Silicone Breast Implant Age Requirements

Is there a minimum age requirement for silicone breast implants?

In the United States, the FDA recommends that women only 22 years of age be implanted with silicone breast implants. It is not “illegal” to implant silicone into women under 22. The age limit is simply a recommendation by the FDA.

What is “off-label” use of silicone gel breast implants?

The use of silicone in women under 22 years of age that do not have a qualifying deformity or are not reconstructive surgery patients can get silicone implants, but the FDA views this as “off-label” use. An example of off-label use is Juvederm, a common filler used in plastic surgery. Juvederm is approved for use in plumping up wrinkles in the face, particularly the nasolabial folds. However, surgeons commonly use it to augmentation lips, as well as plump up other areas in the face. This is considered “off-label” use.

I’m under 22 years of age. I do not have a deformity, and I’m not a reconstructive patient. I’ve consulted with a few plastic surgeons, and some will do silicone and some won’t. Why are some of the surgeons refusing to give me silicone?

Plastic surgeons really vary on this issue. Some surgeons will absolutely not implant silicone breast implants in women under 22 years of age without them meeting certain “reconstructive” or “deformity” requirements. Other surgeons will implant them in patients under 22, particularly if they have very thin skin and are not good candidates for saline. It isn’t illegal to do this.

Will the breast implant manufacturer void my warranty if I don’t meet the requirements to get silicone implants if I’m under 22 years of age?

There is no hard and fast rule stating that the implant manufacturer will void the warranty. Plenty of surgeons place these implants in women under 22 and have had no reports of the warranty being voided. Other surgeons state that the manufacturers do indeed void the warranty. Yet other surgeons will call the manufacturer prior to agreeing to place silicone into an “underage” patient in order to confirm that there will be no issue.

On 8/6/13, I called called Allergan and made an inquiry about this issue in hopes of getting some clarification. What I found out is that this is a gray area in some ways, and in some ways, it isn’t. I was told that if a woman received implants prior to being 22, and the woman did not fall into a reconstructive / deformity category, the warranty WOULD be voided. However, I was also told that Allergan does not “investigate” warranty claims. They do talk to the plastic surgeon, but there is no in-depth investigation that takes place. In cases of silicone recipients under age 22, they do ask if it was for reconstruction or deformity.

I specifically asked the Allergan representative whether or not a surgeon’s recommendation for silicone implants due to very little breast tissue and/or thin skin would qualify as a legitimate reason to void the warranty. The representative said that she could not speak to that reason specifically. She said that in the event that a problem arises that would call for use of the warranty, the best thing to do is speak with the surgeon prior to that.

If you are receiving silicone implants under age 22, your best bet is to talk with the surgeon prior to surgery. Have a conversation with him or her regarding the possibility of a warranty claim within the next 10 years, and whether or not the reasons stated for you getting silicone will satisfy the manufacturer so that your warranty will not be denied.

I’m under 22 years of age, but my plastic surgeon says I can get silicone, but must first sign a waiver. What does this mean?

If your plastic surgeon wants you to sign a waiver, it likely states that you have been made aware that the use of silicone in women under 22 is considered off-label use. However, you need to read the waiver carefully. If it says anything about the warranty being denied should you have a claim, you will have a decision to make. As stated in the previous answer (above), talk with your surgeon and get specific answers regarding potential warranty claims. If you are not satisfied with the answers you receive, you may want to consider opting for saline.