If FDA Does Not Govern the Science of Medicine, Why Can't 18 Year Old Get Silicone Implants?
- Asked by christieNY in NY
- 2 years ago
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?
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.
FDA does have the authority to regulate medical devices.
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!).
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.
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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 how to get this changed.
FDA governs devices
You are correct the FDA does not practice of medicine, but they do control medical devices and drugs which include breast implants.
These answers are for educational purposes and should not be relied upon as a substitute for medical advice you may receive from your physician. If you have a medical emergency, please call 911. These answers do not constitute or initiate a patient/doctor relationship.