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Medical equipment industry

FDA Approval of Silicone Breast Implants Sparks Concern Over Safety Data

Strategic Insights

— 2 min read

The U.S. Food and Drug Administration (FDA) has issued an "approvable letter" to Mentor Corporation for their application for silicone gel-filled breast implants, outlining conditions the company must meet for full approval. However, patient advocates and experts are warning that the safety data for these devices are insufficient to show safety, and that the FDA's decision to approve them could have serious consequences for women.

Key Takeaways:

  • The FDA's decision to approve silicone breast implants is based on incomplete safety data, with experts warning that the devices may be hazardous to women's health.
  • The manufacturers' own data show that over half of cancer survivors and one in five cosmetic patients require additional surgery within 3 years of receiving breast implants.
  • A study conducted by the National Cancer Institute found that women with silicone implants had leukemia and cervical and brain cancers at twice the rate of women without implants.
  • The sale of silicone gel breast implants was restricted in 1992 to women who needed them for medical reasons, and the devices have been available for augmentation since the late 1990s in clinical trials.
  • The FDA has issued a record number of post-market approval conditions for silicone breast implants, including a patient registry, required doctor training, and independent annual data review.
  • However, an FDA report released this March showed that the agency has no power to enforce post-approval conditions and that the majority of companies fail to meet them.
  • Sybil Goldrich, a breast implant activist, had four separate sets of implants after mastectomy and later surgery found silicone in her liver, uterus, and ovaries.
  • The FDA's decision to approve silicone breast implants will completely reverse the standards for safety and data on breast implants of nearly twenty years, established by former FDA Commissioner Mark McClellan.

Statistics:

  • Over 330,000 women received cosmetic breast implant surgery last year, and about 35,000 women had reconstruction after mastectomy. This number has more than tripled since 1997.
  • Approximately half of silicone implants fail within 10 years, and three-quarters will rupture within 20 years, according to independent studies.
  • Over half of cancer survivors and one in five cosmetic patients require additional surgery within 3 years of receiving breast implants, according to the manufacturers' own data.
  • Women with silicone implants have leukemia and cervical and brain cancers at twice the rate of women without implants, according to a study conducted by the National Cancer Institute.

Sources:

  • The New York Times: "Former Mentor Employees Say They Were Told to Suppress Breast Implant Problems" (May)
  • FDA: "Approvable Letter to Mentor Corporation for Silicone Gel-Filled Breast Implants" (July 28)
  • National Cancer Institute: "Breast Implants and Cancer Risk" (study)
  • FDA: "Post-Approval Conditions for Silicone Breast Implants" (March)
  • Command Trust Network: "Statement on FDA Approval of Silicone Breast Implants" (July 28)

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