Salinas-area women waiting for access to long-restricted silicone breast implants will have to remain patient. The U.S. Food and Drug Administration last week upheld a 12-year ban on the implants, except in cases of breast reconstruction for cancer survivors under strictly controlled studies. Silicone implants were banned in 1992, leaving saline-filled implants as the only option available to women undergoing breast augmentation surgery. Some women find silicone implants preferable to saline for aesthetic reasons, but critics have said the gel is linked to connective tissue disease and cancer. "Most women feel that (silicone implants) are more natural feeling. They're less able to tell by look and feel that they are implants," said Dr. Matthew Romans, a Salinas plastic and reconstructive surgeon. "I still know people who go out of the country to get them." The FDA ruled against its advisory panel to keep the ban in place, citing a lack of long-term data on silicone implant risks, and issued updated guidelines for manufacturers. The advisory panel, divided on the issue, voted 9-6 in October to recommend lifting the ban. The main reason for the ban, Romans said, is that earlier generations of silicone implants were prone to break open and deflate. More than 235,000 women underwent breast augmentation surgery in 2002 Romans said he has performed up to 75 breast augmentations on area women each year for the last two years, making it one of his most popular cosmetic procedures. Romans also performs about six silicone implantations each year as part of studies. He said he believes silicone is a perfectly safe material for implants. "From my standpoint there is no question (silicone implants) are safe in terms of systemic disease," he said. "But some people can have complications including deflation, rupture and malpositioning." Romans said he believes those risks have been minimized by advances in implant construction. "The latest generation of silicone implants are really well made," he said. "The standards and quality of product are astronomically better than in the '60s, '70s and '80s. Time will tell that these are safe."
THE ASSOCIATED PRESS contributed to this report. HEALTH CARE SPOTLIGHT appears Thursday in Community. Suggestions for future articles are welcome. See "Share your news" on the section front for details.
BACKGROUND
The Food and Drug Administration upheld a ban on silicone breast implants last week, except in cases of breast reconstruction for cancer survivors, citing a lack of long-term data on the implants. Salinas plastic surgeon Dr. Matthew Romans holds a silicone breast implant Monday in his Salinas office. The FDA upheld a 12-year ban on the implants last week.
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