Insertion and Removal of Vaginal Mesh for Pelvic Organ Prolapse

CLINICAL OBSTETRICS AND GYNECOLOGY Volume 53, Number 1, 99–114 r 2010, Lippincott Williams & Wilkins

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 biologic 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 surgical mesh is permanent, and that some complications associated with the implanted mesh may require additional surgery that may or may not correct the complication Inform patients about the potential for serious complications and their effect on quality of life, including pain during sexual intercourse, scarring, and narrowing of the vaginal wall (in pelvic organ prolapse repair) Provide patients with a written copy of the patient labeling from the surgical mesh manufacturer, if available

www.clinicalobgyn.com 102 Muffly and Barber indication is justified. Some surgeons feel It is also important to consider preo- that transvaginal mesh is indicated for perative patient characteristics when primary repair in any patient who seeks weighing the risks and benefits of trans- durability and who are willing to accept vaginal mesh use for a particular patient. the known risks of surgery. Others choose Patients with significant urogenital atro- to be more cautious and only use mesh phy who have thin vaginal walls may in elderly women who are not sexually be at risk for mesh erosion or exposure active. Many surgeons consider a mesh- after mesh placement. Most experts augmented repair for recurrent prolapse would advocate local estrogen therapy or for patients with a high risk of prolapse preoperatively provided there are no con- recurrence. Well-known risk factors for traindications to its use. Chronic steroid recurrent prolapse include connective tis- use, smoking, uncontrolled diabetes mel- sue disorders, chronic pulmonary disor- litus, or other causes of a compromised ders, stage 3-4 prolapse, and a history of immune system can impair wound healing smoking. In contrast, some clinicians and may wound consider these conditions feel that the risks of transvaginal mesh relative contraindications to vaginal mesh placement outweigh the benefits and only placement. Pelvic pain syndromes such as offer native tissue repair. At the Cleve- endometriosis, vulvodynia, interstitial cysti- land Clinic, we generally reserve the use tis, fibromyalgia, and dyspareunia should of transvaginal mesh for women who be evaluated preoperatively to allow for have recurrent isolated anterior vaginal comprehensive counseling as to the best sur- prolapse with a well-supported apex. An- gical and nonsurgical form of treatment. other population in which we are using In addition to a history of chronic pain, transvaginal mesh is women with stage current and future sexual activity is an- 3-4 uterovaginal prolapse who desire other factor to consider when choosing uterine preservation but not future child- a transvaginal mesh procedure. Mesh bearing. To date, no studies have com- does not have the same elasticity as the pared the impact of these patient selection vaginal wall and therefore may alter the factors on success of pelvic organ pro- functionality of the vagina. A recent study lapse repair using transvaginal mesh. addressed the question of whether trans- There are several situations where mesh vaginal mesh placement worsens sexual use is contraindicated. Many surgeons function 1 year postoperatively. Among would not consider the use of mesh in a women with low or no dyspareunia symp- patient who has had a previous mesh toms at baseline, 23% complained of complication. Mesh augmentations should new onset dyspareunia after transvaginal not be used in pregnant women or women mesh placement. However, in women with who are contemplating future pregnancy higher rates of dyspareunia preoperati- as the mesh does not stretch significantly vely, 45% had improvement postopera- as the patient grows. In patients who have tively. Altman et al12 concluded that overall had pelvic radiation, mesh placement is sexual function worsened after vaginal not recommended because of the risk of mesh placement, but the rates and severity poor wound healing. Similarly, preexisting of dyspareunia neither improved nor wor- local or systemic infection is a contraindi- sened. Some surgeons do not place per- cation for vaginal mesh placement, parti- manent synthetic mesh in sexually active cularly nonabsorbable synthetic mesh. women because of reported de novo dys- Most surgeons would not recommend pareunia and/or altered sexual function. the use of nonabsorbable synthetic mesh More research is needed on the ideal if colorectal surgery is being performed candidate for mesh placement. In most concurrently. cases, the decision to use or not use www.clinicalobgyn.com Mesh for Pelvic Organ Prolapse 103 mesh is based on the surgeon’s best clin- There are several categories of non- ical judgment after carefully weighing absorbable mesh used in pelvic floor the risks and benefits for the individual reconstruction. Amid et al14 classified patient. This must be accompanied by materials based on pore size because of careful preoperative counseling so that its association with infection risk. Mesh the patient is fully aware of the potential with pores greater than 75 mm in size benefits and risks and can make an in- allows the free passage of leukocytes formed decision. A significant emphasis and macrophages which minimizes the of the FDA notification was proper pre- risk of infection. Monofilament synthetic operative counseling before transvaginal meshes that have interstices that are mesh placement. This counseling includes smaller than this may increase the risk of informing patients about the following: infection. All the products examined in (1) implantation of surgical mesh is per- this article use monofilament Amid Type I manent, (2) some complications associated macroporous structure (>75 mm) made with the implanted mesh may require from polypropylene which is the current additional surgery that may or may not mesh of choice for vaginal prolapse re- correct the complication, and (3) there is pair. Polypropylene has a low flexural the potential for serious complications rigidity and is able to remain inert in that may affect quality of life, including an infected field. Recent generations of pain during sexual intercourse, scarring, synthetic mesh use a loose weave to and narrowing of the vaginal wall. make it more accessible to fibroblast migration. This structure is said to pre- Transvaginal Mesh Materials vent encapsulation and scar formation. After deciding to use surgical prostheses, To address problems of dyspareunia the surgeon will have multiple materials and vaginal stiffness, many manufac- from which to choose. The ideal prosthe- turers have recently attempted to improve sis is nonallergenic, noncarcinogenic, the biologic integration and mechanical not modified by tissue fluid, no immune elasticity of synthetic mesh by incorpor- response, manufactured to shape, sterile, ating absorbable synthetic materials or resistant to infection, prevents adhesions, biologic materials with polypropylene and fails at supraphysiologic tensile mesh. One example is the Prolift+ M strength.13 Today’s mesh materials in- (Ethicon Women’s Health & Urology, clude absorbable and nonabsorbable syn- Sommersville, NJ), which consists of thetic mesh and biologic grafts. Currently poliglecaprone-25 knitted with polypro- available absorbable synthetic mesh in- pylene mesh. In 3 months, the poligleca- cludes Polyglactin 910 and polyglycolic prone-25 is absorbed leaving a lower acid (Fig. 1). burden of polypropylene in the vagina

