Any updates on the release of the Allergan style 410 Mentor CPG. I'm scheduled for a revision to my mastectomy in Oct, and would hate it if they were released a month later. I don't want to do this again, but my ps said these would be best for me. The suspense is killing me!
Allergan Style 410 Mentor CPG Release Update?
Doctor Answers (7)
No one knows...
For two years I've thought we were close to seeing approval of the Mentor CPG and Allergan 410. The data with these devices at 3 and 5 years surpasses the results with the other implants, so it stands to reason that they should be approved.
But the approval process takes place pretty much in secret between the manufacturers and the FDA, and no one outside just a few individuals is privy to what is really going on. It's simply anyone's guess when they'll be approved, but as the other respondents have said, many people think that it is something that will happen in the not too distant future.
So you have a few options. You can do it now with a regular implant; you can wait (probably less than a year or two, but who knows), you can travel to Canada or Europe, or you can find a US surgeon who has access to these implants as a part of the manufacturer's clinical trials.
Approval date of these breast implants is unknown
As the other surgeons have said, none of us have access to any information regarding date of release. I have had extensive experience using these implants during my fellowship with on the investigators in the clinical trial. I think they will offer many advantages to the breast reconstruction patient but will not be a panacea for all problems. I would consult with your surgeon to see if the possibility of a form stable device would help your particular situation. If so, I would consider seeking out an investigator in the the ongoing clinical trials. You can contact the company for that information.
410 cohesive gel implants
Your guess as to when the FDA will approve the 410 cohesive gel implants for general use is as good as mine. I thought that they were going to be available months ago, but for some reason they are not yet available.
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410 breast implants are available through trials
We have found the highly cohesive implants to be a very attractive alternative in breast reconstruction as have many plastic surgeons across the country. There are openings in the clinical trials underway and we currently add patients to the Allergan 410 study weekly. As others have said we will not know the FDA release date of either the Allergan or the Mentor form stable implant. You may benefit by contacting the manufacturer to find the location of the clinical trial sites in your area. Your surgeon should also be able to find the trial nearest your area. Your participation may help women everywhere in the US have access to an implant that holds promise of a better breast reconstruction. If Chicago is not too far, we can help. But check your area thoroughly before you wait or give up.
Best of luck,
FDA has works at their own pace
The last informatioin that I heard is that the Style 410 implants will be available soon, possibly by the end of this year. All of the clinical studies have been completed and I understand that the FDA has all of the informaiton needed to make a decision and relase the implants for routine use. Plast surgeons, just like many patients are waiting for this implant to be relased for general use.
The FDA does not provide us advanced notice of silicone implant release
The FDA does not adequately prepare us for this information. In fact when the current form of silicone implants were approved it was late on a Friday afternoon. This caught most of the plastic surgery communtiy by surprise.
Release of Form Stable Silicone Implants
Only the FDA knows when they will allow the new cohesive gel implants be used in America. I just came back from Sweden to review the work of very experienced and talented Plastic Surgeon in Stocholm, Sweden, Dr. Charles Renquist. After looking at the new implants, I would wait for the new implants in the revision reconstructive patient. I hear rumors that they should be available in the next year.
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