Bayer AG is under fire after an F.D.A. panel of experts hammered the pharmaceutical giant for failing to collect necessary data on its controversial contraceptive device, Essure. Approved 13 years ago, Essure is a small metal coil that causes permanent sterility when implanted into a woman’s fallopian tubes. However, after receiving thousands of complaints from women who claim long-term complications due to the device, the F.D.A. is reassessing its position.
At a daylong public meeting held last week at F.D.A. headquarters, women spoke of suffering from a wide variety of complications and years of debilitating pain after Bayer AG’s device was implanted. One woman testified that she experienced more than two years of abdominal pain and over 20 visits to doctors before she ultimately had the device removed.
However, removing the device is not simple, and women often face challenges in finding physicians who are trained in the procedure. In fact, some women resort to undergoing a hysterectomy out of desperation. A study of more than 1,000 women with severe symptoms revealed that 86% of the women described problems with pain. Other commonly reported side effects include fatigue, hair loss, depression, and autoimmune diseases like lupus, celiac disease, or eczema.
Bayer AG is also under scrutiny due to allegations that the manufacturer manipulated trial and study results for the device. Women who participated in the original studies on Essure have reported that if they complained of pain, they were either kicked out of the study or their complaints were ignored by doctors and went unreported. Though Bayer AG denies these allegations, the number of complaints filed against Bayer AG has surged in recent years. It is estimated that approximately 750,000 women have received the implant since 2002.
If you or a loved one has been injured by Essure, please contact The Lambert Firm today for a consultation.