FDA Device Chief Calls for Stricter Regulation of Vaginal Mesh, Other Medical Devices

Nadrich & Cohen, LLP reports that the FDA’s chief device regulator is calling for stricter governance of vaginal mesh and other medical devices.

Los Angeles, CA, March 2, 2012 – Nadrich & Cohen, LLP reports that the U.S. Food and Drug Administration’s top medical device regulator says the federal health agency needs more power to block the approval of unsafe medical devices.

According to a recent Bloomberg report, Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, says that the agency’s current regulatory policies have created a loophole that has allowed unsafe devices to reach the market, including vaginal mesh implants and faulty metal hip replacements. A number of House Democrats introduced a bill earlier this month which would provide for more government oversight of the medical device approval process. Legislators have also appealed to key Republicans to hold congressional hearings on the safety of vaginal mesh.

Legislators are specifically concerned over the FDA’s current 510(k) approval system, which allows medical device manufacturers to seek approval for a product without conducting additional safety testing. Under the 510(k) system, a company only has to demonstrate that their product is substantially similar to an existing product already on the market. It was under this system that Johnson & Johnson was able to gain approval for its Ethicon vaginal mesh implants, which were modeled on a mesh product developed by Boston Scientific Corp. That mesh device has since been recalled from the market.

Vaginal mesh was first approved to treat stress urinary incontinence related to pelvic organ prolapse in 1996. Since 2008, the FDA has received numerous adverse event reports from consumers who say they were injured by a vaginal mesh device. The implants have been linked to a wide range of side effects, including pain, infection, scarring, tissue damage, bladder and bowel perforation, recurrence of pelvic organ prolapse and painful intercourse. In July 2011, the FDA issued an updated safety communication advising patients and health care professionals that the risks associated with transvaginal mesh may outweigh its benefits.

A number of women have subsequently filed suit against several high-profile manufacturers of vaginal mesh devices, including Johnson & Johnson, C.R. Bard and Boston Scientific. The plaintiffs claim that the companies were aware of the potential risk to women who used the mesh devices but did not adequately warn consumers of the dangers.

Women who suffered complications after being implanted with vaginal mesh are urged to seek the advice of an experienced personal injury lawyer to protect their rights. The vaginal mesh attorneys at Nadrich & Cohen, LLP are now offering confidential, no-cost consultations to women in all 50 states who believe they were harmed by one of these devices. Help is available by calling the firm’s injury hotline at 1-800-722-0765 or by completing an online case evaluation form at www.vaginalmeshlegalclaims.com.

Nadrich & Cohen LLP is a national law firm with offices in Los Angeles, Sacramento, San Diego and other cities throughout California. The firm specializes in handling mass tort actions and representing individuals in cases involving pharmaceutical companies, medical device makers and other product manufacturers. The firm is committed to achieving the best outcome possible in every case and has recovered over $200 million in settlements on behalf of its clients.

In addition to handling vaginal mesh side effects claims, Nadrich & Cohen, LLP is also investigating cases involving Yaz, Actos, DePuy Hip Implants, Zimmer Hips, Wright Conserve Hips, Pradaxa, Reflex Sympathy Dystrophy, Fen Phen and PPH, Depakote and Reglan. All cases are accepted on a contingency basis, meaning there is never a fee unless a judgment is recovered on your behalf.

Jennifer Poole
National Client Intake Coordinator
Nadrich & Cohen LLP
12100 Wilshire Blvd.
Suite 1250
Los Angeles, CA 90025
800-718-4658
info@personalinjurylawcal.com
www.personalinjurylawcal.com

This release was published on openPR.