Mentor Gets Conditional Approval for Implant

The Food and Drug Administration on Thursday granted conditional approval to Mentor (MNT Quote) for a silicone gel-filled breast implant, setting the stage for the first such product for cosmetic use since 1992.

Neither the agency nor the company would provide details on the conditions imposed by the FDA or how long it would take Mentor, of Santa Barbara, Calif., to meet all of the FDA's requirements.

The regulators' action, in what is known as an "approvable letter," represents "one of several intermediate steps in the FDA review process of new products," the agency said after markets had closed. ...