless she is followed carefully. The patient may consult another physician about her complications. The primary surgeon—even an expert—often does not know the actual mesh complication rate.

That said, I am sure that some surgeons are particularly adept at using mesh kits for prolapse repair, thereby keeping their mesh complication rate low. The 5% to 17% number is what most gynecologic surgeons should expect for their patients.

DR. RAZ: The complication rates are clearly underreported since very few centers of excellence report on complications and the majority of users don’t report them. Also, the reported complication rate concerns short-term erosion. I imagine that, as time passes and vaginal tissue becomes more atrophic, the incidence of erosion will increase.

Are simple measures enough to resolve erosion?

DR. KARRAM: There seems to be a general perception that most extrusions or erosions can be easily managed in the office by placing estrogen or trimming. In our experience, that approach has been successful in a minority of cases only.

What have you seen?

DR. WALTERS: At the Cleveland Clinic, as at most tertiary care referral centers, we often see the worst cases of extrusion or erosion related to mesh. Estrogen helps in some cases of simple mesh exposure, especially after sacrocolpopexy. If estrogen is going to be effective, however, the problem should clear up relatively quickly; if it isn’t effective after a month or two of therapy, estrogen is unlikely to ever be successful.

When it comes to related problems, such as ridges or strictures in the vagina, dyspareunia, penile pain with insertion, and vaginal burning pain, I have not found simple trimming and estrogen to be effective.

DR. KARRAM: It’s also unlikely that simple excision or placement of estrogen will be successful over the long term. When an extrusion or erosion occurs, we are generally seeing only the tip of the iceberg. That’s because mesh is placed in a certain plane. Although only part of the mesh may be exposed, the entire mesh is likely to be affected because it lies in the same plane.

Also, because of the special nature of vaginal flora, it is unlikely that a foreign body is going to be successfully managed by simple excision or placement of estrogen.

DR. LUCENTE: Management of vaginal exposure really depends on the size of the exposure, its location, and whether there is underlying infection or ischemia of host tissue. When the exposure is small (<1 cm in diameter) and in the midline, with the mesh lying flat below the plane of the vaginal wall, we have been very successful using a conservative approach.

However, even the tiniest of exposures needs to be surgically excised if it traverses the vaginal sulcus. Obviously, any mesh erosion into viscera such as the bladder and bowel also requires surgical intervention. Host-tissue factors always play a contributing role.

I also want to point out that the manner in which exposure is managed depends to some extent on whether the mesh was properly placed. Exposures that arise when mesh is implanted improperly are difficult to correct and usually require complete removal.

Although we, too, started off with an exposure rate around 8%, it is now very low, thanks to technical advancements.

DR. RAZ: A very small vaginal erosion of a mesh sling can sometimes be managed in the office by excision. The cases referred to our service generally involve more extensive areas of exposure that will not be resolved by local treatment.

Is risk of injury operator-dependent?

DR. KARRAM: We’re all seeing very severe complications secondary to mesh placement. Would each of you give your opinion as to whether the severe complications such as significant pain, dyspareunia, and injury of important structures are mostly technical or inherent to mesh placement. Would they happen in the best of hands?

DR. LUCENTE: The more severe complications, for the most part, are very much related to technique. Not that they cannot happen in the very best of hands, but they are extremely rare when technique is meticulous.

Over a 4-year period, after well over 1,000 transvaginal mesh surgeries at our center, we had no death, ICU admission, or transfusion, and our intraoperative complication rate was only 3%, most commonly involving simple cystotomy without long-term consequence. This compares very favorably to the nearly 12% complication rate reported recently in the CARE trial for abdominal sacral colpopexy.⁵

Our primary challenge today is preventing postoperative dyspareunia. Our rate of new-onset dyspareunia is approximately 3.5%. This complication is, I think, more likely to be related to the inherent material properties of mesh, such as elasticity and flexural rigidity, and to host-tissue response to the material itself.

DR. RAZ: I think that the majority of complications are operator-dependent. Thin dissection of the vaginal wall and unrecognized bladder, urethral, and vaginal perforation are the most common reasons for the complications. Mesh does not move after surgery; if there is a problem, it means that the mesh was misplaced.

Another problem is that industry, in an effort to sell more kits, is pushing physicians who are unfamiliar with the principles of pelvic reconstruction to perform this complex procedure. Repair of major vaginal prolapse is not a simple sling procedure.

In addition, there is a greater likelihood of complications in patients who have severe atrophic tissues. These patients should not be candidates for mesh reconstruction.

DR. WALTERS: Many of the complications that we see with mesh are certainly operator-dependent. For example, mesh that is placed under too much tension leaves the vagina tight and stiff, and mesh that is placed with ripples and ridges causes irregularities in the vagina that are often painful, especially during intercourse.

I do not believe that mesh “erodes” into the bladder, urethra, or rectum, but that it is placed there inadvertently and overlooked intraoperatively (FIGURES 1 and 2), Visceral erosion can occur if the primary surgeon made a cystotomy or proctotomy before proceeding with the mesh kit, and the mesh eventually wore through the repaired area.

There are also some problems that are inherent to mesh, and that occur even in the best hands and after surgeries that are performed very competently. Some mesh exposures are inevitable, as are some cases of dyspareunia and rare cases of vaginal burning and pain. In addition, I am seeing more de novo SUI [stress urinary incontinence] with anterior mesh kits. Although this is not really a complication, it does lead to dissatisfaction in patients and merits efforts to prevent it.

DR. KARRAM: Yes. With the current state of mesh, I believe pain and dyspareunia are almost inevitable in some cases.

DR. LUCENTE: Another problem that is currently underaddressed is scar plating along the surface of the mesh. Such plating forms more readily in the absence of mechanical movement or distention during the early stages of wound healing. To make a comparison, even the best reconstructive orthopedic surgeons cannot achieve optimal functional outcomes with an implant surgery without intense postoperative physical therapy, which may simply involve range of motion or movement.

Most everyone is familiar with the capsular fibrosis and contraction that develop around a breast implant if there isn’t immediate postoperative massaging of the breast tissue and implant during wound repair. I am confident that the rate of dyspareunia will decline over time if specialists in reconstructive pelvic surgery pay closer attention to optimizing vaginal length, preserving the cervix (in women with relatively shorter vaginal length), and ensuring optimal apical attachment (that is, above the ischial spine) in younger, sexually active patients.

DR. RAZ: I think it is the surgeon rather than the surgery who causes most complications. In its effort to sell kits, industry sometimes puts them in the hands of surgeons who are not well prepared for the task. This operation can be quite complex, and you cannot create a pelvic surgeon from a physician who is unfamiliar with the anatomy. If you cannot manage the potential complications, you should not perform this type of surgery.

FIGURE 1 When mesh “erodes” into the urethra

Two images of mesh in the urethra. There is some uncertainty here whether mesh that has penetrated the urethra eroded through vaginal tissue or was placed there inadvertently and overlooked intraoperatively.

FIGURE 2 Mesh in the bladder

A segment of tension-free vaginal tape has penetrated into the bladder.

Should mesh be removed at the time of injury?

DR. KARRAM: As we discuss specific complications, let’s start with the most severe, which I would say relate to the inadvertent placement of mesh through important structures such as bowel, bladder, or ureters. If this were to happen and be diagnosed intraoperatively, what would you recommend that the surgeon do—abort the procedure or simply remove the mesh or trocar and attempt to pass it again safely?

DR. LUCENTE: That is a difficult question to answer because so much depends on various intraoperative factors.

I am much more comfortable proceeding with surgery after intraoperative bladder injury than after bowel or rectal injury. We have successfully corrected cystotomies that were small, did not encroach on the ureter, and were easily repaired without tension—and we have seen no fistula formation as a result.

The key is to maintain a high index of suspicion throughout the procedure. We have always diagnosed injuries before mesh is delivered—either during dissection or during passage of the needle or trocar. We have not experienced any ureteral injuries aside from “kinking” of one ureter, which was easily corrected with simple readjustment of the mesh.

If, at any time, we were concerned about potential infection, fistula, or a more severe complication that would be aggravated by proceeding with the operation, we would abort the procedure. However, we would be likely to proceed with an alternative operation to address the pelvic-support defect so that the patient would not awaken with intraoperative injury and no surgical treatment for her primary complaint.

We conduct informed consent in such a way as to preserve our flexibility to adapt the surgical plan to execute the reparative work that is necessary despite the development of a non–life-threatening complication during surgery. In the event of any injury to the bowel that would involve gross spillage of fecal material, of course, I would abort placement of synthetic mesh.

DR. WALTERS: If I placed one of the trocars through the bladder or bowel, I would probably remove it, reposition it, and continue with the surgery. With bladder perforation, this approach is generally no problem, but I would usually leave a Foley catheter in place for 1 week of continuous bladder drainage.

If I placed the trocar through the rectum, I would probably oversew the proctotomy, irrigate the space, and continue with the mesh repair. If I had an outright laceration in the bladder or rectum as part of the dissection, I would repair it and consider converting the surgery to prolapse repair without mesh.

The most dreaded complication: the foreshortened vagina

DR. KARRAM: It would seem that the most difficult complication to deal with is the foreshortened, firm, painful vagina. A patient who has these problems may be perceived, at times, as a pelvic “cripple.” Is this an accepted, albeit rare, complication? Or can it be avoided?

DR. LUCENTE: This is the most feared complication arising from the use of synthetic mesh. I do believe it can almost always be avoided—but I never say never. The key is to pay full attention to considerations of vaginal length before surgery, including, first, preservation of the cervix, and, second, placing the mesh loosely, properly sized, and attached with optimization of apical support to preserve vaginal length.

I also believe that use of second-generation meshes that are lighter, more elastic, and more flexible helps reduce this complication when the mesh is properly placed by a surgeon well trained in the technique.

When the vagina is foreshortened, the sooner it is revised, the better the chance that pain will resolve, whether the mesh is removed or released.

DR. RAZ: Mesh infection, capsular formation, dissection of a thin vaginal wall, and excess vaginal-wall excision lead to the short, firm, and painful vagina. The use and abuse of mesh has created a new subspecialty to manage mesh complications. The PFS syndrome (painful, firm, and short vagina) is one of the most difficult complications to treat because, in many cases, it cannot be reversed without major surgery.

DR. WALTERS: Women who have a foreshortened, firm, or painful vagina after mesh augmentation almost always need to have the mesh removed with reconstruction of the vaginal canal. I have never seen a successful outcome in this type of patient without complete or near-complete removal of the mesh.

