Group Wants Heart Valve Users Warned by Shiley

WASHINGTON â€”  A consumer group asked the Food and Drug Administration on Wednesday to order Irvine-based Shiley Inc. to warn recipients of two of its mechanical heart valves that the devices are potentially defective.

Public Citizen, a Washington-based organization affiliated with Ralph Nader, said the notices should go to an estimated 56,000 people with heart valves manufactured by Shiley, a subsidiary of the pharmaceutical giant Pfizer Inc.

A civil lawsuit filed by the group against Shiley in Los Angeles sought a court order requiring Shiley to make the same notification. The suit was dismissed in May after a judge said the FDA had sole authority to issue such an order.

Shiley voluntarily ended production of the controversial valves in 1986 after defective welds were blamed for deaths around the world. The FDA attributes 246 deaths to defective Shiley valves, but other estimates are far higher.

Nearly 82,000 valves were implanted in people before the devices were withdrawn from the market. The consumer group said at least 56,000 people who still have Shiley valves should be warned of the dangers so they can weigh the risks of surgery to replace the devices.

The group said the notices also should describe the symptoms of imminent valve failure and list the emergency steps necessary to reduce the odds of death or serious injury if a valve malfunctions. The notices also should list U.S. hospitals capable of performing open-heart surgery to replace a defective valve in an emergency, the group said.

“All available evidence indicates that lives will be saved if more patients are notified directly with truthful and accurate information,� said Dr. Sidney M. Wolfe, director of Public Citizen’s health research group.

FDA guidelines call for sensitive medical information to be conveyed to patients through their doctors. A spokesman for Shiley said the company has followed that policy.