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7, more than two years after the attorneys’ lawsuits helped bring about an FDA hearing that resulted in a “black box warning” on the product detailing significant side effects such as perforation of the uterus and persistent pain. The FDA also ordered Bayer, whose U.S. headquarters is in Pittsburgh, Pennsylvania, to conduct a postmarket study on Essure complications over the next few years. “We have a lot of questions, really, for Commissioner Gottlieb,” Susen said of the meeting, which will also include consumer advocate Brockovich. “If the FDA required more safety studies on this product, why is it being left on the market? And why is the product still on the market in the U.S. when in all other countries, it has been withdrawn?” According to Bayer’s website, it stopped distributing Essure in other countries for “commercial reasons only.” Essure is the only FDA-approved non-incisional female sterilization device, and regulators say its benefits outweigh the risks. “It does not require general anesthesia to implant, and most women can return to normal activities within one day of receiving the implant,” according to an FDA statement. “The implant does not contain drugs or hormones, and it is effective at preventing pregnancy. Banning Essure would remove the device from the market for all patients—and would limit the options available to physicians and patients.” Bayer said in a statement that it “stands behind Essure, which is an important option for women considering permanent contraception.” The South Florida lawyers started a litigation groundswell over Essure with a handful of cases they filed in Philadelphia federal court in December 2014. But their efforts illustrate the difficulties of using the court system to raise questions about a device that has already received premarket approval from the FDA.
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