FIGURE 1. Synthetic mesh in surgery.

www.clinicalobgyn.com 104 Muffly and Barber than the classic Prolift kit.15 Some mesh biologic graft does not improve anatomic products like the Avaulta Anterior Plus outcomes when compared with native (CR Bard, Inc, Covington, GA) have a tissue repair.7,8 In fact, one trial of recto- hydrophilic porcine collagen biologic cele repair noted worse anatomic out- coating to minimize tissue adhesions. comes with the use of a porcine-derived, The absorbable coating is said to limit acellular collagen matrix graft compared adhesion formation by acting as a mech- with traditional posterior colporraphy.16 anical barrier in the first 10 to 14 days As such, the routine use of biologic grafts after surgery when inflammation peaks. in prolapse repair cannot be recom- Little or no clinical data exists evaluating mended. If the surgeon determines that whether these newer multimaterial pro- graft augmentation is warranted there ducts improve outcomes or decrease com- are, however, certain circumstances where plication rates compared with standard biologic grafts might be considered over loosely woven polypropylene mesh. Cur- permanent synthetic grafts including his- rently no products meet all the required tory of a complication from synthetic characteristics of the ideal pelvic recon- mesh or concurrent colorectal resection. structive surgery prosthesis. Biologic grafts used in reconstructive surgery can broadly be divided into those Review of Mesh Placement derived from human tissue (allografts) Options and those derived from other species (xe- The 3 general categories of transvaginal nografts) (Fig. 2). Although commonly mesh placement options for the manage- used to augment anterior and posterior ment of pelvic organ prolapse are: (1) self- vaginal prolapse repairs, there is no tailored mesh, (2) commercially available available evidence suggesting the use of trocar-guided mesh kits that use a trans- these grafts improve outcomes. Both the obturator and/or transgluteal approach, Cochrane Review and the SGS systematic and (3) commercially available mesh kits review concluded that current evidence that do not use trocars but rather one of a suggests that augmentation of anterior variety of transvaginal fixation methods and posterior vaginal prolapse repair with (non-trocar kits).

