Breast Augmentation is a procedure used to add breast implants either to reconstruct the breasts after an accident (or cancer) or for cosmetic purposes. There are 2 types of breast implants, filled with gel or a saline solution. If you are considering a Breast Augmentation surgery, you should find out about the FDA approval status for this type of procedure.


Is Breast Augmentation Approved by the FDA?

FDA has approved the use of the following types of breast implants:

  • Breast implants filled with saline solution, which are made up of silicone shells that can be filled with the saline solution before or during the surgery. This type of Breast Augmentation surgery has been approved in 2000, and it may be used in women over the age 18 if used for cosmetic purposes or women of any age if used for reconstructive purposes.
  • The silicone gel breast implants contain silicone shells and are filled with silicone gel before the surgery. These implants have been FDA approved in 2006 and can be used in women over the age of 22 for cosmetic purposes or women of any ages if used for reconstructive purposes.

None of the other types of breast implants have received FDA approval. The other types of breast implants (i.e. gummy bear implants) may be used only in clinical studies.