Firm Recalls Heart Valves Blamed for Deaths of 14

An Irvine-based medical products firm is recalling one of its controversial artificial heart valves because of a mechanical defect that already has caused 14 deaths, a company spokesman said Friday.

Shiley Inc. is asking surgeons not to implant any of its 29-, 31- and 33-millimeter Bjork-Shiley 60-degree Convexo-Concave heart valves manufactured between March and June, 1982, because the struts that hold the valve together could fracture.

“These are only the large-sized valves,” Frank Haskins, Shiley executive vice president, said in a telephone interview. “Approximately 2,700 have already been implanted worldwide. Probably 200 have not been implanted. We’re asking for those 200 back.”

Patient Deaths

Twenty-one of the 2,700 implanted valves have failed, Haskins said, adding that 14 of the failures resulted in the patients’ deaths.

Haskins had no suggestions for the 2,700 heart patients who have already had the valves surgically implanted.

“These people have a very low risk of the valves already in them fracturing,” he said. “Usually people with valves work closely with their cardiologists already. They should continue to work with their cardiologists.

“They should not take any unusual action. I can’t think of anything, especially, they should do.”

The human heart has four valves that regulate the flow of blood. These valves sometimes deteriorate or malfunction as a result of birth defects or disease. When this happens, they can be replaced with artificial valves consisting of a cobalt ring and a pyrolitic carbon disc that is held with a cobalt strut.

When operating properly, the strut allows the disk to flip open and shut, causing blood to pass through the heart. When the strut fractures, the disk is lost in the patient’s body, and the heart can no longer pump blood back and forth the way it does in a healthy person, Haskins said.

“They will become faint-headed and pass out,” symptoms resembling congestive heart failure, he said.

“If the person can get to an operating room in time, they can be saved,” he said.

This is the third recall of Shiley artificial heart valves since the firm opened in 1969, Haskins said. Similar Shiley-made valves were recalled in 1975 and 1983. The severity of this particular defect was discovered earlier this week, when a regular analysis showed that “a small number” of the valves could fracture.

In 1984, George Sherry, a former Shiley engineer, charged that thousands of people have defective artificial heart valves implanted in their chests because of design problems, poor workmanship and lack of training at the Irvine company.

Charges Denied

Haskins denied the charges at the time, saying the valves were “safe and effective.” The valves in the latest recall are the same ones he staunchly defended last year, he said Friday.

When Sherry decried the Shiley valves, the federal Food and Drug Administration said it considered the current models safe.

“We went to the FDA and discussed it with them this week,” Haskins said Friday, but he refused to comment on whether the FDA or his firm made the recall decision. FDA officials could not be reached Friday.