When Will the Style 410 Breast Implants Be Approved by the FDA?

asked 2 years ago by LVal in Ventura CA
Latest answer by Christopher L. Hess, MD
Question viewed 1,176 times
Tags: breasts

6 answers to When Will the Style 410 Breast Implants Be Approved by the FDA?

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.

Steven Wallach, MD
Manhattan Plastic Surgeon

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... more

Christopher L. Hess, MD
Fairfax Plastic Surgeon

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....

Jeffrey Zwiren, MD
Atlanta Plastic Surgeon

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

Scott E. Kasden, MD
Dallas Plastic Surgeon

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

Michael C. Edwards, MD
Las Vegas Plastic Surgeon

www.medwardsmd.com

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... more

Richard Baxter, MD
Seattle Plastic Surgeon

Ask a question

Get Free Email Updates