Product News and Recalls

Consumer advocates: Congress missing opportunity

Some consumer groups are complaining about legislation that recently passed in the U.S. Senate, accusing Congress of passing up an opportunity to keep unsafe medical devices off the market – such as DePuy Orthopaedics all-metal artificial hip joints, and transvaginal mesh implants.

The bill, which regulates funding of the U.S. Food and Drug Administration, passed the Senate by a vote of 96-1, according to a Minnesota Public Radio report. It may soon go up for a vote in the U.S. House.

The legislation more than doubles the fees that medical device and drug companies pay the FDA for safety reviews, in order to fund an increase in review staffing for the agency.

The goal is to shorten the length of time that the FDA takes to review new medical devices. Medical device manufacturers complain that the process can now take years, which discourages investors from putting money into small companies with promising products, keeps potentially life-saving technology away from consumers and prompts device-makers to relocate to other countries where the approval process takes less time.

But some consumers’ rights organizations, including Public Citizen, allege that members of Congress are passing up a chance to reform the medical device approval process, which currently allows a device to get approval without being clinically tested first.

Under the FDA’s 510(k) process, a medical device automatically gets approval if it’s deemed “substantially equivalent” to a device already on the market. And such devices have recently proven dangerous for their recipients.

The all-metal DePuy Orthopaedics hip implant, for example, was recalled in 2010 following complaints that nearly half failed within six years and required patients to get further surgery. Complaints also included metal debris breaking off and getting into patients’ bloodstream.

And sometimes the “equivalence” that served as the basis of the initial approval is dubious at best.

A type of transvaginal mesh implant, used to treat pelvic organ prolapse and urinary incontinence, was approved on the basis of its alleged similarity to a hernia treatment implanted in a different part of the body using a different surgical procedure. An earlier version of the device was even recalled from the market over safety concerns.

Thousands of patients who received the implant suffered symptoms including debilitating pain and organ perforation.

If you’ve received either of these devices, you should consult with a doctor if you have any ongoing symptoms or health concerns. If you have significant injuries, you should also consult with a lawyer familiar with the DePuy hip implant or transvaginal mesh cases to discuss your legal rights.

See the story here:

http://minnesota.publicradio.org/display/web/2012/05/28/medical-device-fda-review-bill/