Ms. Tillman said the agency had determined that silicone-gel-filled
implants are safe and effective for women 22 or older who receive the
appropriate follow-up care. She added that it was not clear how using
the devices without following the recommendations may affect safety
and efficacy. The two largest plastic surgery associations said they
strongly advise members to adhere to the guidelines. Mentor Corporation,
which makes silicone implants, said it supports the product labeling.
The other implant manufacturer, Allergan Inc., said that it encourages
physicians and patients to follow the recommendations and that it offers
training for physicians to understand them. About 330,000 cosmetic breast
augmentations were performed in the United States in 2006, up from about
291,000 in 2005, according to statistics from a survey of doctors conducted
by the American Society of Plastic Surgeons. These numbers do not include
patients who had implants for reconstruction after breast cancer.