Hear Dr Phillips discuss the key points of this series

Vaginal placement of mesh for the correction of pelvic organ prolapse is not an entirely benign procedure. As Mickey M. Karram, MD, and an expert panel discuss in this article—the second of a two-part series—complications secondary to mesh placement can be a challenge to correct and often make life miserable for patients who experience them. Here, these experts address mesh erosion, extrusion, and other serious complications; discuss ways to prevent them; and offer strategies for managing them when they arise.

In Part 1, which appeared in the January 2009 issue of OBG Management, the panel discussed the increasing use of mesh in prolapse repair—in particular, the proliferation of mesh kits.

How common is erosion?

DR. KARRAM: The literature seems to indicate that, even in the best of hands, there is an extrusion, or erosion, rate of between 5% and 17% when mesh is used. Would you agree with this statistic?

DR. LUCENTE: Not completely. The vaginal exposure rate can be as low as 2%, as reported by our center and others, when the mesh is properly placed below all histologic layers of the vaginal wall, as it is when it is “delivered” to the pelvis via the transabdominal route.^1,2

At the other end of the scale, an exposure rate above 17% has been reported when mesh is improperly placed within the vaginal wall—that is, just below the mucosa, as some surgeons have described in the methodology section of their abstract or article.^3,4

THE OBG MANAGEMENT EXPERT PANEL

MICKEY M. KARRAM, MD, moderator, is Director of Urogynecology at Good Samaritan Hospital and Voluntary Professor of ObGyn at the University of Cincinnati School of Medicine in Cincinnati, Ohio.

SHLOMO RAZ, MD, is Professor of Urology and Chief of Pelvic Medicine and Reconstructive Urology at UCLA School of Medicine in Los Angeles.

VINCENT LUCENTE, MD, MBA, is Founder and Director of the Institute for Female Pelvic Medicine and Reconstructive Surgery in Allentown, Pa, and Clinical Professor of ObGyn at Temple University School of Medicine in Philadelphia.

MARK D. WALTERS, MD, is Professor and Vice Chair of Gynecology, Section of Urogynecology and Reconstructive Pelvic Surgery, Department of Obstetrics and Gynecology, at the Cleveland Clinic in Cleveland, Ohio.

We have found that complete, full-thickness dissection of the vaginal wall into the true pelvic space (vesicovaginal and rectovaginal), utilizing small vaginal incisions and limiting hysterectomy and the trimming of vaginal mucosa, can promote a very low vaginal-exposure rate.

DR. WALTERS: Some surgeons tell me that their own extrusion or erosion rate is lower than the published rate of 5% to 17%, but it is impossible to be certain of the long-term outcome in any patient unless she is followed carefully. The patient may consult another physician about her complications. The primary surgeon—even an expert—often does not know the actual mesh complication rate.

That said, I am sure that some surgeons are particularly adept at using mesh kits for prolapse repair, thereby keeping their mesh complication rate low. The 5% to 17% number is what most gynecologic surgeons should expect for their patients.

DR. RAZ: The complication rates are clearly underreported since very few centers of excellence report on complications and the majority of users don’t report them. Also, the reported complication rate concerns short-term erosion. I imagine that, as time passes and vaginal tissue becomes more atrophic, the incidence of erosion will increase.

Are simple measures enough to resolve erosion?

DR. KARRAM: There seems to be a general perception that most extrusions or erosions can be easily managed in the office by placing estrogen or trimming. In our experience, that approach has been successful in a minority of cases only.

What have you seen?

DR. WALTERS: At the Cleveland Clinic, as at most tertiary care referral centers, we often see the worst cases of extrusion or erosion related to mesh. Estrogen helps in some cases of simple mesh exposure, especially after sacrocolpopexy. If estrogen is going to be effective, however, the problem should clear up relatively quickly; if it isn’t effective after a month or two of therapy, estrogen is unlikely to ever be successful.

When it comes to related problems, such as ridges or strictures in the vagina, dyspareunia, penile pain with insertion, and vaginal burning pain, I have not found simple trimming and estrogen to be effective.

DR. KARRAM: It’s also unlikely that simple excision or placement of estrogen will be successful over the long term. When an extrusion or erosion occurs, we are generally seeing only the tip of the iceberg. That’s because mesh is placed in a certain plane. Although only part of the mesh may be exposed, the entire mesh is likely to be affected because it lies in the same plane.

Also, because of the special nature of vaginal flora, it is unlikely that a foreign body is going to be successfully managed by simple excision or placement of estrogen.

DR. LUCENTE: Management of vaginal exposure really depends on the size of the exposure, its location, and whether there is underlying infection or ischemia of host tissue. When the exposure is small (<1 cm in diameter) and in the midline, with the mesh lying flat below the plane of the vaginal wall, we have been very successful using a conservative approach.

However, even the tiniest of exposures needs to be surgically excised if it traverses the vaginal sulcus. Obviously, any mesh erosion into viscera such as the bladder and bowel also requires surgical intervention. Host-tissue factors always play a contributing role.

I also want to point out that the manner in which exposure is managed depends to some extent on whether the mesh was properly placed. Exposures that arise when mesh is implanted improperly are difficult to correct and usually require complete removal.

Although we, too, started off with an exposure rate around 8%, it is now very low, thanks to technical advancements.

DR. RAZ: A very small vaginal erosion of a mesh sling can sometimes be managed in the office by excision. The cases referred to our service generally involve more extensive areas of exposure that will not be resolved by local treatment.

Is risk of injury operator-dependent?

DR. KARRAM: We’re all seeing very severe complications secondary to mesh placement. Would each of you give your opinion as to whether the severe complications such as significant pain, dyspareunia, and injury of important structures are mostly technical or inherent to mesh placement. Would they happen in the best of hands?

DR. LUCENTE: The more severe complications, for the most part, are very much related to technique. Not that they cannot happen in the very best of hands, but they are extremely rare when technique is meticulous.

Over a 4-year period, after well over 1,000 transvaginal mesh surgeries at our center, we had no death, ICU admission, or transfusion, and our intraoperative complication rate was only 3%, most commonly involving simple cystotomy without long-term consequence. This compares very favorably to the nearly 12% complication rate reported recently in the CARE trial for abdominal sacral colpopexy.⁵

Our primary challenge today is preventing postoperative dyspareunia. Our rate of new-onset dyspareunia is approximately 3.5%. This complication is, I think, more likely to be related to the inherent material properties of mesh, such as elasticity and flexural rigidity, and to host-tissue response to the material itself.

DR. RAZ: I think that the majority of complications are operator-dependent. Thin dissection of the vaginal wall and unrecognized bladder, urethral, and vaginal perforation are the most common reasons for the complications. Mesh does not move after surgery; if there is a problem, it means that the mesh was misplaced.

Another problem is that industry, in an effort to sell more kits, is pushing physicians who are unfamiliar with the principles of pelvic reconstruction to perform this complex procedure. Repair of major vaginal prolapse is not a simple sling procedure.

In addition, there is a greater likelihood of complications in patients who have severe atrophic tissues. These patients should not be candidates for mesh reconstruction.

DR. WALTERS: Many of the complications that we see with mesh are certainly operator-dependent. For example, mesh that is placed under too much tension leaves the vagina tight and stiff, and mesh that is placed with ripples and ridges causes irregularities in the vagina that are often painful, especially during intercourse.

I do not believe that mesh “erodes” into the bladder, urethra, or rectum, but that it is placed there inadvertently and overlooked intraoperatively (FIGURES 1 and 2), Visceral erosion can occur if the primary surgeon made a cystotomy or proctotomy before proceeding with the mesh kit, and the mesh eventually wore through the repaired area.

There are also some problems that are inherent to mesh, and that occur even in the best hands and after surgeries that are performed very competently. Some mesh exposures are inevitable, as are some cases of dyspareunia and rare cases of vaginal burning and pain. In addition, I am seeing more de novo SUI [stress urinary incontinence] with anterior mesh kits. Although this is not really a complication, it does lead to dissatisfaction in patients and merits efforts to prevent it.

DR. KARRAM: Yes. With the current state of mesh, I believe pain and dyspareunia are almost inevitable in some cases.

DR. LUCENTE: Another problem that is currently underaddressed is scar plating along the surface of the mesh. Such plating forms more readily in the absence of mechanical movement or distention during the early stages of wound healing. To make a comparison, even the best reconstructive orthopedic surgeons cannot achieve optimal functional outcomes with an implant surgery without intense postoperative physical therapy, which may simply involve range of motion or movement.

Most everyone is familiar with the capsular fibrosis and contraction that develop around a breast implant if there isn’t immediate postoperative massaging of the breast tissue and implant during wound repair. I am confident that the rate of dyspareunia will decline over time if specialists in reconstructive pelvic surgery pay closer attention to optimizing vaginal length, preserving the cervix (in women with relatively shorter vaginal length), and ensuring optimal apical attachment (that is, above the ischial spine) in younger, sexually active patients.

DR. RAZ: I think it is the surgeon rather than the surgery who causes most complications. In its effort to sell kits, industry sometimes puts them in the hands of surgeons who are not well prepared for the task. This operation can be quite complex, and you cannot create a pelvic surgeon from a physician who is unfamiliar with the anatomy. If you cannot manage the potential complications, you should not perform this type of surgery.

FIGURE 1 When mesh “erodes” into the urethra

Two images of mesh in the urethra. There is some uncertainty here whether mesh that has penetrated the urethra eroded through vaginal tissue or was placed there inadvertently and overlooked intraoperatively.

FIGURE 2 Mesh in the bladder

A segment of tension-free vaginal tape has penetrated into the bladder.

Should mesh be removed at the time of injury?

DR. KARRAM: As we discuss specific complications, let’s start with the most severe, which I would say relate to the inadvertent placement of mesh through important structures such as bowel, bladder, or ureters. If this were to happen and be diagnosed intraoperatively, what would you recommend that the surgeon do—abort the procedure or simply remove the mesh or trocar and attempt to pass it again safely?

DR. LUCENTE: That is a difficult question to answer because so much depends on various intraoperative factors.

I am much more comfortable proceeding with surgery after intraoperative bladder injury than after bowel or rectal injury. We have successfully corrected cystotomies that were small, did not encroach on the ureter, and were easily repaired without tension—and we have seen no fistula formation as a result.

The key is to maintain a high index of suspicion throughout the procedure. We have always diagnosed injuries before mesh is delivered—either during dissection or during passage of the needle or trocar. We have not experienced any ureteral injuries aside from “kinking” of one ureter, which was easily corrected with simple readjustment of the mesh.

If, at any time, we were concerned about potential infection, fistula, or a more severe complication that would be aggravated by proceeding with the operation, we would abort the procedure. However, we would be likely to proceed with an alternative operation to address the pelvic-support defect so that the patient would not awaken with intraoperative injury and no surgical treatment for her primary complaint.

