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FDA New Boobie Report: Silicone Breast Implants Safe, But Not Risk-Free

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In a report issued Wednesday, the Food and Drug Administration gave renewed assurance about the safety of silicone breast implants with "preliminary results from follow-up studies it required from manufacturers, including Irvine-based Allergan, when it ended a moratorium on sales of silicone gel-filled breast implants in November 2006," according to the OC Register.

The FDA said preliminary results from the latest studies continue “to support the safety and effectiveness of these implants when used as intended.” But it added that “women should fully understand the risks before considering getting them.”

"Breast implants are not lifetime devices," says the FDA, and removal or replacement is likely. For as long as they're installed, women need to monitor them for tightening of the area around the implant (capsular contracture), tears or holes in the outer shell (implant rupture), wrinkling, uneven appearance (asymmetry), scarring, pain, and infection. The chance of complication increases the longer they're in service.

Notes the OC Register, the FDA reports it has "not yet found evidence that silicone implants lead to more serious health problems."

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“Studies to date do not indicate that silicone gel-filled breast implants cause breast cancer, reproductive problems, or connective tissue disease, such as rheumatoid arthritis. However, no study has been large enough or long enough to completely rule out these and other rare complications,”