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Home E-Weekly July 19, 2011

FDA: Serious Complications From Surgical Mesh "Not Rare"

Published: July 18, 2011

Serious complications associated with the transvaginal placement of surgical mesh to repair pelvic organ prolapse (POP) are not rare, says the Food and Drug Administration in an updated safety warning to healthcare providers and patients.

In the nearly 3 years since the FDA first alerted the public to safety concerns about the use of urogynecological surgical mesh to treat POP and stress urinary incontinence, reports of complications have increased and remained high. From 2008 through 2010, the FDA says it's received 2,874 reports of adverse events associated with transvaginal mesh implantation to treat these 2 conditions.

The most frequently reported complications (not associated with any particular brand of mesh) include mesh erosion through the vagina, pain, infection, bleeding, pain during sexual intercourse, organ perforation and urinary problems. The agency has also identified mesh contraction, or shrinkage, as a "previously unidentified risk" associated with transvaginal placement.

"It is not clear that transvaginal POP repair with mesh is more effective than traditional non-mesh repair in all patients with POP and it may expose patients to greater risk," says the FDA, which has also conducted a systematic literature review of urogynecological surgical mesh.

Based on its findings, the agency is continuing to recommend that healthcare providers be specially trained in each mesh placement technique they practice, watch for potential adverse events from the mesh (such as erosion and infection) and the tools used in transvaginal placement (such as bowel or blood vessel perforations) and inform patients that mesh implantation is permanent and has the potential for serious complications.

The agency also now recommends that providers:

  • Recognize that POP can be treated successfully without mesh.

  • Consider that mesh placed abdominally may be safer than transvaginal POP surgery with mesh.

  • Inform the patients about other, potentially safer options for treating POP, such as non-surgical, non-mesh and non-transvaginal approaches.

  • Provide patients with information about the specific mesh they're planning to use.

    See the FDA's notice for more recommendations and instructions on how to report urogynecological surgical mesh complications. The agency says it will continue to monitor adverse event reports, consider its regulatory options and convene the OB-GYN Devices Panel of its Medical Device Advisory Committee in September to further discuss this issue.

    Irene Tsikitas

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