We conduct informed consent in such a way as to preserve our flexibility to adapt the surgical plan to execute the reparative work that is necessary despite the development of a non–life-threatening complication during surgery. In the event of any injury to the bowel that would involve gross spillage of fecal material, of course, I would abort placement of synthetic mesh.

DR. WALTERS: If I placed one of the trocars through the bladder or bowel, I would probably remove it, reposition it, and continue with the surgery. With bladder perforation, this approach is generally no problem, but I would usually leave a Foley catheter in place for 1 week of continuous bladder drainage.

If I placed the trocar through the rectum, I would probably oversew the proctotomy, irrigate the space, and continue with the mesh repair. If I had an outright laceration in the bladder or rectum as part of the dissection, I would repair it and consider converting the surgery to prolapse repair without mesh.

The most dreaded complication: the foreshortened vagina

DR. KARRAM: It would seem that the most difficult complication to deal with is the foreshortened, firm, painful vagina. A patient who has these problems may be perceived, at times, as a pelvic “cripple.” Is this an accepted, albeit rare, complication? Or can it be avoided?

DR. LUCENTE: This is the most feared complication arising from the use of synthetic mesh. I do believe it can almost always be avoided—but I never say never. The key is to pay full attention to considerations of vaginal length before surgery, including, first, preservation of the cervix, and, second, placing the mesh loosely, properly sized, and attached with optimization of apical support to preserve vaginal length.

I also believe that use of second-generation meshes that are lighter, more elastic, and more flexible helps reduce this complication when the mesh is properly placed by a surgeon well trained in the technique.

When the vagina is foreshortened, the sooner it is revised, the better the chance that pain will resolve, whether the mesh is removed or released.

DR. RAZ: Mesh infection, capsular formation, dissection of a thin vaginal wall, and excess vaginal-wall excision lead to the short, firm, and painful vagina. The use and abuse of mesh has created a new subspecialty to manage mesh complications. The PFS syndrome (painful, firm, and short vagina) is one of the most difficult complications to treat because, in many cases, it cannot be reversed without major surgery.

DR. WALTERS: Women who have a foreshortened, firm, or painful vagina after mesh augmentation almost always need to have the mesh removed with reconstruction of the vaginal canal. I have never seen a successful outcome in this type of patient without complete or near-complete removal of the mesh.

Hear Dr Phillips discuss the key points of this series

Vaginal placement of mesh for the correction of pelvic organ prolapse is not an entirely benign procedure. As Mickey M. Karram, MD, and an expert panel discuss in this article—the second of a two-part series—complications secondary to mesh placement can be a challenge to correct and often make life miserable for patients who experience them. Here, these experts address mesh erosion, extrusion, and other serious complications; discuss ways to prevent them; and offer strategies for managing them when they arise.

In Part 1, which appeared in the January 2009 issue of OBG Management, the panel discussed the increasing use of mesh in prolapse repair—in particular, the proliferation of mesh kits.

How common is erosion?

DR. KARRAM: The literature seems to indicate that, even in the best of hands, there is an extrusion, or erosion, rate of between 5% and 17% when mesh is used. Would you agree with this statistic?

DR. LUCENTE: Not completely. The vaginal exposure rate can be as low as 2%, as reported by our center and others, when the mesh is properly placed below all histologic layers of the vaginal wall, as it is when it is “delivered” to the pelvis via the transabdominal route.^1,2

At the other end of the scale, an exposure rate above 17% has been reported when mesh is improperly placed within the vaginal wall—that is, just below the mucosa, as some surgeons have described in the methodology section of their abstract or article.^3,4

THE OBG MANAGEMENT EXPERT PANEL

MICKEY M. KARRAM, MD, moderator, is Director of Urogynecology at Good Samaritan Hospital and Voluntary Professor of ObGyn at the University of Cincinnati School of Medicine in Cincinnati, Ohio.

SHLOMO RAZ, MD, is Professor of Urology and Chief of Pelvic Medicine and Reconstructive Urology at UCLA School of Medicine in Los Angeles.

VINCENT LUCENTE, MD, MBA, is Founder and Director of the Institute for Female Pelvic Medicine and Reconstructive Surgery in Allentown, Pa, and Clinical Professor of ObGyn at Temple University School of Medicine in Philadelphia.

MARK D. WALTERS, MD, is Professor and Vice Chair of Gynecology, Section of Urogynecology and Reconstructive Pelvic Surgery, Department of Obstetrics and Gynecology, at the Cleveland Clinic in Cleveland, Ohio.

We have found that complete, full-thickness dissection of the vaginal wall into the true pelvic space (vesicovaginal and rectovaginal), utilizing small vaginal incisions and limiting hysterectomy and the trimming of vaginal mucosa, can promote a very low vaginal-exposure rate.

DR. WALTERS: Some surgeons tell me that their own extrusion or erosion rate is lower than the published rate of 5% to 17%, but it is impossible to be certain of the long-term outcome in any patient unless she is followed carefully. The patient may consult another physician about her complications. The primary surgeon—even an expert—often does not know the actual mesh complication rate.

That said, I am sure that some surgeons are particularly adept at using mesh kits for prolapse repair, thereby keeping their mesh complication rate low. The 5% to 17% number is what most gynecologic surgeons should expect for their patients.

DR. RAZ: The complication rates are clearly underreported since very few centers of excellence report on complications and the majority of users don’t report them. Also, the reported complication rate concerns short-term erosion. I imagine that, as time passes and vaginal tissue becomes more atrophic, the incidence of erosion will increase.

Are simple measures enough to resolve erosion?

DR. KARRAM: There seems to be a general perception that most extrusions or erosions can be easily managed in the office by placing estrogen or trimming. In our experience, that approach has been successful in a minority of cases only.

What have you seen?

DR. WALTERS: At the Cleveland Clinic, as at most tertiary care referral centers, we often see the worst cases of extrusion or erosion related to mesh. Estrogen helps in some cases of simple mesh exposure, especially after sacrocolpopexy. If estrogen is going to be effective, however, the problem should clear up relatively quickly; if it isn’t effective after a month or two of therapy, estrogen is unlikely to ever be successful.

When it comes to related problems, such as ridges or strictures in the vagina, dyspareunia, penile pain with insertion, and vaginal burning pain, I have not found simple trimming and estrogen to be effective.

DR. KARRAM: It’s also unlikely that simple excision or placement of estrogen will be successful over the long term. When an extrusion or erosion occurs, we are generally seeing only the tip of the iceberg. That’s because mesh is placed in a certain plane. Although only part of the mesh may be exposed, the entire mesh is likely to be affected because it lies in the same plane.

Also, because of the special nature of vaginal flora, it is unlikely that a foreign body is going to be successfully managed by simple excision or placement of estrogen.

DR. LUCENTE: Management of vaginal exposure really depends on the size of the exposure, its location, and whether there is underlying infection or ischemia of host tissue. When the exposure is small (<1 cm in diameter) and in the midline, with the mesh lying flat below the plane of the vaginal wall, we have been very successful using a conservative approach.

However, even the tiniest of exposures needs to be surgically excised if it traverses the vaginal sulcus. Obviously, any mesh erosion into viscera such as the bladder and bowel also requires surgical intervention. Host-tissue factors always play a contributing role.

I also want to point out that the manner in which exposure is managed depends to some extent on whether the mesh was properly placed. Exposures that arise when mesh is implanted improperly are difficult to correct and usually require complete removal.

Although we, too, started off with an exposure rate around 8%, it is now very low, thanks to technical advancements.

DR. RAZ: A very small vaginal erosion of a mesh sling can sometimes be managed in the office by excision. The cases referred to our service generally involve more extensive areas of exposure that will not be resolved by local treatment.

Is risk of injury operator-dependent?

DR. KARRAM: We’re all seeing very severe complications secondary to mesh placement. Would each of you give your opinion as to whether the severe complications such as significant pain, dyspareunia, and injury of important structures are mostly technical or inherent to mesh placement. Would they happen in the best of hands?

DR. LUCENTE: The more severe complications, for the most part, are very much related to technique. Not that they cannot happen in the very best of hands, but they are extremely rare when technique is meticulous.

Over a 4-year period, after well over 1,000 transvaginal mesh surgeries at our center, we had no death, ICU admission, or transfusion, and our intraoperative complication rate was only 3%, most commonly involving simple cystotomy without long-term consequence. This compares very favorably to the nearly 12% complication rate reported recently in the CARE trial for abdominal sacral colpopexy.⁵

Our primary challenge today is preventing postoperative dyspareunia. Our rate of new-onset dyspareunia is approximately 3.5%. This complication is, I think, more likely to be related to the inherent material properties of mesh, such as elasticity and flexural rigidity, and to host-tissue response to the material itself.

DR. RAZ: I think that the majority of complications are operator-dependent. Thin dissection of the vaginal wall and unrecognized bladder, urethral, and vaginal perforation are the most common reasons for the complications. Mesh does not move after surgery; if there is a problem, it means that the mesh was misplaced.

Another problem is that industry, in an effort to sell more kits, is pushing physicians who are unfamiliar with the principles of pelvic reconstruction to perform this complex procedure. Repair of major vaginal prolapse is not a simple sling procedure.

In addition, there is a greater likelihood of complications in patients who have severe atrophic tissues. These patients should not be candidates for mesh reconstruction.

DR. WALTERS: Many of the complications that we see with mesh are certainly operator-dependent. For example, mesh that is placed under too much tension leaves the vagina tight and stiff, and mesh that is placed with ripples and ridges causes irregularities in the vagina that are often painful, especially during intercourse.

I do not believe that mesh “erodes” into the bladder, urethra, or rectum, but that it is placed there inadvertently and overlooked intraoperatively (FIGURES 1 and 2), Visceral erosion can occur if the primary surgeon made a cystotomy or proctotomy before proceeding with the mesh kit, and the mesh eventually wore through the repaired area.

There are also some problems that are inherent to mesh, and that occur even in the best hands and after surgeries that are performed very competently. Some mesh exposures are inevitable, as are some cases of dyspareunia and rare cases of vaginal burning and pain. In addition, I am seeing more de novo SUI [stress urinary incontinence] with anterior mesh kits. Although this is not really a complication, it does lead to dissatisfaction in patients and merits efforts to prevent it.

DR. KARRAM: Yes. With the current state of mesh, I believe pain and dyspareunia are almost inevitable in some cases.

DR. LUCENTE: Another problem that is currently underaddressed is scar plating along the surface of the mesh. Such plating forms more readily in the absence of mechanical movement or distention during the early stages of wound healing. To make a comparison, even the best reconstructive orthopedic surgeons cannot achieve optimal functional outcomes with an implant surgery without intense postoperative physical therapy, which may simply involve range of motion or movement.

