Complications of Female Incontinence and Pelvic Reconstructive Surgery (Current Clinical Urology) 2nd ed.

8. Transvaginal Mesh Complications

Farzeen Firoozi  and Howard B. Goldman2, 3

(1)

Center for Pelvic Health and Reconstructive Surgery, The Arthur Smith Institute for Urology, Hofstra North Shore-LIJ School of Medicine, 233 7th Street, Suite 203, Garden City, NY 11530, USA

(2)

Center for Female Pelvic Medicine and Reconstructive Surgery, Glickman Urologic and Kidney Institute, The Cleveland Clinic, Cleveland, OH, USA

(3)

Lerner College of Medicine, Case Western Reserve University, Cleveland, OH, USA

Farzeen Firoozi

Email: farzeenfiroozi@aol.com

Abstract

The lifetime risk of requiring pelvic surgery for vaginal prolapse or incontinence for a woman in the United States is 11%, with a risk for reoperation of 29% [1]. Traditional vaginal repairs for prolapse using only the patient’s native tissues have had reported rates of recurrence ranging from 10 to 50% depending on the compartment repaired [2]. In the last 10 years, there have been advancements in pelvic floor reconstructive surgery to create repairs that are reproducible with improved subjective and objective outcomes.

Introduction

The lifetime risk of requiring pelvic surgery for vaginal prolapse or incontinence for a woman in the United States is 11%, with a risk for reoperation of 29% [1]. Traditional vaginal repairs for prolapse using only the patient’s native tissues have had reported rates of recurrence ranging from 10 to 50% depending on the compartment repaired [2]. In the last 10 years, there have been advancements in pelvic floor reconstructive surgery to create repairs that are reproducible with improved subjective and objective outcomes.

Initial attempts were made to augment transvaginal repairs using biologic grafts or absorbable synthetic mesh. In terms of anterior vaginal wall augmented repairs, Meschia et al. compared outcomes of anterior colporrhaphy with and without a porcine dermis onlay graft (Pelvicol™ [Bard Medical, Covington, GA]). The objective failure rate at 1 year, determined by pelvic exam, was 20% in the anterior colporrhaphy group vs. 7% in the porcine dermis onlay group [3]. In 2005, Gandhi et al. reported their experience with the use of solvent dehydrated cadaveric fascia lata (Tutoplast® [RTI Biologics, Inc., Alachua, FL]) in augmenting anterior vaginal wall repairs. Outcomes of anterior colporrhaphy with or without the cadaveric fascia lata were compared. The authors reported no difference in the objective and subjective outcomes between the two groups at 13 months follow up [4] in addition, Weber et al. failed to show any difference in cure rates between Vicryl mesh repairs vs. traditional anterior repairs [5].

The first trial to compare mesh vs. nonmesh repairs in the management of posterior wall vaginal prolapse was published by Sand et al. in 2001. In this study, absorbable Vicryl mesh was used for the augmented repair arm. The authors found virtually no difference in rectocele recurrence rates between the two groups [6]. In 2006, Paraiso et al. compared posterior colporrhaphy, site-specific repair and site-specific repair with porcine small intestine submucosal onlay graft for rectocele repair. From an objective standpoint, there was a higher recurrence rate of rectocele in the graft onlay group vs. the posterior colporrhaphy group. When comparing all three groups, there was no difference in subjective report of prolapse symptoms [7]. As a result of these types of studies, the use of biologic grafts or absorbable synthetic mesh had been largely abandoned as an alternative for augmenting traditional ­vaginal repairs of anterior and posterior compartment prolapse.

In terms of apical prolapse, the gold standard has been the abdominal sacrocolpopexy utilizing mesh attached to the vaginal wall. Success rates for managing apical prolapse repairs using mesh via an abdominal route range between 85 and 100% [2]. The safety of this approach has been well established in numerous studies reported over the last several decades [8].

