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?
April 23, 2009
Answer: 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 the contracture of the capsule but implant manufacturers couldn't use polyurethane compounds so they created the textured look on the silicone polymer shell instead.
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April 23, 2009
Answer: 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 the contracture of the capsule but implant manufacturers couldn't use polyurethane compounds so they created the textured look on the silicone polymer shell instead.
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December 11, 2013
Answer: 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 the process of applying for FDA approval. As of this year, it is not approved yet.
Helpful
December 11, 2013
Answer: 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 the process of applying for FDA approval. As of this year, it is not approved yet.
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