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

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?

Doctor Answers (7)

18 year-old CAN get silicone implants--legally and ethically!

+1

Many medical products and pharmaceuticals are used "off-label" and your example of Botox is one I use frequently! Botox was originally FDA-approved ONLY for the treatment of glabellar frown lines (between the brows). Recently (2013), use in the "crow's feet" areas around the eyes was FDA approved. But prior to that time, I would bet you that every one of my colleagues answering that you can't have silicone implants until you are 22 injected countless of their patients with Botox for crow's feet! And forehead lines!

They did so legally and ethically, since they understood the use, the pharmacology, the risks and benefits, and detailed these in their informed consent discussions with their patients for whom they used Botox off-label.

I do the same with women 18-22 who request, after proper informed consent, that I utilize silicone gel implants. I have them sign a special consent form outlining the FDA recommendation, but it is just that--a recommendation, NOT a restriction!

Additionally, I have never had an implant manufacturer refuse to sell me implants for patients who request off-label use, any more than Allergan would refuse to sell me Botox for use in crow's feet or forehead lines! They have always honored their warranties as well. No physician will "lose his or her license" for appropriate, informed consent use of silicone gel implants in a woman under the age of 22. Many products and pharmaceutical other than silicone gel implants and Botox are used off-label every day, by honest, ethical physicians who choose what they feel is best for their patients.

And manufacturers know multitudes of physicians use their products off-label; they simply cannot promote their products' off-label uses!

Off-label use is perfectly legal and ethical, assuming patients are given full informed consent, including the inanity of the FDA's recommendation, since this recommendation is NOT based in scientific reasoning. You can drink alcohol, go to war, vote, and buy a gun legally at age 21--but you cannot get silicone implants? Does anyone sense my outrage at this non-scientific stupidity?

Malpractice carriers do not specify how their clients practice medicine, nor do they restrict patient choice to only those "recommended" by the FDA.

These "arguments" are specious, but wrong. Seek out plastic surgeons who are not afraid to place the welfare of their patients before an inappropriate "recommendation." I support the right of fully-informed women age 18-22 to choose silicone gel implants, and will happily utilize them if they request that I do so! Best wishes! Dr. Tholen


Minneapolis Plastic Surgeon
5.0 out of 5 stars 109 reviews

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

+1

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. Unfortunately, the use of these implants for these younger patients will negate the breast implant manufacturer warranty.

I hope this, and the attached link, helps.

Tom J. Pousti, MD, FACS
San Diego Plastic Surgeon
5.0 out of 5 stars 682 reviews

Silicone Breast Implants in 18 year old

+1

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
5.0 out of 5 stars 62 reviews

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FDA does have the authority to regulate medical devices.

+1

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 (retired)
Manhattan Plastic Surgeon
5.0 out of 5 stars 9 reviews

Silicone breast implants and age

+1

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
4.5 out of 5 stars 14 reviews

18 year old and silicone implants

+1

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.

Best Wishes

Dr. Peterson

Marcus L. Peterson, MD
Saint George Plastic Surgeon
4.5 out of 5 stars 9 reviews

FDA governs devices

+1

You are correct the FDA does not practice of medicine, but they do control medical devices and drugs which include breast implants.

Jeffrey Hartog, MD
Orlando Plastic Surgeon
4.5 out of 5 stars 35 reviews

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.