A Massachusetts lawmaker has introduced a new bill which would allow for stricter regulation of the medical device approval process. The bill specifically targets Vaginel mesh Device which have become the target of numerous lawsuits filed on behalf of women who say these products caused serious health complications.
At a press conference Thursday morning, Rep. Ed Markey (D-Mass.) introduced the new bill, called the Safety of Untested and New Devices (SOUND) Act. The new legislation would allow the U.S. Food and Drug Administration (FDA) to require manufacturers of medical devices based on existing products that have known safety issues to provide documentation showing that the new product’s design has eliminated potential flaws.
Representative Markey introduced the new bill in the hopes that it would be incorporated into a larger bill that Congress is set to vote on at the end of May. The larger bill, while aimed at increasing FDA oversight of the medical device approval process, does not contain specific wording that would currently close an existing loophole, known as the 510(k) rule. Under the 510(k) guidelines, a medical device manufacturer may seek approval of a device without conducting additional safety testing if it can prove that the device is substantially similar to a product that is already on the market, regardless of whether the existing product has any known safety issues.
Thus far, the bill has yet to gain any Republican support. While the FDA has acknowledged the need for a Congressional measure to help close the existing 510(k) loophole, the agency has not issued any official statement lending to support to the larger bill already before Congress or the new SOUND Act. Earlier this month, Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, spoke out against the loophole, saying it challenges the credibility of the medical device approval process.
The FDA approves an average of 28 devices per year using the 510(k) guidelines. Statistically, a new device is five times as likely to be recalled if its design is based on an older device that has known safety issues. This is the case for the Johnson & Johnson Ethicon Gynecare vaginal mesh system, which was based on an existing mesh product manufactured by Boston Scientific. That product, the ProtoGen mesh system, was recalled shortly after the Ethicon mesh gained approval. Now, the Ethicon Gynecare system, along with vaginal mesh devices manufactured by Boston Scientific, American Medical Systems and C.R. Bard are the subject of numerous lawsuits filed on behalf of women who say these devices caused severe pain, swelling, tissue damage, blood vessel damage, bladder and bowel perforation and other complications. The vaginal mesh helpline hears from women on a daily basis regarding their vaginal mesh complications. Women are suffering, lives have been dramatically altered. Someting must be done. Doctors are still implanting these mesh devices even after the 2008 warning. The stories are horrific and our callers seek justice.
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