The Food and Drug Administration on Thursday granted conditional approval to
( MNT) 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.
In April, an FDA advisory board
voted 7-2 to support Mentor's silicone gel implant for cosmetic use with a host of conditions.
"The conditions outlined in the approvable letter are generally consistent with the Advisory Panel's deliberations, said Joshua H. Levine, president and CEO of Mentor. "We are very encouraged by this communication from the FDA, and view this letter as a positive sign for women and their surgeons that another option will soon be available."
Advisory panel recommendations included restricting the sale of the implants to board-certified plastic surgeons who complete special training and to patients who sign documents showing they understand that the implants could rupture. The panel also said Mentor should prepare a patient registry to examine the implants' long-term health effects and to conduct a clinical study that would assess the implant's rupture rate over 10 years.
"For more than a decade, choices for women seeking breast augmentation and reconstruction have been limited," Levine said. "Mentor is committed to making these important products available to women and will continue working with the FDA to address the approvable conditions."
Silicone gel breast implants, which are sold for cosmetic surgery in foreign markets, have been severely restricted in the U.S. since 1992 because implant-makers haven't been able to convince the FDA of their products' long-term safety.
Silicone gel implants
are available today in the U.S. for patients undergoing reconstructive surgery after a mastectomy, women whose existing gel implants have ruptured and women who have congenital deformities of the breast. These implant recipients must be enrolled in a clinical trial.
Saline implants are available for cosmetic use in the U.S., although plastic surgeons supporting gel implants say these devices have a more natural look and feel than the salt-water implants. Mentor sells saline implants, as does its archrival
One day before the FDA advisory panel approved the Mentor implant,
the panel rejected a silicone-gel breast implant from Inamed by a 5-4 vote. Also based in Santa Barbara, Calif., Inamed recently said it was revising its implant application to the FDA.