Except for two PMA-approved saline-filled breast implants, all other saline-filled breast implants are considered investigational devices because they are not PMA- approved. For a woman to receive an investigational saline-filled breast implant in the U.S., she must enroll in an investigational device exemption (IDE) study.

An IDE study is a clinical study that must be reviewed and approved by FDA to help assure that the resulting data will be meaningful and that patients will not be exposed to unreasonable risks. IDE studies may include augmentation, reconstruction, and/or revision patients. The number of patients and the number of sites are limited in IDE studies. In addition, each woman who participates in an IDE study must give informed consent.⁴ The safety and effectiveness data collected in an IDE study are used to support a future PMA.

Silicone Gel-Filled Breast Implants

Prior to 1991, silicone gel-filled breast implants were sold on the market as either preamendments devices (they were on the market prior to May 1976) or as 510(k)-cleared devices. In April 1991, FDA issued a regulation that required that all silicone gel-filled breast implants be PMA-approved to be sold on the market. However, those companies that had a preamendments or 510(k)-cleared silicone gel-filled breast implants and submitted their PMA within 90 days of the April 1991 regulation were allowed to keep their device on the market until the final decision/actions were made in April 1992. Since April 1992, a silicone gel-filled breast implant must be PMA-approved to be sold on the market.