Most everyone is familiar with the capsular fibrosis and contraction that develop around a breast implant if there isn’t immediate postoperative massaging of the breast tissue and implant during wound repair. I am confident that the rate of dyspareunia will decline over time if specialists in reconstructive pelvic surgery pay closer attention to optimizing vaginal length, preserving the cervix (in women with relatively shorter vaginal length), and ensuring optimal apical attachment (that is, above the ischial spine) in younger, sexually active patients.

DR. RAZ: I think it is the surgeon rather than the surgery who causes most complications. In its effort to sell kits, industry sometimes puts them in the hands of surgeons who are not well prepared for the task. This operation can be quite complex, and you cannot create a pelvic surgeon from a physician who is unfamiliar with the anatomy. If you cannot manage the potential complications, you should not perform this type of surgery.

FIGURE 1 When mesh “erodes” into the urethra

Two images of mesh in the urethra. There is some uncertainty here whether mesh that has penetrated the urethra eroded through vaginal tissue or was placed there inadvertently and overlooked intraoperatively.

FIGURE 2 Mesh in the bladder

A segment of tension-free vaginal tape has penetrated into the bladder.

Should mesh be removed at the time of injury?

DR. KARRAM: As we discuss specific complications, let’s start with the most severe, which I would say relate to the inadvertent placement of mesh through important structures such as bowel, bladder, or ureters. If this were to happen and be diagnosed intraoperatively, what would you recommend that the surgeon do—abort the procedure or simply remove the mesh or trocar and attempt to pass it again safely?

DR. LUCENTE: That is a difficult question to answer because so much depends on various intraoperative factors.

I am much more comfortable proceeding with surgery after intraoperative bladder injury than after bowel or rectal injury. We have successfully corrected cystotomies that were small, did not encroach on the ureter, and were easily repaired without tension—and we have seen no fistula formation as a result.

The key is to maintain a high index of suspicion throughout the procedure. We have always diagnosed injuries before mesh is delivered—either during dissection or during passage of the needle or trocar. We have not experienced any ureteral injuries aside from “kinking” of one ureter, which was easily corrected with simple readjustment of the mesh.

If, at any time, we were concerned about potential infection, fistula, or a more severe complication that would be aggravated by proceeding with the operation, we would abort the procedure. However, we would be likely to proceed with an alternative operation to address the pelvic-support defect so that the patient would not awaken with intraoperative injury and no surgical treatment for her primary complaint.

We conduct informed consent in such a way as to preserve our flexibility to adapt the surgical plan to execute the reparative work that is necessary despite the development of a non–life-threatening complication during surgery. In the event of any injury to the bowel that would involve gross spillage of fecal material, of course, I would abort placement of synthetic mesh.

DR. WALTERS: If I placed one of the trocars through the bladder or bowel, I would probably remove it, reposition it, and continue with the surgery. With bladder perforation, this approach is generally no problem, but I would usually leave a Foley catheter in place for 1 week of continuous bladder drainage.

If I placed the trocar through the rectum, I would probably oversew the proctotomy, irrigate the space, and continue with the mesh repair. If I had an outright laceration in the bladder or rectum as part of the dissection, I would repair it and consider converting the surgery to prolapse repair without mesh.

The most dreaded complication: the foreshortened vagina

DR. KARRAM: It would seem that the most difficult complication to deal with is the foreshortened, firm, painful vagina. A patient who has these problems may be perceived, at times, as a pelvic “cripple.” Is this an accepted, albeit rare, complication? Or can it be avoided?

DR. LUCENTE: This is the most feared complication arising from the use of synthetic mesh. I do believe it can almost always be avoided—but I never say never. The key is to pay full attention to considerations of vaginal length before surgery, including, first, preservation of the cervix, and, second, placing the mesh loosely, properly sized, and attached with optimization of apical support to preserve vaginal length.

I also believe that use of second-generation meshes that are lighter, more elastic, and more flexible helps reduce this complication when the mesh is properly placed by a surgeon well trained in the technique.

When the vagina is foreshortened, the sooner it is revised, the better the chance that pain will resolve, whether the mesh is removed or released.

DR. RAZ: Mesh infection, capsular formation, dissection of a thin vaginal wall, and excess vaginal-wall excision lead to the short, firm, and painful vagina. The use and abuse of mesh has created a new subspecialty to manage mesh complications. The PFS syndrome (painful, firm, and short vagina) is one of the most difficult complications to treat because, in many cases, it cannot be reversed without major surgery.

DR. WALTERS: Women who have a foreshortened, firm, or painful vagina after mesh augmentation almost always need to have the mesh removed with reconstruction of the vaginal canal. I have never seen a successful outcome in this type of patient without complete or near-complete removal of the mesh.

Dear Dr. Mossman:

When I was a resident, attending physicians occasionally cited journal articles in their consultation notes to substantiate their treatment choices. Since then, I’ve done this at times when I’ve prescribed a drug off-label.

Recently, I mentioned this practice to a physician who is trained as a lawyer. He thought citing articles in a patient’s chart was a bad idea, because by doing so I was automatically making the referred-to article the “expert witness.” If a lawsuit occurred, I might be called upon to justify the article’s validity, statistical details, methodology, etc. My intent is to show that I have a detailed, well-thought-out justification for my treatment choice.

Am I placing myself at greater risk of incurring liability should a lawsuit occur?—Submitted by “Dr. W”

Dr. W wants to know how he can minimize malpractice risk when prescribing a medication off label and wonders if citing an article in a patient’s chart is a good or bad idea. In law school, attorneys-in-training learn to answer very general legal questions with, “It depends.” There’s little certainty about how to avoid successful malpractice litigation, because few if any strategies have been tested systematically. However, this article will explain—and hopefully help you avoid—the medicolegal pitfalls of off-label prescribing.

Off-label: ‘Accepted and necessary’

Off-label prescribing occurs when a physician prescribes a medication or uses a medical device outside the scope of FDA-approved labeling. Most commonly, off-label use involves prescribing a medication for something other than its FDA-approved indication—such as sildenafil for women with antidepressant-induced sexual dysfunction.¹

Other examples are prescribing a drug:

• at an unapproved dose
• in an unapproved format, such as mixing capsule contents with applesauce
• outside the approved age group
• for longer than the approved interval
• at a different dose schedule, such as qhs instead of bid or tid.

Typically, it takes years for a new drug to gain FDA approval and additional time for an already-approved drug to gain approval for a new indication. In the mean-time, clinicians treat their patients with available drugs prescribed off-label.

Off-label prescribing is legal. FDA approval means drugs may be sold and marketed in specific ways, but the FDA does not tell physicians how they can use approved drugs. As each edition of the Physicians’ Desk Reference explains, “Once a product has been approved for marketing, a physician may prescribe it for uses or in treatment regimens or patient populations that are not included in approved labeling.”² Federal statutes state that FDA approval does not “limit or interfere with the authority of a health care practitioner to prescribe” approved drugs or devices “for any condition or disease.”³

Courts endorse off-label prescribing. As 1 appellate decision states, “Because the pace of medical discovery runs ahead of the FDA’s regulatory machinery, the off-label use of some drugs is frequently considered to be ‘state-of-the-art’ treatment.”⁴ The U.S. Supreme Court has concluded that off-label prescribing “is an accepted and necessary corollary of the FDA’s mission to regulate.”⁵

Box

Is off-label use malpractice?

Off-label use is not only legal, it’s often wise medical practice. Many drug uses that now have FDA approval were off-label just a few years ago. Examples include using selective serotonin reuptake inhibitors (SSRIs) to treat panic disorder and obsessive-compulsive disorder and valproate for bipolar mania. Though fluoxetine is the only FDA-approved drug for treating depression in adolescents, other SSRIs may have a favorable risk-benefit profile.⁶

Numerous studies have shown that off-label prescribing is common in psychiatry⁷ and other specialties.^8,9 Because the practice is so common, the mere fact that a drug is not FDA-approved for a particular use does not imply that the drug was prescribed negligently.

Are patients human guinea pigs?

Some commentators have suggested that off-label prescribing amounts to human experimentation.¹⁰ Without FDA approval, they say physicians lack “hard evidence” that a product is safe and effective, so off-label prescribing is a small-scale clinical trial based on the doctor’s educated guesses. If this reasoning is correct, off-label prescribing would require the same human subject protections used in research, including institution review board approval and special consent forms.

Although this argument sounds plausible, off-label prescribing is not experimentation or research (Box).^4,11-19 Researchers investigate hypotheses to obtain generalizable knowledge, whereas medical therapy aims to benefit individual patients. This experimentation/therapy distinction is not perfect because successful off-label treatment of 1 patient might imply beneficial effects for others.¹⁰ When courts have looked at this matter, though, they have found that “off-label use…by a physician seeking an optimal treatment for his or her patient is not necessarily…research or an investigational or experimental treatment when the use is customarily followed by physicians.”⁴

Courts also have said that off-label use does not require special informed consent. Just because a drug is prescribed off-label doesn’t mean it’s risky. FDA approval “is not a material risk inherently involved in a proposed therapy which a physician should have disclosed to a patient prior to the therapy.”²⁰ In other words, a physician is not required to discuss FDA regulatory status—such as off-label uses of a medication—to comply with standards of informed consent. FDA regulatory status has nothing to do with the risks or benefits of a medication and it does not provide information about treatment alternatives.²¹

What should you do?

Keep abreast of news and scientific evidence concerning drug uses, effects, interactions, and adverse effects, especially when prescribing for uses that are different from the manufacturer’s intended purposes (such as hormone therapy for sex offenders).²²

Collect articles on off-label uses, but keep them separate from your patients’ files. Good attorneys are highly skilled at using documents to score legal points, and opposing counsel will prepare questions to focus on the articles’ faults or limitations in isolation.

Know why an article applies to your patient. If you are sued for malpractice, you can use an article to support your treatment choice by explaining how this information contributed to your decision-making.

Tell your patient that the proposed treatment is an off-label use when you obtain consent, even though case law says you don’t have to do this. Telling your patient helps him understand your reasoning and prevents surprises that may give offense. For example, if you prescribe a second-generation antipsychotic for a nonpsychotic patient, you wouldn’t want your patient to think you believe he has schizophrenia when he reads the information his pharmacy attaches to his prescription.

Engage in ongoing informed consent. Uncertainty is part of medical practice and is heightened when doctors prescribe off-label. Ongoing discussions help patients understand, accept, and share that uncertainty.

