FDA approval system needs scrutiny

Protecting Patients

With 80,000 deaths and 2 million injuries from faulty medical devices and $8 billion to resolve more than 100,000 patient claims for  vaginal mesh alone, it seems that the US Food and Drug Administration (FDA) needs to find a better way to screen products before they get to market and monitor them afterwards.

According to an editorial in the New York Times, many medical devices are approved for market with virtually no clinical data. “Thanks to regulatory loopholes and lax oversight, most medical devices are poorly vetted before their release into the marketplace and poorly monitored after the fact,” the article said.

Some problems show up many years after the product has been on the market, and they can be hard to correct. Patients involved are subjected to lengthy court battles, and deficient products are likely to stay on the market. Sometimes, regulators claim that there is not enough proof of harm to justify reversing the decision to approve a device in the first place, even when there was little clinical testing and clear evidence of harm.

Faulty products have included a permanent birth control device linked to autoimmune disorders and pregnancy losses, a power morcellator to shred cancerous uterine tissue for removal but which spread the cancer throughout the body, metal hips that released poisonous debris into the body, implantable defibrillators that shock people at random, artificial heart valves with questionable shelf lives, staplers that misfire, temperature control machines that spray bacteria into open chest cavities and robotic surgeons that slap, burn and maim patients. According to the Times, “A combination of dubious regulatory approvals, skimpy post-market surveillance, and faltering responses from regulators caused irrevocable harm that might have been avoided.”

While the FDA has promised “transformative” changes to medical device regulation, there have been few concrete suggestions and an accelerated device approval process. Inasmuch as Dr. Jeffrey Shuren, FDA’s head of device regulation, believes that the benefits of bringing products to market rapidly are worth additional risks, the attempt to innovate does not justify the medical device disasters. Reasonable changes could greatly improve the current system.

The article suggests tightening approval standards to keep companies from bringing new or “updated” medical devices to market without testing them in human trials first, fixing post-market surveillance to make sure companies complete such studies, even when they’re ordered by regulators and establishing a system to make patients aware of product recalls and other safety issues. While the FDA has promised to fix some of the problems, the industry itself ought to be able to develop a worldwide medical device registry to monitor outcomes for medical devices and enable doctors and patients to register concerns and get information. At the same time, the industry needs to have less control over FDA outcomes. In short, the FDA has to make some changes to fulfill its mission, which is to protect patients.


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