Is It Against the Law to Put Silicone Implants in an 18 Year Old?

Question

I am 18 years old and I am starting consultations for a breast augmentation next week. I have recently learned about the 22 year old age restriction with silicone implants. Is it illegal for plastic surgeons to insert silicone implants on an 18 year old or is it just advised against? Is the decision ultimately up to the doctor? I have heard saline implants don't feel as natural and are harder and I would rather have silicone because of that. Do you have any recommendations?

Richard H. Tholen, MD, FACS · Answer

The FDA, as of November 2006, has approved the use of silicone gel breast implants for elective first-time cosmetic breast enlargement in women over the age of 22. Use of silicone gel implants in women under age 22 would be considered "off-label" use, much as Botox used to treat "crow's feet" periorbital wrinkles (the FDA approves Botox Cosmetic only for the treatment of glabellar frown lines--other areas are considered "off-label" use).

	I support the right of properly-informed women between the ages of 18 and 22 to consent and request the implants of their choice.

	(Just as I treat crow's feet with Botox!)

	Properly-informed women who educate themselves about the pros and cons of silicone gel implants and saline-filled implants should be capable of deciding what implants they prefer, and I am happy to help provide the science. You should read my article (found on the About tab on my profile page) titled "Are Silicone Breast Implants Safe?" or click on the link below for more information about implant choices. Best wishes!

Ozge Ergun, MD · Answer

Thanks for the question. You are a good candidate for an breast implant procedure because there is no age for these procedures. I wish you all the best.

Larry S. Nichter, MD, MS, FACS · Answer

There are two great options to consider: 1. IDEAL implants - these are newly released "hybrid implants" double lumen saline implants made to feel like silicone2. I will place silicone implants in patients under 22 yrs old but first have an informed consent and have them sign a waiver that they are aware that they are being used in  "off label' FDA use. #IDEALimplants#breastaugmentation#breastimplants

Jeff Angobaldo, MD · Answer

Thank you for submitting your question. A SIlicone gel implant would be the best option for you at the FDA mandated age of 22 years. Saline implants are can be placed at age 18 years of age. Without photos, difficult to make recommendations. When your ready, make an appointment with a Board Certified Plastic surgeon. Best Wishes

Martin Jugenburg, MD · Answer

In Canada we do not have age restriction. 
	choosing implants is a decision you and your surgeon make

Tom J. Pousti, MD · Answer

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.

Marcus L. Peterson, MD · Answer

Medical devices and drugs are studied and approved by the FDA for United States citizens.  The studies are limited in scope so the approval of a devices is limited to the parameters that were studied.   Silicone breast implants had scientifically valid numbers for women above the age of 22 so this is why the FDA stated that 22 years is the starting age for silicone implants.  Medical devices and drugs are used in an "off label" manner all of the time.  As the consumer you should be advised of this "off label" use and consent to this fact.

	One issue that has not been brought up on this thread is the manufactures warranty.  It is highly likely that if the silicone implants are used in an "off label" purpose the manufacture will not or is not required to honor their warranty.  So, this is the main liability that you as a consumer will take on. 

	Best Wishes

	Dr. Peterson

Peter E. Johnson, MD · Answer

Keep in mind that I am not a lawyer, though there is a label requirement by the FDA which indicates silicone gel has not been studied or approved for use for primary breast augmentation under age 22. I don't think anyone will go to jail for a off label use of a silicone gel breast implant under age 22. We do use gel in some patients under age for breast reconstruction, and do believe the current restriction is arbitrary. Still though you should not discount the saline breast implant as very good results can be had, with a very easy switch as the implant wears, say by age 28 or so. Think of ten or more hassle free years of looking your best.

	Best of luck,

	peterejohnsonmd

Daniel P. Markmann, MD · Answer

Unfortunately, Yes! This is an FDA ruling that we are stuck with. I usually recommend patients wait until they are 22. If you get saline at 18, you may or may not be happy with them. I believe they are a sub-optimal implant and a far step down from silicone. If it were me, I would wait. I always tell patients.... I have never removed a silicone implant because someone "wants" saline. However, I often remove saline because a woman decides that she is dissatisfied with saline and "wants" silicone.

Steven Wallach, MD · Answer

The FDA has mandated that silicone breast implants can not be used in women under 22. I know that I will do not offer this to patients under 22. I do not think this is like a drug that can be used "off-label" using it in people under 22.

Is It Against the Law to Put Silicone Implants in an 18 Year Old?

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