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Watchdogs Want More Oversight of Artifical Knees and Hips

February 21, 2012

ANNAPOLIS, Md. - A new hip or knee joint can give Marylanders a new lease on enjoying the state's outdoor life, but there's a dark side to surgically-implanted medical devices, according to Consumers Union. The group says those devices are subject to almost no government regulation, testing or monitoring.

Lisa McGiffert, who directs the Consumers Union "Safe Patient Project," says seniors are especially at risk, since complications connected to artificial joints or heart stents can be more serious at that stage of life.

"Having to do any surgery when you're older is a dangerous endeavor, but having to do it over again if something goes wrong can really cause a lot of harm."

She says Congress should reauthorize the Medical Device User Fee and Modernization Act this year in order to maintain at least some medical device monitoring. The law requires manufacturers to submit their own clinical data to support their claims, and that they report incidents in which a medical device contributed to a death or serious injury.

In addition to medical device testing, another concern is the use of surgical mesh, which McGiffert says has been known to cause problems after surgery - and she says it's being used more often to replace stitches.

"It's placed internally, so that if it goes awry, it's very, very difficult to remove the mesh and can cause pain for the rest of someone's life."

She says more than 90 percent of medical devices do not require proof that they have been clinically tested and found to be safe and effective before being cleared by the FDA for distribution or sale. And according to the General Accounting Office, more than 700 medical devices are recalled each year.

Details about the Medical Device User Fee and Modernization Act are at 1.usa.gov/ACDxbv.

Deb Courson Smith, Public News Service - MD