FDA proposes strict changes for transvaginal mesh

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by JANET ST. JAMES

WFAA

Posted on April 29, 2014 at 6:57 PM

DALLAS -- The U.S. Food and Drug Administration is calling for stricter safety rules for a product used by tens of thousands of women.

The move comes after a News 8 report last week on transvaginal mesh, a plastic mesh product used to treat stress urinary incontinence and pelvic prolapse.

Pelvic prolapsed occurs when the internal structures that support the pelvic organs become so weak, they drop from their normal positions. The common conditions affect millions of women.

The FDA has received thousands of reports of serious, and sometimes permanent, complications from transvaginal mesh.

Linda Batiste said she can actually feel the surgical mesh inside her body.

"It actually does feel like a scouring pad in your body,” the 64-year old said. “You can feel, in your women parts, what it is. It's there."

Batiste recently won a product liability case against the maker of the mesh sling designed to fix urinary incontinence. It was the first surgical mesh sling case to go to a jury in the state of Texas.

There are about 60,000 similar cases pending against several companies nationwide.

Following years of reports of bleeding, infection, and other adverse events from thousands of women like Batiste, the FDA has proposed changes, which include reclassifying transvaginal mesh as a "high-risk" medical device. The FDA wants also to require manufacturers to prove the products work safely before they hit the market.

According to a press release issued by the U.S. Food and Drug Administration 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,” said Dr. William Maisel, deputy director of science and chief scientist at the FDA’s Center for Devices and Radiological Health. “If these proposals are finalized, we will require manufacturers to provide premarket clinical data to demonstrate a reasonable assurance of safety and effectiveness for surgical mesh used to treat transvaginal POP repair.”

Joleen Chambers, a patient advocate who started the Failed Implant Device Alliance has been fighting for the FDA changes for years.

"I think that it's a real win for women,” Chambers said, “because even if we don't have the surgical mesh ourselves, our sisters get the surgical mesh, our mothers, our daughters. We need to know what it is that's in our body and we need to know that it's safe and effective.”

The FDA is taking public comment on the proposed order for the next 90 days.

The proposal does not include surgical mesh treatments for hernia repair.

E-mail jstjames@wfaa.com

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