When medical implants fail
"The industry's concern about the FDA in the last few years is that while they haven't changed their standards for review, reviews have become much slower and more inconsistent," Nexon said.
But Dr. Hauser cautions that speeding up an already ineffective approval process could be dangerous, because there's also inadequate follow-up after a device hits the market - something called post-market surveillance.
"In the United States, there is no definite requirement for post-market surveillance for defibrillators and heart valves, artificial hearts and so forth," he said. "There's no absolute requirement. In other words, you wait for problems to be reported to you rather than actively seeking out problems, and there's a big difference."
He says active reporting could have saved Joshua Oukrop. Remember, the GAO says the FDA received 26 reports during the three years before Oukrop's death.
"I suspect nobody read the report," Dr. Hauser said.
"FDA has got to know there's a problem here," said Axelrod.
"They do, and Congress knows they have a problem," Dr. Hauser said.
"So when you say there can be tens of thousands of people walking around with faulty devices, I mean, really, tens of thousands? It doesn't have to be, in your view?"
"No," Dr. Hauser said.
Last year, the Institutes of Medicine, an independent advisory group, issued a report stating that the FDA's current regulatory framework for most devices is so flawed it should be thrown out and replaced with a new system that "provides a reasonable assurance of safety and effectiveness."
Advamed's David Nexon says that even though in the last couple of years recalls of device models with problems that could cause serious injury or death have doubled, in his view, the numbers are still small.
The American people, Nexon said, "should be very confident that the FDA and the industry working together have an exemplary safety record. There are 50,000 different models and devices on the market right now. About 20 of those on average they find serious problems with. That's less than two-tenths of one percent."
Lee Oukrop asks, "Why did I have to be the 1 percent? Not wishing it on anybody else, but why does there have to be any? There shouldn't be any. There can't be. When it's that critical of a piece, there can't be that kind of problem with it."
When we finally heard back from the FDA - the agency refused our request for an on-camera interview, providing us instead with a lengthy statement, which said in part:
"The FDA weighs the benefits and risks of every medical device we review. ... We must balance risk with the careful evaluation of patient benefit - this helps promote public health."
Today, Lee Oukrop worries for his other son, Jacob, who inherited the same heart condition as Joshua - and has a defibrillator implanted inside him.
"I mean, I feel confident that it will save me if and when I ever do need it," Jacob said. "They have assured me that this device is a life-saving device and I just put my trust in what the doctors say."
But this isn't Jake's original device. As the luck of the one percent would have it, a part on Jake's defibrillator was faulty. Remember those smaller leads Dr. Hauser described? Jake was among the 268,000 patients who received that "shrunken up" version.
"There was a recall on some of the leads that go from the defibrillator to the heart," Lee Oukrop explained. "The leads were cracking and shorting, and then the defibrillator couldn't deliver a charge if it needed to."
After having that device inside him for nearly three years, it was replaced before Jake was harmed.
But 13 others died.
Lee Oukrop says Jake just had better luck than Joshua - and that's not nearly good enough.
"Somebody out there needs to be looking out for me, for us," said Lee. "We're not doctors, we're not scientists. Here it is six, seven years later, and you still see that stuff is getting through. Stuff is being recalled. And it's all stuff that the FDA should be looking at and they should be paying a little bit more closer attention to."
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