Document informed consent. This will show—if it becomes necessary—that you and your patient made collaborative, conscientious decisions about treatment.²³

Related resources

• Zito JM, Derivan AT, Kratochvil CJ, et al. Off-label psychopharmacologic prescribing for children: history supports close clinical monitoring. Child Adolesc Psychiatry Ment Health. 2008;2:24. www.capmh.com/content/pdf/1753-2000-2-24.pdf.
• Spiesel S. Prozac on the playground. October 15, 2008. Slate. www.slate.com/id/2202338.

Drug brand names

• Fenfluramine and phentermine • Fen-phen
• Fluoxetine • Prozac
• Sildenafil • Viagra
• Valproate • Depakote

Dear Dr. Mossman:

When I was a resident, attending physicians occasionally cited journal articles in their consultation notes to substantiate their treatment choices. Since then, I’ve done this at times when I’ve prescribed a drug off-label.

Recently, I mentioned this practice to a physician who is trained as a lawyer. He thought citing articles in a patient’s chart was a bad idea, because by doing so I was automatically making the referred-to article the “expert witness.” If a lawsuit occurred, I might be called upon to justify the article’s validity, statistical details, methodology, etc. My intent is to show that I have a detailed, well-thought-out justification for my treatment choice.

Am I placing myself at greater risk of incurring liability should a lawsuit occur?—Submitted by “Dr. W”

Dr. W wants to know how he can minimize malpractice risk when prescribing a medication off label and wonders if citing an article in a patient’s chart is a good or bad idea. In law school, attorneys-in-training learn to answer very general legal questions with, “It depends.” There’s little certainty about how to avoid successful malpractice litigation, because few if any strategies have been tested systematically. However, this article will explain—and hopefully help you avoid—the medicolegal pitfalls of off-label prescribing.

Off-label: ‘Accepted and necessary’

Off-label prescribing occurs when a physician prescribes a medication or uses a medical device outside the scope of FDA-approved labeling. Most commonly, off-label use involves prescribing a medication for something other than its FDA-approved indication—such as sildenafil for women with antidepressant-induced sexual dysfunction.¹

Other examples are prescribing a drug:

• at an unapproved dose
• in an unapproved format, such as mixing capsule contents with applesauce
• outside the approved age group
• for longer than the approved interval
• at a different dose schedule, such as qhs instead of bid or tid.

Typically, it takes years for a new drug to gain FDA approval and additional time for an already-approved drug to gain approval for a new indication. In the mean-time, clinicians treat their patients with available drugs prescribed off-label.

Off-label prescribing is legal. FDA approval means drugs may be sold and marketed in specific ways, but the FDA does not tell physicians how they can use approved drugs. As each edition of the Physicians’ Desk Reference explains, “Once a product has been approved for marketing, a physician may prescribe it for uses or in treatment regimens or patient populations that are not included in approved labeling.”² Federal statutes state that FDA approval does not “limit or interfere with the authority of a health care practitioner to prescribe” approved drugs or devices “for any condition or disease.”³

Courts endorse off-label prescribing. As 1 appellate decision states, “Because the pace of medical discovery runs ahead of the FDA’s regulatory machinery, the off-label use of some drugs is frequently considered to be ‘state-of-the-art’ treatment.”⁴ The U.S. Supreme Court has concluded that off-label prescribing “is an accepted and necessary corollary of the FDA’s mission to regulate.”⁵

Box

Is off-label use malpractice?

Off-label use is not only legal, it’s often wise medical practice. Many drug uses that now have FDA approval were off-label just a few years ago. Examples include using selective serotonin reuptake inhibitors (SSRIs) to treat panic disorder and obsessive-compulsive disorder and valproate for bipolar mania. Though fluoxetine is the only FDA-approved drug for treating depression in adolescents, other SSRIs may have a favorable risk-benefit profile.⁶

Numerous studies have shown that off-label prescribing is common in psychiatry⁷ and other specialties.^8,9 Because the practice is so common, the mere fact that a drug is not FDA-approved for a particular use does not imply that the drug was prescribed negligently.

Are patients human guinea pigs?

Some commentators have suggested that off-label prescribing amounts to human experimentation.¹⁰ Without FDA approval, they say physicians lack “hard evidence” that a product is safe and effective, so off-label prescribing is a small-scale clinical trial based on the doctor’s educated guesses. If this reasoning is correct, off-label prescribing would require the same human subject protections used in research, including institution review board approval and special consent forms.

Although this argument sounds plausible, off-label prescribing is not experimentation or research (Box).^4,11-19 Researchers investigate hypotheses to obtain generalizable knowledge, whereas medical therapy aims to benefit individual patients. This experimentation/therapy distinction is not perfect because successful off-label treatment of 1 patient might imply beneficial effects for others.¹⁰ When courts have looked at this matter, though, they have found that “off-label use…by a physician seeking an optimal treatment for his or her patient is not necessarily…research or an investigational or experimental treatment when the use is customarily followed by physicians.”⁴

Courts also have said that off-label use does not require special informed consent. Just because a drug is prescribed off-label doesn’t mean it’s risky. FDA approval “is not a material risk inherently involved in a proposed therapy which a physician should have disclosed to a patient prior to the therapy.”²⁰ In other words, a physician is not required to discuss FDA regulatory status—such as off-label uses of a medication—to comply with standards of informed consent. FDA regulatory status has nothing to do with the risks or benefits of a medication and it does not provide information about treatment alternatives.²¹

What should you do?

Keep abreast of news and scientific evidence concerning drug uses, effects, interactions, and adverse effects, especially when prescribing for uses that are different from the manufacturer’s intended purposes (such as hormone therapy for sex offenders).²²

Collect articles on off-label uses, but keep them separate from your patients’ files. Good attorneys are highly skilled at using documents to score legal points, and opposing counsel will prepare questions to focus on the articles’ faults or limitations in isolation.

Know why an article applies to your patient. If you are sued for malpractice, you can use an article to support your treatment choice by explaining how this information contributed to your decision-making.

Tell your patient that the proposed treatment is an off-label use when you obtain consent, even though case law says you don’t have to do this. Telling your patient helps him understand your reasoning and prevents surprises that may give offense. For example, if you prescribe a second-generation antipsychotic for a nonpsychotic patient, you wouldn’t want your patient to think you believe he has schizophrenia when he reads the information his pharmacy attaches to his prescription.

Engage in ongoing informed consent. Uncertainty is part of medical practice and is heightened when doctors prescribe off-label. Ongoing discussions help patients understand, accept, and share that uncertainty.

Document informed consent. This will show—if it becomes necessary—that you and your patient made collaborative, conscientious decisions about treatment.²³

Related resources

• Zito JM, Derivan AT, Kratochvil CJ, et al. Off-label psychopharmacologic prescribing for children: history supports close clinical monitoring. Child Adolesc Psychiatry Ment Health. 2008;2:24. www.capmh.com/content/pdf/1753-2000-2-24.pdf.
• Spiesel S. Prozac on the playground. October 15, 2008. Slate. www.slate.com/id/2202338.

Drug brand names

• Fenfluramine and phentermine • Fen-phen
• Fluoxetine • Prozac
• Sildenafil • Viagra
• Valproate • Depakote

Dear Dr. Mossman:

When I was a resident, attending physicians occasionally cited journal articles in their consultation notes to substantiate their treatment choices. Since then, I’ve done this at times when I’ve prescribed a drug off-label.

Recently, I mentioned this practice to a physician who is trained as a lawyer. He thought citing articles in a patient’s chart was a bad idea, because by doing so I was automatically making the referred-to article the “expert witness.” If a lawsuit occurred, I might be called upon to justify the article’s validity, statistical details, methodology, etc. My intent is to show that I have a detailed, well-thought-out justification for my treatment choice.

Am I placing myself at greater risk of incurring liability should a lawsuit occur?—Submitted by “Dr. W”

Dr. W wants to know how he can minimize malpractice risk when prescribing a medication off label and wonders if citing an article in a patient’s chart is a good or bad idea. In law school, attorneys-in-training learn to answer very general legal questions with, “It depends.” There’s little certainty about how to avoid successful malpractice litigation, because few if any strategies have been tested systematically. However, this article will explain—and hopefully help you avoid—the medicolegal pitfalls of off-label prescribing.

Off-label: ‘Accepted and necessary’

Off-label prescribing occurs when a physician prescribes a medication or uses a medical device outside the scope of FDA-approved labeling. Most commonly, off-label use involves prescribing a medication for something other than its FDA-approved indication—such as sildenafil for women with antidepressant-induced sexual dysfunction.¹

Other examples are prescribing a drug:

• at an unapproved dose
• in an unapproved format, such as mixing capsule contents with applesauce
• outside the approved age group
• for longer than the approved interval
• at a different dose schedule, such as qhs instead of bid or tid.

Typically, it takes years for a new drug to gain FDA approval and additional time for an already-approved drug to gain approval for a new indication. In the mean-time, clinicians treat their patients with available drugs prescribed off-label.

Off-label prescribing is legal. FDA approval means drugs may be sold and marketed in specific ways, but the FDA does not tell physicians how they can use approved drugs. As each edition of the Physicians’ Desk Reference explains, “Once a product has been approved for marketing, a physician may prescribe it for uses or in treatment regimens or patient populations that are not included in approved labeling.”² Federal statutes state that FDA approval does not “limit or interfere with the authority of a health care practitioner to prescribe” approved drugs or devices “for any condition or disease.”³

Courts endorse off-label prescribing. As 1 appellate decision states, “Because the pace of medical discovery runs ahead of the FDA’s regulatory machinery, the off-label use of some drugs is frequently considered to be ‘state-of-the-art’ treatment.”⁴ The U.S. Supreme Court has concluded that off-label prescribing “is an accepted and necessary corollary of the FDA’s mission to regulate.”⁵

Box

Is off-label use malpractice?

Off-label use is not only legal, it’s often wise medical practice. Many drug uses that now have FDA approval were off-label just a few years ago. Examples include using selective serotonin reuptake inhibitors (SSRIs) to treat panic disorder and obsessive-compulsive disorder and valproate for bipolar mania. Though fluoxetine is the only FDA-approved drug for treating depression in adolescents, other SSRIs may have a favorable risk-benefit profile.⁶

Numerous studies have shown that off-label prescribing is common in psychiatry⁷ and other specialties.^8,9 Because the practice is so common, the mere fact that a drug is not FDA-approved for a particular use does not imply that the drug was prescribed negligently.

Are patients human guinea pigs?

Some commentators have suggested that off-label prescribing amounts to human experimentation.¹⁰ Without FDA approval, they say physicians lack “hard evidence” that a product is safe and effective, so off-label prescribing is a small-scale clinical trial based on the doctor’s educated guesses. If this reasoning is correct, off-label prescribing would require the same human subject protections used in research, including institution review board approval and special consent forms.

