Medical Panel Calls for Further Study of Bayer Sterility Device

The Wall Street Journal, September 24, 2015. Thirteen years after the Food and Drug Administration approved a women’s sterility device called Essure, a panel of outside medical advisers Thursday called on the agency and device-maker Bayer AG to further study why so many women are suffering severe pain from the implant.

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FDA to Establish Patient Advisory Committee on Medical Devices

Star Tribune, September 19, 2015. The U.S. Food and Drug Administration on Friday announced the establishment of its first-ever patient advisory committee on medical devices. The committee, according to the FDA, is designed to inject a patient perspective into the agency’s deliberations on device development, approval and monitoring.

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FDA Revisits Safety of the Essure Contraceptive Device

NPR, September 21, 2015. Many women rely on birth control throughout their lives to prevent unwanted or untimely pregnancies. The Essure contraceptive device is placed in the fallopian tubes essentially sterilizing the woman. This alternative to traditional sterilization methods has caused immense harm to many women and provoked strong responses from patient advocacy organizations and professionals in the health care industry.

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Califf Nomination for FDA Chief Gets Mostly High Marks

Medpage Today, September 16, 2015. The nomination of Robert Califf, MD, as FDA commissioner is getting good reviews from most health policy and cardiology experts. One area that might cause controversy with Califf’s nomination is his ties to the pharmaceutical industry.

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Psst! Industry Has Taken Over FDA

Medical Device and Diagnostic Industry, September 17, 2015. By nominating cardiologist Robert M. Califf to be FDA’s next commissioner, the Obama Administration has taken a giant step away from the agency’s traditional avoidance of even the suspicion of coziness with the industries it regulates.

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