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Breast Implant Illnesses: What’s the Evidence?

…implant companies, the FDA had input into the scientific design of the studies to address the short-comings of previous research. The required studies were conducted, but 5 years after silicone…

Breast Implants: A Research and Regulatory Summary

…of at least 40,000 women with breast implants for 10 years, in order to prove long-term safety. The reason for the safety studies was to provide the kind of long-term…

Is TMS Proven Effective for Depression?

…the FDA FDA’s Questionable Process Is TMS Effective? Examining Key Research on TMS Early Sham-Controlled Studies of TMS Do Recent Studies Show Greater Benefit? Are There Long-Term Benefits of TMS?…

NCHR Report: The Health Risks of MRIs with Gadolinium-Based Contrast Agents

…of short-term side effects, and some have higher risks for long-term accumulation and harm. However, research has been inadequate to answer those questions with confidence. Table of GBCAs Approved…

What You Need to Know About Breast Implants

…the Known Risks? Reports of complications among women with implants have been published in medical journals and discussed at public FDA meetings. There are a number of short-term and long-term…

NCHR Comments on the Proposed Order Reclassification of Electroconvulsive Therapy Devices

…The National Center for Health Research is a nonprofit research center staffed by scientists, medical professionals, and health experts who analyze and review research on a range of health issues….

NCHR Comments to FDA on Nicotine Replacement Therapy (NRT) Product Uses and Labeling Changes

…Tobacco Control. CANCER RESEARCH Catalyst: The Official Blog of the American Association for Cancer Research. November 2017. Available online: http://blog.aacr.org/advances-in-tobacco-control/ James M. Lightwood and Stanton A. Glantz. Short-term Economic and…

Testimony to FDA Advisory Committee on Atrial Septal Defect Occluders

…Muscular VSD Occluder [P040040] was overdue prior to termination of the long- term study. These reports are needed so that you can provide informed advice to the FDA. Frankly, when…

Comments Opposing FDA’s Draft Guidance On Postmarket Safety And Effectiveness Data For High-Risk Devices

…required and patients will participate in long-term data collection. In addition to enormous loss to follow-up in breast implant postmarket studies and the failure to complete postmarket studies of gastric…

NCHR Testimony at FDA Advisory Committee on Implanted Blood Access Devices

…for years, but long-term safety and efficacy data are lacking. Even if you think the short-term safety data are adequate, I’m sure you will agree that long-term implants need long-term…

Breast Implant Injuries Hidden as Patients’ Questions Mount

…the National Center for Health Research, a nonprofit think tank that performs its own research, assesses the quality of others’ research and works with patients. Zuckerman’s center reviewed more than…

NCHR Testimony to FDA Advisory Committee on Inspire Upper Airway Stimulator

…During the time needed to collect longer-term data, the sponsor should also be required to enroll African Americans in the STAR pivotal trial. Although the longer-term data would initially be…

NCHR Testimony at FDA on Gastric LAP-BAND

…that we can’t predict who will benefit in the short-term, and we know even less about the long-term risks and benefits. The research shows there were many adverse reactions, and…

Breast Implant Working Group’s Comments on FDA’s Draft Guidance to Improve Patient Communication on Breast Implants

…Systemic Symptoms: Breast Implant Illness As noted earlier, “Breast Implant Illness” should be the term used, since “systemic symptoms” is not a term that all patients would understand. Also as…

NCHR Testimony on Aximris as an Abuse-Deterrent Opioid for Long-Term Treatment

…even when the drugs are taken as directed. Unfortunately, the term “abuse-deterrent” has contributed to the opioid epidemic. Research shows that doctors, patients, and family members have misunderstood the term,…

The Wrinkle in Facial Injections and Implants: Safety Questions

…of minority groups; it doesn’t even require studies to specify the race of those individuals studied. FDA does not require long-term safety data, but some of these products have long-term…

Is Vaping Safer than Smoking Cigarettes?

…of vaping are more dangerous than others in the short-term and the long-term. To understand the risks for everyone who vapes, research is needed to compare the risks of specific…

NCHR Comments on CPSC Agenda and Priorities for FY2020/2021

…the research that has been done, focusing on independently funded research of short-term and long-term safety issues. We also urge you to carefully examine the EPA/CDCs studies when they are…

NCHR Testimony on FDA Legislation Before the Subcommittee on Energy and Commerce

Thank you for the opportunity to testify about the Subcommittee’s discussion draft FDA legislation. I am Dr. Diana Zuckerman, president of the National Research Center for Women & Families, an…

Public Comments by Women’s Health Experts on General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee Meeting

…at different life stages. The National Center for Health Research is a nonprofit think tank that conducts, analyzes, and scrutinizes research, policies, and programs on a range of issues related…