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One of the first uses of silicone in a medical implant came in the form of lifesaving tubes implanted into young children to funnel excess fluid from the brain into the chest cavity where the fluid could be safely metabolized and excreted Since these shunts were first used in the late 1950s silicone in various forms has come to be an important part of many implants It is used in tracheotomy tubes in artificial lenses for the eye in artificial heart valves and in facial implants for birth defects or re-constructive surgery after cancer Ames 1 The most widely used implementation of silicone is through breast re- constructive surgery through elective surgery of an individual or re- constructive surgery to replace breasts due to women recovering from mastectomies from breast cancer or miscellaneous types of accidents The early history and use of implants showed no ill effects of the use of paraffin or silicone Because of this newly developed surgical process and relatively little use of FDA guidelines there was no comprehensive testing done to ensure the utmost safety of a silicone recipient By this time the millions of women throughout the world who already had Dows silicone prosthesis implanted into their breasts had no idea of the dramatic health risks Because of these potential health risks women should avoid the use of breast implants In 1976 Congress gave the FDA authority to regulate breast implants By this time breast implants had been in use for a significant amount of time and were considered grandfathered This means that they were allowed to remain on the market even though they have not gone through stringent testing The FDA felt there was no evidence to substantiate that the implants were harmful Furthermore Congress also gave the FDA the power to go back and require manufactures to provide proof that the implants were indeed safe and effective if
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