FDA Panel Votes to Approve Silicone-Gel Breast Implants

Strategic Insights -

The Food and Drug Administration's advisory panel voted 7-2 to recommend approval of Mentor's application to sell its silicone-gel implants to any woman who wants them. This decision marks a significant step towards the return of the implants to the U.S. market, which has been restricted since 1992 due to safety concerns.

Key Takeaways:

  • The FDA advisory panel voted 7-2 in favor of recommending approval of Mentor's application to sell its silicone-gel implants.
  • The panel's decision was based on nine conditions, including the requirement for surgeons to complete a training program and the company to continue its core study.
  • Mentor's stock price increased by 77 cents to $35.33 during regular trading and another $4.62 to $39.95 after the panel's decision.
  • The FDA usually follows its advisory panel's recommendations, but it did go against the panel's advice in January 2004 when it did not approve Mentor's original application.
  • Silicone-gel implants have been available only in clinical trials and to women who have had a mastectomy, were born with a deformity, or needed to replace other implants since 1992.
  • The most contentious questions surrounding silicone-gel implants relate to when and why they tear and what happens when they do.
  • Research suggests that silicone gel can lead to health problems if it escapes the implant, but the FDA panel's decision highlights the limited long-term safety data available.
  • Mentor's "core" study of about 1,000 patients has followed them for only two or three years, and an MRI study of women who had had Mentor implants for up to 10 years included only 100 patients.

Statistics:

  • 7-2: The vote ratio of the FDA advisory panel in favor of recommending approval of Mentor's application.
  • 1992: The year the FDA commissioner pulled silicone implants off the market due to safety concerns.
  • 2004: The year the FDA rejected the advisory panel's recommendation to approve Mentor's original application.
  • 1,000: The number of patients in Mentor's "core" study.
  • 10: The number of years some patients had been using Mentor implants.
  • 100: The number of patients included in the MRI study of women who had had Mentor implants for up to 10 years.
  • $35.33: Mentor's stock price before the panel's decision.
  • $39.95: Mentor's stock price after the panel's decision.
  • 77 cents: The increase in Mentor's stock price during regular trading.

Sources:

  • USA TODAY, "FDA panel votes to approve silicone-gel breast implants"
  • FDA advisory panel minutes, January 2004
  • FDA commissioner's decision, 1992
  • Mentor's application, January 2004
  • Inamed's application, January 2004
  • FDA medical officer Sahar Dawisha's statement, January 2004