Is there a date for when 800cc+ implants will be available in the US?

Question

I heard 800cc+ silicone implants are being approved soon. Does anyone have a date on when?

Danielle Dumestre, MD · Answer

Hello!
MENTOR® MemoryGel® Enhance Breast Implants &mdash; the largest silicone gel-filled implants on the market, now available in sizes from 930 cc to 1445 cc. These first-of-their-kind implants are designed specifically for primary and revision reconstruction in post-mastectomy patients, offering an expanded range of base widths, projections, and volumes to provide more personalized outcomes than ever before.

Donovan Rosas, MD · Answer

The Mentor high volume silicone devices received FDA approval in November 2024. There is a planned commercial launch for Mid 2025.

Sales representatives have already been making the rounds introducing the product to surgeons, thus launch is likely imminent.

As always, discuss your concerns with a board certified plastic surgeon (ABPS).

Gerald Minniti, MD, FACS · Answer

I am one of the 22 study surgeons that lead to the FDA approval of Motiva 6th gen implants. There line goes up to 1050 cc, but the largest approved in the US is only 625 cc. There is no word yet on expanding the available line to include larger devices. I've heard that Mentor is also expanding their line beyond 800 cc, but like announcements in the past where their assurance of 'soon' turned into years, I am not holding my breath with them either.

H. Daniel Zegzula, MD · Answer

The implants that you are referring to were originally called Athena implants and I am am art of the study that was used to obtain FDA clearance to use this implants.  I am happy to report that these implants have been approved by the FDA for use and are now available.  Implant sizes up to 1440 cc were approved by the FDA for women undergoing breast reconstruction.

Is there a date for when 800cc+ implants will be available in the US?

Answers (4)

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