In the early 1990s silicone-gel-filled breast implants were voluntarily suspended from the market by breast implant manufacturers at the request of the U.S. FDA. At issue was the theory that these implants contributed to connective tissue or autoimmune diseases (such as rheumatoid arthritis, lupus, and chronic fatigue syndrome) in some women. The U.S. FDA action was specific to the use of silicone-gel-filled implants in breast augmentation only, and implant manufacturers voluntarily took their silicone-gel-filled implants off the market, pending safety review. However, some silicone-gel-filled implants have remained an available option for breast reconstruction patients with specific procedural protocols, and for patients in formal research studies. After multiple lawsuits and credible independent research by the Institute of Medicine (IOM), the U.S. FDA published the Breast Implants Information Update 2000. This document cites the highly regarded IOM studies that dispelled possible links to illness and silicone breast implants in some women. The IOM independent scientific panel found that silicone breast implants do not increase the risk or signs and symptoms of autoimmune diseases in women as some legal claims stated. Specifically, the report stated, “It is unclear at this time whether the signs and symptoms experienced by these women are related to their implants.”
The findings of several other independent studies are also reported in the U.S. FDA Update, including one of the most comprehensive, performed by researchers at Harvard Medical School in 1996. This study reported, “A small but statistically insignificant risk of all CTDs (connective tissue disorders) reported by women with breast implants. . . over a 10-year period, women with breast implants were 1.24 times more likely to report having a CTD or related disorder.” The U.S. FDA summarized all of the studies they reviewed, stating, “When considered together, these studies indicate that the risk of developing a typical or defined CTD or related disorder due to having breast implants is low.” In 2003, a U.S. FDA advisory panel reviewed a petition from breast implant manufacturer Inamed Corporation to market a newer generation of silicone breast implant, one filled with “cohesive” silicone. In October 2003, the panel voted and recommended that the U.S. FDA should approve, with conditions, their implant for use in breast reconstruction, breast augmentation, and revisional breast cosmetic surgery procedures. In January 2004, the U.S. FDA did not, however, act upon the advisory panel’s recommendation, pending further information from Inamed Mentor Corporation has since submitted their version of the cohesive silicone breast implant for U.S. FDA review and approval. The U.S. FDA established MedWatch to report “adverse events” thought to be associated with medical devices or drugs. With regard to silicone-gel-filled breast implants, if you experience a serious adverse effect that you and your physician believe is related to your breast implant, your surgeon should complete a MedWatch Form 3500, provide you with a copy, and submit the document to the U.S. FDA.
Not all of the silicone implants used today differ from those used in the past. It is the newly developed “cohesive” silicone implants that differ greatly. Cohesive means that the silicone with which the implants are filled is binding unto itself and is therefore unlikely to migrate should the implants leak or rupture. Some journalists and physicians have named these “gummy” implants because they have characteristics similar to the gummy bear candies.When cut in half, the highly cohesive implants remain soft and pliable without anything leaking or dripping out. You must understand that this is not a fair characterization of all cohesive implants, as there has been no accepted standard set to define what is cohesive. The newer generation of silicone implants has a shell that is less likely to allow silicone to sweat or bleed through, and this also reduces the chance of capsular contracture. Your best ability to judge whether you will feel comfortable with the silicone implant recommended in your case is to ask to see that implant, and if possible compare the silicone and saline implants.
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