Has the FDA yet approved any implants greater than 800 cc? I was told that one or more manufacturers was seeking permission.

Doctor Answers 8


As other have stated Mentor is currently in trials to make a silicone/gel > 800cc, no one knows when they will receive FDA approval and the labeling will likely also come with the reconstruction tag, so placing them for cosmetic purposes would also require off label use discussions/consent. There are saline implant currently available that can be filled to just shy of 1000cc per manufacture recs.

FDA approved implants larger than 800cc

Thank you for asking. At present silicone gel implants are approved at 800 cc (by Mentor). Larger volumes are bring approved soon. Saline implants can go larger than 800 cc at the present. See a board certified plastic surgeon who discuss this further. Best wishes

Mentor 800-960

There are implants that go to 960 cc from Mentor.  Allergen also has an implant that goes larger than 800 cc.

Is an implant that size wise?

A more important question to ask, in my opinion, is whether an implant of that size is a "safe" option or not.We know that a progressive increase in implant size is accompanied by a consequent increase in weight. This weight must be supported by the tissues of your breast; more specifically the tissues at the bottom of your breast.Before considering an implant of such a size, you should carefully consider the potential impact on your long term appearance and the current strength of your breast tissue.  If you have been through significant weight change, you've had noticeable breast changes from pregnancy, or are at a more advanced age, you may have a very short-lived pleasing appearance if you use an implant of that size.A Board-Certified Plastic Surgeon would be the best person to advise you on your options.  He or she can examine your breasts and provide you with the best advise for the most pleasing long term result. I'd suggest a consultation before setting your sights on a particular implant volume. Best of luck.

Are any implants over 800cc's available?

Thanks so much for your question. Mentor is in clinical trials for silicone/gel implants larger than 800cc's. It's difficult to know for certain when it will be available because it's based on both Mentor and FDA time tables. In the meantime saline implants are available that can be filled to 960cc's.  Also you can have custom silicone/gel implants made that are other sizes.  Hope that helps. 

Shaun Parson, MD
Phoenix Plastic Surgeon
4.8 out of 5 stars 42 reviews

Implants greater than 800 CC

One company (Mentor) is currently performing a clinical trial, but I am not sure when it will be completed and submitted to the FDA for approval. I am unsure whether other companies are performing any at this point.

Stacey Folk, MD
Denver Plastic Surgeon
5.0 out of 5 stars 22 reviews

Large Implants

It is my understanding that one of the implant companies are making larger implants available next year.  Contact the implant implant companies for more information.

Robert E. Zaworski, MD
Atlanta Plastic Surgeon
4.9 out of 5 stars 55 reviews

Large implants

Thank you for your question. It is my understanding that at least one company is investigating the use of larger implants. I believe this is primarily in breast reconstruction patients. You may want to contact the company directly to see what implants are commercially available. Best 
Theo Nyame MD 

Theodore Nyame, MD
Charlotte Physician
5.0 out of 5 stars 24 reviews

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