On Wednesday, the FDA announced stronger safety requirements for breast implants, restricting sales of implants only to providers and health facilities that review potential risks of the devices with patients before surgery.
adding a boxed warning for breast implants, stating that the devices do not last an entire lifetime; that over time the risk for complications increases; and that breast implants have been associated with ALCL, and also may be associated with systemic symptoms such as fatigue, joint pain, and brain fog.
The new requirements have received largely positive reactions from both physicians and patient organizations. In an emailed statement tothe immediate past president of the American Society of Plastic Surgeons, said,"ASPS has always supported patients being fully informed about their choices and the risks, benefits, and alternatives of the options available."We look forward to our continued collaboration with the FDA on the safety of implants and other devices.
To inform patients of risks more clearly,"It's the words like 'associated with' that we feel need to be stronger" she said. She also noted that women who already have breast implants may not be aware of these potential complications, which these new FDA requirements do not address."Placing restrictions on breast implants is a really big step, and we applaud the FDA's efforts," she said.
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