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FDA Panel Examines Avaulta Pelvic Mesh Amid Lawsuits

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Gaithersburg, MDAmid a surging number of lawsuits against Avaulta pelvic mesh and similar products, manufacturers recently faced a panel of the US Food and Drug Administration (FDA) to determine what steps need to be taken to warn of the risks of the implants.

According to Bloomberg, Johnson & Johnson as well as a number of other companies—including C.R. Bard Inc., which manufactures the Avaulta product—told FDA advisers that they agreed more studies need to be conducted to determine the safety of such devices.

Additionally, the manufacturers reportedly told the panel of advisers that they were on board with potential labeling changes to the products that would warn patients of possible health risks associated with their use, the news source said.

Piet Hinoul, a director of medical affairs for the Ethicon unit of Johnson & Johnson, told the panel that while transvaginal mesh may not be the "optimal solution" for all patients, it still could be for some.

The products are used as a support mechanism for women with weak pelvic muscles that do not sufficiently support internal organs, according to the news source. Overall, more than 75,000 women received the implanted meshes last year, but the number of lawsuits against manufacturers is growing, the news provider said.

In fact, patients have reportedly filed nearly 500 lawsuits over alleged personal injuries they have suffered as a result of the mesh products. Defendants in the various lawsuits include Johnson & Johnson and C.R. Bard.

In an interview with the news source, William Maisel, deputy director of the FDA Center for Devices and Radiological Health, said that the overall effectiveness of the mesh products has not yet been shown.

"The clinical effectiveness of surgical mesh for transvaginal repair of pelvic organ prolapse has not been demonstrated," Maisel explained. "We believe proper studies would need to be done."

The FDA panel on transvaginal mesh products comes nearly three years after the federal agency issued a Public Health Notification stating that "serious complications" have been associated with the devices.

According to a release from the FDA, such complications can include infection, pain, blood vessel perforation and urinary problems. Additionally, the agency said that it had received reports from at least nine manufacturers of such products about health problems found in patients receiving the implants to treat Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI).


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