Heart valves for implants made by Shiley Inc. have been recalled for the fourth time in five years after their company reported 14 more deaths have been linked to them.
That brings the total of deaths connected with the valves to about 125 and the number of valves that have broken while in place to more than 190, according to Food and Drug Administration and Shiley documents.
The latest recall was for the Bjork-Shiley 60-degree Convexo-Concave heart valve, in sizes ranging from 29 to 33 millimeters. Company spokesman Frank Haskins said the Convexo valve in other sizes is not being recalled because they "have a much lower fracture rate."
The valves are used to replace defective human valves. They can consist chiefly of tilting discs that open to let blood through, then close against two struts welded on the valve.
It is these struts that have broken and allowed the disc to break off its mounting in Convexo valves over the years. Once such an accident occurs, the chance of death is about two in three.
About 85,000 of the valves are now implanted, according to the company. Only the large valves made between March and June 1982 are being recalled now, because of their high failure rate.
About 2,700 people have had these valves installed, and the company has reported that 21 have failed, with 14 deaths resulting. The other recalls of Shiley Convexo valves were one in 1980, and two, including a 70-degree export model, in 1983.
The risk of open-heart surgery to replace valves is greater than the risks of the valves failing, so no attempt will be made to take out those recalled. About 200 manufacutured but not implanted will be recalled, and Shiley will cease making the large valves.
Frank Haskins, executive vice president of Shiley, said he had no suggestions for those who have had the valves surgically implanted but said anyone who has problems should go to a hospital.
"They will become faint-headed and pass out," symptoms resembling congestive heart failure, he was quoted as saying by the Associated Press. "If the person can get to an operating room in time, they can be saved."
Dr. Sidney Wolfe of the Health Research Group also had some advice: "Patients with any of these valves who develop sudden shortness of breath, loss of the clicking sound of the valve, dizziness or chest pain need immediate emergency medical attention and probable replacement of the valve."
The reason a valve with some chance of killing patients is allowed on the market by the FDA is that valves of types other than the Convexo disc systems, have proved to have a substantial risk of another kind: They can cause fatal blood clots in a small percent of cases.
The risk of using the Convexo valve is far lower. But some, including Wolfe, say the risk of strut failure in the Convexo valve is needless, because the failures result from faulty design and sloppy manufacturing.
Wolfe also criticized the failure to recall the small valves and said, "any cardiac surgeon who implants one is begging for a malpractice lawsuit."
"The recall of the Bjork-Shiley 60 degree heart valves is incomplete and at least 15 months too late," he said. " . . . Although fractures and deaths have occurred in both large valves and small valves, the recall is only for the large valves. FDA and the company, a wholly owned subsidiary of Pfizer Inc., are irresponsibly allowing the smaller valves to stay on the market."
Haskins said the recall of larger sizes was "the most responsible action to be taken at this time," the AP said. He acknowledged small, metal struts also have fractured on some of the smaller valves, but said the failure rate is low.
"The valve is a good valve," Haskins said. "It's safe and effective, and there's no reason to deny patients the smaller sizes."
In 1984, a former Shiley engineer, George Sherry, claimed that thousands of people have defective heart valves implanted in their chests because of design problems, poor workmanship and lack of training at the Irvine, Calif., company.
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 defended then, he said Friday.
After Sherry made the allegations last year, the U.S. Food and Drug Administration said it considered the models safe.