Although this argument sounds plausible, off-label prescribing is not experimentation or research (Box).^4,11-19 Researchers investigate hypotheses to obtain generalizable knowledge, whereas medical therapy aims to benefit individual patients. This experimentation/therapy distinction is not perfect because successful off-label treatment of 1 patient might imply beneficial effects for others.¹⁰ When courts have looked at this matter, though, they have found that “off-label use…by a physician seeking an optimal treatment for his or her patient is not necessarily…research or an investigational or experimental treatment when the use is customarily followed by physicians.”⁴

Courts also have said that off-label use does not require special informed consent. Just because a drug is prescribed off-label doesn’t mean it’s risky. FDA approval “is not a material risk inherently involved in a proposed therapy which a physician should have disclosed to a patient prior to the therapy.”²⁰ In other words, a physician is not required to discuss FDA regulatory status—such as off-label uses of a medication—to comply with standards of informed consent. FDA regulatory status has nothing to do with the risks or benefits of a medication and it does not provide information about treatment alternatives.²¹

What should you do?

Keep abreast of news and scientific evidence concerning drug uses, effects, interactions, and adverse effects, especially when prescribing for uses that are different from the manufacturer’s intended purposes (such as hormone therapy for sex offenders).²²

Collect articles on off-label uses, but keep them separate from your patients’ files. Good attorneys are highly skilled at using documents to score legal points, and opposing counsel will prepare questions to focus on the articles’ faults or limitations in isolation.

Know why an article applies to your patient. If you are sued for malpractice, you can use an article to support your treatment choice by explaining how this information contributed to your decision-making.

Tell your patient that the proposed treatment is an off-label use when you obtain consent, even though case law says you don’t have to do this. Telling your patient helps him understand your reasoning and prevents surprises that may give offense. For example, if you prescribe a second-generation antipsychotic for a nonpsychotic patient, you wouldn’t want your patient to think you believe he has schizophrenia when he reads the information his pharmacy attaches to his prescription.

Engage in ongoing informed consent. Uncertainty is part of medical practice and is heightened when doctors prescribe off-label. Ongoing discussions help patients understand, accept, and share that uncertainty.

Document informed consent. This will show—if it becomes necessary—that you and your patient made collaborative, conscientious decisions about treatment.²³

Related resources

• Zito JM, Derivan AT, Kratochvil CJ, et al. Off-label psychopharmacologic prescribing for children: history supports close clinical monitoring. Child Adolesc Psychiatry Ment Health. 2008;2:24. www.capmh.com/content/pdf/1753-2000-2-24.pdf.
• Spiesel S. Prozac on the playground. October 15, 2008. Slate. www.slate.com/id/2202338.

Drug brand names

• Fenfluramine and phentermine • Fen-phen
• Fluoxetine • Prozac
• Sildenafil • Viagra
• Valproate • Depakote

Mass casualty incidents (MCIs), such as the landing of a US Airways jetliner in New York City's frigid Hudson River, showcase the role hospitalists can play in an ED scrambling to handle a triage scenario.

When the Airbus A320 and its 155 passengers crashed Jan. 15, New York and New Jersey hospitals braced for incoming patients. However, reports showed only a few dozen passengers were treated—the most serious for a fractured leg. Still, at Jersey City (N.J.) Medical Center (JCMC), eight victims brought to the ED meant half a dozen patients had to be discharged to make room.

"The hospitalists were involved only on the periphery this time, as we initially needed their approval to move patients out in anticipation of mass casualties," Douglas Ratner, MD, chairman and program director of JCMC's Department of Medicine, wrote in an e-mail. "They will be integral in future endeavors like this."

To that end, some hospitalists used the "Miracle on the Hudson" as a rallying cry for more training.

"How many of us have gone through rigorous teamwork training to learn to better communicate with our 'cabinmates' during times of stress? Remarkably few," Robert Wachter, MD, a hospitalist as well as a professor and associate chairman of the University of California at San Francisco’s department of medicine, wrote on his blog (the-hospitalist.org/blogs). "How often do we need to demonstrate our continued competency in our specialty? For most board-certified physicians, about every 10 years (up from 'never' 20 years ago). And how well do we learn from our errors? Well, never mind."

Mass casualty incidents (MCIs), such as the landing of a US Airways jetliner in New York City's frigid Hudson River, showcase the role hospitalists can play in an ED scrambling to handle a triage scenario.

When the Airbus A320 and its 155 passengers crashed Jan. 15, New York and New Jersey hospitals braced for incoming patients. However, reports showed only a few dozen passengers were treated—the most serious for a fractured leg. Still, at Jersey City (N.J.) Medical Center (JCMC), eight victims brought to the ED meant half a dozen patients had to be discharged to make room.

"The hospitalists were involved only on the periphery this time, as we initially needed their approval to move patients out in anticipation of mass casualties," Douglas Ratner, MD, chairman and program director of JCMC's Department of Medicine, wrote in an e-mail. "They will be integral in future endeavors like this."

To that end, some hospitalists used the "Miracle on the Hudson" as a rallying cry for more training.

"How many of us have gone through rigorous teamwork training to learn to better communicate with our 'cabinmates' during times of stress? Remarkably few," Robert Wachter, MD, a hospitalist as well as a professor and associate chairman of the University of California at San Francisco’s department of medicine, wrote on his blog (the-hospitalist.org/blogs). "How often do we need to demonstrate our continued competency in our specialty? For most board-certified physicians, about every 10 years (up from 'never' 20 years ago). And how well do we learn from our errors? Well, never mind."

Mass casualty incidents (MCIs), such as the landing of a US Airways jetliner in New York City's frigid Hudson River, showcase the role hospitalists can play in an ED scrambling to handle a triage scenario.

When the Airbus A320 and its 155 passengers crashed Jan. 15, New York and New Jersey hospitals braced for incoming patients. However, reports showed only a few dozen passengers were treated—the most serious for a fractured leg. Still, at Jersey City (N.J.) Medical Center (JCMC), eight victims brought to the ED meant half a dozen patients had to be discharged to make room.

"The hospitalists were involved only on the periphery this time, as we initially needed their approval to move patients out in anticipation of mass casualties," Douglas Ratner, MD, chairman and program director of JCMC's Department of Medicine, wrote in an e-mail. "They will be integral in future endeavors like this."

To that end, some hospitalists used the "Miracle on the Hudson" as a rallying cry for more training.

"How many of us have gone through rigorous teamwork training to learn to better communicate with our 'cabinmates' during times of stress? Remarkably few," Robert Wachter, MD, a hospitalist as well as a professor and associate chairman of the University of California at San Francisco’s department of medicine, wrote on his blog (the-hospitalist.org/blogs). "How often do we need to demonstrate our continued competency in our specialty? For most board-certified physicians, about every 10 years (up from 'never' 20 years ago). And how well do we learn from our errors? Well, never mind."

Too busy rounding on patients to keep up with the blogosphere? We're doing the surfing for you in this first monthly roundup of what your colleagues are buzzing about in cyberspace.

First up: The Happy Hospitalist, who was not happy about Medco CEO Dave Snow's support of treatment protocols, had the following to say last week: "This guy doesn't get it. Cookbook medicine is but a tiny fraction of care. Perhaps 5% or less. I can admit a hemorrhagic stroke, follow standardized protocols, and the next 10 patients will have 10 different permutations of care. I can follow the guidelines to a T and every single patient's comorbid conditions will add layers upon layers of complication to the management."

On SHM's Hospitalist Leader blog, former SHM CEO Rusty Holman touched upon another frustration in the workplace: New hires who complain that "this isn't what I signed up for." Dr. Holman’s advice? When hiring explain that "the job you take today is likely— no, is certain— to be different a year from now." Dr. Holman assures practice managers that "as a leader, you will never be faulted for telling the truth."

Speaking of leaders, Health Beat's Maggie Mahar offered her thoughts on President Obama's inauguration speech: "When President Obama said, 'The time has come to put away childish things,' I couldn't help but recall healthcare reformer Don Berwick, sounding discouraged last winter, as he said, 'Maybe this country just isn't mature enough for healthcare reform.' Berwick, who is the president of the Institute for Healthcare Improvement, was referring to the fact that at times, it seems that everyone wants healthcare for all— but no one wants to pay for it."

Too busy rounding on patients to keep up with the blogosphere? We're doing the surfing for you in this first monthly roundup of what your colleagues are buzzing about in cyberspace.

First up: The Happy Hospitalist, who was not happy about Medco CEO Dave Snow's support of treatment protocols, had the following to say last week: "This guy doesn't get it. Cookbook medicine is but a tiny fraction of care. Perhaps 5% or less. I can admit a hemorrhagic stroke, follow standardized protocols, and the next 10 patients will have 10 different permutations of care. I can follow the guidelines to a T and every single patient's comorbid conditions will add layers upon layers of complication to the management."

On SHM's Hospitalist Leader blog, former SHM CEO Rusty Holman touched upon another frustration in the workplace: New hires who complain that "this isn't what I signed up for." Dr. Holman’s advice? When hiring explain that "the job you take today is likely— no, is certain— to be different a year from now." Dr. Holman assures practice managers that "as a leader, you will never be faulted for telling the truth."

Speaking of leaders, Health Beat's Maggie Mahar offered her thoughts on President Obama's inauguration speech: "When President Obama said, 'The time has come to put away childish things,' I couldn't help but recall healthcare reformer Don Berwick, sounding discouraged last winter, as he said, 'Maybe this country just isn't mature enough for healthcare reform.' Berwick, who is the president of the Institute for Healthcare Improvement, was referring to the fact that at times, it seems that everyone wants healthcare for all— but no one wants to pay for it."

Too busy rounding on patients to keep up with the blogosphere? We're doing the surfing for you in this first monthly roundup of what your colleagues are buzzing about in cyberspace.

First up: The Happy Hospitalist, who was not happy about Medco CEO Dave Snow's support of treatment protocols, had the following to say last week: "This guy doesn't get it. Cookbook medicine is but a tiny fraction of care. Perhaps 5% or less. I can admit a hemorrhagic stroke, follow standardized protocols, and the next 10 patients will have 10 different permutations of care. I can follow the guidelines to a T and every single patient's comorbid conditions will add layers upon layers of complication to the management."

On SHM's Hospitalist Leader blog, former SHM CEO Rusty Holman touched upon another frustration in the workplace: New hires who complain that "this isn't what I signed up for." Dr. Holman’s advice? When hiring explain that "the job you take today is likely— no, is certain— to be different a year from now." Dr. Holman assures practice managers that "as a leader, you will never be faulted for telling the truth."