The use of transvaginal mesh was initially adopted on a large scale after the introduction of synthetic slings for the treatment of urinary incontinence [9]. The safety of synthetic mesh slings has been well established over the last 15 years. The use of synthetic mesh slings for urinary incontinence has shown significant efficacy, durability, and safety, and led the way for innovation towards transvaginal mesh prolapse repairs. This was an intuitive step on the progression of improved transvaginal repairs, especially since biologic and absorbable synthetic mesh trials in the past had failed to demonstrate superiority to traditional repairs. The newly designed synthetic mesh kit procedures were first approved by the Food and Drug Administration (FDA) in 2003. Since their introduction over 8 years ago, a multitude of mesh kit procedures have become available on the commercial market. Although each is designed slightly differently the common goal has been to establish a new transvaginal repair that would prove safe, with improved efficacy and durability when compared to traditional repairs.

Hiltunen et al. reported a significant difference in anterior wall recurrence rates between their traditional repairs vs. their nonabsorbable mesh augmented repairs—38.7% and 6.7%, respectively [10]. Nguyen and Burchette found in their randomized controlled trial that the traditional repair arm had a recurrence rate of 45%, vs. 13% in the nonabsorbable mesh augmentation group [11]. In 2011, a randomized controlled trial of transvaginal mesh kit repair vs. traditional colporrhaphy for anterior vaginal wall prolapse was published in the New England Journal of Medicine by Altman et al. The overall rate of objective success, based on pelvic organ prolapse quantification (POP-Q) stages, was significantly higher in the mesh group (60%) compared to the traditional colporrhaphy group (35%) [12]. The purported benefit in most of these studies was the objective superiority of repairs involving nonabsorbable mesh augmentation. In addition, many of these studies showed trends towards improvements in subjective outcomes in those with mesh but these findings were not significant at the time points evaluated.

The use of synthetic mesh in transvaginal prolapse repairs has not been without controversy. At the heart of the controversy lies the concern by its opponents, that complications related to mesh use outweigh the benefit of augmenting repairs with synthetic mesh. The main issues at hand are the risks of pain, dyspareunia, and mesh extrusion or perforation requiring corrective surgery. Adding significant legitimacy to this side of the debate was the initial white paper published by the FDA in 2008 regarding the use of transvaginal mesh for both incontinence and prolapse surgery. The overall tone of the report was in keeping with the main concern of the detractors of mesh use, namely the risk for intra- and postoperative complications. The recommendations included the proper counseling of patients as to the potential risks of mesh use in incontinence and prolapse surgery. A recent update in July 2011 further expressed the concern for use of synthetic mesh for prolapse surgery, but very clearly separated the use of mesh for urinary incontinence—somewhat of an acknowledgement to the arguments made by many experts that the safety of synthetic mesh slings had been well established over almost 2 decades of study.

There are two general theories that explain the occurrence of mesh complications. The first is that synthetic mesh implanted in the vagina is simply prone to causing pain, extrusion, or perforation. The other is that it is generally problems with appropriate surgical technique that accounts for many mesh complications [13]. We will discuss this portion of the debate in our next section. Regardless, while the use of synthetic mesh has shown some utility in augmenting traditional transvaginal repairs of prolapse a very real aspect of these repairs are the potential intra- and postoperative complications related to the use of mesh. In this chapter, we will review techniques for avoiding complications, recognizing technical issues intra-operatively, and managing complications postoperatively.

Avoiding Complications of Transvaginal Mesh Repairs

Preoperative Considerations

Preoperative preparation of patients for transvaginal mesh repairs begins with optimization of vaginal tissue. We recommend the initiation of vaginal estrogen supplementation 4–6 weeks preoperatively to improve perioperative tissue quality. There are currently many options on the market including Premarin cream, Estrace cream, Vagifem, and E-string. The continued use of local hormone replacement postoperatively is recommended to maintain tissue quality and to facilitate tissue healing.