FIGURE 2. Biologic graft implants. www.clinicalobgyn.com Mesh for Pelvic Organ Prolapse 105

No matter what placement option is points can vary among patients on ac- used, the general surgical approach to count of the 4 basic types of bony pelvis treat anterior vaginal wall prolapse is configurations. The trocar-guided kits fixation of mesh to the arcus tendineus currently available include Prolift (Ethi- fascia pelvis (ATFP) or the iliococcygeus con, Somerville, NJ); Apogee and Perigee muscle (Table 2). A deep sagittal colpot- (American Medical Systems, Minneton- omy incision is made into the paravesical ka, MN); and Avaulta (CR Bard, Murray and pararectal spaces using copious hy- Hill, NJ). Trocar-guided systems use a drodissection. The mesh is spread later- precut sheet of graft material with narrow ally toward the ATFP proximally and lateral appendages for fixation. Non-tro- distally. Similarly, most mesh is fixed car mesh kits include Elevate (American to the sacrospinous ligament or the pre- Medical Systems, Minnetonka, MN) as spinous musculature and the ATFP to well as Pinnacle and Uphold (Boston address posterior prolapse. Scientific, Natik, MA) (Fig. 3). Pelvic surgeons began using a self- Despite the lack of evidence that any tailored mesh for mesh augmentation pro- one placement technique is best in mana- lapse repair because ligamentous fixation ging a patient’s symptoms, most experts

TABLE 2. Characteristics of Mesh Kits for Pelvic Organ Prolapse Repair

Name (Company) Segment Material Delivery System Fixation Point Cost

Apogee Posterior Polypropylene ± Transgluteal Iliococcygeous muscle 1-2 cm $1595 (American apical biologic coating trocar distal to ischial spine Medical Systems) Perigee Anterior Polypropylene ± Helical ATFP and iliococcygeous $1395 (American apical biologic coating transobturator muscle 1-2 cm distal to Medical trocar ischial spine Systems) Anterior Elevate Anterior Polypropylene Trocarless with Sacrospinous ligament and $1895 (American apical self-fixating obturator internus Medical arms Systems) Posterior Elevate Posterior Polypropylene Trocarless with Sacrospinous ligament $1595 (American apical self-fixating Medical arms Systems) Pinnacle (Boston Anterior Polypropylene Capio device ATFP and sacrospinous $1899 Scientific) apical ligament Uphold (Boston Anterior Polypropylene Capio device Sacrospinous ligament $1650 Scientific) apical Anterior Avaulta Anterior Polypropylene ± Transobturator ATFP and iliococcygeous $1695 mesh+ (CR Bard) apical biologic coating and muscle 1-2 cm distal to $299 trocar transgluteal ischial spine trocars Posterior Avaulta Posterior Polypropylene ± Transobturator Iliococcygeous muscle 1-2 cm $1695 mesh+ (CR Bard) biologic coating and distal to ischial spine $299 trocar transgluteal trocars Anterior Prolift Anterior Polypropylene ± Transobturator ATFP $1575 (Gynecare) poliglecaprone-25 trocar with cannula Posterior Prolift Posterior Polypropylene ± Transgluteal ATFP and sacrospinous $1575 (Gynecare) apical poliglecaprone-25 trocar with ligament cannula

ATFP indicates arcus tendineous fascia pelvis.

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FIGURE 3. Comparison of mesh and trocars. would agree on some basic perioperative All techniques should be performed with tenets: the patient in the dorsal lithotomy position The bladder should be drained with a with the knees flexed to 90 degrees. transurethral catheter. Avoid making inverted ‘‘T-shaped’’ inci- A well-estrogenized vaginal wall is preferred sions from a concurrent hysterectomy and before surgery [we use intravaginal estrogen colporrhaphy. cream daily (0.5 to 1.0 g/d) for 2 to 3 wk pre- Exposure of the correct vesicovaginal and operatively]. A vaginal pessary should be rectovaginal planes are performed with removed 1 to 2 weeks before surgery to limit hydrodissection of 20 to 80 mL 0.5% lido- vaginalepitheliumirritation. caine with 1:200,000 epinephrine, dilute As with all pelvic reconstructive surgery, pitressin (20 units in 60 to 100 mL of saline), the procedure should be initiated after anti- or normal saline. The correct space for biotic prophylaxis with a first or second dissection is found using a ‘‘loss of resis- generation cephalosporin 1 hour before tance’’ technique similar to that used by surgery (cefuroxime 1.5 g intravenously). an anesthesiologist placing an epidural. www.clinicalobgyn.com Mesh for Pelvic Organ Prolapse 107

