Why Are Polyurethane-covered Silicone Implants Not Legal in United States?

My fiance's surgeon recommended polyurethane-coated silicone gel breast implants as a way to reduce capsular contraction, but I see they are not FDA-approved in the USA. Why is this?

polyurethane breast implants

Thanks for your question - In addition to the comments posted regarding the uncertainty of the safety of polyurethane implants, significant steps have been made since they're availability to reduce capsular contracture in the currently available implants including placement, triple antibiotic irrigation, minimizing handling, etc. With improvements in the capsular contracture rate that has dis-incentivized these implants coming back on the market.


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