FDA Approves Mentor Corp's Silicone Gel Breast Implants Amid Controversy

Strategic Insights -

Mentor Corp's silicone gel breast implants have cleared marketing clearance from the US Food and Drug Administration (FDA), although with conditions attached, in a move that contrasts with the rejection of a similar application by competitor Inamed Corp. The FDA's General and Plastic Surgery Devices Advisory Panel's vote on 13 April was 7-2 in favor of recommending Mentor's product for approval, while rejecting Inamed's silicone gel breast implants for general use on 12 April.

Key Takeaways:

  • Mentor Corp's silicone gel breast implants have been approved by the FDA, with conditions attached, based on the company's pre-market approval (PMA) application filed in December 2003 and the PMA amendment filed in August 2004.
  • Inamed Corp's application for approval of its silicone gel breast implants was rejected by the FDA's General and Plastic Surgery Devices Advisory Panel on 12 April.
  • The FDA's decision on Mentor's product brings the implant closer to full approval, making it likely that Mentor's Memory Gel products will be the only approved silicone gel-filled breast implants in the USA.
  • Memory Gel is a silicone gel formulation that holds its shape but remains soft, resulting in a more realistic appearance, according to Mentor.
  • Inamed is still pursuing approval for its Style 410 cohesive gel-filled implant, its next-generation breast implant designed for memory and shape retention.
  • Silicone gel-filled breast implants are currently only available in the USA for women who are eligible and participate in an FDA-approved continued access study for breast reconstruction and revision patients.

Statistics:

  • 7-2 vote in favor of recommending Mentor's silicone gel breast implants for approval (Source: FDA's General and Plastic Surgery Devices Advisory Panel).
  • 12 April: FDA's General and Plastic Surgery Devices Advisory Panel recommended rejecting Inamed's silicone gel breast implants for general use(Source: FDA's General and Plastic Surgery Devices Advisory Panel).
  • 2003: Mentor Corp filed its pre-market approval (PMA) application for silicone gel breast implants (Source: Mentor Corp).
  • 2004: Mentor Corp filed its PMA amendment for silicone gel breast implants (Source: Mentor Corp).

Sources:

  • FDA's General and Plastic Surgery Devices Advisory Panel
  • Mentor Corp
  • Inamed Corp