US Has No Good System To Track Medical Implants

DAVID B. CARUSO

NEW YORK (AP) — Three years ago, the maker of a surgical clip called the Hem-o-lok issued an urgent recall notice warning doctors to stop using the fasteners on living kidney donors. It said the clips could dislodge in their bodies, with "serious, even life-threatening consequences."

Not everyone got the message.

Last October, a surgeon in Brooklyn used one of the clips to tie off Michael King's renal artery when he donated a kidney to his ailing wife. Twelve hours later, the clip popped off. King bled to death internally in the hospital as his wife lay helplessly nearby. He was 29.

Experts say such deaths are the result of a major weakness in the nation's system for recalling thousands of medical devices routinely implanted in people's bodies, ranging from screws and plates to artificial knees and hips.

"There is no system for being informed of what the problems are with the products you have in your body. Even your physician may not know," said Terry Fadem, president of the Biomedical Research and Education Foundation in Philadelphia.