Introduction

Pelvic reconstructive surgery for genital prolapse and stress urinary incontinence (SUI) usually results in improved quality of life. However, complications from both traditional and mesh-augmented prolapse repairs and from placement of synthetic slings occur; this chapter discusses these various complications and how best to manage them.

Pelvic organ prolapse and SUI are common and often comorbid disorders in women that can greatly affect quality of life. Population-based studies report an 11% to 19% lifetime risk of women undergoing surgery for one of these conditions, with a recurrence of symptoms common in both groups. Of the women who undergo a pelvic floor repair, 6% to 29% have additional surgery for recurrent prolapse, stress incontinence, or related complications ( ). By year 7 of the extended Care trial, at least 16.7% of patients had additional surgery related to pelvic floor disorders, 5.1% for recurrent prolapse, 6.5% for SUI, and 5.1% for mesh complications ( ).

The success initially observed with the use of surgical mesh in general surgery combined with the perceived high failure rates for traditional native tissue suture repairs for prolapse initially led gynecologic surgeons to implement surgical approaches that use prosthetic materials. Medical device manufacturers have estimated that, in 2006 and 2007, approximately 30% of pelvic organ prolapse repair procedures and 80% of anti-incontinence procedures used reconstructive prosthetic materials. However, concerns raised around the safety of transvaginal mesh and synthetic slings are due to a variety of concerns related to mesh erosion, pain, vaginal constriction, and other complications. Although similar types of complications have occurred with native tissue sutured repairs, the perception is that graft-related complications have been more severe and difficult to manage.

Historically, pelvic floor support defects resulting in pelvic organ prolapse have been compared to a hernia. In 1973, Dr. Stanley Birnbaum described a novel technique for treatment of vaginal prolapse in which fixation of the vaginal vault with a Teflon mesh bridge anchored the vagina to the hollow of the sacrum. This was the initial description of a sacrocolpopexy using a synthetic material. A follow-up article 6 years later noted that 20 of 21 patients treated with this technique maintained good support and vaginal function.

Over the last 15 years there has been a significant refinement and improvement in surgical mesh materials (see also Chapter 28 ). Early on, there were problems with some surgical meshes that were associated with increased erosion and infection rates. In most cases, these meshes were microporous multi-filament materials, which usually require complete explantation for symptom improvement ( ). Fortunately, the majority of these products have been taken off the market. Most synthetic grafts are now Type 1 mesh, meaning that they are macroporous monofilament polypropylene with a pore size greater than 75 μm. They can further be divided by weight (heavy, mid- or light-weight) ( ).

Synthetic mesh utilized for prolapse repairs can be placed abdominally (abdominal sacral colpopexy) or transvaginally. Transvaginal mesh can be self-fashioned, cut to order, or packaged in a kit. The first synthetic mesh kit for prolapse was FDA approved in 2001, and the first trocar-based kit was approved in 2004 ( ).

Suburethral slings use synthetic mesh for treatment of SUI and can be categorized into retropubic, transobturator, and single incision (mini-sling) configurations (see Chapter 20 ). All of the meshes used for these procedures at the present time are macroporous polypropylene with fairly low complication rates.

Many of the complications discussed in this chapter are specific to mesh placement, although some can also occur with native tissue suture repair. The first portion of this chapter will discuss those complications specifically related to meshes, and the latter portion will discuss iatrogenic vaginal complications related to native tissue prolapse repairs.

FDA Warnings

On October 20, 2008, the FDA issued a Public health notification regarding the use of mesh in gynecologic surgery titled “Serious Complications Associated with Transvaginal Placement of Surgical Mesh in Repair of Pelvic Organ Prolapse and Stress Urinary Incontinence.” This was done in response to more than 1000 reports of these complications involving nine different surgical mesh companies and reported through the MAUDE database. The most common complications reported were mesh erosion, infection, pain, and urinary symptoms. Serious injuries to bowel, bladder, and blood vessels did occur but were rare. Several general recommendations were made by the FDA at that time, based on these reports. These included the following:

• 1.
  

  Physicians should seek specialized training for procedures involving the use of mesh, and be alert and recognize complications early.

  
  
• 2.
  

  Physicians should inform patients on the permanent nature of surgical mesh, and that some complications associated with implanted vaginal mesh may require subsequent surgery that may or may not correct the complication.

  
  
• 3.
  

  Physicians should inform patients about the potential for serious complications and the effect on quality of life, including pain during intercourse, scarring, and narrowing of the vagina after prolapse repairs.

