November 5, 2003

Washington, DC - Proponents of approving silicone breast implants sometimes accurately point out that emotion played a role in the FDA's decision in 1992 to withdraw silicone breast implants from the market.  After all, the documented pain and suffering endured by thousands of women with ruptured, leaking implants can make for quite an emotional issue.

 

But this debate is not simply one of emotion versus science.  Contrary to what Mr. Meroney and Ms. Beauchamp would lead you to believe, there is still ample evidence that silicone breast implants pose a serious risk for women.  Research has consistently demonstrated that silicone implants can cause an elevated risk of an immunological response, potentially contributing to the development of systemic illness.  Research at the National Institutes of Environmental Health Sciences and published research by the FDA itself has demonstrated that silicone gel-filled breast implants can cause immunological responses, including a significant association with fibromyalgia, a condition causing widespread pain in joints, muscles, tendons and other soft tissues.

 

The news is even worse for breast cancer survivors.  Nearly half of breast cancer survivors had to endure at least one additional surgery in the first three years and 25 percent had their implants replaced or removed at that time.  Reconstruction patients also experienced high rates of other complications, including implant rupture, breast pain and necrosis, a painful and disfiguring condition where the skin or tissue dies.

 

If this scientific evidence isn’t enough, just listen to what the FDA's own researchers have to say.  FDA scientists who reviewed the manufacturer's data noted that the women studied by the company, Inamed, experienced an increase muscle pain, joint pain, hair loss, rashes and fatigue, all within two years of getting their implants.  When the women were asked about their quality of life, Inamed's own data also showed that they experienced a decrease in almost every measure of physical and emotional health within two years of getting the implants.

 

All of the FDA advisory panel members acknowledged the company had insufficient data to support safety but nevertheless a slim majority of the panel, anchored by four plastic surgeons, opted to put corporate profit over women’s health.  Even Dr. Thomas Whalen, chair of the FDA advisory panel, told the Boston Globe that "it has not been demonstrated to a reasonable degree of certainty that these devices are safe. Therefore they should not be approved." 

This is troubling under any circumstances, but even more so when you consider that eighty percent of women who receive implants do so voluntarily and that 20 percent are women who have already had to endure the trauma of breast cancer.  These are not groundbreaking treatments that make the difference between life and death.  These are devices that should be held to a higher standard.

 

Unfortunately, if the FDA chooses to follow the panel's recommendation in the months to come, it will undoubtedly cause some women to believe that these devices are completely safe and will leave them to discover on their own how badly this trust was misplaced. 

 

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