Breast Implants Essay -- essays research papers

Breast Implants 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 Dow's 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 it was felt that there was a reason to do so. (Bruning 7) "In 1977, Richard Mithoff, a Houston attorney, wins the first lawsuit for a Cleveland woman who claims that her ruptured impla... ...'s internal memo's, thousands of these memo's revealed lack of long term testing, complaints from doctors, and leakage of silicone from the implants. The most outrageous incident discovered was complaints from surgeons of implants rupturing in the operating room, as they tried to install them into women's breasts (Byrne 98). Pathology reports indicate considerable silicone reaction to the extruded material can cause severe foreign body reaction in susceptible individuals. A letter written to Dow Corning from Charles A. Vinnick a predominant cosmetic surgeon in California wrote: " I am loathe to publish my series of cases as I feel that it may open Pandora's box. I do feel, however, that rapid dissemination of this information is very necessary to protect your comapny and my colleagues" (Bryne 98). Vinnick complained to Dow about an incident when he removed a pair of silicone implants, the gel in a ruptured implant was terribly runny while the gel inside the other implant was of ideal cohesion. This difference led him and some others to believe that when silicone gel came into contact with tissue fluids and fat the gel's consistency changed.