The FDA continued to investigate mesh complications, and, based on an updated analysis of reported adverse events and complications described in the scientific literature, released a scientific communication on July 13, 2011, “Update on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse.” They noted that the use of surgical mesh for transvaginal repair of prolapse is an area of continuing serious concern, and concluded that “serious complications associated with surgical mesh for transvaginal repair of prolapse are not rare.” They did not find clear evidence to support increased efficacy of mesh repairs when compared to traditional native tissue repairs, and noted that patients undergoing mesh placement may be exposed to greater risk. It was also stated that mesh placed abdominally for the treatment of pelvic organ prolapse via sacrocolpopexy had a lower rate of mesh complications when compared to vaginally-placed mesh. Finally, mesh used to treat stress incontinence was to remain under continued investigation, with updates to come at a later date.

In light of these FDA findings, it is important to understand the current FDA approval process for new materials, as there is a proposed reclassification of surgical mesh used for transvaginal repair of pelvic organ prolapse. Current mesh products on the market were FDA approved via a simplified regulatory process called a “510(k).” This process allows new medical devices that are similar to a currently-approved FDA device to be approved based on what has been termed as a “predicate” device eliminating the need for the companies to provide specific efficacy and safety data on a new product prior to obtaining FDA approval. Historically, transvaginal mesh kits for prolapse repairs were considered class II devices. Thus a 510(k) process based on a predicate device (synthetic mid-urethral sling) was the approval process, even though mesh used for prolapse repairs involves significantly increased volumes of mesh and involves a different space in which the mesh is placed. Currently-approved synthetic mid-urethral slings were approved by the same process based upon a prior product, the “Protegen sling,” which is no longer on the market due to a poor safety profile.

The FDA is considering a reclassification of vaginal meshes from a Class II to a Class III medical device, which would require a much more rigourous FDA approval process that mandates premarket testing called a “premarket approval” or PMA. If this occurred, then a significant financial investment would be required to bring new mesh kits to market. On January 4, 2012, the FDA issued what have been termed 522 orders requiring postmarket surveillance studies for transvaginal mesh devices currently being sold for pelvic organ prolapse, as well as single incision (mini-sling) kits for SUI. These mandated studies are ongoing and, ultimately, will most likely decide the long-term fate of these devices.

Professional Society Guidelines

The American College of Obstetricians and Gynecologists (ACOG) and the American Urogynecologic Society (AUGS) issued a Committee Opinion in December 2011 regarding vaginal placement of surgical mesh for POP repair. They made a number of recommendations including the following:

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  Surgeons placing vaginal mesh should undergo training specific to each device, and should have experience with reconstructive surgical procedures and a thorough understanding of pelvic anatomy.

  
  
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  Repair of pelvic organ prolapse with vaginal mesh should be reserved for high-risk individuals in whom the benefit of mesh placement may justify the risk, such as individuals with recurrent prolapse (particularly of the anterior compartment) or with medical comorbidities that preclude more invasive and lengthier open or endoscopic procedures.

  
  
• •
  

  Compared with existing mesh products and devices, new products should not be assumed to have equal or improved safety and efficacy unless clinical long-term data are available.

  
  
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  Patients should provide their informed consent after reviewing the risks and benefits of the procedure, as well as discussing alternative repairs.

In addition, the Society of Gynecologic Surgeons (SGS) issued a statement in July 2011, advising the following:

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  SGS is in agreement with the interpretations and recommendations made in the FDA Safety Communication. The general consensus is that this reservation should not apply to synthetic mid-urethral sling procedures or sacral colpopexies utilizing the same mesh materials, but further longer-term evaluations of all of these procedures is important.

  
  
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  For now, thoughtful, discriminant use of transvaginal mesh to augment vaginal defects should be performed by trained surgeons with experience in complex reconstructive surgery, and only in patients who are perceived to have an unacceptable risk of clinical failure when other procedures are performed.

  
  
• •
  

  We should all follow outcomes when we employ new procedures, and should feel comfortable about benefit versus risk before employing them. It is important that patients are informed of the risks and benefits of any surgical procedure, as well as the specific potential adverse events associated with transvaginal mesh use, including outcomes that may still be unclear and require further investigation. Alternative treatments should be explained.

The International Urogynecological Association (IUGA) convened a Grafts Roundtable regarding transvaginal graft use in 2010 ( ), and advised:

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  Individual patient characteristics have to be included in the risk-benefit ratio when counseling patients regarding transvaginal mesh repair.

  
  
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  Informed consent for vaginal reconstructive surgery with mesh should include verbal and written review with the patient of expected benefits, therapeutic alternatives, and potential risks.

