The Return of Silicone Gel Breast Implants
After 14 years of public controversy, federal debate, and civil litigation, silicone gel breast implants made an eminent return to the American market. During the silicone implant ban initiated by the United States Food and Drug Administration in the early nineties, silicone became a frightening word, synonymous with physically devastating, and in some cases disfiguring, post-surgical complications. During this time, saline implants emerged as a reliable alternative and became the standard in breast augmentation surgery.
Though a relatively safe and suitable replacement, saline proved that it, too, has physical and aesthetic limitations, which is why cosmetic surgeons and patients alike continued to long for the FDA to lift its ban on silicone implants. In the wake of scientific evidence demonstrating the safety of silicone, and a race to develop a silicone gel implant that met FDA safety requirements, silicone implants were once again approved for use in the United States in November 2006.
Investigating Silicone Gel Breast Implants
The United States Food and Drug Administration began restricting the use of silicone gel breast implants in 1992, due to an overwhelming number of reports the implants were making recipients ill. As a result, silicone was marked by a stigma that it still has not shaken, despite scientific findings that have repeatedly indicated its safety.
After the FDA prohibited the use of silicone implants, theories as to why they would cause adverse systemic reactions were explored in numerous medical trials and studies. Silicone had been blamed for causing serious autoimmune disorders and connective tissue diseases including firbromyalgia, lupus, scleroderma, Sjogren's syndrome, rheumatoid arthritis, and cancer. Some experts have claimed that, when a silicone implant ruptured, the gel would leak or migrate (depending on consistency) into the surrounding tissue, wreaking havoc on the immune system. Still other researchers claimed that, over time, the platinum contained in the implant shell had the potential to leach out from the implants in dangerous levels, oxidizing within surrounding tissues and resulting in a harmful, highly allergenic form of the inert metal.
Studies conducted in the wake of the ban, many of which were published in peer-reviewed medical journals, categorically refuted the existence of a link between silicone gel breast implants and disease. Evidence supporting the safety of silicone implants was so compelling that the FDA approved silicone breast implants for limited use in supervised studies involving breast reconstruction patients who had undergone mastectomy. Although the FDA gave approval for this very specific usage, the agency required further data before it would consider more widespread approval.
Saline v. Silicone Implants
During the ban on silicone gel implants, saline implants came to dominate the market as the only implant option for non-cancer-related breast enhancement surgery. However, like silicone gel implants, saline implants are not impervious to rupture or leakage and must be replaced when either occurs. Additionally, because saline filler lacks the viscosity and cohesion of silicone gel, the liquid shifts, which can affect the shape of the implant. The shell may ripple along the seam, causing pleat-like ridges to appear around the periphery of the augmented breast. Rippling also can disrupt the integrity of the implant’s structure, making it more susceptible to rupture or leakage.
Cohesive Silicone Gel Breast Implants
The newer classes of cohesive silicone gel implants were available in Europe and South America for breast augmentation, lift, and reconstruction surgeries ten years before the FDA approved them for use in the United States. Surgery with these implants consistently yields excellent aesthetic results with minimal complications. Compared to saline implants, INAMED and Mentor Corp.’s form-stable silicone gel implants offer a more reliable and natural looking shape. This is due to the thickness of the silicone gel, which in INAMED’s newest silicone model, style 410, has been compared to the consistency of a gummy bear. The relatively solid state of the implant makes rippling and implant collapse an impossibility, and the multi-layer outer shell ensures that the silicone gel remains inside of the implant. Furthermore, manufacturers have textured the outer shell of the new implants which creates added friction to keep the implant in proper position, minimizing the possibility of capsular contracture.
Today’s Silicone Breast Implant Industry
The silicone breast implant debacle had market-shattering effects, causing the originator of the silicone breast implant, Dow Corning, to file for chapter 11 bankruptcy in 1995. The crippling burden of federal involvement and a tidal wave of costly lawsuits changed the face of the breast implant industry, making way for competitors to develop silicone implants that would lay to rest the fears of physicians, the FDA, and patients. Two main companies emerged at the forefront of the silicone gel evolution: INAMED (a division of Allergan) and Mentor Corporation. Both companies were locked in direct competition, each striving for widespread approval by the United States FDA for their respective models of cohesive gel implants.
The Final Stages of FDA Approval
In April 2005, the FDA granted approval for Mentor to release its implants on a very limited basis so that patients could be closely monitored. Shortly thereafter, INAMED’s implants were approved under similar conditions.
Both companies finally received full FDA approval for their breast implants in November 2006.
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