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Patients need to help to separate fact from fiction.
Dr Rosenblatt is Director in the Division of Urogynecology, Department of Obstetrics and Gynecology, Mount Auburn Hospital, Cambridge, Massachusetts, in the Department of Obstetrics and Gynecology, Beth Israel Deaconess Medical Center, Boston, Massachusetts and Assistant Professor of Obstetrics, Gynecology and Reproductive Biology, Harvard Medical School, Boston, Massachusetts.
Dr Dessie is Urogynecology Module Lead in the Mid-Atlantic Permanente Medical Group, District of Columbia/Suburban Maryland.
Pelvic organ prolapse (POP) is very common in women, affecting as much as 41% of the female population.1 Conservative treatment includes expectant management, pelvic muscle exercises, and pessary support. Surgical repair of POP is the most commonly performed inpatient procedure among women aged 70 and older.2 Every year, more than 200,000 surgical procedures are performed in the United States for POP.3
Surgical options can be divided into 2 main categories: reconstructive and obliterative procedures. The decision about which type of surgery to perform depends, in part, on the medical status of the patient and her wishes regarding current or potential sexual activity. Women who are sexually active or wish to be sexually active generally choose to undergo a reconstructive procedure because it preserves vaginal caliber and enables easier continued evaluation of cervical and uterine issues.
A variety of reconstructive surgical approaches can be employed. The 3 major approaches to reconstructive prolapse surgery are abdominal, vaginal, and endoscopic (either laparoscopic or robotic). Each approach has advantages and drawbacks, and the choice of approach is dependent on many factors, including surgeon training and experience, comparative success rates and risks, and the patient’s medical condition and coexisting pathology. Vaginal reconstructive surgery is the least invasive of these approaches. The traditional approach to vaginal reconstructive surgery has been native tissue repair, which involves using the patient’s own tissues to re-support prolapsed organs.
Anterior and posterior colporrhaphy comprise the majority of prolapse procedures and are used to treat cystocele and rectocele, respectively, but unfortunately these procedures have a wide range of failure rates, on the order of 7% to 70%.4-9 Several issues with this approach can lead to failure of this type of repair. First, the tissues themselves are often weakened in patients who present with prolapse, and therefore, are prone to failure. Second, anterior and posterior wall defects are often not due to a generalized thinning or distention of the anterior and posterior vaginal walls. Rather, anatomic studies have demonstrated that site-specific defects are responsible for resulting herniation of the vaginal walls. The process of plication does not take into consideration the site-specific nature of many cystoceles and rectoceles, which accounts for the high failure rate associated with these repairs.10,11 In addition, apical prolapse (prolapse of the top of the vagina, whether or not the uterus is present) accounts for many cases of anterior and posterior vaginal wall prolapse. Anatomic studies have demonstrated that 50% of cystoceles will resolve with proper support of the apex.12
Vaginal apical suspension procedures such as uterosacral ligament suspension, McCall culdoplasty, and sacrospinous ligament suspension can effectively treat uterine and vaginal vault prolapse. Unfortunately, these procedures may also fail if the patient’s own tissues are weakened, which is often the case in women who present with symptomatic POP.
To improve outcomes of vaginal reconstructive surgery, surgeons have employed graft augmentation, which may consist of either synthetic or biologic grafts.13 Use of synthetic grafts dates back to the 1990s, when surgeons first began using mesh in POP repair after seeing its successful use in treatment of abdominal wall hernia and stress urinary incontinence (SUI).14 Early studies demonstrated that recurrence rates were significantly reduced with use of synthetic mesh augmentation, although there was a tradeoff, particularly mesh exposure and, more infrequently, erosion into neighboring organs. Other complications such as bleeding, infection, injury to adjacent organs, pelvic pain, and dyspareunia have also been reported, though these complications may be seen with native tissue repairs as well.15-17
Between 2008 and 2010, approximately 75,000 transvaginal mesh (TVM) procedures were performed annually in the United States. In 2008, the Food and Drug Administration (FDA) released a Public Health Notification (PHN) regarding use of TVM. They stated that surgeons and patients should be aware of complications associated with mesh, including mesh erosion and exposure. The FDA made several recommendations, including stressing the need for adequate informed consent and specialized training for specific mesh kits.18 Three years later, the FDA issued a Safety Update, which reiterated the information from the 2008 PHN but further stated that the complications noted in the 2008 PHN were “not rare.” The FDA issued orders to medical device companies to perform postmarket surveillance studies on mesh kits for prolapse, as well as for single-incision slings for SUI. The only pelvic floor mesh devices for which these studies were not required were full-length midurethral slings (either retropubic or transobturator) and mesh marketed for sacrocolpopexy.19
In early 2016, the FDA reclassified TVM for POP from a Class II (moderate risk) to a Class III (high-risk) device and also required manufacturers of TVM to submit premarket approval (PMA) applications to the FDA for new products, as well as for existing products on the market. The PMA application is a more rigorous process that requires extensive clinical experience demonstrating both safety and efficacy before a device can gain FDA approval.20
Many studies have been published in the literature on TVM, both with custom-cut mesh from sheets and with commercially available mesh kits. There is a significant range of both success rates (objective and subjective) and complications, which may imply that results are often dependent on the surgeon’s training and technique.13 Several surgical techniques are considered to be important for reducing complications in TVM surgery.21 One important factor is the depth of dissection; a full-thickness dissection into the true vesicovaginal space (for anterior repair) or rectovaginal space (for posterior repair) is important for reducing postoperative mesh exposure into the vagina.22 Experienced surgeons will usually perform hydrodissection in these spaces to assist in sharp dissection. Placing mesh in a tension-free manner, without over-tightening the mesh arm attachments to surrounding structures, is also important in reducing the incidence of pelvic pain and dyspareunia.23
Several studies have attempted to compare outcomes and complications following native tissue versus TVM-augmented repairs for POP. Conclusions that can be made from comparisons between the 2 approaches are significantly limited due to variations in the type of mesh used, surgical technique, and outcome measures assessed. Despite this, we have attempted to summarize the recent data comparing treatment modalities.
