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The first documented attempt to augment (enlarge) the breast happened 119 years ago. For the first 68 years, breast augmentation was attempted by direct injection with materials, including paraffin, fat, and free silicone. These attempts led to disastrous consequences including infection, hard breast lumps, deformity, fat absorption, fat necrosis, and chronic inflammatory reactions. Removal was difficult, sometimes leading to measures as drastic as mastectomy. After the invention of the mammogram, these injections were found to create artifacts that made cancer screening more difficult. For these reasons, direct injections of the breast were abandoned by most plastic surgeons in the US. Free silicone injections into the breast for augmentation still continued in many other countries into the latter part of the 20th century, however. Commercially made breast implants were first available in the US in 1958, and over 200 different implant types and designs have been made since then. Experts estimate that 60% of these were silicone gel filled implants with the exception of 1992-2006, when the FDA moratorium was in place. During this time, saline filled implants dominated the market. Dow Corning dominated the implant market for the first 30 years, but over 15 other companies made breast implants during the 1980s. Although Congress gave the FDA authority to regulate medical devices in 1976, breast implants had been "grandfathered in", and few of the products underwent rigorous testing in clinical trials prior to sale on the open market. Regulation of breast implants did not occur until 1991, when the FDA asked companies to submit premarket approval applications. As a result, the implant industry was caught "blind sided" when the FDA demanded comprehensive data with a 90-day deadline for completion of all safety studies. With the simultaneous onslaught of thousands of lawsuits, the implant manufacturers were caught in a vice between the new demands of the FDA, the chorus of "expert witnesses" claiming silicone-immune links, and the tidal wave of litigation. Without good data to defend silicone implant safety, the industry collapsed in less than three years. In 1992, the FDA banned the use of silicone gel filled implants outside of an FDA-approved research protocol due to concerns of safety. During the 1990s, all but two of the breast implant manufacturers went out of business or stopped making implants as a result of the breast implant litigation. In 1996, the courts appointed a National Science Panel that reviewed over 2,000 medical documents and heard testimony from legal, medical, and scientific experts. The panel released their findings in 1998, concluding that there are no identifiable associations between the use of silicone implants and disease. In 1999, the National Academy Institute of Medicine issued a 455-page report that concluded that connective tissue diseases, cancer, neurological diseases, or other systemic complications are no more common in women with breast implants than in women without implants. In 2006, the FDA lifted the moratorium on silicone gel filled implants, with the condition that the two remaining manufacturers did large post approval studies involving 81,260 patients over a 10-year period starting November 17, 2006. Today most patients in the US are choosing silicone gel implants for both cosmetic and reconstructive breast surgery again, but the capsular contracture (breast hardening) rates are no better today than they were in the 1960s when these implants were first developed. In retrospect, capsular contracture was the major complication with the first attempt at augmentation in 1890 and is still the major complication with breast augmentation in 2009. Despite this well known fact, the majority of the attention given to implants over the 119-year period has focused on implant rupture and unsubstantiated claims that implants cause systemic human disease. Current silicone gel filled implants in the US are what many call "4th generation" implants, which have much stricter manufacturing standards and testing standards. "5th generation" implants have already been in use in Europe for ten years and in Canada for five years, but are still not approved by the FDA. These "5th generation" implants are cohesive gel implants commonly referred to as "gummy bear" implants. The advantages of these implants include less rippling and the lack of gel extrusion/leak if the silicone elastomer shell breaks. There are also hopes that these implants would have a lower capsular contracture rate, but preliminary evidence suggests that contracture is still a major problem as with all previous generations of implants. We must learn from the history of silicone gel implants and not repeat history again. Good scientific research must precede commerce and marketing. The cost of bringing a new implant to market has exponentially increased as a result of FDA requirements and legal risk. Now most new implants are first being tested in Europe or South America and often are approved decades there before approval in the US. Many clinical trials are being done worldwide on existing implants and on new implants before US market approval is obtained. Long term studies still need to be done on implant rupture rates. Innovations need to be made to reduce the most common complication, capsular contracture, which still occurs today after 119 years of history. Dr. Mai Brooks is a surgical oncologist/general surgeon, with expertise in early detection and prevention of cancer. More at www.drbrooksmd.com, thecancerexperience.wordpress.com and progressreportoncancer.wordpress.com. Dr. Mai Brooks is a surgical oncologist/general surgeon, with expertise in early detection and prevention of cancer. More at www.drbrooksmd.com, thecancerexperience.wordpress.com and progressreportoncancer.wordpress.com
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breast, implant, cosmetic, surgery, contracture, augmentation, complication,
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