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Federal lawmakers seek to close FDA approval loophole

Last week, we wrote that the U.S. Food and Drug Administration had ordered additional research into the vaginal mesh products that have caused injury and even death to women throughout the country.

Vaginal mesh, which is manufactured primarily by two New Jersey companies, was approved for sale by the FDA under the agency's 510(k) system. This loophole requires the FDA to approve medical products without any human testing if they are similar to products already on the market. Now, several members of the U.S. House of Representatives have introduced a bill that would effectively close that loophole and require that all products undergo individualized testing before being released to the market.

The vaginal mesh products manufactured by New Jersey-based Johnson & Johnson and C.R. Bard Inc. are being used as an example in the bill because they were approved based on their "substantial equivalence" to a mesh that was manufactured by Boston Scientific more than 10 years prior. Despite the fact that the product was recalled for safety issues, it was still used as a basis for the FDA approval of the Johnson and C.R. bard meshes.

Under the law as proposed in the House, situations like this would no longer arise. The bill would allow the FDA to withhold its approval if the past device were removed from the market for safety concerns. It would also require the FDA to review previously approved products to determine whether they would still receive approval under the new law.

It is unclear whether this bill will succeed, but we will continue to update our blog with any new developments.

If you or a family member has been injured by a dangerous or defective product that has been approved by the FDA, please contact Breslin & Breslin for a free consultation.

Source: Bloomberg, "Democrats Want to let FDA Block Medical Devices Tied to Safety Recalls," Alex Nussbaum, Feb. 2, 2012

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