Medical Devices

Silicone Gel-Filled Breast Implants

Description:

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:

Summary of Safety Information:

Woman holding a pair of silicone-gel filled breast implants in her hands.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

Page Last Updated: 09/20/2013
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.