November 18, 2019. We therefore respectfully urge the FDA to revise the proposed guidance in ways that ensure that all medical devices undergo more rigorous testing prior to being approved or cleared.
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FDA Challenged Over Metal Implants ‘Public Health Travesty’
International Consortium of Investigative Journalists, November 14, 2019. The FDA needs to require better research before implants are approved and put in patients’ bodies, instead of just counting problems after the implants are used by thousands of patients.
Read More »FDA Advisers Hear About Problems, Research Needs With Metal Implants
MedPage Today, November 14, 2019. Comparing different implants could prevent many women and men from harm resulting from metals and other substances that set off negative reactions in patients.
Read More »How the FDA and EPA’s Failure to Communicate Could Put Patients in Danger
Politico, November 7, 2019. While EPA wants to shut down facilities that sterilize medical devices using a carcinogenic chemical, the EPA and FDA should have harmonized their standards years ago to protect patients and consumers.
Read More »As Essure Implant Return Deadline Nears, FDA Study Enrollment Inches Up
MedTech Dive, November 5, 2019. The original clinical data supporting FDA’s approval of Essure was insufficient, as seen in Bayer’s small sample size in the Essure postmarket study.
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