Insertion and Removal of Vaginal Mesh for Pelvic Organ Prolapse
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CLINICAL OBSTETRICS AND GYNECOLOGY Volume 53, Number 1, 99–114 r 2010, Lippincott Williams & Wilkins Insertion and Removal of Vaginal Mesh for Pelvic Organ Prolapse TYLER M. MUFFLY, MD and MATTHEW D. BARBER MD, MHS Department of Obstetrics and Gynecology, Center for Urogynecology and Pelvic Reconstructive Surgery, Obstetrics, Gynecology and Women’s Health Institute, Cleveland Clinic, Cleveland, Ohio Abstract: A variety of surgical meshes are available A woman’s risk of requiring surgery for to correct pelvic organ prolapse. This article discusses prolapse is approximately 7% by the age benefits and risks of vaginal mesh use. Emphasis is 1 placed on the appropriate surgical technique to im- of 80 years. Of those who receive surgery, prove outcomes and minimize mesh complications. an estimated 13% will require a repeat Placement options are reviewed with the discussion operation within 5 years and as many of self-tailored mesh, trocar-based mesh kits, and non- as 29% will undergo another surgery trocar mesh kits. This article also reviews the manage- for prolapse or a related condition at ment of mesh complications including the technique 1,2 for mesh removal. some point during their life. Given the Key words: pelvic organ prolapse, surgical mesh, mesh rates of prolapse recurrence after surgery, kits, mesh erosion many pelvic reconstructive surgeons have incorporated the use of synthetic or bio- logic graft materials into their repairs in an attempt to improve outcomes. The concept of using mesh or grafts to im- Introduction prove native tissue repairs is not novel. Pelvic organ prolapse is one of the most The use of synthetic mesh for inguinal and common indications for surgery in wo- ventral hernia repair is well supported men with approximately 200,000 inpati- in the general surgery literature and is ent surgical procedures performed for this currently considered the ‘‘gold standard’’ indication in the United States annually.1 approach.3 The use of synthetic mesh during sacral colpopexy to suspend the Correspondence: Matthew D. Barber, MD, MHS, vaginal apex from abdominal or laparo- Section of Urogynecology and Pelvic Reconstructive scopic approach is well established and Surgery, Obstetrics, Gynecology and Women’s Health 4 Institute, Cleveland Clinic, Desk A81, Cleveland, OH. supported by level I evidence. In the last E-mail: [email protected] 5 years, there has been an increase in the The authors have no potential conflicts of interest. use of synthetic and biologic mesh to CLINICAL OBSTETRICS AND GYNECOLOGY / VOLUME 53 / NUMBER 1 / MARCH 2010 www.clinicalobgyn.com | 99 100 Muffly and Barber augment transvaginal prolapse surgery. Nonabsorbable synthetic graft use may This has largely been driven by the recent improve anatomic outcomes of the anterior availability and marketing of commer- vaginal wall, but there are trade-offs in cially available pre-packed mesh delivery regard to additional risks systems or ‘‘mesh kits.’’ Despite a paucity There are no comparative studies to guide of consistent data, the use of new syn- any recommendation on the use of nonab- thetic materials, including mesh kits, is sorbable synthetic mesh in the posterior or apical compartments when compared with rapidly expanding. In this chapter, we will native tissue repair. summarize the potential benefits and risks They noted, however, that no high or associated with vaginal mesh use, describe even moderate quality evidence existed to the currently available synthetic and bio- guide their recommendations and that logic graft materials, review the various in some cases evidence was so limited that surgical approaches for vaginal mesh no recommendation could be offered. As placement, and provide a step-wise ap- such, they emphasized that future re- proach for managing postoperative mesh search was likely to have an important complications. effect on their estimates and may even change them.7 Similar to the SGS review, Benefits and Risks of the Cochrane Collaboration completed a Vaginal Mesh Use systematic review and concluded that the Current data is sparse, but suggests that use of mesh or graft inlays at the time the use of mesh or graft to augment of anterior vaginal wall repair may reduce vaginal prolapse surgery is associated the risk of recurrent cystocele, but that with both potential benefits and risks. there was insufficient evidence to make The pelvic surgeon must carefully consid- recommendations for posterior vaginal 8 er the balance of these benefits and risks wall or apical repair. when considering the use of mesh for Potential complications related to graft transvaginal prolapse repair. Most data and mesh include erosion, infection, on the outcomes and complications