July 22, 2014 — A petition to completely ban vaginal mesh has been denied (PDF) by the U.S. Food and Drug Administration (FDA), but the agency has “tentatively” agreed that the implants are high-risk and should be subject to stricter approval requirements.
The FDA will not ban vaginal mesh because they believe there are possible benefits and they are still evaluating risks. The agency also refused to recall vaginal mesh because they do not have enough evidence that all products can cause serious side effects.
Instead, the FDA wants to re-classify vaginal mesh as a Class III (“high-risk”) medical device. They also want stricter pre-marketing requirements for new devices.
According to the FDA:
“FDA believes that the appropriate approach at this time is to propose to up-classify the device and require the filing of premarket approval applications. The agency does not believe that a ban is warranted at this time.”
Most vaginal mesh products currently on the market were cleared through the 510(k) loophole, which allows new products on the market so long as they are “substantially equivalent” to a product that is already approved. In some cases, the FDA approved new devices with 510(k) applications based on products that had been recalled in the 1990s due to safety concerns.
The petition was filed in August 2011 by Public Citizen, a consumer advocacy group. In July 2011, the FDA issued a Safety Communication to warn that serious adverse events were “not rare” and they had received more than 4,000 adverse event reports. There are currently more than 60,000 vaginal mesh lawsuits pending in federal court in West Virginia.
Do I have a Vaginal Mesh Lawsuit?
The Schmidt Firm, PLLC is currently accepting vaginal mesh induced injury cases in all 50 states. If you or somebody you know has been injured by vaginal mesh, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Devices Litigation Group or call toll free 24 hours a day at (866) 920-0753.
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