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Why Are Polyurethane-covered Silicone Implants Not Legal in USA?
Polyurethane-coated silicone implants were never approved through the FDA's premarket approval process in the US, so they're not legal here even though they're used in other countries. The theoretical concern is the coating's breakdown product, a chemical called TDA, which raised questions about long-term carcinogenic risk. That risk was never definitively proven, but it was enough to keep the FDA from clearing it, especially given cheaper alternatives already existed.
The polyurethane foam works by encouraging tissue to grow into the implant surface, which disrupts the smooth capsule that normally forms and tightens around any implant. That's real and effective for reducing capsular contracture. But since the polyurethane implants first appeared, surgeons have significantly cut contracture rates through submuscular placement, antibiotic irrigation, and minimal-touch surgical technique. So the pressure to bring polyurethane back has faded.
Worth noting: textured implant surfaces, a different category, have been linked to BIA-ALCL, which is why smooth implants now dominate US practice. Any implant decision should happen with a board-certified plastic surgeon reviewing your specific case.
Clinical Context
TDA is a breakdown product of the polyurethane coating that raised early cancer concerns. Studies found only small amounts released slowly over time, not enough to prove a clear risk, but also not enough to rule one out. Because the danger was theoretical rather than confirmed, the FDA held these implants to a stricter approval standard than implants without this coating. This differs from textured-implant concerns, where BIA-ALCL cases are directly documented and counted.
