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In 1976 medical devices were added to the Food, Drug and Cosmetic Act, placing metal hip implants under FDA regulation. At this time metal-on-metal hip implants were categorized under a Class III or “high risk,” category. Nonetheless, the FDA made the determination to allow regulation of hip implant devices through the 510(k) fast track approval process. Metal-on-metal hip implants were not widely used during the next twenty years, however by the late 1980’s, second-generation metal hip implant designs had been introduced.
A recent study, published in the Journal of American Medical Association has many men who are currently taking a testosterone drug wondering about risks they may have been unaware of. This particular study concluded that men taking testosterone supplements had a 29% higher risk of experiencing a cardiovascular event such as heart attack or stroke and, in some cases, the risk could include death.
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