F.D.A. Hearing to Focus on Replacement Hips (NY Times)
The Food and Drug Administration will start a two-day hearing on Wednesday meant to help doctors find ways to better monitor the risks posed by all-metal replacement hips.
The ball section of an artificial hip removed during surgery at Massachusetts General Hospital.
Once promoted by industry and doctors as an innovative orthopedic breakthrough, the devices have failed prematurely in thousands of cases, causing many patients to undergo repeat surgeries and producing crippling injuries in some of them. As they wear, the devices shed tiny particles of metallic debris that can damage a patient’s muscle and tissue.
Experts caution that definitive answers are not likely to emerge from the hearing. And they add that neither government, industry nor the medical profession appear eager to address the fundamental issue raised by the episode: Why were these devices implanted in 500,000 people without adequate testing?
“There was not enough data to support” their widespread use, said Dr. Henrik Malchau, an orthopedic surgeon at Massachusetts General Hospital in Boston.
Under F.D.A. rules, orthopedic implant makers did not have to run c...
