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Medical equipment industry

FDA Approves Wider Sales of Silicone Gel-Filled Breast Implants

Strategic Insights

— 1 min read

The Food and Drug Administration (FDA) has given conditional approval to Inamed Corp. for the sale of its silicone gel-filled breast implants, pending the resolution of outstanding safety concerns. This decision comes after the company addressed the primary safety concerns raised by a federal advisory panel in April. The approval is expected to return the implants to the US market by the end of the year, with sales worth approximately $300 million annually.

Key Takeaways:

  • The FDA has granted conditional approval to Inamed Corp. for the sale of its silicone gel-filled breast implants, following the company's provision of additional information to address safety concerns.
  • The agency took a more lenient stance with Inamed than with its rival, Mentor Corp., which received similar approval in July.
  • Federal advisers had previously expressed concerns about the long-term safety of silicone gel implants, which can leak silicone gel with little warning.
  • Inamed withdrew from consideration an implant responsible for the highest rupture rates, a key factor in the FDA's decision.
  • Women say silicone gel implants look and feel more realistic than versions filled with saltwater, with silicone implants accounting for 90 percent of European sales.
  • The reconstructive market accounts for 25 percent of implant sales in the United States, according to Amit Hazan, a SunTrust Robinson Humphrey analyst.
  • Silicone implants are expected to edge out saline implants quickly, with $75 million in sales expected in 2006, according to Hazan.
  • A national association representing plastic surgeons paid travel expenses for healthy women and their doctors to testify in favor of relaxing restrictions on implants.
  • Women's advocates accused the FDA of signaling it will approve an application without sufficient safety data, citing the need for proven safety.

Statistics:

  • The annual market for silicone breast implants is worth approximately $300 million.
  • Inamed Corp.'s stock price climbed higher after the FDA's approval, closing at $77.42, a 8.9 percent increase.
  • Mentor Corp.'s stock fell 3.5 percent, closing at $50.70.
  • Silicone implants account for 90 percent of European sales, with the pricier option expected to edge out saline implants quickly.
  • $75 million in sales are expected for silicone implants in 2006.
  • The reconstructive market accounts for 25 percent of implant sales in the United States.

Sources:

  • The Boston Globe, (no date provided)
  • SunTrust Robinson Humphrey analyst Amit Hazan

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