Go Back   Just Breast Implants Forum JBI Surgeon Forums > Ask Dr. Revis (Florida)
 
|
Forgot Username/Password?
Forum Home Blogs FAQ Members List Calendar Today's Posts Mark Forums Read



Ask Dr. Revis (Florida) In this forum, you can ask Fort Lauderdale, Florida plastic surgeon, Dr. Don Revis, questions about breast augmentation and other plastic surgery procedures.


Like Tree25Likes
  • 21 Post By drdonrevis
  • 2 Post By drdonrevis
  • 1 Post By drdonrevis
  • 1 Post By drdonrevis

XL SIlicone Implants Update

Old 03-17-2015, 06:34 AM
  #1  
Certified by the ABPS
Thread Starter
 
Join Date: Dec 2007
Location: fort lauderdale florida
Posts: 3,830
drdonrevis is just really nice drdonrevis is just really nice drdonrevis is just really nice drdonrevis is just really nice drdonrevis is just really nice
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!

Cupcake85, BFH, breanne and 18 others like this.
drdonrevis is offline  
The Following User Says Thank You to drdonrevis For This Useful Post:
Old 06-20-2021, 01:18 PM
  #2  
 
Join Date: Jun 2021
Posts: 4
Goldyz is on a distinguished road
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
Goldyz is offline  
Old 06-20-2021, 03:40 PM
  #3  
Certified by the ABPS
Thread Starter
 
Join Date: Dec 2007
Location: fort lauderdale florida
Posts: 3,830
drdonrevis is just really nice drdonrevis is just really nice drdonrevis is just really nice drdonrevis is just really nice drdonrevis is just really nice
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.”

Shellibelle and twinpearls like this.
drdonrevis is offline  
Old 06-21-2021, 09:10 AM
  #4  
 
Join Date: Jun 2021
Posts: 4
Goldyz is on a distinguished road
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.
Goldyz is offline  
Old 06-21-2021, 09:23 AM
  #5  
Certified by the ABPS
Thread Starter
 
Join Date: Dec 2007
Location: fort lauderdale florida
Posts: 3,830
drdonrevis is just really nice drdonrevis is just really nice drdonrevis is just really nice drdonrevis is just really nice drdonrevis is just really nice
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.
drdonrevis is offline  
Old 06-21-2021, 11:05 AM
  #6  
 
Join Date: Jun 2021
Posts: 4
Goldyz is on a distinguished road
Oh wow! October? Okay I'll call right now to get in to see you.
Goldyz is offline  
Old 06-21-2021, 12:32 PM
  #7  
Certified by the ABPS
Thread Starter
 
Join Date: Dec 2007
Location: fort lauderdale florida
Posts: 3,830
drdonrevis is just really nice drdonrevis is just really nice drdonrevis is just really nice drdonrevis is just really nice drdonrevis is just really nice
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.
drdonrevis is offline  
Old 06-21-2021, 03:09 PM
  #8  
 
Join Date: Jun 2021
Posts: 4
Goldyz is on a distinguished road
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?
Goldyz is offline  
Old 06-21-2021, 05:52 PM
  #9  
Certified by the ABPS
Thread Starter
 
Join Date: Dec 2007
Location: fort lauderdale florida
Posts: 3,830
drdonrevis is just really nice drdonrevis is just really nice drdonrevis is just really nice drdonrevis is just really nice drdonrevis is just really nice
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!
drdonrevis is offline  
Old 10-12-2021, 12:40 PM
  #10  
 
twinpearls's Avatar
 
Join Date: Oct 2020
Location: OH, USA
Posts: 234
twinpearls is on a distinguished road
Originally Posted by drdonrevis View Post
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.”
Are you able to share how many doctors and who they are, that are participating in the clinical trials?
twinpearls is offline  
Old 10-12-2021, 12:44 PM
  #11  
Certified by the ABPS
Thread Starter
 
Join Date: Dec 2007
Location: fort lauderdale florida
Posts: 3,830
drdonrevis is just really nice drdonrevis is just really nice drdonrevis is just really nice drdonrevis is just really nice drdonrevis is just really nice
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.
drdonrevis is offline  
Old 10-13-2021, 10:32 AM
  #12  
 
twinpearls's Avatar
 
Join Date: Oct 2020
Location: OH, USA
Posts: 234
twinpearls is on a distinguished road
Originally Posted by drdonrevis View Post
...and the trial is underway in breast cancer patients.
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.
twinpearls is offline  
Old 10-13-2021, 10:39 AM
  #13  
Certified by the ABPS
Thread Starter
 
Join Date: Dec 2007
Location: fort lauderdale florida
Posts: 3,830
drdonrevis is just really nice drdonrevis is just really nice drdonrevis is just really nice drdonrevis is just really nice drdonrevis is just really nice
FDA Study

Originally Posted by twinpearls View Post
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.
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.

twinpearls likes this.
drdonrevis is offline  
Old 10-25-2021, 07:41 PM
  #14  
 
Join Date: Oct 2021
Posts: 6
boobgreed1050 is on a distinguished road
my surgeon has been using motiva since they came on the market (which i think was 2004) with excellent results
boobgreed1050 is offline  
Old 10-25-2021, 07:49 PM
  #15  
Certified by the ABPS
Thread Starter
 
Join Date: Dec 2007
Location: fort lauderdale florida
Posts: 3,830
drdonrevis is just really nice drdonrevis is just really nice drdonrevis is just really nice drdonrevis is just really nice drdonrevis is just really nice
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.

twinpearls likes this.
drdonrevis is offline  
Old 10-26-2021, 03:36 AM
  #16  
 
twinpearls's Avatar
 
Join Date: Oct 2020
Location: OH, USA
Posts: 234
twinpearls is on a distinguished road
Originally Posted by drdonrevis View Post
There may be some surgeons importing XL silicone gel implants and using them quietly
Sounds risky for them. If caught, that's going to get ugly for them! Probably lose their license and destroy their career.
twinpearls is offline  

Posting Rules
You may not post new threads
You may not post replies
You may not post attachments
You may not edit your posts

BB code is On
Smilies are On
[IMG] code is On
HTML code is Off
Trackbacks are Off
Pingbacks are Off
Refbacks are Off