A wheal or blanching illustrates incorrect intraepithelial placement of the fluid. Hy- drodissection in the correct plane will cre- ate a fluid bubble in the avascular vesicovaginal and rectovaginal spaces. As opposed to an anterior colporrhaphy where the vaginal epithelium and muscularis are split for plication, mesh should be placed underneath the vaginal muscularis. It is vital that the surgeon perform a full-thickness dissection deep into the vesicovaginal and rectovaginal spaces to avoid erosion of the mesh postoperatively. Pro- per hydrodissection, as described above, FIGURE 4. Use of a surgeon tailored mesh facilitates the identification of the proper into a trapezoid shape and attached to the dissection plane. arcus tendineus fascia pelvis. From Am J The mesh should be placed loosely. Loosely Obstet Gynecol. 2006;195:1832–1836. place the prosthesis because mesh can contract by up to 20% after placement sion, and infracoccygeal sacropexy. No compromising vaginal length and caliber. Allow enough room for Mayo scissors to studies have compared standard repair be easily placed between the mesh and techniques using self-tailored mesh with the vagina. In addition, ensuring that the other mesh placement techniques. mesh is placed flat and minimal tension will improve fibroblast growth and mini- TROCAR-BASED MESH KITS mize complications of pain or erosion. Trocar-guided devices can be used to The vaginal epithelium should not be suspend mesh by passing needles through trimmed. Trimming the vaginal epithelium the transobturator and ischiorectal can lead to discomfort and may also con- fossa. Although a variety of different tract. The colpotomy incision is closed using kits are available, the technique is ge- a non-locking continuous absorbable suture. nerally similar. For kits designed to augment Cystoscopy, digital rectal examination and, the anterior vaginal segment, a weighted if necessary, protoscopy should be per- speculum, self-retaining retractor, or formed routinely after mesh placement to identify potential visceral injury. Deaver retractors are placed in the vagina. Allis clamps are positioned at the urethrovesical junction for traction and 1 cm proximal to the vaginal apex. The SELF-TAILORED MESH PLACEMENT bladder can be palpated between the 2 FOR PROLAPSE REPAIR Allis clamps. As opposed to an anterior Self-tailored mesh can be customized by colporrhaphy in which the vaginal epithe- the surgeon to match the size and shape of lium and muscularis are split for plication, each patient’s individual pelvic anatomy. the mesh is placed underneath the mus- Mesh is cut into a trapezoid multiarmed cularis to maintain a vascularized epithe- shape for compartment augmentation lium. To enter this potential space, the and fixed to sacrospinous ligaments, ob- surgeon injects a dilute vasopressin solu- turator fascia, ATFP, and/or the distal tion of 0.5% lidocaine with 1:200,000 bladder neck (Fig. 4).17 This type of sur- epinephrine underneath the vaginal mus- gery requires a strong set of vaginal surgi- cularis to facilitate dissection and mini- cal skills as it involves dissections similar mize blood loss. Irrigation may help to sacrospinous ligament fixation, iliococ- during the dissection as the defect is a cygeus suspension, uterosacral suspen- glistening white line. A sagittal colpotomy

