Vaginal Mesh Implants: Safety and Side Effects Study Ordered by FDA

If you’re a woman and you suffer from urinary incontinence, take heed.

The United States Food and Drug Administration recently issued an order requiring makers of implantable surgical mesh used to treat urinary incontinence in women to study the rates of organ damage and complications linked to vaginal mesh implants.

U.S. regulators were responding to reports by patient advocates claiming the devices have caused infections, pain other complications and even serious injuries in women.

On January 4, the FDA wrote Johnson & Johnson (JNJ), C.R. Bard Inc. (BCR) and 31 other manufacturers, ordering them to conduct three years of trials on the safety and effectiveness of the vaginal mesh products, Dr. William Maisel, the chief scientist of the F.D.A. division that oversees medical devices, told Bloomberg.

The letters ask each manufacturer to collect data on the results and potential complications of these procedures, Bloomberg reported.

In 2008, the FDA issued a warning that the use of surgical mesh was associated with complications but said at the time that such problems were rare.

But in July 2011, an FDA report found that from 2008 to 2010 deaths, injuries or malfunctions linked to the products increased by fivefold, and in September, an FDA advisory panel recommended that the agency require new studies.

Female incontinence is often caused by pelvic organ prolapse, in which muscles supporting the internal organs including the bladder weakens, allowing it to descend and press against the vaginal wall. Or it may be caused by stress urinary incontinence, also brought by the weakening of muscles.

In 2010, almost 300,000 synthetic meshes were implanted in American women in 2010 to treat incontinence or shore up pelvic muscles, the FDA estimates. In a transvaginal procedure, the hammock-like meshes are threaded in place through an incision in the vagina.

But studies found that the edges of mesh fibers can constrict or cut into internal organs after they’ve been implanted.

The procedure is also prone to infection because the vagina through which the devices are inserted isn’t a sterile environment, Clifford Wheeless, an emeritus associate gynecology professor at Johns Hopkins University School of Medicine told Bloomberg in 2010.

In its July report, the FDA also said it wasn’t clear from available studies whether the mesh provided a benefit over older methods, in which a patient’s own ligaments are used to strengthen the vaginal wall.

Currently, there are more than 650 lawsuits against manufacturers for injuries allegedly caused by the failures of the mesh and reports of these injuries have spurred the FDA to review its 510(k) program that cleared the products for sale without human testing.

Last year, the FDA made a similar ruling, ordering producers of all-metal artificial hips to undertake patient studies. The hips and mesh products belong to a class of implantable devices that manufacturers do not have to study in patients before they are marketed or closely follow in patients afterward, the New York Times reported.

Under the FDA’s 510(k) system, such devices are allowed to go to market without human testing if the agency decides they’re similar to devices already for sale.

“Now these companies are going to have to tell the truth,” said Lana Keeton, a mesh recipient and patient advocate from Austin, Texas. Companies say their implants are safe but “up until now, there’s been no data,” she said. “It’s all been marketing.”

Top producers of vaginal mesh include Boston Scientific, C. R. Bard, Ethicon and W. L. Gore & Associates.

According to Bloomberg, the FDA letters covered only devices already on the market and Amy Allina, a policy director at the National Women’s Health Network in Washington said that consumer groups want the action to be just a first step toward requiring studies before the products can reach the market.