While silicone injections remained popular during the 1950s, surgeons continued to experiment without success, attempting to implant glass and ivory balls, and wool and ox cartilage. However, the transition to the 1960s marked a new era in breast augmentation surgery. Houston plastic surgeons Thomas Cronin and Frank Gerow developed the first silicone breast prosthesis with the Dow Corning Corporation in 1961 and the first woman was implanted in 1962. The implant was made of a silicone rubber envelope or sac filled with a thick, viscous silicone gel. The basic design remains unchanged for the next 30 years. A French surgeon later developed the first saline filled prosthesis in 1965, but it was considered inferior by the medical community since it was prone to spontaneous deflation. Women felt that the feel of saline filled prostheses weren’t as natural as those filled with silicone gel. Pictured: saline breast implant.
Disconsonant notes rang loudly in the 1980s and that same bell continued to toll through the 1990s. Designed to decrease incidents of capsular contracture – the most common complication of silicone implants – manufacturers coated implants with polyurethane. Studies showed that polyurethane may break down in the body degrading into carcinogenic substances, and the FDA pulled these implants from the market. During the late 1980s, several physicians and consumer advocates questioned the safety of silicone amidst reports that the gel often leaked out of the sacs and into the body. Reports that became available in the early 1990s suggested that silicone implants may precipitate autoimmune diseases. Dow Corning left the implant business as class action suits began to organize.
Surgeons used the safe saline implants that were developed in France in the mid 1960s while the silicone gel lawsuits made their way through the courts and retrospective studies on the effects of silicone were initiated. The FDA later determined that silicone did not induce autoimmune diseases, but stated that serious questions remained and they refused to allow silicone implants back on the market. Meanwhile, manufacturers experimented with alternative fillers such as soybean oil, which eventually gained approval in Europe and were marketed as a “natural” alternatives to silicone. However their use was short lived as studies later revealed that the oil may degrade into toxic substances in the body. European governments recommended that the implants be removed from the market before the FDA ever entertained their approval for the States. Silicone implants are currently taking small steps towards a comeback. Backing down from their recent position on the original or regular silicone gel implants, the FDA has approved studies of cohesive silicone gel implants – a silicone gel that does not leak if the integrity of the implant sac is compromised. These silicone gel implants are available to special study participants. Certain patients may also be candidates for receiving the original silicone gel implants (also referred to as regular silicone gel implants) . Saline filled prostheses continue to be used as more women continue to undergo breast augmentation surgery in record numbers. Pictured: Cohesive gel implant cut to show no leakage.