Certain patient populations with impaired wound healing or damaged vaginal skin may be at greater risk for mesh extrusion. Patients who have had pelvic radiotherapy, those on steroids and possibly smokers are examples of these types of patients. Very careful consideration of risk profiles and an acknowledgement of increased rates of extrusion should be undertaken before surgery is performed in this population.

Intra-operative Considerations

A cornerstone of transvaginal mesh repair is developing the proper plane of dissection. Probably the best way to accomplish this is with copious hydrodissection of the vaginal wall to aid in the actual sharp and blunt dissection that follows. The vaginal wall incision is made through the viscerofascial layer to the potential space (filled with a gelatinous fluid after hydrodissection) between the fascial layer (either pubocervical or prerectal) and the underlying viscera. This plane is much deeper than the typical superficial plane external to the viscerofascial layer used for a traditional repair. If the superficial plane is inadvertently utilized for mesh placement vaginal wall necrosis and ulceration or extrusion may ensue. In addition to vaginal wall extrusion, the risk for vaginal/pelvic pain and dyspareunia are increased by dissection and mesh placement in too superficial a plane.

Once dissection is completed hemostasis is of utmost importance. Initial postoperative pain following transvaginal mesh repairs can be secondary to perioperative bleeding. This is typically in the form of a hematoma, which can exert pressure on the vaginal tissues eliciting pain. In addition to pain, hematomas can also delay healing and promote wound separation. Wound separation in the setting of mesh use may result in extrusion of the synthetic material. For these reasons, it is paramount that adequate hemostasis is achieved at the completion of the case and a tight vaginal pack is typically placed overnight as well.

Dissection should be adequate to allow the mesh to lay flat over the defect both side to side and proximal to distal. When a trocar-based system is used one must take care to make the lateral dissection wide enough to allow the arms to be spread as they pass through that area to avoid bunching of the mesh. Bunching and buckling of the mesh can predispose to pain and extrusion.

Similar to placement of synthetic mesh slings, the mesh placed during transvaginal repair is meant to be placed without tension. The main reason for this surgical tenet is the avoidance of postoperative vaginal/pelvic pain. Whether a trocar or trocarless kit is used, there should be no tension after completion of mesh placement. This can be done by loosening the arms if a trochar-based system is used, and making a releasing incision in the body of the mesh if necessary. Again, the goal is placement of a tension-free system.

Prior to closure, the practice of vaginal wall trimming (common to traditional repairs) needs to be avoided in transvaginal mesh repairs. Only excoriated areas should be removed and only in a very judicious fashion. The reasoning behind minimization of vaginal wall trimming relates to the competency of the wound. A wound under tension has the increased risk of developing a possible separation or compromised coverage of the underlying mesh predisposing to extrusion of the synthetic graft.

Postoperative Considerations

A Foley catheter and vaginal packing are typically left indwelling at the completion of the case. The vaginal packing serves to tamponade the vagina and reduce the risk of postoperatively bleeding and can be removed within 24 h after surgery.

Intra-operative Complications

With correct dissection, bleeding involving the vaginal wall or the tissue remaining deep to this dissection plane should be minimal during transvaginal mesh repairs. If bleeding does occur on either the vaginal wall or plane of mesh placement, hemostasis can typically be achieved with electrocautery. If bleeding persists, absorbable suture placed in figure of eight interrupted fashion can be used as a further means of hemostasis. Bleeding can also occur with passage of external trocars or internal trocars with both anterior and posterior approaches. The first maneuver should be direct compression at the site of bleeding. If bleeding persists, optimal exposure of the site of bleeding is paramount. Typically, the source of bleeding is an aberrant vessel which cannot be managed with compression alone. Once further dissection is performed and exposure of the bleeding vessel is achieved, judicious placement of small clips may be performed to halt further bleeding. Some surgeons use hemostatic agents such as Floseal if there is venous oozing in a deep area where it is difficult to see. If significant bleeding cannot be controlled packing followed by embolization must be considered.

