This article published by the Regulatory Affairs Professionals Society provides an excellent summary of key responses to the FDA’s request for public comment on regulations for hernia mesh. It clearly shows the conflicting perspectives of the device industry and healthcare experts about patients’ need for specific information about the risks and benefits of hernia mesh.
Read More »News That Quotes Us & Our Work
We are often quoted in major newspapers and magazines, and on well-respected TV shows, radio programs, and websites where we share our opinion on issues that matter to you and your health. Stay up to date on health news and our take on it by reading the articles in this section.
FDA Panel Urges Caution, More Data on Dermal Filler Use in Decolletage Area
Dr. Diana Zuckerman urged the FDA to require better research and quantify risk information at the Aug 2025 FDA Advisory Panel reviewing risks of dermal fillers in decolletage area above the breast. We agreed with panel members concerns that filler could interfere with cancer diagnosis and breastfeeding, and cause a stroke. We also pointed out that this cosmetic procedure can cause pain, swelling, bruising, and lumps could last weeks or months, which will undermine any cosmetic improvement. Panel members also focused on risks of interfering with cancer diagnosis and breastfeeding
problems.
After 10 Years, the FDA Is Still Letting Women Down
This excellent Drugwatch article explains that FDA lets women down when they approve drugs and devices for cancer and many other serious diseases, which often don’t work well on women and can be harmful. The article quotes Dr. Diana Zuckerman and other experts, and provides examples of specific medical products that you may have used or want to avoid.
Read More »Medical device industry says future MDUFA hikes unsustainable
MedTech Dive, August 5, 2025: NCHR’s Diana Zuckerman and Patient, Consumer, and Public Health Coalition’s Tess Robertson-Neel are quoted in the MedTech Dive’s article about the MDUFA VI meeting at FDA in August 2025. Alex Baum of Coalition member Generation Patient is also quoted. They focused on including patient and consumer stakeholders in MDUFA negotiations and using user fees for post-market safeguards and other efforts to improve the quality of medical devices.
Read More »F.D.A. Panel to Reassess Hormone Therapy Warnings
New York Times July 17, 2025: This FDA panel hosted by Commissioner Makary ignores evidence of the serious risks of hormone therapy for menopause, such as breast cancer, endometrial cancer, and stroke. Instead it focuses only on benefits, relying on misleading and erroneous information. The panel wants to remove the “black box” warning that tells women about the risks. No public comment was allowed at the meeting. We would have disagreed strongly, except with the issue of whether hormonal cream used in the vagina should not have the same black box warning as the hormonal pills.
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