drdonrevis

Good morning everyone!

I have been asked a lot about the forthcoming XL silicone gel implants from Mentor. Currently the plan is to initiate clinical studies in the summer-ish 2015 time frame, up to 1400cc's. Initially the studies will be confined to breast reconstruction for cancer patients only, per Mentor's agreement with the FDA. The study may be enlarged to include augmentation patients, but not at the outset of the study. Stay tuned for future updates!

Goldyz

Hello Dr. Revis,

I have been to you in the past for a consultation, maybe 6 years ago or more, but to this date I have not gotten anything done. My question tom you is about the XL silicone breast implants and the study. I currently have 700 cc mentor gel implants with bottoming out and a rupture on one side so I need them replaced and I love the silicone implants I have but 800cc isn't going to make any difference. Do you have anymore information on this study/trial and are they opening up for letting those that need revision or reconstruction be a part of the study. I am very very interested in getting this done. Thank you

drdonrevis

Good evening- so here we are six years after my original answer….still waiting on the FDA to give the green light. Facts- the Athena Trial has been underway for some years now- all good data as expected. Fact- a month ago I had the opportunity to see, touch and feel the XL silicone gel implants with the head of the R&D Department at Mentor. His answer to my burning question “when?” was “probably 2 years from now.”

Goldyz

Thank you for your reply. I know that I can't wait any longer and I'm looking at getting surgery to have these replaced at the beginning of August. You are experienced with XL breast implants and this is what I'm looking for. I think I would be happy with 1100cc's, but I am nervous about saline implants. Are you part of the motiva breast implant study, or do you use Ideal structured breast implants. Please give me your thoughts and opinion and maybe I need to come back in but with my fiance this time and have a consultation with you so we both can ask you our questions and maybe feel more at ease about moving forward.

drdonrevis

Good morning!
I do perform over 200 XL augmentations a year, more than any other surgeon in the U.S. I am not involved in the Motiva study, and I do not use Ideal implants. I use Mentor saline shells overfilled to achieve any volumes over 800cc. Patients love them! Come see me any time you like, but be aware I am very booked- our first available surgery dates are in October, so figure about four months lead time between consult and surgery.

Goldyz

Oh wow! October? Okay I'll call right now to get in to see you.

drdonrevis

Definitely call soon- I perform over 500 augmentations a year, and we book about four months in advance. About 80% of patients fly in from somewhere else to have surgery.

Goldyz

I called and I can't even get in to have a consult with you until July 29th unless I do an email consult and then she said that appointment would be a lot sooner and I could get into surgery sooner as well. I do want and need this done as soon as possible because I don't like the way I'm looking and it is bothersome on my right side and I definitely have issues trying to sleep on that side and want to look and feel better as soon as possible, but I feel like an in person consultation is better so that you can see my situation in person and so that we can talk about all of our concerns and get our questions answered, and I want my fiance to meet you in person so he can feel at ease as well. I took the July 29th date but should I just call every few days to see if a sooner date opens up? What is your suggestion?

drdonrevis

I have an idea- but not on a public forum. Email me directly at [email protected] and I will fill you in on the details!

twinpearls

Are you able to share how many doctors and who they are, that are participating in the clinical trials?

drdonrevis

Good afternoon,
I actually don't know a single one- I live in the cosmetic/aesthetic side of things, and the trial is underway in breast cancer patients.

twinpearls

That's quite interesting that it is being done in breast cancer patients. I would assume that those patients have a fear in them from their battle with cancer, that would make them hesitate about a test with a device that is not yet FDA approved (i.e., if the test goes poorly, they may face life threatening circumstances again). Moreover, once approved, I would assume that most XL silicone recipients would be glamour models. I would not think that cancer survivors would be aiming to enlarge their breasts that significantly. I would think that cancer survivors would be aiming to regain a modest breast mound (e.g., few hundred CC's).

Hmm, interesting. Thanks for the feedback.

drdonrevis

Cancer patients often have large defects that 800cc just won’t fill. Additionally, it’s very political- the FDA is much more likely to feel sympathetic for a class of patients with a disease, and are more likely to approve the devices, for cancer patients vs. elective use.

boobgreed1050

my surgeon has been using motiva since they came on the market (which i think was 2004) with excellent results

drdonrevis

There may be some surgeons importing XL silicone gel implants and using them quietly- that’s not my style- but the FDA has not approved any silicone implants made by any manufacturer over 800cc.

twinpearls

Sounds risky for them. If caught, that's going to get ugly for them! Probably lose their license and destroy their career.