Product News and Recalls

Defibrillator concerns spotlight problems with medical devices

A cardiologist who conducted a study of St. Jude Medical defibrillator leads said surgeons should stop implanting them in patients until more research is done about safety concerns surrounding the devices.

The New York Times quotes Dr. Robert G. Hauser of Abbott Northwestern Hospital in Minneapolis as saying: “There is no need to use this lead until we have more confidence in its performance.”

The devices are wires that connect a patient’s heart to a defibrillator, which is supposed to deliver a jolt of electricity and interrupt a potentially fatal heart rhythm. The leads have been dogged by reports of failure. The U.S. Food and Drug Administration recently recommended that patients who received them get imaging tests, and ordered St. Jude Medical to conduct additional studies.

Public safety watchdogs have pointed to the faulty leads 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. A jury recently awarded the plaintiff $5.5 million in the first such case to go to court.

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

According to the New York Times, Hauser’s research suggests that a material used to coat the wires is breaking down prematurely and, in some cases, leading to failure of the device.

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/2012/08/22/business/cardiologist-warns-about-safety-of-st-jude-heart-device-component.html