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Silicone breast implants bounce back

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Silicone breast implants are making a comeback-good news for manufacturers, but bad news for those protesting the US Food and Drug Administration's (FDA's) possible reapproval

Silicone breast implants are making a comeback-good news for manufacturers, but bad news for those protesting the US Food and Drug Administration's (FDA's) possible reapproval. On Oct. 15, 2003, FDA advisors recommended that an eleven-year ban be lifted.

Many women who've had breast implantation blame silicone for several health problems, including unrelenting pain and autoimmune disease. Another problem is leakage, resulting in a 46-per-cent removal rate within three years after surgery.

Health Canada also restricted silicone implants in the 1990s. Saline-filled implants are the only ones currently approved for open sale, but Health Canada still approves silicone augmentation on a case-by-case basis.

Among those who presented evidence to the FDA was Sidney M.

Wolfe, MD, director of Public Citizen's Health Research Group (publiccitizen.org). Wolfe said it was "foolhardy" to reapprove silicone breast implants based on only three years of data.

Ironically, silicone implants are becoming the first choice for Canadian women. In the past four years, 57 per cent of breast augmentation surgeries-almost 3,000 cases-used silicone, suggesting this federal "ban" has missed its mark.

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