Speaking of leaders, Health Beat's Maggie Mahar offered her thoughts on President Obama's inauguration speech: "When President Obama said, 'The time has come to put away childish things,' I couldn't help but recall healthcare reformer Don Berwick, sounding discouraged last winter, as he said, 'Maybe this country just isn't mature enough for healthcare reform.' Berwick, who is the president of the Institute for Healthcare Improvement, was referring to the fact that at times, it seems that everyone wants healthcare for all— but no one wants to pay for it."

New data from the American Hospital Association (AHA) showing hospitalists number 23,000 and now practice in 4 out of 5 large hospitals drew the same response from doctors and administrators alike: We know.

"I don’t think a hospitalist program is optional," says Mark Larey, MD, vice president of medical affairs at St. Joseph's Mercy Health Center in Hot Springs, Ark. "In today’s environment, due to the regulatory issues, trying to improve patient satisfaction, trying to manage the increased unassigned population, it would be increasingly difficult to keep everything balanced … without a hospitalist service."

Dr. Larey's 309-bed hospital has a team of five internists and one nurse practitioner, and is adding a sixth full-time position this fall to absorb increased stress on the emergency department. The situation is typical of the exponential growth of the industry since it started in 1996 with as few as 500 hospitalists, says Larry Wellikson, MD, CEO of SHM.

In many hospitals, hospital medicine has become a quality-care necessity—one that increases satisfaction scores, trims length of stay, and increases emergency-room throughputs, Dr. Wellikson says. AHA figures culled from the 2007 survey of nearly 5,000 community hospitals show that at hospitals with 200 or more beds, 83% have hospital medicine programs. SHM estimates the current hospitalist workforce at 29,000.

"It took emergency medicine 25, 30 years to get to the point hospital medicine got to in 10 years," Dr. Wellikson says. "It’s the growth of a specialty on steroids."

For more information, visit http://www.aha.org/aha/research-and-trends/health-and-hospital-trends/2008.html.

New data from the American Hospital Association (AHA) showing hospitalists number 23,000 and now practice in 4 out of 5 large hospitals drew the same response from doctors and administrators alike: We know.

"I don’t think a hospitalist program is optional," says Mark Larey, MD, vice president of medical affairs at St. Joseph's Mercy Health Center in Hot Springs, Ark. "In today’s environment, due to the regulatory issues, trying to improve patient satisfaction, trying to manage the increased unassigned population, it would be increasingly difficult to keep everything balanced … without a hospitalist service."

Dr. Larey's 309-bed hospital has a team of five internists and one nurse practitioner, and is adding a sixth full-time position this fall to absorb increased stress on the emergency department. The situation is typical of the exponential growth of the industry since it started in 1996 with as few as 500 hospitalists, says Larry Wellikson, MD, CEO of SHM.

In many hospitals, hospital medicine has become a quality-care necessity—one that increases satisfaction scores, trims length of stay, and increases emergency-room throughputs, Dr. Wellikson says. AHA figures culled from the 2007 survey of nearly 5,000 community hospitals show that at hospitals with 200 or more beds, 83% have hospital medicine programs. SHM estimates the current hospitalist workforce at 29,000.

"It took emergency medicine 25, 30 years to get to the point hospital medicine got to in 10 years," Dr. Wellikson says. "It’s the growth of a specialty on steroids."

For more information, visit http://www.aha.org/aha/research-and-trends/health-and-hospital-trends/2008.html.

New data from the American Hospital Association (AHA) showing hospitalists number 23,000 and now practice in 4 out of 5 large hospitals drew the same response from doctors and administrators alike: We know.

"I don’t think a hospitalist program is optional," says Mark Larey, MD, vice president of medical affairs at St. Joseph's Mercy Health Center in Hot Springs, Ark. "In today’s environment, due to the regulatory issues, trying to improve patient satisfaction, trying to manage the increased unassigned population, it would be increasingly difficult to keep everything balanced … without a hospitalist service."

Dr. Larey's 309-bed hospital has a team of five internists and one nurse practitioner, and is adding a sixth full-time position this fall to absorb increased stress on the emergency department. The situation is typical of the exponential growth of the industry since it started in 1996 with as few as 500 hospitalists, says Larry Wellikson, MD, CEO of SHM.

In many hospitals, hospital medicine has become a quality-care necessity—one that increases satisfaction scores, trims length of stay, and increases emergency-room throughputs, Dr. Wellikson says. AHA figures culled from the 2007 survey of nearly 5,000 community hospitals show that at hospitals with 200 or more beds, 83% have hospital medicine programs. SHM estimates the current hospitalist workforce at 29,000.

"It took emergency medicine 25, 30 years to get to the point hospital medicine got to in 10 years," Dr. Wellikson says. "It’s the growth of a specialty on steroids."

For more information, visit http://www.aha.org/aha/research-and-trends/health-and-hospital-trends/2008.html.

Question: Can a D-dimer level assess the risk of recurrent venous thromboembolism (VTE) after a course of anticoagulation therapy has been completed?

Background: The duration of anticoagulation therapy for first unprovoked VTE is uncertain. Identifying risk of recurrent VTE will help clinicians make decisions on optimal duration of anticoagulation.

Study design: Systematic review and meta-analysis.

Setting: Patients who have completed therapy for an episode of VTE without known risks.

Synopsis: Seven high-quality studies totaling 1,888 patients with first unprovoked VTE were analyzed. All patients received standardized therapy for at least three months with warfarin (Coumadin). A D-dimer had been checked in all patients between three and six weeks after stopping anticoagulation. The annual rate of VTE recurrence among patients with a positive D-dimer result was 8.9% (confidence interval (CI), 5.8% to 11.9%) compared with 3.5% (CI, 2.7 to 4.3%) for those with a negative result.

False-positive or false-negative D-dimer results could have occurred due to the heterogeneity in duration of anticoagulation and timing of D-dimer testing among the various studies. Since none of the studies were blinded to a history of VTE, there is potential for outcome ascertainment bias due to studying a sample deemed susceptible to disease recurrence.

Bottom line: D-dimer testing holds promise in identifying risk of VTE recurrence and could aid therapeutic decision-making regarding duration of anticoagulation.

Citation: Ann Intern Med. 2008;149:481-490

–Reviewed for the eWire by Rebecca Allyn, MD, Smitha Chadaga, MD, Mary Dedecker, MD, Vignesh Narayanan, MD, Eugene S. Chu, MD, Division of Hospital Medicine, Denver Health and Hospital Authority

Question: Can a D-dimer level assess the risk of recurrent venous thromboembolism (VTE) after a course of anticoagulation therapy has been completed?

Background: The duration of anticoagulation therapy for first unprovoked VTE is uncertain. Identifying risk of recurrent VTE will help clinicians make decisions on optimal duration of anticoagulation.

Study design: Systematic review and meta-analysis.

Setting: Patients who have completed therapy for an episode of VTE without known risks.

Synopsis: Seven high-quality studies totaling 1,888 patients with first unprovoked VTE were analyzed. All patients received standardized therapy for at least three months with warfarin (Coumadin). A D-dimer had been checked in all patients between three and six weeks after stopping anticoagulation. The annual rate of VTE recurrence among patients with a positive D-dimer result was 8.9% (confidence interval (CI), 5.8% to 11.9%) compared with 3.5% (CI, 2.7 to 4.3%) for those with a negative result.

False-positive or false-negative D-dimer results could have occurred due to the heterogeneity in duration of anticoagulation and timing of D-dimer testing among the various studies. Since none of the studies were blinded to a history of VTE, there is potential for outcome ascertainment bias due to studying a sample deemed susceptible to disease recurrence.

Bottom line: D-dimer testing holds promise in identifying risk of VTE recurrence and could aid therapeutic decision-making regarding duration of anticoagulation.

Citation: Ann Intern Med. 2008;149:481-490

–Reviewed for the eWire by Rebecca Allyn, MD, Smitha Chadaga, MD, Mary Dedecker, MD, Vignesh Narayanan, MD, Eugene S. Chu, MD, Division of Hospital Medicine, Denver Health and Hospital Authority

Question: Can a D-dimer level assess the risk of recurrent venous thromboembolism (VTE) after a course of anticoagulation therapy has been completed?

Background: The duration of anticoagulation therapy for first unprovoked VTE is uncertain. Identifying risk of recurrent VTE will help clinicians make decisions on optimal duration of anticoagulation.

Study design: Systematic review and meta-analysis.

Setting: Patients who have completed therapy for an episode of VTE without known risks.

Synopsis: Seven high-quality studies totaling 1,888 patients with first unprovoked VTE were analyzed. All patients received standardized therapy for at least three months with warfarin (Coumadin). A D-dimer had been checked in all patients between three and six weeks after stopping anticoagulation. The annual rate of VTE recurrence among patients with a positive D-dimer result was 8.9% (confidence interval (CI), 5.8% to 11.9%) compared with 3.5% (CI, 2.7 to 4.3%) for those with a negative result.

False-positive or false-negative D-dimer results could have occurred due to the heterogeneity in duration of anticoagulation and timing of D-dimer testing among the various studies. Since none of the studies were blinded to a history of VTE, there is potential for outcome ascertainment bias due to studying a sample deemed susceptible to disease recurrence.

Bottom line: D-dimer testing holds promise in identifying risk of VTE recurrence and could aid therapeutic decision-making regarding duration of anticoagulation.

Citation: Ann Intern Med. 2008;149:481-490

–Reviewed for the eWire by Rebecca Allyn, MD, Smitha Chadaga, MD, Mary Dedecker, MD, Vignesh Narayanan, MD, Eugene S. Chu, MD, Division of Hospital Medicine, Denver Health and Hospital Authority

The truth about EHR systems is that their implementation is never easy. It's a lot of work. It takes time and money, and despite the best laid plans there will be trauma and frustration. So expecting problems to arise is key to keeping perspective.

When our office implemented an electronic health records system in 2000, our system crashed 25–75 times a day for 5 months, and we lost patient data each time. I repeat: We lost patient data each time. Extensive troubleshooting ensued. Ceiling tiles were ripped out to see if the fluorescent lights were interfering with the network cables, a consultant was brought in, and our server and network were reinstalled. Finally, the cause of the crashes was determined to be a bug in our Microsoft program. As nightmarish as this situation was, I would say that such technology challenges were nothing compared to challenges in managing processes and people.

From a process perspective, a common mistake involves attempting to make the EHR system conform to what is done with paper. The whole point is to imagine a process that can help your office save time and money instead of mirroring what you did for years with a paper-based system.

