Consumers Union Says Medical Devices, Implants Need to Carry Warnings like Those for Pharmaceuticals

On Monday, the Consumers Union, which publishes the highly popular Consumer Reports, announced that it has filed a petition with the FDA in which it requests that the federal agency require all advertisements for implantable devices -- including knee, hip, and heart valve replacements, cosmetic implants, and heart stents -- carry a warning about the possibility of dangerous infections or failures of the devices that could happen after the devices have been implanted.

"We are concerned that serious and possibly deadly side effects like infections are consistently understated in these device ads...We're asking the FDA to require clear warnings about the dangers of infection during and following such surgery, and information about how long the devices are likely to last once they are in the body...We do not want to discourage those in pain and facing loss of mobility from seeking out medical advice on implants. But we do believe that unintended side effects, which can include death, can be minimized if the public is better educated," said Bill Vaughan, senior policy analyst for Consumers Union.

This is far from the first petition or request of such kind that the FDA has received in recent times.

There has been increasing concern about diseases acquired by patients in hospitals, especially in the wake of forthcoming changes in the ways that Medicare is going to start reimbursing medical facilities for treating those infections and diseases, has increased the demand for medical products that are coated with infection-fighting antimicrobial substances.

Experts say that anywhere from five to 10 percent of all hospital patients get an infection while they are making their stay, and these cost an average of $15,000 each. Many of these infections get linked back to implanted devices.

There has also been concern over medical device failures.

There has recently been controversy over whether or not state courts are allowed to allow lawsuits filed against companies who have manufactured and sold implant devices that then fail after they have been surgically implanted. Most companies that make such devices insist that if they have had their product pass the rigorous tests of the FDA, then their product is safe, and failures are the result of random, uncontrollable factors, or faulty medical procedures on the part of doctors or surgeons handling them. They insist that medical devices cannot become regulated by a myriad of lawsuits.

Studies have shown that the rates of implanted device failures decreased from 1994-1998, but then were on the rise again from 1998-2002, only to begin trailing off again over the last five years. The general conclusion was that as the devices become more complex they become less reliable, but manufacturers then begin retooling them to take out the bugs.

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