The articles in this section focus on NCHR’s 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.
American Health Care Act
- Statement of Diana Zuckerman, PhD, President, National Center for Health Research, Regarding the American Health Care Act – March 9, 2017. The goal of the American Health Care Act is to replace the Affordable Care Act (ACA) with something better, but instead it represents a giant step backward for health care for all Americans.
FDA Approval of Mentor Implants
- Is Bigger Better? Mentor Receives FDA Approval to Conduct Clinical Trials for Larger Breast Implants– Are bigger implants better? Our president and senior staff member discuss a new clinical trial studying the safety of large silicone gel breast implants.
FDA Approval of Natrelle 410 Implants
- Statement of Dr. Diana Zuckerman on FDA Approval of New Silicone-Gel Breast Implant Natrelle 410– February 21, 2013. Diana Zuckerman, president of the National Center for Health Research, responds to the FDA’s approval of a new style of breast implant.
Breast Implant Regulation In the U.S. and Europe
- Public Health Implications of Differences in US and European Union Regulatory Policies for Breast Implants – Tens of thousands of defective silicone breast implants were recalled in Europe in 2011–12 soon after the FDA’s unrelated announcement that a rare cancer of the immune system was associated with all saline and silicone gel breast implants.
- The FDA & Breast Implants – December 2012. A brief history of between the FDA and breast implants. This history spans from when breast implants first entered the U.S. market in the 1960s to more recently in 2011.
FDA Hearing on Silicone Gel Breast Implants
- Statement of Dana Casciotti, MPH, PhD at the FDA on Breast Implants – August 2011. Testimony at the FDA Advisory Committee Meeting on Breast Implants discussing the downfalls of adjunct studies on newer silicone breast implant models from Mentor and Allergan.
- Testimony of Margaret Dunkle at the FDA on Silicone Gel Implant Studies – August 2011. Dunkle testifies at the FDA against the continued approval of Mentor and Allergan’s silicone gel implants due to low enrollment in long-term clinical studies.
Safety and Regulatory Update
- FDA Update on Silicone Gel Breast Implant Safety: Many Unanswered Questions – June 22, 2011. The FDA released a new report entitled Update on the Safety of Silicone Gel-Filled Breast Implants on June 22, 2011. The FDA summarized the report as showing that breast implants cause many complications and often need to be removed, but that if “used as directed” (including regular MRIs) implants are “reasonably safe.”
- Breast Implants: A Research and Regulatory Summary – February 2011. Diana Zuckerman, Elizabeth Santoro, and Judith Faucette provide a summary of research surrounding breast augmentations.
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.
Informed Consent Critiques
- The Need to Improve Informed Consent for Breast Cancer Patients – February 2008. Many of the more than 182,000 women who will be newly diagnosed with breast cancer this year will not have access to all the information they need to make the surgical and treatment choices that are most appropriate for them.
- 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 Diana Zuckerman, PhD at the FDA on Silicone Gel Breast Implants – April 2005. Zuckerman testifies in front of the FDA pointing out the small sample size and diversity of breast implant studies. Zuckerman believes the lack of participants makes these studies unreliable.
- 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 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 Diana Zuckerman, PhD, at the FDA for Silicone Gel-Filled Breast Protheses – October 15th, 2003. Zuckermann highlights the Lori Brown breast implant study as a guide for future studies.
- 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.
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.
- Testimony of Diana Zuckerman, PhD at the FDA on Saline Breast Implants – July 9, 2002. Zuckerman testifies in front of the FDA urging the agency to review industry breast implant studies.
- Testimony of Jae Hong Lee, MD at FDA on Silicone Breast Implants – July 9, 2002. Jae Hong Lee, MD, MPH, National Center for Health Research, July 9, 2002 Two years after the FDA’s controversial approval of saline breast implants.
- Epidemiology of Silicone-Gel Breast Implants – May 2002. Silicone breast implants have been marketed in the United States since 1963. Questions remain unanswered on the safety of these medical devices despite their popularity and availability.
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.