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Medical equipment industry

FDA Panel Votes to Approve Silicone Breast Implants

Strategic Insights

— 1 min read

After a 13-year ban, a Food and Drug Administration advisory panel has approved the sale of silicone breast implants manufactured by Mentor, a move that has improved the chances for more implants to re-enter the market. Industry analysts say the decision has opened the door for other companies to follow suit, but the FDA's final ruling is still pending. The approval came with strict conditions, and the agency has not indicated when it will make its final decision.

Key Takeaways:

  • The FDA advisory panel voted 7-2 in favor of allowing Mentor to sell its silicone-gel-filled breast implants, but imposed strict conditions.
  • The approval is seen as a positive development for the industry, with analysts expecting more silicone implant manufacturers to seek FDA approval in the next few years.
  • Long-term data on the rupture rate of silicone implants will be the determining factor for FDA approval.
  • Mentor's shares on the New York Stock Exchange jumped $2.58, or 7 percent, to close at $37.91 yesterday, while Inamed dropped $3.21 to $60.30 on the Nasdaq Stock Market.
  • Industry analysts, including Amit Hazan of SunTrust Robinson Humphrey Capital Markets, say the vote has paved the way for Inamed and other companies to follow suit.
  • Senior analyst Juan Noble of Oppenheimer & Co. Inc. lowered his rating for Inamed to "neutral," while keeping his "buy" rating for Mentor.
  • Dr. Donald Kress, a Frederick, Md., plastic surgeon, expressed enthusiasm for the possibility of using silicone implants for his healthy patients, citing the unsatisfactory nature of saline implants.

Statistics:

  • 7-2: The vote in favor of allowing Mentor to sell its silicone-gel-filled breast implants.
  • $2.58: The increase in Mentor's share price on the New York Stock Exchange over the previous day's close.
  • 7%: The percentage jump in Mentor's share price over the previous day's close.
  • $60.30: The closing price of Inamed's shares on the Nasdaq Stock Market.
  • 1992: The year the FDA banned the use of silicone implants, except for specialized cases.
  • 5: The number of years Dr. Donald Kress, a Frederick, Md., plastic surgeon, performs on average five breast-implant surgeries a week.

Sources:

  • The Washington Times

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