When Essure was approved in 2002, the FDA expressed concern that the research presented to them only followed the women for 2 years while the implant is designed to be permanent. For that reason Conceptus (the owner until 2013) was directed to conduct a 5-year follow up study. The study wasn’t released until late April 2015, 8 years after the study should have been completed. The study, paid for by the pharmaceutical company (of course)  and published in the Journal of Minimally Invasive Gynecology, concluded that, “The findings from extended follow-up of the phase III trial with Essure inserts further support the effectiveness, tolerability, and satisfaction of this nonhormonal, nonincisional, option for permanent contraception.” Many question the research, pointing out that 518 women started the trial and only 449 women were still accounted for at the end of the 5-year period. There was not one pregnancy reported among the 449, which is unlikely — even tubal ligation fails for a small percent. The “comfort” of Essure was rated “good” to “excellent” by women still using Essure 5 years later. Satisfaction was rated 98% by combining the “somewhat” and the “very satisfied” groups. Only 3 severe events were reported. With results so at variance to hundreds or more anecdotal stories, it would be helpful to have the information on why 69 women, more than 10%, needed to drop out of the study. Another challenge to the quality of the study was raised by National Center for Health Research. In their words: The FDA conducted a review in June 2014 of adverse events reported on MedWatch, the governmental reporting system for medical devices. The FDA reported that: The FDA did not release any context for this data. It does not supply how many women these devices were implanted into in the US. The report concludes that, “To date, none of the above information the FDA reviewed has established a causal connection between Essure and certain reported problems, such as extreme fatigue, depression, and weight gain.”