FDA Issues Public Health Notice on Surgical Mesh

FDA has issued a public health notice about complications associated with transvaginal placement of surgical mesh to treat pelvic organ prolapse and stress urinary incontinence. In the past three years, FDA has received over 1000 adverse event reports regarding these applications from nine different manufacturers of surgical mesh. The most frequent complications included erosion through vaginal epithelium, infection, pain, urinary problems, and recurrence of prolapse and/or incontinence.

October 22, 2008

1 Min Read
FDA Issues Public Health Notice on Surgical Mesh

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. FDA has not yet determined whether particular types of patients are at increased risk for these types of complications.The agency recommends that surgeons be aware of these issues and be specially trained for each mesh placement technique. They should also watch for complications associated with the tools used in transvaginal placement, especially bowel, bladder and blood vessel perforations. And they should tell patients that surgical mesh implants are permanent and can bring complications -- and provide them with a copy of product labeling, if possible.The agency has also posted consumer information documents on surgical mesh for hernias and pelvic organ prolapse/stress urinary incontinence. It has not issued a public health notice on hernia applications because it does not yet have specific recommendations for physicians regarding hernia repair.

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