Both the medical and scientific communities have scrutinized silicone gel breast implants more than any other medical device in the world. There is a mountain of data that has accumulated over the last four decades, and this data has been analyzed by multiple disciplines of professionals and scientists. Mass media, class action lawsuits, the downfall of a major manufacturer of silicone implants, and the schizophrenic response of the FDA served to both confuse the public and intensify the scrutiny of these devices.
Initial implants were silicone oil soaked sponges that caused significant local scarring known as capsular contracture. Improvements led to the creation of a device consisting of a silicone elastomer (synthetic rubber) outer shell that was filled with a mixture of silicone oils or gels. These ‘second generation’ implants were still leaky of silicone oils. Improvements to the outer shell and the creation of semisolid silicone gels (cohesive) have lead to the ‘low bleed’ implant.
In 1992, a number of coincidental events lead to a unique situation that changed the course of history for silicone-filled implants. While the FDA began its revue of these implants that year, a class action lawsuit was brought against Dow Corning, a manufacturer of these devices. The primary allegation was that silicone had caused debilitating injuries in thousands of women, predominantly autoimmune type diseases. ‘Investigative reporting’ was coming into its own, which served to catapult this issue into the nightly news, informing the public about these ‘dangerous’ devices. The FDA’s committee recommended more research to be conducted by manufacturers while continuing production and sale of silicone filled breast implants. The Commissioner of the FDA disregarded their recommendations, and placed a moratorium on silicone implant sale, citing the lack of sufficient data to prove safety and efficacy. In the light of this, Dow Corning chose to settle the lawsuit out of court, which would eventually lead to its bankruptcy. The FDA then invited the other manufacturers of silicone gel breast implants to begin research that would last fourteen years.
Silicone breast implants are now widely available in the United States since their approval by the FDA in 2006. Consensus among plastic surgeons like me who have performed thousands of silicone gel breast augmentations is that they are excellent devices that give women a more natural breast with great durability and longevity, and are extremely safe.
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