Breast Implants: Q&A
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When Will the Style 410 Breast Implants Be Approved by the FDA?
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7 Doctor Answers |
Asked by
LVal
in Ventura CA
+2
410 approval by FDA?
No one knows exactly when the FDA will approve the cohesive gel 410 implants. When I was at out national meeting of the Aesthetic Society last month in Las Vegas, we were told it was any day? Only the FDA knows.
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Style 410 Gummy Bear Implants; the Next Generation of Silicone Implants
The new Gummy Bear Implants are Coming Soon! These are the implants that have been widely used in Europe and South America. Although I feel this implant will not be right for everybody, I believe it will be very useful in certain groups of women in particular those patients who lack breast tissue or muscle and those at high risk for capsular contraction. Having more viable options to choose from will allow me to better care for and cater to certain groups of patients who can benefit from...
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Why would you want them?
If you follow me on RealSelf you understand that I answer these things very frankly. So why do you want to stuff a gummy bear into your breasts? They look like gummy bears and they feel like gummy bears. Not soft, not breast like. Hell, we use this same product in the operating room as cushions for patients for long prone operations.
The 410 is an extreme that only patients that are still freaked out about the whole untrue silicone thing will want. If we keep putting out products...
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No date currently set for Style 410 release
The style 410 implant from Allergan has been up for FDA approval for at least 2 years. No one at Allergan seems to know or has any control over the release date. This implant will be appropriate for many patients and will be an excellent addition to the implants that are currently available....
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Can't/won't say
I tried to get this info out of the rep and he wouldn't even give me a tip. They are in a period with the FDA where they can not reveal anything. It is my understanding however that they are anatomically shaped.
sek
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No none knows for sure
The wheels of progress turn very slowly at our FDA although there was a new chief recently appointed and I am not sure of her stance on silicone implants. It could be within the month, the year, who knows.
Dr Edwards
+1
You'll have to ask the FDA about 410's
The application to the FDA for approval of the 410 "gummy bear" implants has been pending since 2007. There is no way to predict when the FDA will act however. While there are some important advantages to the shaped implants (Allergan 410, Mentor CPG) these do not apply universally and there are important disadvantages for some as well. Most experts predict that they will be used for about 15-20% of patients at the most, so it is important to talk to your surgeon in detail about...
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