Another potential intra-operative complication of transvaginal mesh repair is injury to other pelvic organs including the bladder or rectum. If bladder injury occurs, multilayer closure of the cystotomy should be performed with absorbable suture. A Foley catheter should be left indwelling for approximately 10 days prior to cystogram for confirmation of bladder healing. If a rectal injury is encountered, consultation with surgery is recommended. The ultimate decision of primary repair of rectal injury vs. repair with diversion is at the discretion of the consultant surgeon. With either bladder or rectal injury, placement of mesh at the same setting is discouraged. The main concern for mesh placement would be a risk for mesh perforation of the organ given compromised tissue healing and infection after an injury.

Evaluation of Mesh Complications

History

There are a litany of complaints that patients can present with after transvaginal mesh repair. In this chapter we will concentrate on patients who present with mesh extrusions and perforations. In 2010, the ICS and IUGA created a classification system to help promote a universal language that could be used by all pelvic floor surgeons in order to aid with reporting of mesh complications. The new classification system uses three components to describe complications related to the use of prosthesis/grafts, which include the category (C), time (T) and site (S). The C includes the anatomical site which the graft/prosthesis complication involves and identifies degree of exposure. More severe complications would involve increasing migration/protrusion into surrounding anatomical structures, opening into surrounding organs, and systemic compromise. The T for the complication is when it is clinically diagnosed. There are three time periods used: intra-operative to 48 h, 48 h to 6 months, and over 6 months. The S selection of this division incorporates the current sites where the graft/prosthesis complications have been noted.

The first step in taking a history from a patient involves documenting the presenting complaint, which can include dyspareunia, prolonged ­vaginal discharge, severe incontinence, rectal discharge, recurrent prolapse, urinary tract infection, defecatory dysfunction, and thigh drainage or infection. Vaginal and pelvic pain are also presenting complaints, which are ­covered in another chapter.

A complete review of systems should be performed, specifically those symptoms which have occurred since the time of surgery. If the original case was performed by another surgeon, the preoperative records, operative reports, and any other hospital reports should be reviewed. Any intra-operative issues such as bleeding or injury to pelvic organs or problems that occurred postoperatively such as prolonged bladder catheterization, blood transfusion, or need for reoperation should be closely reviewed. These issues tend to signify a complicated postoperative course, which may relate to the complication at hand. Finally, a detailed history of any events that followed surgery is useful in any future medical or surgical management of mesh complications. Good documentation of one’s findings is critical as these cases may end up under medicolegal review.

Physical Exam

The focused physical exam involves a complete genitourinary exam which includes a thorough pelvic exam with a speculum with internal or external light source. Before the speculum exam, careful initial palpation can be performed to elicit any areas of pain. These areas can be associated with folded over mesh, contracted mesh, or taut arms of the mesh if present. Care should be taken to evaluate each vaginal compartment in mapping out all areas of pain. Often it is easier to palpate extruded mesh than to see it and thus a very careful palpation of the entire vaginal surface should be performed.

In terms of the speculum pelvic exam, systematic evaluation of the entire vagina should be carried out. Any areas of mesh extrusion should be documented. If a patient complains of pain over the mesh—the specific sites of pain should be mapped out. Other important findings such as fistulae should be evaluated closely. Other urologic testing such as cystoscopy to rule our mesh perforation, cystogram or methylene blue test to confirm presence of fistula, and urodynamics for bladder dysfunction may also be performed based on presenting symptoms. Those patients who present with rectal bleeding or discharge should be evaluated with proctoscopy.

Management of Mesh Complications

Mesh Extrusion

Complications from transvaginal mesh repairs may present days to years after initial surgery. Vaginal mesh extrusion typically occurs as a result of wound separation, infection or vaginal atrophy. Typically, mesh extrusion noted in the immediate postoperative period, usually within 6 weeks, is a result of wound separation. If the wound does not appear infected, additional attempt at wound closure may be offered under local anesthesia with or without sedation. If the wound appears infected, a short course of antibiotics may rectify the issue, with close observation to ensure closure of the wound. Vaginal estrogens should be applied during this time. If the infection persists, then excision of the exposed area is recommended.

