With proposals in the 21st Century Cures Act poised to reduce patient safeguards in the approval of new medical devices, Trudy Lieberman continues her look at the gaping holes that already exist in the FDA’s oversight of the industry.
For the second time in a month the news media has told the sorry tale of two failing medical devices that remained on the market long after their manufacturers were aware of problems that could harm patients. In late December came the Los Angeles Times piece advising readers that Olympus, the manufacturer of endoscopes linked to transmission of antibiotic-resistant bacteria that killed 21 people and sickened some two dozen more, was still being used long after problems had surfaced. The Times found that “Even as patients died and others were put at risk, Olympus continued to sell the device and failed to warn U.S. hospitals that the scopes were tied to dangerous infections.”
NBC Nightly News recently offered a similarly scary follow-up to its investigation last fall (see here and here) that showed a device called the C.R. Bard Recovery Filter implanted in the body to stop blood clots from moving to the heart and lungs had fatal flaws. The device had caused 27 deaths and 300 non-fatal medical events.
I liked the NBC piece but noted that it might have gotten more attention had the network reported the FDA had sent Bard a warning letter a few months before the show aired which described several violations of the Food, Drug, and Cosmetics Act. NBC’s follow-up is first rate and adds to the growing body of work showing that despite FDA approval, dangerous devices lurk in the marketplace driven by the corporate quest to squeeze out more profits and the FDA’s political imperative to please the industry. NBC News got a hold of confidential company records that show Bard was concerned about the failure of its G2 series filters within four months of receiving FDA clearance to market the product. A confidential memo from a Bard executive written in late 2005 soon after the filter got the FDA’s okay told of his concern about “problems with…migration,” “tilting” and “perforation.” A later document that includes data through 2010 showed, according to NBC, that the “G2 series had more fractures, migrations and reported problems than any of its competitors.” The G2 series filters stayed on the market until 2010. Bard maintains the device is safe telling NBC, “We steadfastly believe in the safety and efficacy of these devices when used as instructed.”
“The number of complications, the frequency of severe failures makes it obvious that it was never safe to be implanted,” says Dr. William, Kuo, an interventional radiologist at Stanford Health Care’s IVC Filter Clinic. He estimates he has removed 1,000 failed filters in the last 10 years. “What we’ve learned the hard way is that we can no longer rely on medical device companies to do what’s in the best interest of the patient. And we can no longer rely on the FDA to property regulate these devices.”
Kuo’s observation circles back to a question we keep asking: who will warn the public?
Trudy Lieberman is a veteran health care journalist and regular blogger for HealthNewsReview.org. She often writes about consumer cost and safety issues. She tweets as @Trudy_Lieberman.