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Essure believed to be defective medical device

Opponents of the popular birth control device Essure expressed their frustration with the Food and Drug Administration for allowing it to remain on the market. Widely associated with many adverse effects and injuries, women in California and across the rest of the United States are suffering while the FDA appears to be doing very little. Currently, the FDA has made only minor recommendations and also requested that Bayer -- its manufacturer -- conduct another study. Some believe this is simply not enough action for what appears to be a defective medical device.

Advertised as a form of permanent birth control, Essure has been linked to several disturbing health issues. Thousands of women reported ongoing headache, fatigue and abdominal pain. Other complaints reported that the Essure device was not easily removed or that it actually broke while still in use. Perhaps most disturbing are the four deaths that have been linked back to the birth control device.

Nearly 10,000 complaints have rolled in to the FDA since its Nov. 2002 approval, but little has been done to stem the ongoing issues. The agency recently ordered Bayer place a warning on the device to alert patients to possible issues. This order is in addition to a surveillance study that Bayer must conduct, which will examine two groups of women, one of which will use an Essure device and another that will undergo a more traditional approach to permanent birth control. The official results of this study will not be available until 2023, although incremental reports will be issued in March and Sept. of 2017.

In addition to the wide range of possibly related injuries, one study determined that women with Essure required reoperations at a higher rate than women who opted for tubal ligations. California women should be able to trust that they are not receiving a defective medical device when undergoing procedures that affect their health. When that trust is broken by manufacturers, victims have the right to hold them accountable for their negligence through the successful actions of premises liability claims.

Source: raps.org, "FDA Signs Off on Bayer Study of Essure Following Numerous Adverse Events, Deaths", Zachary Brennan, Sept. 2, 2016

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