FDA Panel Recommends Approval of Mentor's Saline Breast Implants

The FDA Medical Devices Advisory Committee has recommended approving Mentor Corp.'s saline-filled mammary prostheses premarket approval (PMA) application.

Along with other manufacturers, Mentor (Santa Barbara, CA) received notification from the FDA on August 17, 1999, to file a PMA application for its saline-filled breast implant products by November 17, 1999. Mentor submitted its PMA to FDA on November 12, 1999.

Following the Advisory Committee deliberations, the FDA will review the Panel's recommendations and make a final decision. For a company to continue marketing saline-filled breast implants in the United States, the FDA will ultimately need to approve each manufacturer's PMA.

Edited by Ursula Jones