FDA Moves Female Incontinence Device to 'High Risk' Status
TUESDAY, April 29, 2014 (HealthDay News) -- Vaginal mesh devices that support the pelvic organs and help ease incontinence in women will get stricter oversight in the future due to safety concerns, the U.S. Food and Drug Administration announced Tuesday.
"The FDA has identified clear risks associated with surgical mesh for the transvaginal repair of pelvic organ prolapse and is now proposing to address those risks for more safe and effective products," Dr. William Maisel, deputy director of science and chief scientist at the FDA's Center for Devices and Radiological Health, said in an agency news release.
The FDA said it plans to reclassify the devices, moving them from its "moderate" to "high" risk category. The agency will also require manufacturers to submit pre-market approval applications to the FDA, so it can better evaluate a device's safety and effectiveness beforehand.
The new rules apply to surgical placement of the mesh devices through the vagina to fix pelvic organ prolapse -- a weakening or stretching of internal structures that support pelvic organs such as the bladder, bowel and uterus.
These organs then drop to below their normal position and bulge (prolapse) into the vagina. This can cause pelvic pain, disruption of sexual activity and problems with urination and defecation, the FDA explained.
However, the mesh devices have been fraught with problems for years, including pain, infection, bleeding, pain during intercourse and urinary problems, the FDA said.
The proposals, which will be open for comment for 90 days, do not apply to other uses of surgical mesh, the FDA said.
Abdominal or vaginal surgery that uses traditional stitches is an alternative method of treating pelvic organ prolapse. In a safety warning issued in 2011, the FDA said surgical placement of mesh through the vagina may pose greater risks than other surgical methods, without offering any added benefits.
In 2011, Meisel said the FDA was "asking surgeons to carefully consider all other treatment options and to make sure that their patients are fully informed of potential complications from surgical mesh."
He stressed that the mesh "is a permanent implant -- complete removal may not be possible and may not result in complete resolution of complications."
In a statement released in 2011, the American College of Obstetricians & Gynecologists said it "shares the FDA's concerns and encourages patients and physicians to review the FDA's White Paper that describes, in detail, the health risks associated with the surgical mesh products when used to treat pelvic organ prolapse."
The American Urogynecologic Society has more about pelvic organ proplapse.
SOURCES: U.S. Food and Drug Administration, news release, April 29, 2014; American College of Obstetricians & Gynecologists, statement, 2011