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Medical equipment industry

Silicone Breast Implants Make a Comeback in US Market

Strategic Insights

— 1 min read

The US Food and Drug Administration's conditional approval of Santa Barbara-based Inamed Corp.'s silicone gel-filled implants marks a significant step towards bringing back the use of silicone breast implants in the US market, which has been banned for the past 13 years due to health concerns. This move follows the FDA's approval of Mentor Corp.'s silicone implants in July. Analysts predict that the companies could obtain final FDA approval by the end of this year or early next year, allowing the implants to be sold for cosmetic surgery.

Key Takeaways:

  • Inamed Corp. received a conditional approval from the FDA for its silicone gel-filled implants, joining Mentor Corp. as the second manufacturer to receive such approval.
  • The approval is subject to certain conditions, which were not disclosed, and final government approval is pending.
  • The companies' shares reacted differently to the news, with Inamed's shares jumping 9% to $77.42, while Mentor's shares declined 3.5% to $50.70.
  • The FDA ban on silicone implants was imposed in 1992 due to concerns about health problems from leaks or ruptures, and implants are now available only for breast reconstruction or FDA-approved clinical trials.
  • Silicone breast implants are still available in Europe, where they are more popular than saline implants due to their natural look.
  • Worldwide sales from breast implants were approximately $500 million in fiscal 2004, with Inamed and Mentor controlling nearly the entire US market and about 80% of global sales.
  • Inamed and Mentor have a combined workforce of over 2,500 employees, with manufacturing and research facilities in multiple countries.

Statistics:

  • The US FDA ban on silicone breast implants has lasted for 13 years.
  • The two companies, Inamed and Mentor, control nearly 100% of the US market.
  • Worldwide sales from breast implants were approximately $500 million in fiscal 2004.
  • Inamed and Mentor employ a combined workforce of over 2,500 employees.
  • The FDA approval is conditional and subject to certain conditions.

Sources:

  • Debora Vrana, "Silicone Breast Implants Make a Comeback in US Market" (Los Angeles Times)
  • Jayson Bedford, analyst with Adams Harkness Inc., as quoted in the Los Angeles Times article.
  • Diana Zuckerman, president of National Research Center for Women and Families, as quoted in the Los Angeles Times article.

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