Study: FDA OKs Harmful Medical Devices too Easily

Laurie Lawes, Melissa Lawes
Laurie Lawes, right, and her daughter Melissa, who had to have faulty defibrillators removed.

The FDA approves new medical devices in hopes of saving lives. But in 2006, some devices were linked to more than 2,800 deaths and close to 120,000 injuries, reports CBS News medical correspondent Dr. Jon LaPook.

Laurie Lawes said that when an alarm from her defibrillator - designed to prevent cardiac arrest - it sounded like a French police car siren. When Lawes and her daughter Melissa had them implanted, they never imaged the devices might be defective.

"It was scary to know I had the exact same model," Melissa said.

Their defibrillator was withdrawn from the market in 2007 after 13 deaths were links to wiring problems. The FDA approved the device using some of its strictest criteria, but still did not require testing in humans. The device was then implanted in 268,000 people.

"Devices used for life sustaining indications should undergo rigorous testing before approval. That's clearly not happening," said Dr. Steven Nissen, a cardiologist at the Cleveland Clinic.

Easier FDA approval programs were meant for low-risk devices, like tongue depressors and minor changes to existing devices. But a study out Monday in the Achieves of Internal Medicine found that even the FDA's easiest criteria have often been used to clear high-risk devices. Of the 113 high-risk devices recalled from 2005 to 2009, 71 percent were cleared without requiring clinical trials. Other recalled devices included intravenous pumps, glucose meters and breathing machines.

Dr. Laurence Epstein, a cardiologist, has removed thousands of faulty defibrillators.

"On the one hand, you want to approve devices that are as safe as possible, but on the other hand, you want patients to have access to the latest technology as soon as they can," Epstein said. "If you approve things very quickly, you run the risk of implanting things in people that are ultimately going to fail."

It costs the FDA about 50 times more to review an application using the more rigorous criteria. An industry trade group strongly disagrees with Monday's study, saying that a fraction of one percent of devices are recalled and that the FDA is already looking at ways to improve the process.

"Under the current process, the FDA already has the tools it needs to require further studies as needed," said Steven Ubl, CEO of AdvaMed, an industry trade group.

Laurie Lawes had her broken defibrillator replaced. Melissa's didn't malfunction, but she had hers replaced, too.

"If you're going to put something in somebody, you really need to make sure it's safe," Laurie said.

The FDA is reviewing the current approval process.

  • Jon Lapook
    Jonathan LaPook

    Dr. Jonathan LaPook is the chief medical correspondent for CBS News. Follow him on Twitter at @DrLaPook