Native tissue anterior and posterior compartment repairs consist primarily of anterior and posterior colporrhaphies. These procedures usually involve plication of the stretched-out tissues after opening of the vaginal wall and dissection of underlying tissues away from the epithelium. Apical native tissue vaginal repairs studied in the literature primarily include uterosacral ligament suspension and sacrospinous ligament suspension.
A recent Cochrane review demonstrated that use of TVM in prolapse repair decreases patient awareness of prolapse at 1 to 3 years postoperatively as well as the need for repeat surgery for prolapse, and recurrent prolapse (Stage 2 or greater in any compartment) when compared to native tissue repair. However, when examining need for repeat surgical intervention due to recurrent prolapse, SUI, and mesh exposure, women undergoing TVM procedures had a significantly higher rate of needing repeat surgery than those undergoing native tissue repairs due to additional surgeries from mesh complications.13
Rates of various complications from TVM repair vary widely in the literature. A 2010 randomized controlled trial comparing Prolift repairs to traditional vaginal colpopexy repairs without mesh was halted after median follow-up of 9.7 months due to a high mesh erosion rate of 15.6%.24 Conversely, a recent publication by Altman et al examined outcomes 1 year after Uphold Vaginal repair and found high anatomic success rates but a low rate of serious complications (4.3%).25
Over the past several years, all the major medical device companies that produce pelvic floor mesh kits for prolapse and midurethral slings for SUI have been the targets of large multi-district litigation (MDL) claiming defects in the design and manufacturing of these devices.26 Each of the major medical device manufacturers, including Ethicon, Bard, and American Medical Systems (which became Astora Women’s Health in 2015), faced tens of thousands of lawsuits that were consolidated into MDLs in recent years. Although most companies are actively fighting these cases, Astora decided to settle more than 20,000 of its own cases for reportedly more than $2.4 billion. It is the opinion of these authors as well as many leaders in the field of pelvic surgery that Astora’s parent company, Endo Pharmaceuticals, was motivated to reduce any further liabilities when deciding to sell its male health division to Boston Scientific in 2015.
As a result of the litigation and the FDA requirement to perform expensive postmarket surveillance (522 studies) on many products, several manufacturers of mesh kits and slings voluntarily withdrew their products. Prolapse mesh kits Prolift (Ethicon), Apogee/Perigee (Astora), and Avaulta (Bard) were withdrawn from the market. In addition, several single-incision slings, including miniArc (Astora), TVT-SECUR (Ethicon), and Adjust (Bard), were also voluntarily withdrawn.
One of the most dramatic repercussions of the current litigious environment was the sudden announcement on February 29, 2016 by Endo Pharmaceuticals that they were shutting down all operations of Astora Women’s Health by the end of the following month. With the closing of Astora, several popular devices such as the Monarc and RetroArc slings, as well as the Elevate kit for prolapse, were unsupported and discontinued. 27
The only TVM kits now commercially available are Uphold (Boston Scientific) and Direct Fix (Coloplast). The Uphold device uses a lightweight mesh with adjustable arms that are deployed into the sacrospinous ligament using a Capio suturing device with leg assemblies that transition between suture, a dilating plastic tube, and a mesh arm covered with a plastic sleeve. Direct Fix is a pre-formed mesh designed for either anterior or posterior vaginal support. Surgeons also have the option of cutting a custom mesh shape out of a flat piece of polypropylene mesh and attaching the mesh to surrounding structures, such as the sacrospinous ligament or the arcus tendineous fascia pelvis.
Unfortunately, a significant portion of the litigation surrounding transvaginal mesh has focused on midurethral slings. In 2014, the board of directors for the American Urogynecologic Society and the Society of Urodynamics, Female Pelvic Medicine and Urogenital Reconstruction released a position statement on mesh midurethral slings for treatment of SUI. In it, they stated that monofilament polypropylene mesh midurethral slings are the most extensively studied anti-incontinence procedure in history and are the gold standard of care for patients desiring surgical management for SUI.28 Similarly, in 2013, the FDA website reported that “the safety and effectiveness of multi-incision slings is well-established in clinical trials that followed patients for up to one year.”29
TVM has had a complicated history in treatment of women with POP. Although data have shown consistently high success rates, more data are needed to better understand risk factors for surgical complications. The current litigious atmosphere threatens to derail any further innovation and progress in use of synthetic materials to treat the growing number of women who suffer from POP. As providers, it is our responsibility to continue to educate patients and separate fact from fiction regarding use of TVM.
Dr Rosenblatt reports receiving salary/honoraria, intellectual property rights, and consulting fees from Astora; salary/honoraria and consulting fees from Boston Scientific and Coloplast; and performing contracted research for Boston Scientific and Coloplast. Dr Dessie has no conflicts of interest to report in respect to the content of this article.
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