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Silicone breast implants approved by FDA in US

23-Nov-2006

Silicone gel breast implants have been approved for use in breast reconstruction and augmentation  procedures by the US Food and Drug Administration (FDA), following a 14-year ban.

The FDA has approved applications by two manufacturers, Mentor and Allergan, although the implants are only to be used for cosmetic purposes in women over the age of 22.

The decision has been applauded by both the American Society for Aesthetic Plastic Surgery (Asaps) and the American Society of Plastic Surgeons (Asps), which said the move would allow American women to make "informed choices about their health care".

Dr James Stuzin, president of Asaps, commented: "It is clear that the agency has carefully evaluated the data presented by the manufacturers, as well as the testimony of physicians, patients and advocacy groups and has made a thoughtful decision to give our patients the access to silicone gel breast implants that women in 60 countries around the world have."

The FDA banned the use of silicone gel breast implants in the early 1990s, following concerns that leaking implants were making women ill and suggestions of a link with cancer and lupus.

However, studies have failed to verify any such links and Dr Daniel Schultz, head of medical devices at the FDA, said that there was reasonable assurance that the implants were safe and effective.

Silicone implants are said to look and feel more natural than those filled with saline, which frequently suffer from visible rippling and deflation.

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