30LikesXL SIlicone Implants Update
03-17-2015, 05:34 AM
#1
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XL SIlicone Implants Update
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!
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!
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06-20-2021, 12:18 PM
#2
Join Date: Jun 2021
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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
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
06-20-2021, 02:40 PM
#3
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XL Silicone Gel Implants
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.”
06-21-2021, 08:10 AM
#4
Join Date: Jun 2021
Posts: 4
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.
06-21-2021, 08:23 AM
#5
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XL Implants
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.
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.
06-21-2021, 11:32 AM
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Busy Schedule
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.
06-21-2021, 02:09 PM
#8
Join Date: Jun 2021
Posts: 4
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?
06-21-2021, 04:52 PM
#9
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Consultation
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!
10-12-2021, 11:40 AM
#10
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Originally Posted by 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.”
10-12-2021, 11:44 AM
#11
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Mentor Athena Trial
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.
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.
10-13-2021, 09:32 AM
#12
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Originally Posted by drdonrevis
...and the trial is underway in breast cancer patients.
Hmm, interesting. Thanks for the feedback.
10-13-2021, 09:39 AM
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FDA Study
Originally Posted by 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.
Hmm, interesting. Thanks for the feedback.
10-25-2021, 06:49 PM
#15
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XL Silicone Implants
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.
10-26-2021, 02:36 AM
#16
Join Date: Oct 2020
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Originally Posted by drdonrevis
There may be some surgeons importing XL silicone gel implants and using them quietly
01-25-2022, 11:05 AM
#17
Join Date: Dec 2021
Posts: 11
I just had my pre-op and we're planning to us 700-800cc due to me having a larger frame. My Doctor called Mentor while I was there to check on size charts and all that. He was informed that 1000 to 1200cc silicone implants should be an option within the next year.
01-25-2022, 11:15 AM
#18
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XL Silicone Athena Trial
Good afternoon,
That timing seems to be accurate based on what I am hearing- I’m in pretty close contact with the Mentor R&D Department and it’s all up to the FDA now- the data has been submitted and now it’s just a waiting game, and no one can predict how fast or how slow the FDA will crawl across this finish line- 2023? 2024? 2025? They’re in no hurry…..
That timing seems to be accurate based on what I am hearing- I’m in pretty close contact with the Mentor R&D Department and it’s all up to the FDA now- the data has been submitted and now it’s just a waiting game, and no one can predict how fast or how slow the FDA will crawl across this finish line- 2023? 2024? 2025? They’re in no hurry…..
03-01-2022, 04:25 AM
#19
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Location: OH, USA
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@drdonrevis do you know the actual FDA document that states 800cc is the max silicone implant allowed? I'm sure it is dry boring regulatory jargon, but I was interested in reading it. I assume it is publicly available.
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