Product News and Recalls

Medical device makers partner with FDA

A story in the Star Tribune out of Minnesota concerns a partnership between medical device manufacturers and the U.S. Food and Drug Administration, designed to help industries get through the regulatory approval process for new devices.

The Medical Device Innovation Consortium will serve as a public-private partnership between the manufacturers and the FDA’s Center for Devices and Radiological Health. Organizers intend to include leaders of industry, academia and government agencies.

The story notes that lobbyists with the medical device industry have been lobbying Capitol Hill to reform and FDA review process they say is too punishing for companies. But many consumer safety activists claim the FDA’s standards are too lax, allowing inherently dangerous devices to make it onto the market.

For example, an all-metal artificial hip manufactured by DePuy Orthopaedics was recalled in 2010 after a number of studies showed nearly half needed replacement within six years. The implants were also prone to shedding toxic metal debris in patients’ bodies.

And transvaginal mesh implants, used to treat urinary incontinence and pelvic organ prolapse, have generated widespread recalls and complaints that they cause severe pain and injuries for recipients.

Both devices were approved under an FDA regulatory loophole that allows for medical devices to go on the market based on their ostensible similarity to previously approved products.

You should consult with a doctor if you have any ongoing symptoms or health concerns from a DePuy hip or transvaginal mesh implant. If you have significant injuries, you should also consult with a DePuy hip or transvaginal mesh lawyer to discuss your legal rights.

See the story here: