“About 95% or more of [medical devices] have not been required to be proven safe or effective in clinical trials…. Whether it’s a hip implant, or a breast implant, or certainly a cardiac implant, you would want to assume those have been studied in patients to make sure that they’re safe and that they work. But that isn’t the case.”
Diana Zuckerman, in an NPR interview
Throughout her career, Diana Zuckerman has courageously spoken out on the need for policy change and quality, comprehensive research to improve American healthcare. Currently President of The National Center for Health Research, a nonprofit organization that promotes the health and safety of adults and children, and provides consumers with free information about the risks of specific medical devices (at firstname.lastname@example.org). Diana previously spent ten years as a Congressional staffer in the House and Senate, as a scientist working in the White House, and at the U.S. Department of Health and Human Services. She conducted research while on the faculty at Vassar and Yale, and at Harvard.
Diana’s work specifically focuses on drawing attention to dangerous medical devices and corporate-sponsored medical research. In 2011, along with Paul Brown and Dr. Steven Nissen, she was the lead author on a groundbreaking study about the dangers of medical devices, determining that most devices recalled by the U.S. Food and Drug Administration (FDA) for being potentially deadly or high-risk were not thoroughly researched before being put on the market. In 2014, she was the lead author of the first study to determine that most medical implants were being sold in the U.S. without any publicly available evidence that they will benefit patients.
“Let the buyer beware before getting an implant in their body, because there may be no evidence the implant is going to benefit them and no study done in case it might harm them,” she explained.
Diana has also championed the rights of patients considering Essure to have access to the information they need to make informed choices. She has called for a “well-designed long-term study of women who underwent Essure sterilization compared to tubal ligation,” research she notes would be “long overdue.”
The Bleeding Edge filmmakers were inspired to make the documentary after seeing her speak, and are grateful for her stalwart dedication to medical device safety. They celebrate Diana and her steadfast advocacy for the rights of individuals to be fully aware of medical risks, and for patients to be valued over profits.
Watch Diana Zuckerman and her powerful call for quality medical device research in the Netflix Original documentary, The Bleeding Edge, available on July 27.