Managing mesh complications after surgeries for urinary incontinence and pelvic organ prolapse

Introduction

Pelvic reconstructive surgery for genital prolapse and urinary stress incontinence usually results in improved quality of life ( ). However, numerous complications from mesh-augmented prolapse repairs, as well as placement of synthetic slings, have been reported in the literature. This chapter is aimed at discussing these various complications and how best to manage them.

Pelvic organ prolapse (POP) and stress urinary incontinence (SUI) are common and often comorbid disorders in women and can greatly impact quality of life. Population-based studies report an 11% to 19% lifetime risk of women undergoing surgery for one of these conditions, with recurrence of symptoms common in both groups. In total, 6% to 29% of women who undergo a pelvic floor repair have additional surgery for recurrent prolapse, stress incontinence, or related 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 POP repair procedures and 80% of antiincontinence procedures used reconstructive materials. However, recently there have been concerns raised around the safety of transvaginal mesh and synthetic slings because of a variety of complications related to mesh erosion, pain, vaginal constriction, and other complications. Although similar types of complications have occurred with native tissue suture repairs, the perception is that graft-related complications have been more severe and difficult to manage.

Historically, loss of pelvic floor support resulting in POP has been compared with 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. Early on there were problems with some surgical meshes that increased erosion and infection rates. In most cases these meshes were microporous multifilament materials, which require complete explantation for symptom improvement ( ). Fortunately, the majority of these products have been taken off the market. Currently used meshes are type 1 mesh, meaning they are macroporous monofilament polypropylene with a pore size greater than 75 microns. They can further be divided by weight (heavy-, mid- or lightweight) ( ; ). (See Chapter 7 for more information on the properties and biomechanics of mesh.)

Synthetic mesh used 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 approved by the US Food and Drug Administration (FDA) in 2001, and the first trocar-based kit was approved in 2004 ( ). Recent changes have led to the removal of transvaginal mesh for POP from the US market (see US Food and Drug Administration Warnings). Mesh for use in sacrocolpopexy has not been affected. (See Chapter 7 for more details.)

Suburethral slings use synthetic mesh placed suburethrally for treatment of SUI and can be categorized into retropubic, transobturator, and single-incision (minisling) configurations ( Chapter 17 ). All of the meshes used for these procedures at the present time are macroporous polypropylene with fairly low complication rates. Synthetic slings were also not affected by the recent FDA action.

Many of the complications discussed in this chapter are specific to mesh placement, while some can also occur with native tissue suture repair. This chapter will only discuss those complications specifically related to mesh procedures for POP and SUI.

US food and drug administration warnings

On October 20, 2008 the FDA issued a public health notification regarding the use of mesh in gynecologic surgery entitled “Serious Complications Associated with Transvaginal Placement of Surgical Mesh in Repair of Pelvic Organ Prolapse and SUI.” This was done in response to over 1000 reports of these complications involving surgical mesh produced by nine different companies. These reports were reported through the Manufacturer and User Facility Device Experience (MAUDE) database. The most common complications reported were mesh erosion, infection, pain, and urinary symptoms. Serious injury to bowel, bladder, and blood vessels did occur, albeit rarely. Several general recommendations were made by the FDA at that time based on these reports. These included the following:

• 1.

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

• 2.

  That physicians 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.

  That physicians 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 entitled “Update on Serious Complications Associated with Transvaginal Placement of Synthetic Mesh for Pelvic Organ Prolapse and SUI.” 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 with traditional native tissue repairs, and concluded that patients undergoing mesh placement may be exposed to greater risk. It was also noted that mesh placed abdominally for the treatment of POP via sacrocolpopexy had a lower rate of complications when compared with vaginally placed mesh. Lastly, mesh used to treat stress incontinence was to remain under continued investigation, with updates to come at a later date.

In the light of these FDA findings, it is important to understand the history of the FDA approval process for new materials. Mesh products were allowed to remain on the market without passing the rigorous FDA approval process that mandates premarket testing because they underwent a much more simplified regulatory process called a “510K.” This process allowed new medical devices that were similar to a currently FDA-approved (or “predicate”) device to be approved based on this similarity, eliminating the need for the companies to provide specific efficacy and safety data on a new product before obtaining FDA approval. Historically, transvaginal mesh kits were considered class II devices, and thus a 510K process based on a predicate device, a synthetic midurethral sling, was the approval process that was used, even though prolapse repairs involve significantly increased volumes of mesh that are placed in a different space than midurethral slings. Currently approved synthetic midurethral slings were approved by the same process based upon a prior product, the Protegen sling, which is no longer on the market because of a poor safety profile. On January 4, 2012 the FDA issued 522 orders requiring postmarket surveillance studies for transvaginal mesh devices currently being sold for use in POP, as well as single-incision (minisling) kits currently being promoted for SUI, and companies undertook these studies. In 2016 the FDA reclassified vaginal meshes from class II to class III medical devices, which require premarket approval through a scientific review to ensure safety and efficacy before going to market. In July 2018, the FDA ordered the manufacturer of the last mesh surgical products on the market for the transvaginal repair of POP in the posterior compartment (rectocele) to stop selling and distributing its products. Lastly, in April 2019, the FDA ordered all manufacturers of surgical mesh intended for transvaginal repair of anterior compartment prolapse (cystocele) and vaginal vault prolapse to stop selling and distributing their products immediately. The FDA determined that reasonable assurance of safety and effectiveness for these devices had not been demonstrated. Synthetic mesh products for the treatment of SUI and sacrocolpopexy were not affected by this FDA order.