Vaginal mesh extrusion noted more than 6 weeks after surgery may be due to technical error, local infection, vaginal atrophy, or wound separation secondary to hematoma. Initial conservative therapy with local estrogen may be offered in order to avoid reoperation. If conservative therapy fails, partial or complete mesh excision should be pursued. Typically only the areas of mesh that are involved in an extrusion need to be excised—much of the uninvolved mesh can usually be safely left behind. Some very small extrusions can be excised under local anesthesia in the office by just cutting the exposed portion and allowing the vaginal skin to heal over the area. Many patients with point tenderness can be treated in a similar fashion with just those areas causing tenderness excised. In such cases one must carefully map out the areas of pain preoperatively as there will be no extruded mesh to guide you at the time of operation.

Surgical Technique for Excision of Mesh Extrusion

Under either intravenous sedation or general anesthesia, the patient is placed in the dorsal lithotomy position and the vagina and lower abdomen are prepped and draped in standard fashion. One percent lidocaine with 1:200,000 epinephrine is used to infiltrate under the vaginal skin around the site of the extrusion. Bilateral vaginal flaps are created extending at least 2 cm lateral to the visible mesh. One cm of skin immediately around the mesh is usually discarded. The mesh is then incised in the midline and dissected off of the bladder or rectum in either direction at least 1–2 cm lateral to where the skin will be closed. Once the lateral extent of the mesh is dissected, the mesh is excised. The vaginal wall is then closed in a single layer with absorbable suture. A vaginal packing is placed and removed later in the recovery room.

Mesh Perforation

Once mesh perforation of the bladder or rectum has been diagnosed, mapping of the areas of perforation must be documented. Mesh perforation of the bladder is typically seen at the bladder base or lateral bladder walls where mesh arms can sometimes be found (Fig. 8.1). If the mesh has been in the bladder for an extended period of time, calcification of the synthetic material may occur. We have described the purely transvaginal excision of bladder and rectal mesh perforation as safe and efficacious [14] and feel that often the easiest way to remove the mesh is via the same route it was placed.

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Fig. 8.1

(ah) Excision of transvaginal mesh

Surgical Technique for Excision of Mesh Perforation of the Bladder

Under general anesthesia, the patient is placed in the dorsal lithotomy position and the vagina and abdomen are prepped and draped in standard fashion. Retrograde pyelograms are performed to rule out ureteral involvement (if there is ureteral involvement, a JJ stent is placed retrograde or a percutaneous nephroureteral stent is left indwelling to maintain continuity of the urinary tract during reconstruction). If no ureteral involvement is noted, temporary bilateral open-ended ureteral stents are inserted. 1% lidocaine with 1:200,000 epinephrine mixture is infiltrated under the vaginal skin and an inverted U-shaped incision is made. The vaginal wall is dissected to create an inverted U-flap, which serves as the final layer of closure for the repair (in cases where there is a vesico-vaginal fistula [VVF] closer to the vaginal apex a true (noninverted) U-flap is created with the bottom of the U at the VVF site) (Fig. 8.1a). Dissection of the vaginal skin is performed laterally from the U-flap towards the pelvic sidewall (Fig. 8.1b). When only a small area of mesh has eroded into the bladder the remainder may be found relatively superficially under the vaginal wall. If a substantial amount of mesh has eroded into the bladder the mesh may not be as easy to find and the detrusor muscle may need to be incised vertically in the area of the mesh (which can be determined with cystoscopic guidance) until one comes across it. A right angle clamp can be used to mobilize the mesh off the bladder in the midline (Fig. 8.1c). An incision is made in the midline of the mesh after which the lumen of the bladder is visible (Fig. 8.1d). Any remaining overlying tissues (superficial to the mesh) are bluntly and sharply dissected. By grasping on the midline (incised edge) of the mesh and pulling laterally, the bladder wall underneath the mesh is carefully peeled off using both sharp and blunt dissection. If there is a fistula present, it can be seen in its entirety at this point (Fig. 8.1e). The mesh is incised as far laterally as feasible and removed (Fig. 8.1f). The ureteral catheters can be both palpated and visualized. The mucosal layer is reapproximated using 3-0 absorbable suture taking care to stay medial to the ureteral catheters. The detrusor layer is then closed in two layers using 2-0 vicryl suture (Fig. 8.1g). The anterior vaginal wall is closed with 2-0 vicryl suture (Fig. 8.1h). Although not mandatory, the open-ended ureteral stents can be replaced with JJ ureteral stents to prevent any potential ureteral obstruction from inflammation and edema involving the bladder. A vaginal packing is placed and an 18 French Foley catheter is left per urethra.

