Do Medical Devices Need More Monitoring?

Posted on December 19, 2011

Legislation was introduced in the U.S. Senate on December 14 that would require medical device makers to track their products after they are implanted in patients. As amazing as it sounds, that doesn’t happen now. And even more astonishing, many implantable medical devices do not undergo a premarket review for safety before they are sold for use.

In recent years, the Food and Drug Administration (FDA) has overseen the recall of artificial hips which are known to fail prematurely in patients. Reports of complications from defective synthetic surgical mesh have increased five-fold in recent years, according to the FDA, and still it remains on the market. Both of these medical devices were approved without scrutiny for safety under the agency’s 510(k) approval process for marketing alone. It just requires the device be “substantially equivalent” to a device already on the market.

The Institute of Medicine reported this summer that the 510(k) process is “fatally flawed’ and should be abandoned in favor of patient safety, not the marketability of products.

The bill, introduced by Herb Kohl of Wisconsin, Richard Blumenthal of Connecticut, and Charles E. Grassley of Iowa, would require medical device manufacturers to track data on the device’s performance. The legislation would also give the FDA more authority to address product recalls.

The Florida medical product liability attorneys at Farah & Farah understand that this pro-patient bill was introduced to counter the rash of legislation introduced by industry-friendly Congress members that would actually streamline FDA rules and allow products to make it to market more quickly with less regulation.

As of October, The New York Times reports about 3,500 lawsuits have been filed against Johnson & Johnson over its Articular Surface Replacement artificial hip (ASR), a metal-on-metal product known to wear out well in advance of its 15-year lifespan. An Australian report said J & J knew there were problems with the device before the company issued a recall last year.

Unfortunately for about 93,000 patients who have received the implant, they must wait and see whether their medical device will fail too.


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