after dyspareunia, fistula, and chronic pain.9 transvaginal mesh placement has con- Rates of these complications vary greatly sisted of retrospective or uncontrolled and have not always been consistently case series. More recently, a few random- reported. Erosion of mesh varies after vagi- ized, controlled trials have been published nal prolapse repair varies widely from 3% which demonstrate improved anatomic to 17% 3 to 12 months after placement outcomes, but similar subjective out- with synthetic mesh carrying a greater risk comes and higher complication rates after than biologic grafts.5,10 Multifilament mesh placement when compared with tra- mesh has a higher rate of erosion and com- ditional vaginal repairs.5,6 In 2008, the plication than wide pore monofilament Society of Gynecologic Surgery (SGS) mesh. Additional risk factors include con- systematically reviewed the literature current hysterectomy and tobacco use. and published clinical practice guidelines Although some experienced surgeons have on vaginal graft use.7 In this statement, reported erosion rates as low as 2% to the authors made the following conclu- 3%, the largest series describing short- sions based on the literature available at term complications in 289 women noted the time of their review: an erosion rate of 10% with transvaginal placement of loosely woven polypropy- Native tissue repair remains appropriate lene mesh.11 when compared with biologic graft use or absorbable synthetic graft use for all com- Other complications such as fistula, partments de novo dyspareunia, and chronic pain www.clinicalobgyn.com Mesh for Pelvic Organ Prolapse 101 have also been reported but mostly in was noted in 94% and 93%, respectively case reports and small series. In October (P = 0.90), the proportion with stage 3 2008, the Food and Drug Administra- or 4 prolapse was similar 3% versus 0% tion (FDA) issued a public health noti- (P = 0.11) and the rate of reoperations fication (http://www.fda.gov/cdrh/safety/ for prolapse recurrence was only 1% in 102008-surgicalmesh.html) and made re- each group. Moreover, the women whose commendations regarding the serious surgery was augmented with mesh had a complications associated with transvagi- higher rate of new onset stress urinary nal placement of surgical mesh for the incontinence (22% vs. 10%, P<0.02) repair of pelvic organ prolapse and stress and mesh exposure (17% vs. 0%).5 This urinary incontinence in which they de- trial illustrates the balance of risks and scribe receiving 1000 reports of compli- benefits that the surgeon and patient cations over 3 years (Table 1). The most must consider before considering the use frequent complications noted in the FDA of vaginal mesh or graft for the treatment public health notification included ero- of pelvic organ prolapse. sion through vaginal epithelium, infection, To summarize, the current evidence pain, urinary problems, and recurrence of would support the use of synthetic mesh prolapse and/or incontinence. Also noted to augment repairs of anterior vaginal was vaginal scarring, which in some cases prolapse but at the expense of an increased led to a significant decrease in patient rate of complications, particularly mesh quality of life due to discomfort and pain, exposure. More data is needed to deter- including dyspareunia. mine the role of synthetic vaginal mesh A recent randomized trial by Hiltunen use for posterior vaginal wall and apical et al5 that compared anterior colporraphy prolapse and to determine the role of with and without polypropylene mesh biologic grafts in vaginal prolapse repairs augmentation provides a good example for all segments. of both the benefits and risks of vaginal mesh use. In this trial, the cure rate 12 months after surgery (defined as pelvic Indications and Preoperative organ prolapse quantification stage 0 or 1) Preparation was significantly higher after the mesh- Given the current state of the literature, augmented repair compared with standard clinical judgment must be relied upon to anterior colporraphy (61.5% vs. 93.3%, determine the indications for using trans- P<0.001). However, symptomatic cure vaginal mesh use at this time. Surgeons’ (absence of vaginal bulge symptoms) views differ as to when using mesh for this TABLE 1. FDA Administration Public Health Notification Recommendations: Serious Com- plications Associated with Transvaginal Placement of Surgical Mesh in Repair of Pelvic Organ Prolapse and Stress Urinary Incontinence Obtain specialized training for each mesh placement technique and be aware of its risks Be vigilant for potential adverse events from the mesh, especially erosion and infection Watch for complications associated with the tools used in transvaginal placement, especially bowel, bladder, and blood vessel perforations Inform patients that implantation of