  
  
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  Manufacturers should provide detailed product description, data on biologic properties, cadaveric studies, and well-designed prospective clinical trials to support the claimed benefits of the new product.

  
  
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  A process of added surgeon qualification for transvaginal mesh placement is desirable.

The AUGS also issued guidelines for providing privileges and credentials to physicians for transvaginal placement of mesh for POP.

In the past, there were few guidelines for surgical learning, and physicians usually attended an industry-sponsored 1- or 2-day course to learn these procedures using cadaveric trainers. The new AUGS recommendations call for documentation of each of the following: (1) knowledge of pelvic anatomy, (2) surgical skill, (3) surgical experience, and (4) internal audits for quality assurance. Informed consent should highlight potential benefits and complications of transvaginal mesh; alternatives including nonsurgical options and other surgical treatments; and potential complications of transvaginal mesh that may require additional interventions, as well as the fact that symptoms may not be completely resolved with mesh removal. Furthermore, the surgeon who approaches management of mesh complications after pelvic surgery should possess a comprehensive understanding of materials utilized in POP repair, pelvic floor anatomy, and advanced surgical skills in order to individualize the management of such complications specific to each patient.

The AUGS in conjunction with the Society of Urodynamics and Female Urology recently released a position statement on mesh midurethral slings for SUI ( http://www.augs.org/p/bl/et/blogid=16&blogaid=192 ). The statement stated that “Polypropylene mesh mid-urethral sling is the recognized worldwide standard of care for the surgical treatment of stress urinary incontinence. The procedure is safe, effective, and has improved the quality of life for millions of women.” Justification for the position statement included:

• 1.
  

  Polypropylene material is safe and effective as a surgical implant for midurethral slings.

  
  
• 2.
  

  The monofilament polypropylene mesh midurethral sling is the most extensively studied anti-incontinence procedure in history.

  
  
• 3.
  

  Polypropylene mesh midurethral slings are the standard of care for the surgical treatment of SUI and represent a great advance in the treatment of this condition for our patients.

  
  
• 4.
  

  The FDA has clearly stated that the polypropylene midurethral sling is safe and effective in the treatment of SUI.

In response to increasing complications associated with mesh use in gynecologic and urologic surgery, IUGA and the International Continence Society (ICS) agreed on standardized terminology and a classification method for complications associated with insertion of mesh ( ). Terminology is specifically defined in the article and the classification system is based on three items: category, time and site (CTS). Chapter 8 and Appendix D provide details about this classification system.

Avoiding Synthetic Mesh Complications

Mesh Complications after Sacrocolpopexy

Sacrocolpopexy is an abdominal, laparoscopic, or robotic procedure that involves attaching a Y-shaped graft (usually synthetic mesh) to the anterior and posterior vaginal wall and securing it to the anterior longitudinal ligament of the sacrum. Mesh complications after abdominal sacrocolpopexy are uncommon and primarily center on mesh or suture erosion ( Fig. 30.1 A and B ) An early comprehensive review of abdominal sacrocolpopexy revealed an overall mesh erosion rate of 3.4%. Polypropylene had the lowest erosion rate at 0.5%, whereas Teflon had the highest rate of erosion at 5.5% ( ). A more recent follow up of the CARE trial noted that the probability of mesh erosion at 7 years increased to 10.5% ( ).

Vaginal mesh erosion after abdominal sacrocolpopexy. A , Gortex mesh erosion seen transvaginally after abdominal sacrocolpopexy. B , Polypropylene mesh erosion seen transvaginally after abdominal sacrocolpopexy.

There are mixed data regarding the risk of mesh erosion when sacrocolpopexy is performed with concomitant hysterectomy. , and all reported an increased risk of mesh erosion with concomitant hysterectomy. reported no increased erosion rate in 60 women undergoing sacrocolpopexy with concomitant hysterectomy when compared to 61 women undergoing sacrocolpopexy alone ( ). Another study compared mesh erosion rates after sacrocolpopexy with concomitant supracervical hysterectomy as compared to sacrocolpopexy alone. A total of 277 patients were included in this study, 195 with concomitant supracervical hysterectomy with sacrocolpopexy and 82 with sacrocolpopexy alone. There were three patients with mesh erosion diagnosed at a mean follow-up of 8 months, one (0.5%) in the supracervical hysterectomy with sacrocolpopexy group and two (2.4%) in the sacrocolpopexy-alone group, a nonsignificant difference. In their extensive review of the literature, concluded that the risk of vaginal mesh exposure is significantly increased in cases of sacrocolpopexy associated with concomitant total hysterectomy (8.6%) in comparison to 2.2% in women with previous hysterectomy, 1.5% after sacrocolpo-hysteropexy and 1.7% after supracervical hysterectomy.

