B Lite implants contain glass or plastic microspheres (commonly used material in plastics used in car parts to remove weight). Why didn't any of these "cutting edge", very educated people site this technology advancement and that it just isn't currently approved for use in the US? When I talk to PS surgeon friends (in Cali and FL)..I'm told that the push is for larger implants...Why wouldn't a lighter weight version be a huge improvement for this fast growing market?
Answer: Implants In the USA, doctors will use the implants that are FDA approved. There is as long history concerning the safety of these implants in women. Just because something works well in a car does not mean it will work well in the human body. In the meantime, animal testing can be done to see what reactions will occur with this product. Other products have been tried with less favorable results. Plastic surgeons don't want a repeat of the 90's.
Helpful 1 person found this helpful
Answer: Implants In the USA, doctors will use the implants that are FDA approved. There is as long history concerning the safety of these implants in women. Just because something works well in a car does not mean it will work well in the human body. In the meantime, animal testing can be done to see what reactions will occur with this product. Other products have been tried with less favorable results. Plastic surgeons don't want a repeat of the 90's.
Helpful 1 person found this helpful
February 29, 2020
Answer: New Implants Thank you for your question. All implants have to go through rigorous testing and FDA approval before they can be used in humans. All silicons are not created equal. There was a large recall of PIP implants (used in Europe) b/c they were using industrial grade silicone, which has not been approved for humans. Just b/c you're cutting edge, doesn't mean you throw safety out the window.
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February 29, 2020
Answer: New Implants Thank you for your question. All implants have to go through rigorous testing and FDA approval before they can be used in humans. All silicons are not created equal. There was a large recall of PIP implants (used in Europe) b/c they were using industrial grade silicone, which has not been approved for humans. Just b/c you're cutting edge, doesn't mean you throw safety out the window.
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Answer: Non-answer means more information is needed Prior to FDA clearance and further experience with the device, the conversation is moot. You will have a durable result by choosing the correct sized implant for your body and breast type. Trying to circumvent that with some space age implant is silly. Also, the key question will be long term biocompatibility. Implant surgery is always about what comes later and thus the need to FDA trials, etc.
Helpful 1 person found this helpful
Answer: Non-answer means more information is needed Prior to FDA clearance and further experience with the device, the conversation is moot. You will have a durable result by choosing the correct sized implant for your body and breast type. Trying to circumvent that with some space age implant is silly. Also, the key question will be long term biocompatibility. Implant surgery is always about what comes later and thus the need to FDA trials, etc.
Helpful 1 person found this helpful
March 20, 2017
Answer: B-lite lightweight breast implants Thank you for your post. The B-Lite implant is an exciting innovation in breast implants since the implants are 30% lighter than standard silicone implants. The only problem is that they are not FDA-approved for use in the United States. FDA approval can take years (along with millions of dollars). If you really want them, you may consider traveling to Europe to get them. However, if you developed a complication once you returned to the US, you may find it difficult to find a surgeon willing to help you fix your problem. Best wishes!
Helpful 2 people found this helpful
March 20, 2017
Answer: B-lite lightweight breast implants Thank you for your post. The B-Lite implant is an exciting innovation in breast implants since the implants are 30% lighter than standard silicone implants. The only problem is that they are not FDA-approved for use in the United States. FDA approval can take years (along with millions of dollars). If you really want them, you may consider traveling to Europe to get them. However, if you developed a complication once you returned to the US, you may find it difficult to find a surgeon willing to help you fix your problem. Best wishes!
Helpful 2 people found this helpful
March 20, 2017
Answer: B-lite implants Having just come back from an international aesthetic plasti csurgery meeting in Tokyo, I saw a few different breast implant innovations that have not yet made it through the FDA to be offered to patients in the USA. The be -light implant which adds air to the silicone making it weigh less certainly seems like a great idea. Since this silicone gel does not yet exist in the United States, this company may need to go through a PMA or premarket approval which may take many years and cost millions of dollars. Should you want this technology today you may have to travel to Europe or the far east. Best of luck.
Helpful 2 people found this helpful
March 20, 2017
Answer: B-lite implants Having just come back from an international aesthetic plasti csurgery meeting in Tokyo, I saw a few different breast implant innovations that have not yet made it through the FDA to be offered to patients in the USA. The be -light implant which adds air to the silicone making it weigh less certainly seems like a great idea. Since this silicone gel does not yet exist in the United States, this company may need to go through a PMA or premarket approval which may take many years and cost millions of dollars. Should you want this technology today you may have to travel to Europe or the far east. Best of luck.
Helpful 2 people found this helpful
