Once thought of as a long-term solution to pelvic organ prolapse, currently synthetic mesh augmentation is regarded as a dark area that is being critically assessed by surgeons, hospitals, industry, and most importantly the Food and Drug Administration. The development of midurethral sling kits has revolutionized the surgical treatment of stress incontinence. These systems, however, were not rigorously tested but instead marketed after being cleared by the Food and Drug Administration through a simple regulatory process using a previously approved predescent material. This article reviews the management of mesh complications of synthetic slings and mesh used to augment prolapse repair.
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Mesh complications related to synthetic slings are relatively rare and can usually be managed in a fairly straight forward fashion.
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Complications reported from mesh kits for prolapse repair significantly increased between 2008 & 2010, resulting in an FDA warning and in changing the classification of these kits to class III devices.
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Vaginal constriction and pain remain the most challenging of all mesh complications to manage.
Introduction
Once thought of as a long-term solution to pelvic organ prolapse, currently synthetic mesh augmentation is regarded as a dark area that is being critically assessed by surgeons, hospitals, industry, and most importantly the Food and Drug Administration (FDA). With industry integrated so deeply in the medical field, more and more products have been produced in the hope of accommodating the needs of physicians. For the last 15 years, industry has made a big financial commitment in the field of pelvic floor surgery, initially developing slings for incontinence and then later investing in prolapse mesh kits.
The development of midurethral sling kits has revolutionized the surgical treatment of stress incontinence. Retropubic and transobturator (TOT) slings have excellent long-term efficacy with acceptable complication rates.
Mesh used to augment a prolapse repair ideally should be durable, carry no carcinogenic potential, be unlikely to get infected or inflamed, have lifelong durablity, and carry no risk of erosion. Despite all of the research, this ultimate material is yet to exist. Grafts of various materials were developed, some of a synthetic nature and others of biologic origin. Kits also varied in their shape and insertion technique.
These systems, however, were not rigorously tested but instead marketed after being cleared by the FDA through a simple 510 K regulatory process using a previously approved predescent material. An FDA safety net, known as the “Maude database,” allows self-reporting of complications by surgeons and requires mandatory reporting of all complications reported to the manufacturer of the device or material. A significant increase in reported complications of mesh between 2008 and 2010 prompted a series of actions by the FDA that resulted in reclassifying mesh kits to class III devices and requiring the manufacturers of these devices to pursue research studies specific to their device (522 studies) if they desire to continue to market and sell their devices.
This article reviews the management of mesh complications resulting from synthetic slings and mesh used to augment prolapse repair.
Definitions
Terms used to describe mesh complications include erosion, extrusion, contraction, vaginal constrictions, paraurethral banding, dyspareunia, and diffuse pelvic and groin pain. Mesh extrusion refers to the mesh pushing itself out of the tissue and producing a protrusion, whereas mesh erosion refers to the absence or destruction of the vaginal layer theoretically covering the mesh, which then migrates usually into the vaginal lumen. Erosion into a neighboring viscus (bowel bladder or urethra) has also been reported. Erosion seems to be a more chronic issue depending on the graft nature and the interaction between the local tissue and the implant.
Mesh contraction refers to the graft shrinking over time, typically unequally, with up to 75% shrinkage possible. Because of the reduced vaginal wall conformity and subsequent wall stiffness, the repercussions can be severe, impacting sexual, defecatory, and urinary function of the patient. Dyspareunia refers to pain with intercourse associated with penetration and is very commonly present in any woman who develops postoperative pelvic pain after mesh placement. The frequency of pelvic pain is believed to increase significantly as more mesh is implanted in the vagina; however, this is difficult to prove because very few randomized trials comparing mesh augmentation with native tissue repair exist.
Synthetic slings, have been associated with a significant positive impact on sexual function secondary to the high success of correcting incontinence. However, in some patients this positive sexual outcome may be offset by paraurethral banding, the pain generated by penile manipulation of the mucosa underneath the sling. This complication is specific to TOT slings where a band is palpable at the midurethral region, perpendicular to the axis of the urethra, along the tract of the entire sling to the vaginal sidewalls. Tenderness is typically reproducible on manipulation of the band. This is associated with vaginal pain and dyspareunia. In a retrospective study by Cholhan and coworkers, 52% of women developed some banding after having a TOT sling placed with up to 24% of these patients developing dyspareunia and subsequent deterioration in their sexual life. The same study assessed patients who had undergone retropubic synthetic slings and could not identify banding in any of these patients.
Definitions
Terms used to describe mesh complications include erosion, extrusion, contraction, vaginal constrictions, paraurethral banding, dyspareunia, and diffuse pelvic and groin pain. Mesh extrusion refers to the mesh pushing itself out of the tissue and producing a protrusion, whereas mesh erosion refers to the absence or destruction of the vaginal layer theoretically covering the mesh, which then migrates usually into the vaginal lumen. Erosion into a neighboring viscus (bowel bladder or urethra) has also been reported. Erosion seems to be a more chronic issue depending on the graft nature and the interaction between the local tissue and the implant.