A variety of risk factors have been identified for mesh and suture erosion after sacrocolpopexy. A secondary analysis from the Colpopexy and Urinary Reduction Efforts (CARE) trial evaluated mesh and suture erosion rates among the 322 women who underwent sacrocolpopexy ( ). They identified 20 women (6%) with mesh/suture erosion within 2 years of surgery; 3 were suture only and 17 had exposed mesh. Three identifiable risk factors were found: concurrent hysterectomy, which increased erosion rate from 4% to 14% in this study population; the use of expanded polytrafluoroethylene (ePFTE; Gore-Tex; GORE Medical, Newark, NJ), which had a 4-fold higher risk (19% versus 5%) of mesh erosion when compared to non-ePTFE mesh; and smoking, which was associated with a 5-fold increase in risk of mesh erosion. No other significant factors were identified for mesh erosion, including estrogen status, diabetes, and prior surgery. The management of the three women with suture erosion included simple suture removal, and two of the three had confirmed complete healing. Four of the 17 mesh erosions were managed without surgery, and no resolution was noted in any of these 4. Thirteen women underwent at least one surgery, one had two surgeries, and one had three surgeries. Of these 13 women, two had symptom resolution, six had persistent mesh erosion, and five were lost to follow-up.

Managing mesh erosion after sacrocolpopexy may require only observation and topical estrogen; however, in the authors’ experience, it almost always requires surgical excision. Surgical management of mesh erosion after sacrocolpopexy can be technically challenging, partially due to the high apical location within the vaginal canal, the amount of mesh used in the procedure, and the ingrowth of tissue into the mesh, making surgical dissection difficult. Vaginal and abdominal techniques for mesh excision have been described. In the authors’ experience, most mesh exposures can be successfully managed vaginally by using a technique of sharp dissection of the exposed mesh away from surrounding tissue, with aggressive downward traction on the mesh ( Fig. 30.2 A and B ). The mesh is cut away as high as possible and the vaginal defect closed. Vaginal entrance into the peritoneum significantly facilitates successful removal of the mesh.

The technique of vaginal removal of an eroded synthetic mesh after abdominal sacral colpopexy. A , Note that the mesh is undermined and grasped (usually with Kocher-type clamps), with aggressive downward traction applied on the mesh. B , The mesh is sharply dissected away from the vaginal tissue and any other tissue that it is adherent to, and, with aggressive downward traction, it is excised as high as possible. The goal is to create as much distance as possible between the closed vaginal cuff and the cut edge of the mesh (see inset).

published their experience with excision of mesh in 31 patients after sacrocolpopexy, including a novel method for endoscopic-assisted transvaginal excision of mesh. Vaginal excision involves sharp dissection of the vagina around the area of erosion, and excision of the mesh with closure of mucosal edges with suture. Endoscopic-assisted transvaginal excision was used for patients with a sinus tract at the vaginal apex. The sinus tract opening was extended using a scalpel if needed to accommodate a 17-French cystoscope. The endoscope is placed into the sinus tract and advanced toward the sacrum to view the extent of the mesh. The scope was used for direct visualization during dissection of mesh from retroperitoneal tissues and during mesh excision. Abdominal excision of mesh also was done by laparotomy; the presacral space was entered, and mesh was detached from the sacrum and removed from the vaginal apex. Fourteen women underwent transvaginal mesh excision, which was successful in 9, whereas 17 women underwent endoscopic-assisted transvaginal mesh excision, which was successful in 7. The overall success rate for vaginal excision was 53%. However, multiple attempts at vaginal excision were required in several patients for symptom resolution. Seven patients underwent abdominal excision, each having failed one of the two transvaginal excision methods. All had symptom resolution, and no severe complications were noted. The abdominal group had two intraoperative bowel injuries during lysis of adhesions, one wound infection, and one readmission for fever requiring antibiotics. It was concluded that complete removal of mesh may improve outcomes and decrease persistent symptoms, although significant morbidity can occur.

Although erosion of mesh into the bladder or rectum is rare after abdominal sacrocolpopexy, its possibility should be considered in women with vaginal mesh exposure, especially if the patient also has pelvic pain, dyspareunia, tender mesh on palpation, or bladder or rectal pain. Preoperative cystoscopy and careful rectal examination or proctoscopy are recommended to help in surgical planning.