SILVER SPRING, Md.—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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The panel of doctors—which didn’t take a formal vote—was reacting to a parade of witnesses who described yearslong debilitating pain and other symptoms in testimony before a Food and Drug Administration advisory committee examining Essure, which Bayer acquired in a 2013 merger.
Several women said they told doctors in the original clinical studies about these side effects, but their complaints were disregarded.
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Dr. Diana Zuckerman, president of the National Center for Health Research, testified that her center conducted a study of more than 1,000 women with severe symptoms, and that “86% of them described problems with pain.” She also said many reported fatigue, hair loss, depression and other symptoms, some of which could signal autoimmune disease.
“Women are telling us that if they reported pain during a study they were thrown out of the study,” Dr. Zuckerman said. This sentiment echoed similar remarks from women testifying—that their descriptions of pain and other symptoms were pushed aside by doctors, and not recorded.
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