www.clinicalobgyn.com 108 Muffly and Barber incision is made between the Allis clamps fingers placed into the vagina can retract long enough to admit 2 fingers com- the colon, elevate the bladder, and mini- fortably. Next, countertraction along the mize deviation of the trocar tip with direct entire incision line is achieved with either palpation. For anterior compartment serial Allis clamps or a self-retaining mesh, the surgeon immediately identifies retractor. The vaginal epithelium and the incoming trocar passing through muscularis are dissected away from the the ATFP. The Perigee system uses a bladder defect. Sharp and blunt dissection proprietary helical trocar which pierces of the bladder is then performed while the iliococcygeus muscle rather than the keeping the muscularis and epithelium sacrospinous ligament at the level of the on the vaginal flaps. As this full-thickness ischial spine akin to the IVS Tunneler dissection plane is advanced, superiorly (Tyco Healthcare, US Surgical, Norwalk, loose areolar tissue is encountered. CT). Other transobturator mesh kits such The posterior incision is 4 to 5 cm long as the Anterior Prolift use a slightly C- in the posterior vaginal epithelium 1.5 cm shaped curved trocar for passes. Through below the vaginal apex. Again, the inci- the posterior dissection, support can also sion should be deep where the moving tips be re-established. The posterior Prolift of the Metzenbaum scissors are not visible and Apogee systems tunnel through the as the surgeon removes the muscularis ischiorectal fossa to the midportion of the from the rectum side of the dissection. sacrospinous ligament. The prosthesis is The posterior dissection of the ischiorec- loosely placed in a ‘‘tension-free’’ manner tal space extends to the level of the ischial because mesh can contract by up to 20% spines and the sacrospinous ligament after placement, compromising vaginal with a combination of sharp and blunt length and caliber. A finger should be dissection. To perform this posterolateral kept inside the vagina whenever tension- dissection, we use Briesky-Navratil re- ing the graft. This provides countertrac- tractors and long instruments. At the time tion and splints the tissue at the points of this step is performed, the mesh is pre- fixation. A rectovaginal examination pared to be placed into the dissected gently pushes cephalad to confirm the paravaginal and/or pararectal space. absence of tension on the rectum and After the mesh is prepared by slightly anterior or posterior trocar-guided mesh trimming the precut shape, the prosthesis appendages. Stay sutures can be used to is implanted. The most common mesh help the mesh lay flat against the vagina. revision is dividing the mesh into anterior If the surgeon conserves the uterus, then and posterior pieces. The mesh should be permanent sutures can be placed into the altered this way if the uterus will be pre- cervical stroma to stabilize the mesh served or to maximize apex elasticity. If and prevent enterocele. A cystoscopic less than 1 cm of space remains between and rectal examination before, during, the anterior and posterior mesh pieces, and after each portion of the surgery then enterocele may be prevented. The can be helpful. Once adequate hemostasis lateral edges of the mesh may be scalloped is obtained, the vaginal epithelium is as needed in women with narrow pelvises. closed with a continuous non-locking Cutaneous incisions that are 4 to 7 mm in stitch of delayed absorbable suture. Pla- length are made over the obturator fora- cing a lubricated vaginal pack may mini- men and gluteus to pass trocars. When mize bleeding and keep the mesh flat placing multiple mesh arms through the during healing. After desired tensioning, transobturator space, the superior and all ends of the mesh arms should be inferior puncture sites should be at least trimmed below the surface of the skin, 3 cm apart so the mesh can lay flat. Two the cannulaes exteriorized if used, and the www.clinicalobgyn.com Mesh for Pelvic Organ Prolapse 109 incisions closed. Concurrent procedures, such as a pubovaginal sling, should be carried out through a separate vaginal incision at this time.

NON-TROCAR MESH KITS Unlike trocar-guided kits, which require a level of comfort with the transobturator space, the non-trocar kits use a standard vaginal sharp dissection approach to the ligaments of the pelvis. Possibly as a result of the general adversity to blind procedures, many surgeons have embraced the total vaginal approach. With completely transvaginal kits, the mesh appendage placement can be carried out under direct visualization. The technique for the non-trocar kits FIGURE 5. Fixation devices for non-tro- begins similarly to the technique for trocar mesh kits. car-guided kit placement. After the vesicovaginal and/or rectovaginal space(s) are dissected, pertinent fixation points vagina palpates the anterior tendineus are identified. The sacrospinous ligament fasciae pelvis from the ischial spine to mesh arms serve to elevate the prolapsed the posterior pubis. The mesh can be vagina above the pelvic floor and secure it passed through the upper third of the in a posterior midline axis. The surgeon ATFP using the same fixation methods. can identify the ischial spine if he or she With the Uphold device, there are no displaces the rectum contralaterally. The ATFP arms to implant. The mesh arms operator’s index and middle fingers are are slowly and individually adjusted to a placed at the medial aspect of the patient’s loose tension, then the mesh is sutured ischial spine. Once identified, any fibrous flat. The vagina is minimally trimmed tissue from the sacrospinous ligament of any areas where Allis clamps may point of insertion is cleaned off using have caused ischemia. When the vaginal a finger sweep medially. The surgeon epithelium is removed during any proce- palpates the location of interest, then dure, excessive vaginal wall trimming identifies the sacrospinous ligament one should be avoided because the redun- fingerbreadth medial to the ischial spine. dancy of vaginal tissue over the mesh The ligament is penetrated using the sur- will be reduced as the epithelium scars. geon’s device of choice. The Pinnacle and The colpotomy is closed and the vagina Uphold kits use the Capio transvaginal packed as described above. suture capturing device (Boston Scienti- fic, Natik, MA) to suture the mesh arms to the sacrospinous ligament, and ATFP. Management of Mesh Alternatively, the Elevate system (Amer- Complications ican Medical Systems, Minnetonka, MN) Mesh or graft erosion, one of the most uses self-fixating appendage tips delivered common postoperative complications, is by vaginal trocars to the same site (Fig. 5). unique to graft placement. Treatment The ATFP mesh arms ensure lateral options consist of observation, treat- spread. An index finger placed into the ment with estrogen cream, office excision,

