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FDA Claims It’s Doing More to Protect Against Faulty Mecical Devices

February 26, 1990

WASHINGTON (AP) _ The head of the Food and Drug Administration said Monday the agency has taken steps to minimize the chances that faulty medical devices ever reach consumers.

″We believe that the agency’s procedures have matured significantly over the last decade,″ since the FDA approved a mechanical heart valve made by Shiley Inc. that later was removed from the market after reports of fatal malfunctions, said Acting FDA Commissioner James Benson.

″This maturation minimizes the possibility that faulty devices can reach the market,″ he told members of the House Energy and Commerce investigations subcommittee.

But Rep. John Dingell, D-Mich., chairman of the panel, said: ″We have no assurance that the conditions at the FDA which permitted this valve to enter the market and stay for far too long have been corrected.″

He charged that the FDA moved too slowly against the heart valve and exposed hundreds of patients to unnecessary risk.

Among the steps the FDA said it has taken are stronger criteria for approving implantable devices, better scientific analysis in the approval process and an improved early-warning system for detecting problems with devices already on the market, he said.

A report by the subcommittee’s majority staff raised quesions about the FDA’s ″willingness and ability to fulfill its regulatory mandate to protect public health″ and charged that Shiley, owned by Pfizer Inc., misled the agency and failed to keep the FDA informed of malfunction reports.

Pfizer officials denied those charges. Robert Fauteux, a spokesman for the company, said, ″we met the obligations under the law.″

Republican members of the subcommittee, while concerned about the Shiley valve, said they were also concerned that report failed to recognize the inherent risks of medical devices and that the heart valve has saved the lives of tens of thousands of patients.

The risks of the Shiley valve ″must be considered with a great deal of caution,″ said Rep. Thomas Bliley, R-Va. ″We must to everything possible to avoid alarming″ patients who are living with the device.

Shiley’s convexo-concave 60-degree heart valve, approved in April 1979, has been implanted in 85,000 people, including about 40,000 in the United States. After reports of malfunctions and product withdrawals, Shiley removed it from the market in November 1986.

About 4,000 of Shiley’s 70-degree valves have been implanted in patients overseas. That device was never marketed in the United States.

Shiley has reported to the FDA a total of 295 fractures of the 60-degree valve, with 178 deaths resulting, and 94 fractures and 70 deaths involving the 70-degree valve, according to the subcommittee’s report.

The valve consists of a disc inside a metal ring covered by a teflon sewing ring that is sutured to the heart to hold the valve in place. The disc, pivoting on two thin metal struts, opens to either a 60-degree or 70-degree angle to allow blood to flow through, and then closes.

The fractures have occurred in the struts. When a fracture occurs the disc escapes from the ring, allowing an uncontrollable blood flow through the heart.

Benson said that when the FDA approved the mechanical valve, agency officials were aware of the strut fracture problems with the Shiley valve, but they believed it produced fewer life-threatening blood-clot complications than older-model valves on the market.

After evaluating the clinical data submitted by Shiley, the agency concluded that ″this advantage outweighed, or at least balanced, the strut fracture problem,″ Benson said.

But in June 1984, the FDA performed its own analysis and determined that the Shiley valve did not decrease blood-clotting complications.

Responding to criticism that the FDA notified physicians rather than patients about the risk of strut fracture in the valves, Benson said the agency continues to believe the informing physicians is most appropriate, since they can judge the extent to which a warning causes anxiety in a patient.

However, Frederick Barbee of Minong, Wis., whose wife died after her valve fractured, said that if he had known about the risks, he might have been able to get his wife appropriate medical care faster and save her life.

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