Product News and Recalls

FDA issues warning letter about heart device

The U.S. Food and Drug Administration has sent a warning letter to medical device manufacturer St. Jude Medical, warning of problems with manufacturing and quality control at the California plant where the company makes implantable heart defibrillators.

A story in the New York Times notes that the St. Paul-based company has been struggling to deal with problems involving wires that are used to attach the defibrillator to the heart. The wires have generated widespread reports of failure, which public safety watchdogs point to as evidence that the FDA’s approval process for medical devices is inherently flawed.

Other dangerous devices have made it onto the market without clinical testing in humans, based on their alleged similarity to previously approved devices.

For example, the DePuy all-metal hip implant was recalled in 2010 because of its high early failure rate and tendency to leave toxic metal debris in patients’ bodies. And vaginal mesh implants have generated thousands of lawsuits from women who claim the devices failed and injured them.

An earlier version of St. Jude Medical’s defibrillator leads, called the Riata, was recalled after it was shown to jolt the heart unnecessarily or to fail to work when needed.

According to the story in the New York Times, the FDA has said it will not approve new product lines at the St. Jude Medical plant until the problems are corrected, although the agency is not asking the company to recall any 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:

http://www.nytimes.com/2013/01/15/business/fda-warns-st-jude-medical.html?_r=0