As of the date of this handbook, no company has PMA approval for a silicone gel-filled breast implant. Therefore, all silicone gel-filled breast implants are considered investigational. For a woman to receive a silicone gel-filled breast implant in the U.S., she must enroll in an IDE study or an adjunct study.

An IDE study is described in the Saline-Filled Breast Implants section above.

An adjunct study is different from the IDE study in terms of its purpose and study design. In April 1992, FDA determined that the silicone gel-filled breast implant PMAs submitted in 1991 did not include adequate safety data to support PMA approval. However, FDA believed that there was a public health need to have breast implants available for reconstruction and revision patients. Therefore, companies that had not withdrawn their PMAs prior to the April 1992 decision were given the opportunity to submit an adjunct study protocol, for FDA approval, to address the public health need. Only Mentor Corporation and Inamed Corporation received approvals for their adjunct studies.

Adjunct studies are limited to reconstruction and revision patients. Women who want silicone gel-filled implants for augmentation (cosmetic reasons) cannot be enrolled in an adjunct study. New reconstruction and revision patients are continuously being enrolled in the adjunct studies because there is no limit on the number of patients or the number of sites. Each woman who participates in an adjunct study must give informed consent.⁵ The safety data collected in an adjunct study are used as supplemental data to support a future PMA.

Alternative Breast Implants