Another option for removal of mesh perforation of the bladder would be a transabdominal approach. A Pfannenstiel incision is made in the lower abdomen. The incision is carried down to the level of the rectus fascia using electrocautery. The rectus fascia is incised transversely and the space of Retzius is entered. The bladder is filled via the indwelling Foley catheter to aid in identification. The bladder is then bivalved with a vertical incision using electrocautery. The mesh can now be visualized. The incision is carried down to the mesh. Bladder flaps are now created lateral to the body of the mesh. The mesh is then excised. The vaginal wall is closed using 2-0 absorbable suture. If possible a portion of omentum should be mobilized and placed as an interposition graft between the vagina and bladder. The bladder is then closed in two layers with 2-0 absorbable suture. A vaginal packing is placed and an 18 French Foley catheter is left per urethra.

We prefer the transvaginal approach and find it to be less morbid for the patient.

Surgical Technique for Excision of Mesh Perforation of the Rectum

Under general endotracheal anesthesia, the patient is placed in the jackknife position, the perineum and buttocks are prepped and the rectum is cleaned with betadine irrigation. A Hill Ferguson retractor is placed to aid in visualization (Picture 1). Mucosal flaps are developed around the exposed mesh. The mesh is then ­dissected off of the underlying rectal wall and excised. The mucosal flaps are closed with vicryl suture.

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Picture 1 

Mesh perforation into rectum

Palpable Tender Mesh Arm in Fornix of Vagina

Occasionally, a patient will note pain near the fornix and one can palpate a tense arm of mesh at that spot. In such cases, division of the mesh arm may ameliorate the patient’s symptoms. Under IV sedation and local or general anesthesia palpate the arm of interest, inject some lidocaine with epinephrine in the vaginal wall overlying it, incise through the vaginal skin at that site, identify and dissect out the mesh arm and then cut it and close the vaginal skin.

Conclusion

The use of synthetic mesh for the management of pelvic organ prolapse has been debated for the past few years. At the heart of the controversy lies the concern that complications related to mesh use outweigh any benefit of augmenting repairs with mesh. Although studies have shown objective benefit to mesh augmentation of transvaginal repairs, particularly in the anterior compartment, there is still concern about potential complications [1215]. On the other hand many believe that the issue is not mesh itself but to a large degree the surgical techniques in use by many [13]. While all would agree that complications can occur there are published case series in the literature of transvaginal mesh repairs performed in the hands of experts with very low complication rates. Furthermore, most complications after transvaginal mesh repairs have been shown to be manageable with resolution of most presenting complaints [16]. The authors have extensive experience in the management of mesh complications secondary to the use of commercially available kits and in our experience, these complications are generally able to be successfully managed transvaginally with minimal morbidity [17].

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Firoozi F, Ingber MS, Moore CK, et al. Purely transvaginal/perineal management of complications from commercial prolapse kits using a new prostheses/grafts complication classification system. J Urol, 2012;187(5):1674–9.