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FIGURE 6. Mesh erosion treatment algorithm. OR indicates operating room. excision in the operating room, and removal 2 weeks as the epithelium becomes better of the maximum amount of mesh or graft estrogenized.18 The patient will return for (Fig. 6). If the patient is asymptomatic, examination 6 to 8 weeks after treatment not sexually active, and the erosion is very is instituted. We continue this regimen small (<3 mm) or if the use of vaginal if improvement is noted. Some providers estrogen is contraindicated, we will con- use intravaginal metronidozole gel or sider observation. The patient will be other intravaginal antibiotic ointments observed at 3 and 6 months and then for managing small mesh erosions, how- followed every 6 to 12 months. Although ever, no data are available on the efficacy the erosion will often not heal sponta- of this approach. neously, it rarely progresses. For most If the erosion persists after estrogen use patients, however, we advocate the use or if the use of vaginal estrogen is contra- of vaginal estrogen. Admittedly, there is indicated, we will proceed to mesh exci- little evidence to suggest an improved sion. When the erosion is less than 5 mm, rate of healing with vaginal estrogen over excision can often be accomplished in the observation alone. However, given the office. The area will be injected with local known effects of vaginal estrogen on the anesthetic and a clamp (Allis, tonsil) will vaginal epithelium and blood supply, it be used to grasp the mesh or graft. The seems a reasonable conservative option exposed mesh or graft will be excised for managing small mesh erosions or sharply. The edges of vaginal epithelium exposures. Although many different will be trimmed and reapproximated treatment regimens are available, we using absorbable suture. If the patient will typically use 1 g of vaginal estrogen cannot tolerate this procedure in the of- nightly for 2 weeks and then 3 times fice, it can easily be accomplished in the weekly thereafter. The systemic absorp- operating room. When the mesh exposure tion is minimal, especially after the first is larger than 5 mm, we prefer to perform www.clinicalobgyn.com Mesh for Pelvic Organ Prolapse 111 this procedure in the operating room, (CooperSurgical, Trumbull, CT) is used to as more tissue has to be mobilized and aid visualization and exposure. reapproximated. In these cases, the mesh 3. The vaginal epithelium covering the mesh is excised as described above. The edges is injected with a dilute vasoconstricting of the vaginal epithelium are mobilized, agent for hydrodissection and hemostasis. creating a 5 to 10 mm circumferential flap. The vaginal epithelium is then opened with a scalpel, and the flaps of the vaginal Then, the vaginal epithelium is reapproxi- epithelium are developed with sharp dis- mated. Care should be taken to avoid section, using a similar technique seen in putting tension on the repair or narrow- the initial steps of mesh placement. Care is ing the vagina. Postoperatively, we treat taken to develop a vaginal epithelium flap patient with vaginal estrogen until the as thick as possible to prevent button holes area is well-healed. and tearing, which can require removal In cases where mesh excision has failed, of a large portion of the epithelium, thereby when the exposure is greater than 1 to placing the patient at risk for vaginal nar- 2 cm, or when infection, fistula, or chronic rowing. This dissection is performed as far pain is present, we advocate removal of laterally as possible to achieve adequate the majority of the mesh. Although this visualization. procedure can be technically difficult, our 4. When removing polypropylene mesh, the surgeon will find it often interlaced with experience suggests that it can be per- fibrotic scar tissue, whereas biologic graft formed safely with few complications tends to be encapsulated. For mesh, once and high relief of symptoms, although the layer containing the mesh and the 19 some symptoms can persist. If the mesh fibrotic overlay is identified, the surgeon was originally placed from a completely mobilizes this layer away from the bladder transvaginal approach, then it may be or rectum, starting either in the midline or possible to remove the mesh in its entirety. laterally, wherever access is easier. Later- If trocars were used to place the mesh, as is ally, an instrument such as a right angle the case with many commercially avail- clamp, Kelly clamp, or tonsil clamp is used able mesh kits, it is often not possible or to undermine beneath the mesh tissue layer prudent to remove the arms of the mesh to provide a starting point. In cases where there is no access laterally, the mesh is because they pass through the ischiorectal incised in the midline using a scalpel, taking fossa and/or obturator space. In these care to avoid the underlying bladder or cases, we advocate removal of as much rectum. of the mesh as possible through a vaginal 5. Once an edge is identified, it is then grasped approach while leaving the mesh arms with Allis clamps to provide traction. The in place. Our technique for transvaginal bladder or rectum is then dissected off the mesh removal is as follows: mesh, using sharp dissection with scissors and gentle blunt dissection to peel the 1. At the initial clinic visit, the operative underlying tissue or vaginal skin from the notes are requested and reviewed. This mesh (Fig. 7). Hydrodissection, firm trac- allows preoperative planning and provides tion of the mesh flap away from the bladder expectations that guide initial surgical or rectum, and pointing the tips of the dissections. Metzenbaum scissors toward the mesh 2. An examination under anesthesia is per- and away from the bladder or rectum are formed and the problematic areas of mesh used to avoid visceral injury. This traction are identified. The mesh is usually easy is also valuable in visualizing the lateral to palpate vaginally and rectally. Initial mesh arms (Fig. 8). cystoscopy, rectal examination, and/or 6. Once the mesh arms are visualized, ten- proctoscopy are used to identify the pre- sion is used to expose the maximum sence of mesh in the bladder or rectum on a amount of mesh. The mesh arms are trans- case-by-case basis. A Lone Star retractor ected at the most lateral aspect possible.

