New York, New York (PRWEB) February 05, 2012
Bernstein Liebhard LLP reports that on January 31, 2012, Democratic Representative Edward Markey of Massachusetts introduced a bill (HR3847) that would block medical devices from utilizing the 510(k) process in order to receive market approval by the U.S. Food and Drug Administration (FDA) if approval is predicated on the similarity of a previously recalled device.* If passed, the legislation would close a loophole that lets devices like transvaginal mesh receive market clearance if they are substantially similar to a product that has been previously pulled from the market. According to Bloomberg News, [v]aginal implants spurred a Food and Drug Administration alert last year amid patient complaints of pain and internal injuries. The devices were cleared by the agencys 510(k) system, which allowed them to be sold without human testing once the FDA rules they are similar to existing products. In support of the new legislation, House Democrats cited injuries stemming from pelvic mesh implants, which are manufactured by medical device powerhouses including Johnson & Johnson subsidiary, Ethicon, and C.R. Bard. The bill would give the FDA authority to reject medical devices if their predecessors were subject to a recall or in the process of being recalled. It would also require medical device manufacturers to explain why their products are different from earlier versions.
Bill Follows Calls For Congressional Hearings To Examine Safety Of Medical Devices
Previously, on January 20, 2012, Representative Henry Waxman of California led House Democrats from the Energy and Commerce Committee in writing a letter to several chairmen, requesting that the Committee hold hearings to review the safety of medical devices implanted into patients.** In support of their petition, the congressmen cited problems associated with medical devices, such as vaginal mesh implants, which have caused serious injuries to patients. According to the congressmen, these harms demonstrate the need for regulatory reform. In order for the bill to become law, HR3847 would need to be passed in the Republican-dominated House and Democratic-controlled Senate before being signed by President Obama.
