FDA notice: Transvaginal mesh associated with serious complications

November 6, 2008

The FDA has issued a public health notification about what it is calling rare but potentially serious complications of transvaginal placement of surgical mesh to treat pelvic organ prolapse and stress urinary incontinence.

The FDA has issued a public health notification about what it is calling rare but potentially serious complications of transvaginal placement of surgical mesh to treat pelvic organ prolapse and stress urinary incontinence.

Over the past 3 years, the agency said it has received more than 1,000 reports from nine surgical mesh manufacturers of complications that were associated with surgical mesh devices used to repair prolapse and stress incontinence.

The most frequent complications included erosion through vaginal epithelium, infection, pain, urinary problems, and recurrence of prolapse and/or incontinence. There were also reports of bowel, bladder, and blood vessel perforation during insertion. In some cases, vaginal scarring and mesh erosion led to a significant decrease in patient quality of life due to discomfort and pain, including dyspareunia.

Treatment of the various types of complications included additional surgical procedures, IV therapy, blood transfusions, and drainage of hematomas or abscesses. Specific characteristics of patients at increased risk for complications have not been determined, but contributing factors may include the patient’s overall health, the mesh material, the size and shape of the mesh, the surgical technique used, concomitant procedures undertaken, and possibly estrogen status.

To reduce the risk of adverse events, FDA said physicians should:
• 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
• provide patients with a written copy of the patient labeling from the surgical mesh manufacturer, if available.