Be Selective When Using Surgical Mesh Transvaginally for Pelvic Organ Prolapse, FDA Warns

July 18, 2011

The surgical placement of mesh through the vagina to repair pelvic organ prolapse (POP) may expose patients to greater risk than other surgical interventions, said the FDA in an updated safety communication. It also stated that with the exposure to greater risk comes no evidence of greater clinical benefit, such as improved quality of life.

The surgical placement of mesh through the vagina to repair pelvic organ prolapse (POP) may expose patients to greater risk than other surgical interventions, said the FDA in an updated safety communication.1 It also stated that with the exposure to greater risk comes no evidence of greater clinical benefit, such as improved quality of life.

Surgical repair of POP can be performed abdominally or transvaginally using stitches alone or stitches coupled with surgical mesh to reinforce the repair and correct the anatomy. In 2010, there were at least 100,000 surgical repairs of POP that used surgical mesh.1 In about 75% of those repairs, the mesh was placed transvaginally.

Surgical mesh, generally used to repair weakened or damaged tissue, is made from porous absorbable or nonabsorbable synthetic material or absorbable biologic material. In urogynecologic procedures, surgical mesh is permanently implanted to reinforce weakened vaginal walls to repair POP or to support the urethra to treat stress urinary incontinence (SUI). No single type or brand of surgical mesh has been linked to complications related to the product’s use in transvaginal repair of POP or SUI.

In October 2008, the FDA issued a warning about serious complications related to transvaginal placement of surgical mesh to treat POP and SUI. After further analysis of reported adverse events and complications described in scientific literature from 1996 to 2011, the FDA determined that use of surgical mesh for transvaginal repair of POP is an area of continuing concern. In its analysis, the FDA uncovered 4 important findings.1 First, mesh used in transvaginal POP repair introduced risks that were not present in traditional non-mesh surgery for POP. Second, mesh placed abdominally for POP repair resulted in lower rates of mesh-related complications compared with mesh placed transvaginally. Third, there was no evidence that transvaginal repair to support the top of the vagina (apical repair) or the back wall of the vagina (posterior repair) with mesh provided any added benefit compared with traditional surgery without mesh. And fourth, although transvaginal repairs with mesh to correct weakened tissue between the bladder and the vagina (anterior repair) may provide an anatomic benefit compared with traditional POP repair without mesh, this anatomic benefit may not result in better symptomatic results. Ultimately, evidence seems to show that the risks outweigh any benefit to using surgical mesh as standard practice.

The FDA warns that serious complications associated with surgical mesh placed transvaginally in a POP repair are not rare. From January 2008 to December 2010, the FDA received 2874 new reports of complications involving surgical mesh to repair POP or SUI.1 The FDA acknowledges that adverse event reports do tend to increase after a safety notification, but the number of reported events has remained high. In addition, there are uncertainties about whether transvaginal repair of POP using mesh is more effective than traditional repairs that do not use mesh.

This new FDA warning does not extend to the use of surgical mesh for the treatment of SUI. However, an expert panel is convening September 8-9, 2011 to discuss and make recommendations about the safety and effectiveness of using surgical mesh for transvaginal repairs of POP and SUI.

The most frequently reported complications related to use of surgical mesh during POP repair are mesh erosion or exposure through vaginal tissue, pain, infection, bleeding, pain during sexual intercourse, organ perforation from surgical tools during the procedure, and urinary problems. Recurrent prolapse, neuromuscular complications, vaginal shrinkage related to scarring or mesh contraction, and emotional problems were also reported. In some cases, additional surgeries or hospitalizations are required to manage complications or to attempt removal of the mesh.

Mesh contraction is a previously unidentified risk of transvaginal POP repair with mesh and is associated with vaginal shortening, vaginal tightening, and vaginal pain. Reports of this complication surfaced in literature after the FDA issued their initial notification in October 2008. Pain or irritation of the penis in men who have sexual intercourse with women who have mesh erosion has also been reported.

The FDA is recommending that health care providers be very selective when using mesh for a POP repair, keeping in mind that most cases of POP can be repaired successfully without mesh. The agency also reminds physicians that surgical mesh is a permanent implant that can make any future surgical repairs or procedures more challenging and can increase the patient’s risk for additional complications and surgeries. Physicians should consider that for POP repair, mesh placed abdominally may reduce the number of mesh complications compared with mesh placed transvaginally. In addition, patients should be made aware of the risks and benefits of transvaginal POP repair with mesh, and physicians should specifically inform patients that mesh is being used.

In response to this updated FDA safety communication, the American Urogynecologic Society (AUGS) issued a statement supporting the FDA’s decision. The AUGS believes that the approval process for vaginal mesh was too lenient and advocates for an improved approval process for such materials.2 Specifically, the AUGS supports better and longer-term randomized trials before going to market and improved postmarket surveillance. They also suggest that surgeons placing vaginal mesh should undergo special training.
 

Video: Excision of Transvaginal Mesh Extrusion

 

 

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IUGA: Postoperative specific complications following transvaginal mesh repair of pelvic organ prolapse: etiology, prevention, and management

References:

References
1. U.S. Food and Drug Administration. FDA Safety Communication:Update on serious complications associated with transvaginal placement of surgical mesh for pelvic organ prolapsed. July 13, 2011. Accessed July 15, 2011.
2. American Urogynecologic Society. AUGS response: FDA safety communication. Accessed July 15, 2011.