When will these implants be available in the US? Any trials going on currently? What Doctors would be selected for the trials?
Answer: Sebbin Biconvex gluteal implants I am not aware of any pending application for use of these implants into the USA. Furthermore, although a nice invention to reduce the problems of a round implant potentially flipping like a pancake, their aesthetic contour within the buttock is not always so natural. They often produce a pointy gum drop defect from the side profile view, especially when patients bend over. Finally, because of the extreme time and cost of research to get past the FDA, and the of silicone gel breast implants, I do not ever foresee these implants ever becoming FDA approved in the USA.
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Answer: Sebbin Biconvex gluteal implants I am not aware of any pending application for use of these implants into the USA. Furthermore, although a nice invention to reduce the problems of a round implant potentially flipping like a pancake, their aesthetic contour within the buttock is not always so natural. They often produce a pointy gum drop defect from the side profile view, especially when patients bend over. Finally, because of the extreme time and cost of research to get past the FDA, and the of silicone gel breast implants, I do not ever foresee these implants ever becoming FDA approved in the USA.
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Answer: Silicone gel, gluteal implants It is unlikely the FDA will ever approve silicone gel implants. There are many reasons for this. The FDA took silicone breast implants, aftermarket, even though there was no signs supporting doing so. They did not want to put them back on the market, but they were forced to do so, because the science overwhelmingly supported the use of silicone implants as being safe. There is such a little demand for gluteal implants in the United States that no company would go through clinical trials to market such a product. I’m no expert, but most plastic surgeons in the United States. Don’t offer gluteal implants, and the procedure is not done commonly in this country. You should also recognize that all implants will eventually wear out, and the capsule will break. Sitting on your implant on a daily basis is a recipe for disaster if your implant has silicone gel in it. It’s not a matter of if it’s going to break it is a matter of when it’s going to break. Perhaps I sound a bit opinionated and I probably am. I also don’t know that much about gluteal gel implants, but I can tell you it is unlikely you will find them available to use in the United States legally in your lifetime. Best, Mats Hagstrom, MD
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Answer: Silicone gel, gluteal implants It is unlikely the FDA will ever approve silicone gel implants. There are many reasons for this. The FDA took silicone breast implants, aftermarket, even though there was no signs supporting doing so. They did not want to put them back on the market, but they were forced to do so, because the science overwhelmingly supported the use of silicone implants as being safe. There is such a little demand for gluteal implants in the United States that no company would go through clinical trials to market such a product. I’m no expert, but most plastic surgeons in the United States. Don’t offer gluteal implants, and the procedure is not done commonly in this country. You should also recognize that all implants will eventually wear out, and the capsule will break. Sitting on your implant on a daily basis is a recipe for disaster if your implant has silicone gel in it. It’s not a matter of if it’s going to break it is a matter of when it’s going to break. Perhaps I sound a bit opinionated and I probably am. I also don’t know that much about gluteal gel implants, but I can tell you it is unlikely you will find them available to use in the United States legally in your lifetime. Best, Mats Hagstrom, MD
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