Does getting silicone implants under the age of 22 void the warranty?

Question

I am wanting silicone implants. I'm wanting to get them within the next month. My PS has not gotten back to me yet this week for my questions due to weather knocking out power in their area. I am wanting to recover before I start working again. I do not want saline implants. I've done a lot of research, just can't find a difinitive answer whether signing the waiver and doing off label voids the warranty or not.

Sheila S. Nazarian, MD · Answer

Silicone implants in patients under the age of 22 is considered "off label" so yes, the manufacturer may waive the warranty. You will need to decide if that is a risk you want to take. My best,
Dr. Sheila Nazarian
@drsheilanazarian on Instagram

Matthew H. Steele, MD · Answer

Thank you for your question.  Unfortunately, use of silicone gel implants for cosmetic purposes in patients under 22 years of age is consider "off-label" by the FDA.  However, the very same implant can be placed in a patient under 22 if it is for a "reconstructive" purpose.  It really makes no sense, as there is no study suggestion these devices are somehow unsafe until the patient turns 22.  I have placed these implants for cosmetic purposes in a patient under 22 as long as they are willing to sign a waiver stating that the implant company may waive the warranty.  I think the answer will largely depend on the implant company.  Probably best to check with them or ask your surgeon's office to see if they can find out.  Good luck.

Robert A. Hardesty, MD, FACS · Answer

Dear Ms. Carleycl,Thank you for your questions.The FDA unfortunately made a a decision, based on patients ages of their study protocol, to make (to many plastic surgeons) a arbitrary decision to select age 22 as a criteria to use silicone breast implants.Their have been in the past "loop holes" to use silicone breast implants for congenital deformities (you have a mild case of tubular breasts=constricted breasts) and reconstructive breast cases.i would query directly Sientra, Allergan and Mentor your question regarding warranty of their silicone gel implants inserted under the age of 22.I trust your Plastic Surgeon is Certified by the American Board of Plastic Surgery and is ideally a memberof the American Society for Aesthetic Plastic Surgery (denoting by membership as having met additional criteria and a focus on Cosmetic Plastic Surgery).My best wishes, R. A. Hardesty, MD, FACSDiplomate and Certified by the Am. Bd. of Plastic Surgerywwwimagineplasticsurgery.com4646 Brockton AveRiverside, Ca 92506(951) 686-7600

Barry L. Eppley, MD, DMD · Answer

While the manufacturer may choose to void the warranty in women who get breast implants under age 22, they are probably unlikely to do so. It is a gamble but in my experience I have yet to see the manufacturers challenge any warranty on a failed breast implant.

Arko Demianczuk, MD · Answer

In Canada, the Health Protective Branch (equivalent to FDA) allows use of a silicone implant in patients under age 22 but it is considered off label. As such, the implant company is not mandated to cover these implants under warranty. There is no good reason as to why age 22 was picked, as it makes no clinical sense, but it is the rule.

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Does getting silicone implants under the age of 22 void the warranty?

Answers (8)

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