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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.
Breast augmentation is one of the most commonly performed cosmetic procedures in the United States, with over 300,000 procedures annually. Modern breast implants are available in saline and silicone gel formulations, in round and anatomic (teardrop) shapes. Implant placement can be subglandular (over the muscle) or submuscular (partially or fully under the pectoralis muscle).
Board certification by the American Board of Plastic Surgery requires years of specialized surgical training beyond medical school and residency.

