USA halts sales of pelvic mesh tied to injuries in women

The U.S. Food and Drug Administration on Tuesday ordered makers of transvaginal surgical mesh implants to immediately stop sale and distribution of the products in the United States.

In 2016, the FDA reclassified surgical mesh products intended for transvaginal fix to indicate they were the most high risk of devices the agency evaluated, according to an agency statement.

The devices, made of synthetic or biological material, are commonly implanted in women to fix weakened or damaged tissue and provide support in cases of pelvic organ prolapse (POP).

"In order for these mesh devices to stay on the market, we determined that we needed evidence that they worked better than surgery without the use of mesh to fix POP", Jeffrey Shuren, a physician and director of the FDA's Center for Devices and Radiological Health, said in a statement.

The FDA said makers of the products such as Boston Scientific Corp and Coloplast A/S did not demonstrate a reasonable assurance of safety and effectiveness of these devices in their premarket applications.

The companies will have 10 days to submit plans to withdraw these products from the market, the FDA said.

Public Citizen, a consumer advocacy organization, petitioned for a ban against the mesh products in 2011 and then testified before an FDA advisory committee earlier this year, according to Dr. Michael Carome, director of the nonprofit's Health Research Group. Women who may have been planning a surgical mesh procedure should discuss other options with their doctors. The proportion of transvaginal procedures using surgical mesh decreased after the FDA issued warnings about risks associated with transvaginal mesh. The agency cleared the first mesh device for transvaginal fix of POP in 2002.

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Wang compared the agency's decision regarding transvaginal mesh to those it made on silicone-gel-filled breast implants, which were also subject to a reclassification by the FDA after concerns arose about safety.

About one in eight women will need surgery to fix POP, and a portion of such surgeries have been done transvaginally with the use of surgical mesh.

Boston Scientific and Coloplast will be required to continue follow-up of patients who underwent transvaginal fix procedures using the mesh products in "522" clinical studies. "There is no need to take additional action if they are satisfied with their surgery and are not having complications or symptoms".

"Patients should notify their healthcare professionals if they have complications or symptoms, including persistent vaginal bleeding or discharge, pelvic or groin pain, or pain with sex", according to the statement.

They should also inform their health care provider if they have surgical mesh, especially if they're scheduled for another surgery or medical procedure.

The FDA action does not apply to mesh products used to treat other conditions such as hernias or incontinence.

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