FDA Tightens Controls |on Transvaginal Mesh

WASHINGTON (CN) - As reports of serious complications continue to rise, the Food and Drug Administration has issued two orders to manufacturers to strengthen requirements for transvaginal surgical mesh.

The FDA's orders reclassify these medical devices from class II, moderate-risk devices, to class III, high-risk devices, and require manufacturers to submit a premarket approval application to enhance the safety and effectiveness of surgical mesh used for transvaginal, or through the vagina, repair of pelvic organ prolapse, which is believed to be less invasive than abdominal surgery.

The mesh is designed to treat conditions where organs in the pelvis, such as the bladder or bowel, drop (or prolapse) from their normal placement and push into the walls of the vagina. The condition can occur from muscles stretching during childbirth, or after a hysterectomy or menopause. Estrogen, which helps with collagen formation when levels are normal, can contribute to weakening of supportive tissues as levels drop with age or due to surgery.

The mesh device is also used to treat an associated condition called 'stress incontinence,' which can cause bladder leakage when coughing, sneezing, laughing or during exercise, again due to loss of muscle strength.

The new FDA directives only apply to mesh used for these two applications. Surgical mesh has been used since the 1950s for abdominal hernias, and this use is not affected by these new orders.

Transvaginal uses began in the 1990s, and the mesh was cleared for use as a class II moderate-risk device in 2002, according to the agency's announcement.

By October 2008, the FDA issued an alert to practitioners that it had received over one thousand reports of complications from mesh manufacturers over a three year period, which included vaginal erosion, infection, pain, urinary problems, and perforations of the bladder, bowel or blood vessels. At that time, nine manufacturers were making the mesh.

The agency updated its notice to practitioners in July 2011 to specify that the complications were "not rare," as an additional 2,874 complication reports were received in an intervening two-year period.

The agency's update in July 2013 included three deaths associated with the mesh implants due to perforations.

A November 2014 U.S. Judicial Panel report indicated more than 55,000 pending actions at the U.S. District Court level against six manufacturers of the device.

Under the new FDA orders, the five manufacturers currently marketing this transvaginal device will have 30 months to submit a premarket approval for devices that are already on the market. Manufacturers of new devices must submit a premarket approval before those devices can be approved for marketing. The manufacturers either declined to comment, or did not immediately respond to requests for comments.

"These stronger clinical requirements will help to address the significant risks associated with surgical mesh for repair of pelvic organ prolapse," William Maisel, M.D., M.P.H., deputy director of science and chief scientist for the FDA's Center for Devices and Radiological Health, said. "We intend to continue monitoring how women with this device are faring months and years after surgery through continued postmarket surveillance measures."

Both orders are effective Jan. 5, 2016.

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