FDA Says 'Yes' to Silicone Breasts

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"Public Citizen has opposed the use of silicone gel breast implants since the fall of 1988, when we petitioned the FDA to ban them after receiving numerous documents from FDA scientists concerned about their safety," says Dr. Sidney Wolfe, director of Public Citizen's Health Research Group.

"In terms of adverse safety and health information known at the time of approval … silicone gel breast implants are the most defective medical device ever approved by the FDA. The approval makes a mockery of the legal standard that requires 'reasonable assurance of safety.'"

At the same time of the FDA action, concerns surrounding lawsuits lodged against silicone breast implant manufacturer Dow Corning remain. A now bankrupt Houston-based trust set up to settle claims after Dow Corning itself went bankrupt in 1995 is still expected to dole out as much as $2.25 billion in outstanding claims by women who silicone breast implants harmed their health. Some attorneys represent hundreds of women whose claims have not yet been settled.

Looking Back at the Ban

The FDA issued the moratorium on silicone breast implants for cosmetic use after thousands of women complained that silicone from leaky or burst implants made them seriously ill.

Since then, however, the implants largely have been exonerated of concerns that they might cause serious or chronic illnesses such as cancer or lupus.

"A certain number of women develop health conditions without implants put in the breast," said Dr. Julius Few, a plastic surgeon at Northwestern Memorial Hospital and assistant professor of plastic surgery at Northwestern University's Feinberg School of Medicine. "The same woman who, through heredity or genetics, will develop a condition regardless of implants, will develop the condition after implants are placed because it was predetermined.

"This does not mean the implants caused the problem," he added. "The problem was destined to occur."

"There have been several retrospective studies done, and all of them have shown that there is no statistical correlation between leakage of silicone implants and autoimmune issues," Song said. "I think that all surgeons and most people involved in health care believe there is no correlation."

However, surgeons are quick to point out that FDA approval does not mean silicone implants are entirely risk-free.

"Everyone needs to realize … that any medical device can fail," Olding said. "Implants are no exception. They will not last forever and will ultimately break."

If silicone gel implants break, it is possible that the gel will leak out, causing inflammation of the surrounding area. Aside from the risk of breakage, the implants can also cause infection and painful, hard scar tissue in some cases. The presence of an implant may also obscure the results of a mammogram, making detection of breast cancer more difficult.

Little Surprise for Plastic Surgeons

The FDA decision was largely anticipated by the U.S. plastic surgery community. In July 2005, the FDA issued conditional approval for silicone breast implants manufactured by Mentor Corp. September 2005 saw the same conditional approval for silicone implants manufactured by Inamed Corp. (now owned by Botox-maker Allergan).

And in April of this year, the American Society for Aesthetic Plastic Surgery presented a course in Orlando, Fla., designed to update and instruct American plastic surgeons on the use of silicone gel implants.

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