Breast Augmentation: Information
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, FACS
Diplomate and Certified by the Am. Bd. of Plastic Surgery
4646 Brockton Ave
Riverside, Ca 92506
Silicone Breast Implant Warranty
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.
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.
Silicone implants under age 22
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.
Dr. Sheila Nazarian
@drsheilanazarian on Instagram
Implant warranty under 22 years of age
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.
The implant company will be the one to decide if they will honor the warranty or not. Your surgeon can contact them on your behalf and find out. If the warranty is voided, you might consider waiting until you are at least 22.
Gels under 22 years of age
To place gel implants in a woman of under 22 years of age, is done outside of FDA sanctioning and is called an off label use of a medical device that is otherwise approved. Physicians can use this device in patients under 22 and it is up to the individual breast implant manufacturer to decide if the off label use of their product voids the warranty. Your best off to check with your plastic surgeon who can then based on which implant company they are using, whether this would apply to you. Good luck.
I think you'd need to contact the implant company. Your surgeon can tell which company they like to work with, and then you could reach out to their customer service. My guess is that it WILL void warranty. Best wishes.