• E-mail
• Print
• RSS

FDA approves second silicone breast implant

Ambulatory Surgery Reimbursement Update, September 27, 2005

The Food and Drug Administration (FDA) has approved a second manufacturer of silicone gel-filled breast implants to return its implants to the U.S. market if the devices meet certain conditions, according to the Associated Press (AP).

The FDA did not detail what conditions Inamed Corp., the manufacturer of the implants, needed to meet before the devices would be approved for marketing.

The approval comes after another manufacturer, Mentor Corp., received similar approval for its silicone gel-filled implants in July. Like Inamed, Mentor was given confidential conditions the company needed to meet before receiving approval for sale. It has yet to receive the final approval.

The FDA's decision to approve Inamed devices goes against a recommendation from an advisory panel that said the implants should not be approved because of safety concerns with long-term durability, according to the AP.

Without offering details, the FDA said last week that Inamed had provided information addressing the panel's concerns.

• E-mail to a Colleague
• Print
• RSS
• Archive