The Daily Beast, September 24, 2014. After participating in clinical trials for Essure, a contraceptive implant, several women complained of severe pain and bleeding—but they say their trial records were altered.
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FDA Panel Weighs Complaints on Essure Contraceptive Implant
The New York Times, September 24, 2015. A panel of experts convened by the Food and Drug Administration excoriated the manufacturer of a contraceptive device for not collecting data that they say could have helped predict risks for women. The device has received thousands of complaints from women who say they were harmed by it.
Read More »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.
Read More »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.
Read More »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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