Essure Birth Control Injury News & Info

New Warnings for Essure Issued by FDA

Talcum Powder LawsuitsWe trust the companies we buy from to have our best interests in mind. After all, our best interests are their best interests, right? Unfortunately, this isn’t always true – and that’s where federal oversight of the products we buy and use daily is so important. But what if federal agencies like the Food and Drug Administration didn’t have all the facts presented to them accurately?

In 2014, a plaintiff claimed that Bayer, the creator of Essure, actively concealed negative reports from the Food and Drug Administration. This concealment allowed for the pharmaceutical giant to gain premarket approval for the device, which guards a company against product liability lawsuits. The lawsuit also claims that doctors were inadequately trained in the implanting process. Three coils – instead of the intended two – were implanted into the plaintiff’s Fallopian tubes, eventually leading to five hospitalizations and a hysterectomy.

Two years later, the FDA has mandated new warnings for Essure. It recently announced it will require black box warning labels for the device, calling attention to “serious or life-threatening risks.” The FDA will also require Bayer to study women undergoing the sterilization process, be it through Essure or another method.

Still, some advocates say this is not enough. The device still remains on the market and there is no enforcement for the FDA’s recommendations for Bayer. “I feel as if the FDA truly failed these women,” one advocate told CNN.

More than 5,000 adverse events have been reported to the FDA in the years following the approval of Bayer’s Essure permanent birth control device. Complaints range from abdominal pain to unintended pregnancy to organ perforation.

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The Law Offices of Richard J. Serpe, PC are currently investigating potential injury claims for anyone who has suffered from complications or has been seriously injured by an Essure permanent birth control device.

If you or a loved one has suffered from an injury related to an Essure permanent birth control device, you may want to contact an attorney. Our dangerous and defective products attorneys offer a free, no obligation, consultation. Additionally, our no fee promise means you don’t owe us any legal fees unless we settle or win your case. Contact us to discuss your situation today 877-544-5323.