Saline-Filled Breast Implants

Description:

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:

Allergan (formerly called McGhan and Inamed) Medical RTV Saline-Filled Breast Implant (Premarket application number: P990074) 

• Patient Labeling (Nov 2004)
• Physician Labeling (2005)
• Approval Order
• Summary of Safety and Effectiveness

Mentor Saline-Filled and Spectrum Breast Implants (Premarket application number: P990075)

• Patient Labeling (2009)
• Physician Labeling (2009)
• Approval Order
• Summary of Safety and Effectiveness

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 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.

For more information about the safety of saline-filled breast implants: 

• FDA Medical Device Safety Communication: Reports of Anaplastic Large Cell Lymphoma (ALCL) in Women with Breast Implants
• Anaplastic Large Cell Lymphoma (ALCL) In Women with Breast Implants: Preliminary FDA Findings and Analyses
• Risks of Breast Implants

Advisory Panel Information:

• March 2000 Panel for Saline Breast Implants
• July 2002 Panel for Saline Breast Implants (Postapproval Update)