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Heart patients 'should be warned of faulty valve implant'

Heart patients 'should be warned of faulty valve implant'

作者:越檬牿  时间:2019-02-26 05:16:00  人气:

By CHRISTOPHER JOYCE in WASHINGTON DC THE AMERICAN manufacturer of an artificial heart valve should warn all its recipients of the possibility that the valve may break, according to a pressure group in the US. Among 80 000 patients fitted with the valve worldwide, there have been almost 400 cases where the valve has broken, 37 of them in Britain. In about two-thirds of these incidents, the patient has died. The Health Research Group (HRG), a pressure group in Washington DC, says that all patients should be warned of the risk from the valve and some of their medical costs should be paid. But the US government’s Food and Drug Administration says that surgical removal of the valve is more risky than keeping it in place. The FDA has said that physicians should weigh the benefits of warning patients of the risk against the anxiety the warning might induce. Last week HRG announced that it was suing the manufacturer, Pfizer Corporation, to demand action. Pfizer and its subsidiary, Shiley Inc. of Irvine, California, withdrew the valve from the market in 1986 after repeated inquiries about its safety by the Food and Drug Administration. According to the FDA, about 40 000 people in the US had one of several types of Shiley’s valves implanted before 1986. Most of the remainder were patients in Britain and Europe. By January 1990, 389 valves had broken, according to a Congressional committee that investigated the valves. Sweden had 39 incidents and the US 140. The valve consists of a disc of carbon, suspended within a metal ring by flexible struts. It replaces faulty aortic or mitral valves, which are essential for maintaining the correct flow of blood through the heart. The device, known as the Bjork-Shiley valve, the Convexo-concave valve, or simply the C-C valve, was available between 1979 and 1986. HRG’s lawsuit demands that Pfizer and Shiley notify all patients carrying the valve of its defects and failure rate, and pay for them to have medical consultation. Such consultations should include discussion of the risk of removing the valves, the symptoms of impending valve failure, and steps to reduce the odds of death should such symptoms appear. Sidney Wolfe, HRG’s director, claimed last week that the companies ‘have engaged in a longstanding and continuing course of deceptive and fraudulent conduct in order to conceal the valve defects and their risks’. By 1985, Shiley and Pfizer had issued seven recalls of valves of various sizes. After each recall and redesign, Shiley claimed the struts were improved. These claims ‘were often unfounded’, according to a statement published last month by the FDA. Shiley finally removed all its valves from the market in 1986. Although Shiley has informed physicians several times about problems with its valves, these warnings do not necessarily reach the recipients, said Wolfe. The FDA advises patients against removing a valve that has already been implanted. The risk that a large valve will fracture is about 13 in 10 000 per year, says the administration,