Silicone Gel-Filled Breast Implants
Silicone gel-filled breast implants have a silicone outer shell that is filled with silicone gel. They come in different sizes and have either smooth or textured shells.
Silicone gel-filled breast implants are approved for breast augmentation in women age 22 or older and for breast reconstruction in women of any age. They are also used in revision surgeries, which correct or improve the result of an original surgery.
There are five silicone gel-filled breast implants that have been approved by the FDA:
- Allergan Natrelle (Premarket application number: P020056) (Approved November 2006)
- Allergan Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants (Premarket application number: P040046) (Approved February 2013)
- Mentor MemoryGel (Premarket application number: P030053) (Approved November 2006)
- Mentor MemoryShape (Premarket application number: P060028) (Approved June 2013)
- Sientra’s Silicone Gel Breast Implants (Premarket application number: P070004) (Approved March 2012)
Summary of Safety Information:
Breast implants are not lifetime devices. The longer a woman has implants, the more likely it is that she will need to have surgery to remove or replace them.
The most frequent complications and adverse outcomes experienced by breast implant patients include capsular contracture, reoperation, and implant removal (with or without replacement). Other common complications include implant rupture, wrinkling, asymmetry, scarring, pain, and infection. In addition, women with breast implants may have a very low but increased likelihood of being diagnosed with anaplastic large cell lymphoma (ALCL).
MRI continues to be an effective method of detecting silent rupture of silicone gel-filled breast implants. If you have silicone gel-filled breast implants, the FDA recommends that you receive MRI screening for silent rupture 3 years after receiving your implant and every 2 years after that.
There is no apparent association between silicone gel-filled breast implants and connective tissue disease, breast cancer, or reproductive problems. However, in order to definitively rule out these and other rare complications, studies would need to be much larger and longer than those conducted so far.
In June 2011, the FDA issued an Update on the Safety of Silicone Gel-Filled Breast Implants. This update included preliminary results of the studies required by the manufacturers at the time of approval as well as a review of other available scientific data.
The Summary of Safety and Effectiveness for each of the five approved silicone gel filled breast implants details safety information known at the time of FDA approval. As the FDA learns of new safety information, it requires companies to update their product labeling. The most current safety information about silicone gel-filled breast implants can be found in the labeling.
- FDA Approves New Silicone Gel-filled Breast Implant
5 Things to Know About Breast Implants
- Executive Summary: An Update on the Safety of Silicone Gel-Filled Breast Implants
- Update on the Safety of Silicone Gel-Filled Breast Implants: FDA White Paper (PDF - 1.5MB)
- FDA Medical Device Safety Communication: Reports of Anaplastic Large Cell Lymphoma (ALCL) in Women with Breast Implants [ARCHIVED]
- Anaplastic Large Cell Lymphoma (ALCL) In Women with Breast Implants: Preliminary FDA Findings and Analyses
Risks of Breast Implants