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FIGURE 8. The bladder or rectum was dissected off the mesh, using sharp dissection FIGURE 7. The vaginal epithelium was with scissors and gentle blunt dissection with a opened with a scalpel and flaps of vaginal peanut, finger, or sponge to peel the under- epithelium were developed with sharp dis- lying tissue or vaginal skin from the mesh. section, using a similar technique seen in the initial steps of colporrhaphy. mesh or graft for the treatment of recurrent prolapse at the time of mesh removal. Neovascularization of the mesh arms is 9. Upon completion, cystoscopy and rectal exa- frequently noted and suture ligation of mination and/or proctoscopy are performed the arms and surrounding tissue is often necessary to control bleeding (Fig. 9). Con- trolling bleeding is especially important when dissecting the posterior mesh arms as it requires entry into the ischiorectal fossa where bleeding is often encountered. 7. For the excision of posterior mesh, a finger placed in the rectum during dissection is used to delineate the superior, inferior, and lateral borders of the mesh and further helps to avoid proctotomy. 8. As discussed above, it is often not possible to remove all of the mesh, including the lateral portions of the mesh arms travel- ing through the obturator foramen and ischiorectal fossa. Once the excision is com- plete and hemostasis is achieved, the vaginal epithelium is then reapproximated. If FIGURE 9. Once a mesh edge was identi- recurrent prolapse is present, concomitant fied, it was grasped with Allis clamps to procedures to correct pelvic organ prolapse provide traction. This traction was also valu- using native tissue can be performed when able in visualizing the lateral mesh arms. necessary. We do not advocate placing www.clinicalobgyn.com Mesh for Pelvic Organ Prolapse 113

