The articles in this section focus on testimonies that have been presented at FDA meetings. If you want to learn more about the debate around breast implant safety click on a link to learn more.
FDA Review of Link Between Cancer and Breast Implants
- FDA Review Indicates Possible Association Between Breast Implants and a Rare Cancer – January 26, 2011. The U.S. Food and Drug Administration today announced a possible association between saline and silicone gel-filled breast implants and anaplastic large cell lymphoma (ALCL), a very rare type of cancer.
FDA Consideration of Silicone Breast Implants
- Testimony of Shannon Scott at the FDA on Silicone Gel Breast Implants – April 2005. Scott criticizes FDA’s oversight of Mentor breast implant studies. She was not given informed consent and her medical records were incomplete afterwards.
- Testimony of Ed Brent at the FDA on Silicone Gel Breast Implants – April 2005. Brent states that breast implants may have contributed to his wife’s suicide. His two daughters who were breast fed after his wife’s augmentation are very sick.
- Testimony of Dawn Miller at the FDA on Silicone Gel Breast Implants – April 2005. Miller states that her silicone gel implants caused high levels of platinum in her blood. This caused hearing loss and a heart arrhythmia.
- Testimony of Linda MacDonald Glenn at the FDA on Silicone Gel Breast Implants – April 2005. Glenn argues that the autonomy breast implants are marketed to have is cannot be a factor in new breast implant approvals. As the benefits of breast implants are not measurable and the risks are significant.
- Testimony of Marcy Gross at the FDA on the Lack of Breast Implant Studies – April 2005. Gross criticizes the FDA’s lack of objective breast implant studies. Despite breast implants 40-year history on the market, the industry lacks long-term studies demonstrating the safety of breast implants.
- Testimony of Claudia Miller, MD at the FDA on Silicone Gel Implants – April 2005. Testimony at the FDA Advisory Panel for Silicone Gel Breast Implants on the severity of toxicant-induced loss of tolerance (TILT) in women with silicone gel breast implants.
- Testimony of Audrey Sheppard at the FDA on Silicone Gel Implants – April 2005. Discusses the risks of the approval of new silicone gel implants at the FDA Advisory Panel for Silicone Gel Breast Implants. Sheppard moves on to present evidence which deems the risks to these implants outweigh the benefits.
- Testimony of Judy Norsigian at FDA on Silicone Breast Implants – Judy Norsigian, Our Bodies Ourselves, April 2005
FDA Hearing Silicone Gel Implants
- Testimony of Becky S. at the FDA on Silicone Gel Breast Implants – October 15, 2003.
- Testimony of Susan Pope Helman, PhD at the FDA on Silicone Gel Breast Implants – October 15, 2003. Dr. Pope states that doctors misled her when inserting her breast implants. She was treated like a guinea pig in an experiment that should never have happened.
- Testimony of Anne Kasper, PhD at the FDA on Silicone Gel Breast Implants – October 14, 2003. Kasper, PhD discusses the downfalls of the Inamed study before the FDA Advisory Committee on Silicone Gel Breast Implants. With this testimony, implant complications after reconstructive breast surgery are listed and discussed.
- Testimony of Suzy Cunningham at the FDA on Silicone Gel Breast Implants – October 14, 2003. Cunningham notes that her health problems dissipated when her implants were removed.
- Testimony of Marcy Gross at FDA on Silicone Breast Implants – October 14, 2003. Marcy L. Gross, State of Maryland’s Women’s Health Promotion Council, October 14, 2003.
- Testimony of Sherry Henderson at the FDA on Silicone Gel Breast Implants – October 14, 2003. Henderson discusses her health problems stemming from her breast implants. Breast implants are not life saving devices and should not be available unless completely safe.
FDA Hearing on Saline Breast Implants
- Testimony of Cynthia Pearson at the FDA on Saline Breast Implants – July 9, 2002. Pearson testifies at the FDA highlighting the lack of enrollment in breast implant studies.
Congressional Presentation on the FDA’s Regulation of the Breast Implant Industry
- The FDA’s Regulation of Silicone Breast Implants – 1993. This report contains a description of the FDA’s regulation of the breast implant industry in 1993.