Mesh contraction refers to the graft shrinking over time, typically unequally, with up to 75% shrinkage possible. Because of the reduced vaginal wall conformity and subsequent wall stiffness, the repercussions can be severe, impacting sexual, defecatory, and urinary function of the patient. Dyspareunia refers to pain with intercourse associated with penetration and is very commonly present in any woman who develops postoperative pelvic pain after mesh placement. The frequency of pelvic pain is believed to increase significantly as more mesh is implanted in the vagina; however, this is difficult to prove because very few randomized trials comparing mesh augmentation with native tissue repair exist.
Synthetic slings, have been associated with a significant positive impact on sexual function secondary to the high success of correcting incontinence. However, in some patients this positive sexual outcome may be offset by paraurethral banding, the pain generated by penile manipulation of the mucosa underneath the sling. This complication is specific to TOT slings where a band is palpable at the midurethral region, perpendicular to the axis of the urethra, along the tract of the entire sling to the vaginal sidewalls. Tenderness is typically reproducible on manipulation of the band. This is associated with vaginal pain and dyspareunia. In a retrospective study by Cholhan and coworkers, 52% of women developed some banding after having a TOT sling placed with up to 24% of these patients developing dyspareunia and subsequent deterioration in their sexual life. The same study assessed patients who had undergone retropubic synthetic slings and could not identify banding in any of these patients.
Management of complications of synthetic midurethral slings
Vaginal Erosion or Extrusion
When mesh is exposed in the lumen of the vagina (should occur in <3% of cases) it only needs to be treated if it becomes symptomatic. Common symptoms include penile pain during intercourse or what has been termed “hisparunia,” and vaginal discharge and spotting. The goal in managing such patients is to remove the exposed mesh and cover the defect with healthy well-vascularized vaginal tissue. Up to 30% of the time women may develop recurrent stress urinary incontinence (SUI) after such procedures.
Urethral and Bladder Erosion
Treatment of urethral and bladder erosion usually involves complete excision of all sling material from the urethra or bladder, with mobilization of healthy tissue to close the defect in layers. Timing from initial surgery is crucial. If urethral erosion is identified within the first 2 weeks postoperative, it may be possible to simply remove the sling by grasping it vaginally and applying continuous traction to pull it out. In the authors’ experience complete tissue ingrowth occurs somewhere between 14 and 21 days postoperative, after which such a maneuver is impossible. Urethral closure in layers in a tension-free fashion is mandatory to prevent tissue breakdown and subsequent fistula formation. If a bladder or urethral erosion is detected after this timeframe, alternative techniques may be used. Transurethral or cystoscopic techniques have been described whereby the edges of the sling are resected with a Holmium laser. In 2005, Giri and coworkers reported on excisions after intravesical sling erosions occurred. In 2011, Doumouchtsis also reported transurethral laser excisions that were noted to require further resection at a later stage. The laser is used to trim the edges of the sling tape once identified. If traversing the urethra, ensuring resection deep to the urethral mucosa is important to prevent stone formation at the resected edge and to ensure adequate healing at that site. If a stone is already present on the mesh, it is advisable to break it down mechanically, and then proceed with the tape resection cystoscopically.
If excision is initiated vaginally for urethral erosion or bladder erosion that can be addressed vaginally, a midline or inverted U-shaped vaginal incision is performed. The rationale for use of the U incision is to avoid having the vaginal suture line covering the urethral incision. After resection of the mesh is done and the urethra or bladder is repaired primarily, it is important to drain the bladder with a catheter for a prolonged period of time (10–14 days of continuous drainage).
Paraurethral Banding
In cases where slings are removed because of paraurethral banding, it may be advisable to excise as much of the TOT sling as possible. If recurrent SUI occurs, a pubovaginal or retropubic synthetic sling should be performed. Excision is preferably performed under general anesthesia to allow for more extensive access to the sling ends. The routine vaginal preparation is placed and the urethra catheterized with a Foley catheter. Then, the band is identified, followed by infiltrating a solution of local anesthetic and epinephrine along the entire accessible tract of the TOT, followed by incising the skin in the midline down to the sling. A gritty feeling typically indicates proximity to the sling and the appropriate dissection depth. Release of the sling from the underlying tissue is then performed. Inserting a right-angle clamp can facilitate this process as long as the posterior urethral wall is protected. Opening the right angle clamp releases the sling further. Then, the sling is incised in the midline and the edges are held with clamps, and careful dissection of the overlying mucosa and underlying tissues is performed all the way to the obturator membrane if accessible. Deng and coworkers reported the technique of extensive excision and urethrolysis with subsequent urethral reinforcement with a second layer of paraurethral tissue after the sling was mobilized. The need for extensive excision and not simple midline release is to prevent future erosion and banding which may occur along the sidewalls.
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