This reflects upon recent circumstances in other countries. In the past few years, synthetic mesh has become no longer available to use in POP surgery in the United Kingdom, Scotland, New Zealand, and Australia.

Professional society guidelines

The American College of Obstetricians and Gynecologists (ACOG) and the American Urogynecologic Society (AUGS) issued a statement in December 2011 regarding vaginal placement of surgical mesh for POP repair. They advised that:

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

• Use of reconstructive materials by surgeons experienced with the specific procedure is a reasonable option for women with factors that increase the risk of prolapse recurrence (e.g., recurrent prolapse, medical comorbidities that preclude more invasive and lengthier open and endoscopic procedures). Such use should be individualized, and surgeons should counsel patients about the lack of efficacy and safety data, and about alternative treatments.

• 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:

• 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 midurethral sling procedures or sacral colpopexies utilizing the same mesh materials, but further longer-term evaluations of all of these procedures is important.

• 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 on 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 Urogynecologic Association (IUGA) convened a Grafts Roundtable regarding transvaginal graft use in 2010 ( ), and advised that:

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

• 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.

• 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.

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

In the past there were minimal guidelines for this process, 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 to mesh, 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. The article addresses surgeons who are not performing transvaginal mesh repairs but would like to begin doing so, as well as those currently performing these procedures. The surgeon who approaches management of mesh complications after pelvic surgery should possess a comprehensive understanding of materials used in POP repair and pelvic floor anatomy, as well as advanced surgical skills to individualize the management of such complications specific to each patient. Patients should also understand that removal of mesh may not completely resolve all symptoms.

The American Urogynecology Society, in conjunction with the Society of Urodynamics and Female Urology, released a position statement on mesh midurethral slings for SUI in 2014, with updates in 2016 and 2018. The statement stated that “polypropylene mesh midurethral sling is the recognized worldwide standard of care for the surgical treatment of SUI. The procedure is safe, effective, and has improved the quality of life for millions of women.” Justification for the position statement was as follows:

• 1.

  Polypropylene material is safe and effective as a surgical implant.

• 2.

  The monofilament polypropylene mesh midurethral sling is the most extensively studied antiincontinence 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 2017, ACOG and AUGS issued a joint committee opinion on the management of mesh and graft complications in gynecologic surgery. They concluded that:

• 1.

  Short-term voiding dysfunction after placement of a synthetic midurethral sling is common and, if improving, can be managed expectantly for up to 6 weeks. However, retention (inability to empty the bladder) or small-volume voids with larger postvoid bladder residual volume should receive earlier intervention.

• 2.

  Asymptomatic exposures of monofilament macroporous meshes can be managed expectantly.

• 3.

  A trial of vaginal estrogen can be attempted for small (e.g., <0.5 cm) mesh exposures.

• 4.

  Persistent vaginal bleeding, vaginal discharge, or recurrent urinary tract infection after mesh placement should prompt an examination and possible further evaluation for exposure or erosion.

• 5.

  Pelvic pain (including dyspareunia), possibly related to nonexposed mesh, is complex, may not respond to mesh removal, and should prompt referral to a clinician with appropriate training and experience, such as a female pelvic medicine and reconstructive surgery specialist.

• 6.

  Mesh removal surgery should not be performed unless there is a specific therapeutic indication.

More recently, ACOG and AUGS issued clinical guidelines for POP. The purpose is to review information on the current understanding of POP in women and to outline guidelines for diagnosis and management that are consistent with the best available scientific evidence.

Finally, the AUGS-IUGA issued a joint position statement on the management of mesh-related complications for the Female Pelvic Medicine & Reconstructive Surgery (FPMRS) specialist (2020). It has four goals:

• 1.

  Using the best and most relevant evidence available, provide guidance for the FPMRS subspecialist caring for patients who may be experiencing mesh complications.

• 2.

  Provide an algorithm to outline treatment choices for patients with mesh-related complications that can be used as a platform for shared decision making in the treatment of these complications.

• 3.

  Identify and prioritize gaps in evidence concerning specific mesh complications and their treatments.

• 4.

  Identify provider and health facility characteristics that may optimize the outcomes of treatments for these complications.

Avoiding synthetic mesh complications

In general, there are a number of modifiable risk factors that may help to diminish mesh-related complications, and these are reviewed in Box 25.1 .