Silicone breast implants for 21 year old women #plasticsurgery
The FDA labelling for silicone implants details that they are indicated for female patients aged 22 or older. The use of a silicone implant in a 21 year old female would be considered an 'off label' use of the medical device.
What Plastic Surgeon Will Give Me Silicone Implants if I am 21 Years Old
No one, because the FDA has expressly published that breast augmentation is indicated for women 22 years of age or older. Hence, any plastic surgeon that did a breast augmentation for a woman who was under the age of 21 would assume liability not just for the operation, but for some sanction related to doing a procedure that the FDA said is not indicated. This is different from using a drug for another use than the indication for which it received FDA approval. That is done all the time. But the language of the FDA states specifically that the procedure is not indicated. While this seems arbitrary to many, it was decided by a committee of the FDA when the silicone gel implants were put back on the market for elective breast augmentation. If you did have the procedure, the warranty would be valid. That is a contract between you and the manufacturer.
Silicone implants are available and used by all Plastic Surgeons. All implants have warranties of varying lengths.
Hello,Many surgeons will. It is only an FDA approval status for women 22 and older. You will be fine with silicone gel, no laws will be broken, and your implant warrantee will be valid. Go get silicone!Best of luck!
What Plastic Surgeon will give me silicone implants?
Although, the FDA has guidelines for the use of silicone implants in which they state they silicone implants are "safe and effective" in women of all ages for reconstructive purposes; they limit this approval to women 22 years of age or older for cosmetic purposes. I believe, most of my colleagues would agree that this determination by the FDA was driven more by political considerations than scientific evidence of a problem with performing the procedure on women younger than 22 years of age. It is perfectly legal to have a beast augmentation with silicone implants even if one is under age 22, but it is considered an "off label" use of the implant. Many plastic surgery practicies, including our own, offer silicone implants to their patients who are under 22 years of age. However, we do have the patients sign a waiver acknowledging that they understand that this is an "off label" use of the device. Potentially, an implant manufacturer could void their warranty in cases where the implants were used in patients under 22 years old. However, in our practice we have not had a situation where the manufacturer refused to honor their warranty, even if the patient was under 22 when they had their surgery. Best wishes, Dr. Lepore.
Most surgeons can do this for you
and if they have great relationships with their implant provider, the warranty issues can usually be managed should something happen to you down the road. But make sure your surgeon will still be working long enough (>10 years left in career) so you can have it taken care down the road if problems arise. There is no evidence to say that something magical happens at age 22 that allows for them to have gel implants and those younger not. The key word is 'off label'.
What Plastic Surgeon will give me silicone implants?
Thank you for your question. The reason the FDA limited silicone implants to patients 22 and older is that in the studies to get FDA approval, that was the youngest patient. So they can only state definitively that they are "safe and effective" in patients 22 years of age or older. That being said, I am sure the implants could be safe in younger patients, but the warranty from the manufacturer may not be in place, that is not within the surgeon's control. If a surgeon chose to use silicone implants in you, it would be considered an "off-label" use of the device and you would need to understand that.
If you wanted to "stay within the rules," you could always just wait until 22. Or get saline implants placed now and plan to go back and replace them with silicone implants in a year or so when you are old enough.
Hope this helps!
if your plastic surgeon feels the silicone implants would be better for you than the saline, then he can legally use them, it is just called an off label use.
Thank you for your question. You may legally drink, vote and join the military to get your head shot off in Afghhanistan but according the FDA you need to be 22 to be able to get silicone breast implants. For years I couldn't understand how the FDA came up with that age until I learned that the youngest patients in the trials that were submitted to the FDA were 22. It makes no sense but that is unfortunately the way it is. There are plenty of plastic surgeons, myself included, who will use silicone gel implants in patients under 22 but such use is considered "off label" and as such can be grounds for the manufacturer to void the warranty. How the manufacturer chooses to handle a warranty claim in such a case is beyond the surgeons control. I inform my patients of this and let them make the decision whether to go ahead and use silicone, wait until they are 22 or use saline. Although I cannot speak for the manufacturer I don't think they would refuse to honor the warranty unless there was some sort of irregularity such as having the surgery done by a non plastic surgeon.
Silicone breast implants for patients under age of 22?
In my opinion, there is no good reason why there is an FDA mandated age of 22 for patients to receive silicone breast implants. There are many patients under the age of 22 who would (based on their body type and the advantages of silicone breast implants) benefit from the use of silicone gel breast implants; I therefore use these implants for any appropriate patient (regardless of age) routinely. I hope this, and the attached link, helps. Best wishes.