Why Are Polyurethane-covered Silicone Implants Not Legal in USA?

My fiance's doctor 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?

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6 Doctor Answers | Asked by nique in NY in NYC

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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.

Polyurethane breast implants reduce capsule formation: not available in US

Polyurethane covered breast implants became available about 1980 in the US and in our practice at the time we used quite a number of them. The structure of the implant was similar to a regular silicone gel implant, though on the cover a coating of polyurethane was applied much like a textured surface. Capsule contracture had been, and still is, such a problem with subglandular breast augmentation with a silicone gel implant that the polyurethane coating was a very attractive advantage, and... more

Polyurethrane implants.

The surgeons who used these implants liked them. But subsequent to the silicone implant moratorium in 91, they ceased to be available. At this point in time the costs of submitting these implants to the FDA is not justified by the percieved market. Therefore, no manufacturer has an interest in resurrecting this implant. Despite, their popularity, many questions about the fate and consequences of the polyurethrane remain unanswered.

Otto Joseph Placik, MD

33 reviews

Chicago Plastic Surgeon

Poly-urethane implants

A variety of polyurethane coated implants, or fuzzies, showed extraordinarily low incidence of capsular contracture. However, many of them had very thin shells and the poly-urethane crystals disappeared leaving thin shells that ruptured or simply weren't seen on re-operation. Polyurethane was later found to cause liver cancer in rats so the FDA banned them. These implants were the precursors to the textured silicone implants since the texturization was thought to be important in reducing... more

Robin T.W. Yuan, MD

4 reviews

Beverly Hills Plastic Surgeon

These breast implants are not FDA approved yet

FDA approval is a long process. These implants were available in the 1980's in the US. Plastic surgeons who used them were very pleased with the result and the decreased incidence of capsular contraction. The polyurethane layer is usually gone by 10-15 years and following that the incidence of capsular contraction is the same. There was some reports regarding the degradation product of the polyurethane. I met with the CEO of the Silimed company some 5 years ago. At that time they were in... more

To my knowledge they haven't been available since 1989

Back in '89 they were the hottest implant and were called Replicons and were made by Surgitek. As soon as the implant scare started in '91, drums of spilled industrial polyurethane were shown on TV and the parent company dissolved Surgitek. I haven't heard of them since.