If FDA Does Not Govern the Science of Medicine, Why Can't 18 Year Old Get Silicone Implants?

asked 6 months ago by christieNY in NY
Latest answer by Laurence Weider, MD
Question viewed 97 times
Tags: age 17 or under, silicone implant, FDA, reasons

If most Plastic Surgeons use Medical Devices for off label use, they why can't I get silicone implants? Plastic Surgeons use botox for off-label use and breast implants for off-label,(when they re-use them) so what is the difference?

5 answers to If FDA Does Not Govern the Science of Medicine, Why Can't 18 Year Old Get Silicone Implants?

Silicone Breast Implants in 18 year old

Silicone gel implants are FDA approved for women who are 22 years old or older. Using them in a woman younger than 22 years of age is off label use but not illegal. While I can't speak for others, my malpractice carrier will not cover me if I implant them in a woman who is younger than 22 years of age. The age restriction does seem rather arbitrary however.

Laurence Weider, MD
Dallas Plastic Surgeon

FDA does have the authority to regulate medical devices.

Hi. You see, the implant manufacturers will not knowingly sell silicone breast implants for use in a women under the age of 22. So the plastic surgeon would have to deceive the manufacturer. A reputable surgeon is not going to do that. So, even though it may not make much sense, I would either get saline implants or wait till you are older (or go abroad!).

George J. Beraka, MD
Manhattan Plastic Surgeon

Silicone breast implants and age

That is a very good question and I do not have a good answer for you. In fact I do not have a good answer as to why they chose the ages that they did as a cutoff. You certainly could have gel implants but you would need to find a very brave plastic surgeon who would not be afraid of our government and his/her peers.

John P. Stratis, MD
Harrisburg Plastic Surgeon

18 year old and silicone implants

There is no law against using silicone implants for ladies under 22 years of age. Obviously you should be of legal age and have a full understanding of the FDA guidelines as well as the manufacturer's warranty. Off-label use of FDA approved implants is possible and is done on a limited basis. Many plastic surgeons will refuse to do it but there is no reason a patient can not accept this responsibility. I would encourage ladies to call the FDA and ask them... more