“Needless to say, device manufacturers are not always forthcoming. Throughout the 1980s and 1990s, a device known as the Björk-Shiley heart valve malfunctioned in hundreds of the 86,000 patients it was implanted in–resulting in at least 900 deaths. Yet, according to a year-long investigation conducted by the House Subcommittee on Oversight and Investigations, the product remained on the market for years because its manufacturer "continually provided the medical community with incomplete and misleading information regarding the number of strut fractures and the severity of the problem."
http://www.thepoptort.com/2009/03/setting-time-bombs-in-our-chests-our-unreliable-fda.html

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