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Engineering and the law: the Biomaterials Access Assurance Act of 1998

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Congress passed legislation protecting suppliers of bulk components and raw materials for implants from law-suits, The legislation is called the Biomaterials Access Assurance Act of 1998 (BAAA). The BAAA applies to all implant raw materials and components except the silicone gel and the silicone envelope utilized in a breast implant containing silicone gel. The new law supersedes otherwise applicable state laws and procedures by precluding any civil action, regardless of the legal theory upon which it is based, for harm, other than commercial loss or loss of or damage to an implant, caused by an implant. The BAAA was passed in response to a serious problem: the embargo by manufacturers of bulk biomaterials such as silicone gel and Teflon. This embargo arose from some legal decisions making the suppliers of bulk biomaterials liable for injuries allegedly caused by finished implants. Unfortunately, Congress and the President lost sight of the original goal in the flurry of lobbying by plaintiffs' lawyers and component-part manufacturers. The result is a bill that provides a much broader umbrella than is necessary to protect biomaterials suppliers, and no protection for suppliers of silicone gel, one of the bulk materials that led to the legislation

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Engineering in Medicine and Biology Magazine, IEEE  (Volume:18 ,  Issue: 2 )