“I think people make the assumption that when their doctor implants a device, whether it be an artificial joint or a pacemaker, that it’s undergone very rigorous testing,” Nissen told CBS News. “That assumption isn’t always true.”
A number of medical devices, in particular surgical mesh and metal-on-metal hip implants, have attracted scrutiny recently due to failures and U.S. Food and Drug Administration recalls. The FDA has required 21 companies to do post-market studies into whether their implants shed high levels of metal debris into patients’ bloodstreams.
Nissen, a former student activist at the University of Michigan who’s well-known as an outspoken critic of the drug industry (and one of Time Magazine’s 100 most influential people in the world in 2007), isn’t likely to receive any birthday cards from the device industry, either.
“There is a consistent pattern of failure in medical devices,” he said. CBS noted that Nissen co-authored a report that found more than 2,800 people died in 2006 because of faulty devices.
Of course, it remains to be seen whether Nissen will become to device companies what he is to Big Pharma — but there’s little doubt that he possesses the ability (and maybe even the desire) to be a thorn in the side of industry. The New York Times lauded him in 2007 as “a Naderesque figure and the nation’s unofficial arbiter of drug safety.”
A new investigation by Consumer Reports could bring even more scrutiny to the device industry. The report states that devices often aren’t tested before they come to market, there’s no “systematic” way for people to spot or learn about problems with devices and there’s not much patients can do about it.
Caught in the middle between medical device companies and consumers who’ve suffered from failing devices is the beleaguered FDA. The device industry frequently complains that the agency moves too slow, stifles innovation, is inconsistent and too risk-averse. Consumer groups, in turn, complain that the FDA is too lax in its oversight of the industry, often at the expense of patient safety.