Staff challenges are by far the toughest ones to manage because they require changing the minds and habits of individuals who don't feel comfortable giving up paper-based processes. Persistent naysayers can sabotage EHR implementation by convincing others that the changes cannot be made. Over the years, four of five staff members have left. When new staff members were hired, we emphasized the fact that our office was computerized and those individuals have successfully adapted to a paperless system. Among the lessons we've learned over the years are these:

▸ Don't skimp on training. When you're spending thousands of dollars on an EHR system it's tempting to shave costs and training may appear to be part of the discretionary spending budget. But giving training short shrift can cost you a lot more than you saved in the long run.

Even if you're the most technologically savvy physician, avoid the “I can do it all” mentality. Your time is best spent seeing patients and making money. Make sure that others are well trained so you feel comfortable delegating EHR responsibilities.

▸ Train the Luddites last. Once you've worked out all the kinks in the training process with those who are most comfortable using computers, it'll go a lot more smoothly for those who are less tech-savvy. Don't let anyone opt out of training. That can cost tens of thousands of dollars in the long run.

▸ Include everyone in brainstorming sessions. While no one likes meetings, get everyone involved in implementation meetings, not just the doctors and the office manager, because you will get good ideas from everyone. In addition, if they are involved in the brainstorming sessions, they are far more likely to adopt new behaviors.

▸ It doesn't have to be perfect. During the transition phase to an EHR system, there's a temptation to try to make everything perfect. Soon after we went live with our system, I spent a lot of time checking electronic charts to make sure the staff had included consultation notes. It was really a wasted step, because 99% of the time they had done it. In the rare event that the notes don't get into the chart, it doesn't affect patient care. The key is knowing when to accept a process as good enough and move on.

▸ Get a leader. You need a leader with a vision to organize the troubleshooting, both to build support and to keep everyone on track. The most common cause of EHR failure is lack of a leader.

The truth about EHR systems is that their implementation is never easy. It's a lot of work. It takes time and money, and despite the best laid plans there will be trauma and frustration. So expecting problems to arise is key to keeping perspective.

When our office implemented an electronic health records system in 2000, our system crashed 25–75 times a day for 5 months, and we lost patient data each time. I repeat: We lost patient data each time. Extensive troubleshooting ensued. Ceiling tiles were ripped out to see if the fluorescent lights were interfering with the network cables, a consultant was brought in, and our server and network were reinstalled. Finally, the cause of the crashes was determined to be a bug in our Microsoft program. As nightmarish as this situation was, I would say that such technology challenges were nothing compared to challenges in managing processes and people.

From a process perspective, a common mistake involves attempting to make the EHR system conform to what is done with paper. The whole point is to imagine a process that can help your office save time and money instead of mirroring what you did for years with a paper-based system.

Staff challenges are by far the toughest ones to manage because they require changing the minds and habits of individuals who don't feel comfortable giving up paper-based processes. Persistent naysayers can sabotage EHR implementation by convincing others that the changes cannot be made. Over the years, four of five staff members have left. When new staff members were hired, we emphasized the fact that our office was computerized and those individuals have successfully adapted to a paperless system. Among the lessons we've learned over the years are these:

▸ Don't skimp on training. When you're spending thousands of dollars on an EHR system it's tempting to shave costs and training may appear to be part of the discretionary spending budget. But giving training short shrift can cost you a lot more than you saved in the long run.

Even if you're the most technologically savvy physician, avoid the “I can do it all” mentality. Your time is best spent seeing patients and making money. Make sure that others are well trained so you feel comfortable delegating EHR responsibilities.

▸ Train the Luddites last. Once you've worked out all the kinks in the training process with those who are most comfortable using computers, it'll go a lot more smoothly for those who are less tech-savvy. Don't let anyone opt out of training. That can cost tens of thousands of dollars in the long run.

▸ Include everyone in brainstorming sessions. While no one likes meetings, get everyone involved in implementation meetings, not just the doctors and the office manager, because you will get good ideas from everyone. In addition, if they are involved in the brainstorming sessions, they are far more likely to adopt new behaviors.

▸ It doesn't have to be perfect. During the transition phase to an EHR system, there's a temptation to try to make everything perfect. Soon after we went live with our system, I spent a lot of time checking electronic charts to make sure the staff had included consultation notes. It was really a wasted step, because 99% of the time they had done it. In the rare event that the notes don't get into the chart, it doesn't affect patient care. The key is knowing when to accept a process as good enough and move on.

▸ Get a leader. You need a leader with a vision to organize the troubleshooting, both to build support and to keep everyone on track. The most common cause of EHR failure is lack of a leader.

The truth about EHR systems is that their implementation is never easy. It's a lot of work. It takes time and money, and despite the best laid plans there will be trauma and frustration. So expecting problems to arise is key to keeping perspective.

When our office implemented an electronic health records system in 2000, our system crashed 25–75 times a day for 5 months, and we lost patient data each time. I repeat: We lost patient data each time. Extensive troubleshooting ensued. Ceiling tiles were ripped out to see if the fluorescent lights were interfering with the network cables, a consultant was brought in, and our server and network were reinstalled. Finally, the cause of the crashes was determined to be a bug in our Microsoft program. As nightmarish as this situation was, I would say that such technology challenges were nothing compared to challenges in managing processes and people.

From a process perspective, a common mistake involves attempting to make the EHR system conform to what is done with paper. The whole point is to imagine a process that can help your office save time and money instead of mirroring what you did for years with a paper-based system.

Staff challenges are by far the toughest ones to manage because they require changing the minds and habits of individuals who don't feel comfortable giving up paper-based processes. Persistent naysayers can sabotage EHR implementation by convincing others that the changes cannot be made. Over the years, four of five staff members have left. When new staff members were hired, we emphasized the fact that our office was computerized and those individuals have successfully adapted to a paperless system. Among the lessons we've learned over the years are these:

▸ Don't skimp on training. When you're spending thousands of dollars on an EHR system it's tempting to shave costs and training may appear to be part of the discretionary spending budget. But giving training short shrift can cost you a lot more than you saved in the long run.

Even if you're the most technologically savvy physician, avoid the “I can do it all” mentality. Your time is best spent seeing patients and making money. Make sure that others are well trained so you feel comfortable delegating EHR responsibilities.

▸ Train the Luddites last. Once you've worked out all the kinks in the training process with those who are most comfortable using computers, it'll go a lot more smoothly for those who are less tech-savvy. Don't let anyone opt out of training. That can cost tens of thousands of dollars in the long run.

▸ Include everyone in brainstorming sessions. While no one likes meetings, get everyone involved in implementation meetings, not just the doctors and the office manager, because you will get good ideas from everyone. In addition, if they are involved in the brainstorming sessions, they are far more likely to adopt new behaviors.

▸ It doesn't have to be perfect. During the transition phase to an EHR system, there's a temptation to try to make everything perfect. Soon after we went live with our system, I spent a lot of time checking electronic charts to make sure the staff had included consultation notes. It was really a wasted step, because 99% of the time they had done it. In the rare event that the notes don't get into the chart, it doesn't affect patient care. The key is knowing when to accept a process as good enough and move on.

▸ Get a leader. You need a leader with a vision to organize the troubleshooting, both to build support and to keep everyone on track. The most common cause of EHR failure is lack of a leader.

A recently expanded palliative care program at University Hospital in Salt Lake City is the latest window into ancillary revenue streams hospitalists can tap during the continuing economic crisis.

Stephen Bekanich, MD, a hospitalist and medical director of the Utah center's palliative-care team, says his program saves money for the hospital and increases the value of its hospitalists. In October, Dr. Bekanich's team expanded into outpatient clinic treatment one half-day a week. While he plans to study the revenue generated through that month before expanding further, Dr. Bekanich thinks palliative-care teams are a strong revenue source for hospitalists.

"It’s a natural tie-in," he says. "The people that probably win the most with having palliative care established within the hospital is the hospital itself. We see that in our patient satisfaction."

Palliative care can lower hospital expenditures by cutting down on costly procedures that may not improve a patient's quality of life, as well as by trimming lengths of stay, Dr. Bekanich says. In the first half of 2008, Dr. Bekanich's team saved University Hospital about $600,000. The team’s 2008 budget was roughly $330,000 for about 500 encounters.

There are obstacles, though. Because palliative care is a recognized specialty, starting a program requires a hospitalist who is willing—and able—to become certified and hospital administration willing to front expenditures.

"The idea of starting this from scratch is going to become more difficult," Dr. Bekanich says, "but it’s worthwhile."

A recently expanded palliative care program at University Hospital in Salt Lake City is the latest window into ancillary revenue streams hospitalists can tap during the continuing economic crisis.

Stephen Bekanich, MD, a hospitalist and medical director of the Utah center's palliative-care team, says his program saves money for the hospital and increases the value of its hospitalists. In October, Dr. Bekanich's team expanded into outpatient clinic treatment one half-day a week. While he plans to study the revenue generated through that month before expanding further, Dr. Bekanich thinks palliative-care teams are a strong revenue source for hospitalists.

"It’s a natural tie-in," he says. "The people that probably win the most with having palliative care established within the hospital is the hospital itself. We see that in our patient satisfaction."

Palliative care can lower hospital expenditures by cutting down on costly procedures that may not improve a patient's quality of life, as well as by trimming lengths of stay, Dr. Bekanich says. In the first half of 2008, Dr. Bekanich's team saved University Hospital about $600,000. The team’s 2008 budget was roughly $330,000 for about 500 encounters.

There are obstacles, though. Because palliative care is a recognized specialty, starting a program requires a hospitalist who is willing—and able—to become certified and hospital administration willing to front expenditures.

"The idea of starting this from scratch is going to become more difficult," Dr. Bekanich says, "but it’s worthwhile."

A recently expanded palliative care program at University Hospital in Salt Lake City is the latest window into ancillary revenue streams hospitalists can tap during the continuing economic crisis.

Stephen Bekanich, MD, a hospitalist and medical director of the Utah center's palliative-care team, says his program saves money for the hospital and increases the value of its hospitalists. In October, Dr. Bekanich's team expanded into outpatient clinic treatment one half-day a week. While he plans to study the revenue generated through that month before expanding further, Dr. Bekanich thinks palliative-care teams are a strong revenue source for hospitalists.

"It’s a natural tie-in," he says. "The people that probably win the most with having palliative care established within the hospital is the hospital itself. We see that in our patient satisfaction."

Palliative care can lower hospital expenditures by cutting down on costly procedures that may not improve a patient's quality of life, as well as by trimming lengths of stay, Dr. Bekanich says. In the first half of 2008, Dr. Bekanich's team saved University Hospital about $600,000. The team’s 2008 budget was roughly $330,000 for about 500 encounters.

There are obstacles, though. Because palliative care is a recognized specialty, starting a program requires a hospitalist who is willing—and able—to become certified and hospital administration willing to front expenditures.

"The idea of starting this from scratch is going to become more difficult," Dr. Bekanich says, "but it’s worthwhile."