The articles in this section focus on NCHR’s testimonies that have been presented at FDA and other meetings. If you want to learn more about the debate around breast implant safety click on a link to learn more. To see more testimonies visit Other Testimonies about Breast Implant Complications
Guidance for easy-to-understand information for FDA black box warning and Patient Informed Consent Check List
Breast Implant Working Group’s Comments on FDA’s Draft Guidance to Improve Patient Communication on Breast Implants – We urge FDA to require a black box warning and Patient Informed Consent Check List with in explicit and easy-to-understand information.
Comment on General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting [FDA-2019-N-0426]
NCHR Public Comment to FDA on breast implant safety – NCHR submitted a comment to the FDA regarding the safety of breast implants, making suggestions for patient checklists, registry changes, and more.
- Public Comments by Women’s Health Experts on General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee Meeting – We submitted a comment to the FDA’s advisory committee meeting regarding the safety of breast implants with five other women’s health organizations.
MD Anderson Study of 100,000 Women Linking Breast Implants to Autoimmune Disorders
- Statement of Dr. Diana Zuckerman, President of the National Center for Health Research, Regarding the New Study of 100,000 Women with Breast Implants – September 2018. Researchers at The University of Texas MD Anderson Cancer Center have reported that women with silicone implants are more likely to be diagnosed with several rare diseases, autoimmune disorders, and other conditions.
American Health Care Act
- Statement of Diana Zuckerman, PhD, President, National Center for Health Research, Regarding the American Health Care Act – March 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 Natrelle 410 Implants
- Statement of Dr. Diana Zuckerman on FDA Approval of New Silicone-Gel Breast Implant Natrelle 410– February 2013. Diana Zuckerman, president of the National Center for Health Research, responds to the FDA’s approval of a new style of breast implant.
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.
- Statement of Diana Zuckerman Regarding FDA Legislation Before the Subcommittee on Energy and Commerce – June 2007. Zuckerman testifies that medical devices are not usually proven safe and effective. The 510(k) pre-market approval process leads to increasingly unsafe approvals for medical devices.
FDA Approval of Silicone Gel Implants
- FDA Approves Silicone Breast Implants Despite Safety Concerns – November 2006. Zuckerman’s statement regarding FDA approval of silicone gel breast implants. This decision is a “triumph of corporate lobbying over good science and women’s health.”
Canadian Parliament’s Consideration of Silicone Breast Implants
- Invited Testimony of Diana Zuckerman, PhD, Before the Standing Committee on Health, Canadian Parliament, Ottawa – June 2006. Zuckerman’s statement to Parliament on the danger’s of Inamed’s silicone breast implants. These studies contained many methodological flaws.
FDA Consideration of Silicone Breast Implants
- Statement of Diana Zuckerman, PhD on FDA Approval of Breast Implants – September 2005. Zuckerman’s statement on the FDA’s approval of Inamed Breast Implants. These devices were not appropriately studied in patients who had previously had breast cancer.
- Statement of Dr. Diana Zuckerman, President of the National Center for Health Research, Regarding the FDA Breast Implant Decision – July 2005. Zuckerman argues that the FDA took a step in the wrong direction when it approved silicone breast implants. More long-term studies are needed.
- 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.
FDA Approval of Inamed’s Silicone Gel Breast Implants
- NCHR Press Release on Inamed High Complication Rates for Breast Implant Patients – October 2003. The approval of these implants is not good for patients. The company’s own research indicates that there is a high complication rate within the first three years.
FDA Hearing on Silicone Gel Breast Implants
- Testimony of Diana Zuckerman, PhD, at the FDA for Silicone Gel-Filled Breast Protheses – October 2003. Zuckerman highlights the Lori Brown breast implant study as a guide for future studies.
FDA Hearing on Saline Breast Implants
- Testimony of Diana Zuckerman, PhD at the FDA on Saline Breast Implants – July 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 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.
FDA Approval of Mentor and Inamed Saline Breast Implants
- The Role of FDA on Breast Implants – Watchdog or Grandma? – May 2000. Zuckerman states that it is the FDA’s job to regulate products, not to simply warn citizens about risks.