March 1, 2023 Location: FDA White Oak Campus, Silver Spring, MD-Building 1, Great Room FDA attendees: Robert Califf (Commissioner, virtual due to exposure to viruses), Peter Marks (Director, CBER, virtual), Owen Faris (OPEQ Principal Deputy Director, CDRH, virtual); In person: Julia Tierney (Chief of Staff, Office of the Commissioner), Jacqueline Corrigan- Curay, (Principal Deputy Director, CDER), Dayle Cristinizio (Director, Stakeholder Engagement, Office of External Affairs), Hilary Maston (Chief Medical Officer), Namandje Bumpus (Chief Scientist, AdCom responsibilities), Kaveeta Vasisht (A ..read more

Debate swirls over the risks of breast implants, and physicians and patients are justifiably confused by the conflicting information available.  Despite surgeons’ claims that implants are proven safe, tens of thousands of women with breast implants have reported that they have serious symptoms that they refer to as “breast implant illness.”  Many women with these symptoms report that they recovered when their implants are removed.  Our report finds clear scientific evidence that implants increase the chances of those symptoms and removing impla ..read more

Debate swirls over the risks of breast implants, and physicians and patients are justifiably confused by the conflicting information available.  Despite surgeons’ claims that implants are proven safe, tens of thousands of women with breast implants have reported that they have serious symptoms that they refer to as “breast implant illness.”  Many women with these symptoms report that they recovered when their implants are removed.  Our report finds clear scientific evidence that implants increase the chances of those symptoms and removing impla ..read more

October 26, 2022 I’m Dr. Diana Zuckerman, president of the National Center for Health Research. We scrutinize the safety and effectiveness of medical products, and we don’t accept funding from companies that make those products. So I have no conflicts of interest. My expertise is based on post-doctoral training in epidemiology and public health, my previous policy positions at Congressional Committees with oversight over FDA, my previous position at the U.S. Department of Health and Human Services, and as a faculty member and researcher at Harvard and Yale. There are unique issues for the ..read more

by Julie Halpert , October 25, 2022 With new FDA warnings, troubling research, and a growing online population sharing stories and symptoms, experts and women with implants weigh in. JENNIFER JOHNSON, 43, of Wilcox, NE, underwent a preventative double-mastectomy—a surgical procedure that removes all tissue from both breasts—in July 2008 at age 29 after learning she carried the BRCA2 genetic mutation. Research shows that having BRCA2 increases risk of developing breast cancer (BC) by 45%. Johnson’s family history didn’t make her keen to play the odds: Her moth ..read more

Eleanor Cummins, Slate, June 9th, 2022 Robyn Towt didn’t want new boobs. But when she was diagnosed with breast cancer and underwent a double mastectomy at 44, friends and doctors told her she needed to “look like a woman” and feel “whole” again. Implants would help put her “back together.” “I was talked into it,” Towt recently told me over a poolside phone call from her home in Arizona. She quickly regretted the decision. But it wasn’t the look or feel of her new cleavage that was the problem. Rather, within days of her 2017 implant surgery, she developed strange symptoms, including severe in ..read more

Celine Castronuovo and Jeannie Baumann, Bloomberg Law, August, 26, 2022 A House report detailing coordinated attempts by Trump White House officials to influence the FDA’s pandemic response underscores the need for more transparency at an agency that’s facing historically low public trust, health policy analysts say. The House Select Subcommittee on the Coronavirus Crisis said this week that advisers to former President Donald Trump sought to build support for hydroxychloroquine as a Covid-19 treatment, despite limited evidence on its efficacy. The report serves as a remind ..read more

APPROXIMATELY 12,600 SETTLEMENT CLAIMS AGAINST DOW CORNING BREAST IMPLANTS ARE ENTITLED TO $$$ BUT HAVE MOVED OVER THE YEARS AND WILL NOT RECEIVE ANY MONEY UNLESS THEY CONTACT THE SETTLEMENT FACILITY ON OR BEFORE SEPTEMBER 17, 2022 On June 13, 2022, the Court entered “Closing Order 5,” which directs the Dow Corning Legal Settlement to post the system ID (SID) numbers of all claims that were filed against Dow Corning and approved because of rupture, symptoms, or disease.  Each woman is entitled to thousands of dollars!  Some already received some of that money in 2016 or 2017 but ..read more

Katie Kindelan, Good Morning America, May 2, 2022 Former NASCAR driver Danica Patrick revealed she had her breast implants removed after suffering medical complications she believes were caused by the implants. Patrick, who turned 40 in March, shared in an Instagram post that she had her implants removed this month, nearly eight years after undergoing breast augmentation surgery. “I wasn’t sure I was ready to share this…. but then I remembered that true vulnerability is sharing something you’re not really ready to. So here it is,” Patrick wrote on Instagram, before going on to describe the com ..read more

By Diana Zuckerman, PhD. An article entitled “A Practical Guide to Managing Patients With Systemic Symptoms and Breast Implants” was published in the  Aesthetic Surgery Journal, (Volume 42, Issue 4, April 2022, Pages 397–407). This is a journal of the Aesthetic Society, which is the second largest association of plastic surgeons.  The authors are Patricia McGuire, MD, Daniel J Clauw, MD, Jason Hammer, MD, Melinda Haws, MD, and William P Adams, Jr, MD There are many outrageous articles denying the existence of breast implant illness, but this may be the worst since it was publish ..read more