Product News and Recalls

Mother who lost job from implant wants reforms

A mother of three who had to quit her truck-driving job because of debilitating pain from a faulty vaginal mesh implant spoke up on Thursday, calling for federal lawmakers to close the loophole that allowed the implant to go on the market in the first place.

“It’s a question of loss,” said Colorado resident Jay Nevarez. “I lost my job and my health, and am in the process of losing my home.”

According to a report in The Boston Globe, Nevarez joined U.S. Representative Edward Markey (D-MA) at a press conference in Washington, D.C., to help draw attention to the issue.

Markey and some of his colleagues in the House of Representatives have sponsored the Safety of Untested and New Devices Act of 2012 (SOUND Devices Act), which they hope to add to a larger medical device bill that Congress is set to vote on at the end of May.

Under current law, the FDA must approve medical devices on the sole basis of their similarity to devices that have already been approved – even if the original devices were recalled for major safety problems.

While the FDA hasn’t lent its official support to Markey’s bill, spokesperson Karen Riley said the agency has raised issues about the loophole to members of Congress. On average, Riley said, the FDA clears only 28 devices a year based on a previous device that was already approved but since recalled. But a new device is five times as likely to be recalled with a design flaw if it is based on an older device that was itself pulled for safety problems.

“We’re stuck in the position of allowing these devices to get on the market,” she said. “We can only turn them down if there was a mandatory recall of the older product, not a voluntary one, and those mandatory recalls are very rare.”

Medical devices approved under that provision include the vaginal mesh implants – used to treat incontinence and weakened muscles that can no longer hold up internal organs – and all-metal hip replacement implants.

If you’ve suffered problems from either a DePuy Orthopaedics hip implant or a transvaginal mesh implant, contact Lopez McHugh for a free consultation to discuss your legal options.

See the article here: http://articles.boston.com/2012-03-23/health-wellness/31223983_1_vaginal-mesh-medical-device-fda-approval