The FDA stopped short of pulling Essure from the market, but is requiring them to conduct additional studies into the device. Bayer has indicated that since 2002 over 750,000 women have received the implant as a means of birth control. The FDA has received thousands of concerns, complaints and Adverse Event Reports (AERs) regarding it use with injuries that include severe pelvic plain and bleeds that require removal of the device. The litigation as a whole, however, has not fared well, as many of the cases were ruled pre-empted by the device standard set forth in federal law which indicates if the FDA has approved the device, you may not be able to commence an action. In contrast, Bayer has had to spend over a billion dollars settling litigation for women who took Yaz, Yasmin, Ocella, Safyral, Gianvi, and endured injuries such as deep vein thrombosis (DVT), Pulmonary Embolisms (PE), SVT – either superficial venous thrombosis or sagittal venous thrombosis, strokes or death. The case involved a new generation of hormone that caused an increased risk of clots. Women included in the settlement group had injuries contemporaneous with its usage until the label change in April 2012. Any form of birth control has side effects and it is paramount to speak with your doctor about the risks versus potential benefits. If you feel you are suffering from any adverse experience from the product, you should immediately communicate it with your doctor, or if severe enough call 911.
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