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

Doctor Answers (7)

410 approval by FDA?

+2

 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.


Manhattan Plastic Surgeon
4.5 out of 5 stars 17 reviews

Style 410 Gummy Bear Implants; the Next Generation of Silicone Implants

+1

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 these shaped firmer implants.

At the moment they have not been approved by the Food and Drug Administration (FDA) for use in the United States. Whether these implants will become the most popular implants in my practice down the road is unknown. Like all implants the style 410 has its pros and cons. I strongly believe it will help women that are in need of reconstruction and hopefully improve the capsule rate dramatically.

Dr. Leonard M. Hochstein, MD

Leonard Hochstein, MD
Miami Plastic Surgeon
4.5 out of 5 stars 90 reviews

Why would you want them?

+1

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 that undermine the science behind silicone we'll never move ahead.

Get rid of the 410 and use the current cohesive silicone implants. Silicone in inert, it won't hurt you.

Christopher L. Hess, MD
Fairfax Plastic Surgeon
5.0 out of 5 stars 17 reviews

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No date currently set for Style 410 release

+1

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
5.0 out of 5 stars 9 reviews

Can't/won't say

+1

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
4.5 out of 5 stars 46 reviews

No none knows for sure

+1

 

 

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, FACS
Las Vegas Plastic Surgeon
5.0 out of 5 stars 11 reviews

You'll have to ask the FDA about 410's

+1

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 all of your options.

Richard Baxter, MD
Seattle Plastic Surgeon
5.0 out of 5 stars 23 reviews

These answers are for educational purposes and should not be relied upon as a substitute for medical advice you may receive from your physician. If you have a medical emergency, please call 911. These answers do not constitute or initiate a patient/doctor relationship.