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Medical implant material suppliers are being lured by profits offered by this $1 billion/year business, and many seem to be forgetting the expensive lesson learned by Dow Corning after its involvement with silicone breast implants forced it into bankruptcy in the 1990s. Armed with the legal protection of the Biomaterials Access Assurance Act of 1998, established companies and a growing number of start-ups are marketing implantables, forgoing risks in order to exploit growing demand for polymer-containing devices from an aging population. Dow Corning and others remain cautious about providing plastics to be used in the body longer than 30 days. As in the case of radiation, how safe is safe? Can legal protections safeguard the patient without hampering the manufacturer?
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