Did FDA screw up its reporting of Essure deaths?

QMED, February 17, 2016. An independent analysis of FDA MAUDE data shows 303 fetal deaths related to the Bayer contraceptive medical device, but FDA itself has only reported five. A U.S. congressman is officially demanding answers while also alleging that some doctors implanting the device received illegal kickbacks. Continue reading

Investigation: Advisory panel suggests limited use of popular contraceptive Essure

WCBD NEWS 2, September 29, 2015. An advisory panel is now recommending limited use of the popular birth control Essure until more is known about its safety. The advisory panel suggests women with an allergy to metal, an autoimmune disease or history of pelvic inflammatory disease stay away from Essure right now. Continue reading

Women with Essure contraceptive implant needed more surgeries, study finds

The New York Times, October 13, 2015. Women who sought permanent sterilization through a contraceptive implant called Essure were 10 times as more likely to be back for surgery within a year than women who had their tubes tied, according to a new study of 52,326 women Continue reading

How medical device companies test products out on patients—after they’re released

Pacific Standard, October 8, 2015. Federal scrutiny has been a long time coming for Essure: Since the device was approved nearly 13 years ago, thousands of women have filed complaints reporting punctured tubes, debilitating muscle fatigue, and severe pain. Continue reading

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. Continue reading

F.D.A. 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. Continue reading

Long-Term Data on Complications Adds to Criticism of Contraceptive Implant

The New York Times, May 3, 2015. When a new contraceptive implant came on the market over a decade ago, it was considered a breakthrough for women who did not want to have more children, a sterilization procedure that could be done in a doctor’s office in just 10 minutes. Continue reading

Essure Study Criticized

NBC News, November 4, 2013. Dr. Diana Zuckerman, who leads the National Research Center for Women and Families, a non-partisan FDA watchdog, said the survey questionnaires exhibit dubious research methods. “These studies are always done by the company that is selling the product so it is not exactly unbiased,” Zuckerman said. Continue reading