Breast implants are medical devices that are implanted under the breast tissue or under the chest muscle to increase breast size (augmentation) or to rebuild breast tissue after mastectomy or other damage to the breast (reconstruction). They are also used in revision surgeries, which correct or improve the result of an original surgery.

There are two types of breast implants approved for sale in the United States: saline-filled and silicone gel-filled. Both types have a silicone outer shell.  They vary in size, shell thickness, and shape (contour).  The information provided on this website is designed to support, not replace, the relationship that exists between a patient and a physician. We have provided this information to:

• Help women make informed decisions about whether or not to get breast implants.

• Explain the risks of breast implants and describe the surgical procedures used to implant them.

• Provide information on saline-filled and silicone gel-filled breast implants, including data supporting a reasonable assurance of safety and effectiveness, approval letters, labeling and information on post-approval studies.

• Provide information on reports of anaplastic large cell lymphoma (ALCL) in women with breast implants.

• Outline the regulatory history of breast implants in the United States. 

                               
                                 Saline-filled Implants:

Saline-filled breast implants contain a silicone outer shell filled with a sterile saltwater (saline) solution.  Some are pre-filled and others are filled during the implant operation.  Saline-filled implants come in different sizes and have either smooth or textured shells.  The FDA approved saline-filled breast implants for breast augmentation in women age 18 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.  FDA-Approved Saline-filled Breast Implants:
 

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 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 with deflation, 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).

There is no apparent association between saline-filled breast implants and connective tissue disease, breast cancer, or reproductive problems.  However, in order to rule out these and other rare complications, studies would need to be much larger and longer than those conducted so far.

The safety information known at the time of approval is detailed in the Summaries of Safety and Effectiveness.  As the FDA learns of new safety information, it requires that companies update their product labeling.  The most current safety information about saline-filled breast implants can be found in the labeling.


                              Silicone gel-filled 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 cosmetic surgery.  FDA-Approved Silicone-filled Breast Implants:

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 them.