to rule out visceral injury. The vagina pelvic organ prolapse and urinary in- is packed overnight to assist with hemo- continence. Obstet Gynecol. 1997;89: stasis. 501–506. 2. Clark AL, Gregory T, Smith VJ, et al. Conclusions Epidemiologic evaluation of reoperation In conclusion, the use of synthetic mesh for surgically treated pelvic organ pro- for transvaginal repair of pelvic organ lapse and urinary incontinence. Am J prolapse results in improved anatomic Obstet Gynecol. 2003;189:1261–1267. outcomes for the anterior vaginal wall 3. Scott N, Go Peter MNYH, Graham P, but with a higher rate of complications et al. Open mesh versus non-mesh for groin hernia repair. Chichester, UK: John when compared with traditional native Wiley & Sons, Ltd; 2001. tissue repairs. There is currently insuffi- 4. Maher C, Baessler K, Glazener CM, et al. cient data to determine the role of Surgical management of pelvic organ transvaginal mesh for apical or posterior prolapse in women: a short version vaginal wall prolapse. Moreover, there Cochrane review. Neurourol Urodyn. are no long-term data for pelvic floor 2008;27:3–12. repairs using mesh and therefore in- 5. Hiltunen R, Nieminen K, Takala T, formed consent for transvaginal mesh et al. Low-weight polypropylene mesh placement should be a thorough process. for anterior vaginal wall prolapse: a There remains little data regarding the randomized controlled trial. Obstet Gy- ideal prosthesis delivery that minimizes necol. 2007;110(2 Pt 2):455–462. morbidity while maximizing anatomic 6. Nguyen JN, Burchette RJ. Outcome after anterior vaginal prolapse repair: and subjective outcomes. Thus, treatment a randomized controlled trial. Obstet should be individualized, based on pro- Gynecol. 2008;111:891–898. vider experience and patient preference, 7. Murphy M. Society of Gynecologic depending on their tolerance for risk. All Surgeons Systematic Review. Clinical patients considering transvaginal mesh practice guidelines on vaginal graft use should be offered a copy of the FDA from the society of gynecologic surgeons. public health notification, before provid- Obstet Gynecol. 2008;112:1123–1130. ing consent. In addition, the patient 8. Maher C, Baessler K, Glazener CM, et al. should be provided a written copy of the Surgical management of pelvic organ labeling from the surgical mesh manu- prolapse in women. Cochrane Database facturer, if available. Document that an Syst Rev. 2007;3:CD004014. 9. Diwadkar GB, Barber MD, Feiner B, adequate trial of medical or nonsurgi- et al. Complication and reoperation rates cal management has been offered and after apical vaginal prolapse surgical re- attempted or refused (informed refusal) pair: a systematic review. Obstet Gynecol. before any operative procedure. Un- 2009;113(2 Pt 1):367–373. known durability and lack of long-term 10. Debodinance P, Berrocal J, Clave H, et al. data are the unique risks of mesh and Changing attitudes on the surgical treat- should be discussed. Physicians who ment of urogenital prolapse: birth of the have a strong understanding of the consent tension-free vaginal mesh. J Gynecol process and the variety of various mesh Obstet Biol Reprod. 2004;33:577–588. options will be best prepared to illustrate 11. Abdel-Fattah M, Ramsay I, West of the risks and benefits of transvaginal mesh. Scotland Study Group. Retrospective multicentre study of the new minimally invasive mesh repair devices for pelvic organ prolapse. BJOG. 2008;115:22–30. References 12. Altman D, Elmer C, Kiilholma P, et al. 1. Olsen AL, Smith VJ, Bergstrom JO, et al. Sexual dysfunction after trocar-guided Epidemiology of surgically managed transvaginal mesh repair of pelvic organ

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prolapse. Obstet Gynecol. 2009;113: three surgical techniques including graft 127–133. augmentation. Am J Obstet Gynecol. 2006; 13. Cosson M, Debodinance P, Boukerrou 195:1762–1771. M, et al. Mechanical properties of 17. Simsiman AJ, Luber KM, Menefee SA. synthetic implants used in the repair of Vaginal paravaginal repair with porcine prolapse and urinary incontinence in dermal reinforcement: correction of women: which is the ideal material? Int advanced anterior vaginal prolapse. Am Urogynecol J Pelvic Floor Dysfunct. 2003; J Obstet Gynecol. 2006;195:1832–1836. 14:169–178; discussion 178. 18. Pschera H, Hjerpe A, Carlstrom K. 14. Amid PK, Shulman AG, Lichtenstein IL, Influence of the maturity of the vaginal et al. Biomaterials for abdominal wall epithelium upon the absorption of hernia surgery and principles of their vaginally administered estradiol-17 beta applications. Langenbecks Arch Chir. 1994; and progesterone in postmenopausal 379:168–171. women. Gynecol Obstet Invest. 1989;27: 15. Cobb WS, Kercher KW, Heniford BT, 204–207. et al. The argument for lightweight poly- 19. Ridgeway B, Walters MD, Paraiso MFR, propylene mesh in hernia repair. Surg et al. Early experience with mesh excision Innov. 2005;12:63–69. for adverse outcomes after transvaginal 16. Paraiso MF, Barber MD, Muir TW, et al. mesh placement using prolapse kits. Am Rectocele repair: a randomized trial of J Obstet Gynecol. 2008;199:703.e1–703.e7.