Jim Adler | The Tough, Smart Lawyer
By Jim Adler March 20, 2017

fda investigates essure injuries

How bad are Essure birth control injuries? So bad that the United States Food and Drug Administration has been investigating the defective contraceptive implants since the spring of 2015 and recently issued a black box warning for the products’ labels.

Part of the FDA investigation includes evidence that Bayer Healthcare Pharmaceuticals Inc., maker of the Essure Permanent Birth Control System, deceived the FDA and the public. (An expanding coil that’s implanted in fallopian tubes to prevent pregnancy, Essure was created by Conceptus Inc., which was bought by Bayer in 2013. Bayer is now responsible for it.)

It’s believed that Bayer manufactured Essure products with defective materials, failed to reveal harmful Essure side effects, falsified and changed medical records to the point of fraud during Essure’s clinical trials and deceived the FDA and the public regarding the safety and efficiency of Essure.

FDA Recall, Warning for Essure?

Has the FDA ordered an Essure recall? No, not yet. Nor has Bayer voluntarily withdrawn the dangerous birth control device from the market, despite thousands of women suffering serious injuries and Essure side effects and reporting their injuries to the FDA.

These Essure injuries include organ perforation, severe pain, severe allergic reactions and migration of the implant to the fallopian tubes. Defective Essure implants also may need to be surgically removed, which in some cases has led to hysterectomies.

Essure even can lead to pregnancy, the very thing it’s designed to prevent. Yet it was marketed as 100 per cent effective in preventing pregnancy.

Though no FDA Essure recall has been issued so far, the agency has taken some action against the product. In late November of 2016, it issued an FDA black box warning for Essure. Such warnings are made only for drug or medical device products with the chance for the most severe side effects.

In this case, the FDA black box warning alerts women that Essure has caused serious adverse events in some women, including uterine perforation, severe pain and the need for surgical removal of the device.

New Essure labels also feature a patient checklist to help women determine if the product is right for them. Further, the FDA has made statements stressing the importance of weighing the  possible benefits of using Essure against possibly harmful Essure side effects.

Of course, the FDA itself approved of Essure’s release, back in 2002, and nearly a million American women have used it since then. But it’s far from the first time the federal agency has approved of a drug or medical device which later proved defective. And in this case, FDA approval may have been partly based on fraudulent reports of clinical trials.

Essure Lawsuits Continue

Meanwhile, Essure injury lawsuits continue against Bayer. Several such lawsuits have claimed that Bayer is in violation of the FDA’s pre-market approval terms and also has violated federal laws.

Bayer reportedly revealed just 22 perforations by Essure to the FDA, even though it had data regarding 168 such injuries. It’s also believed that Bayer changed some patients’ medical records during clinical trials, which would constitute fraud.

The experienced injury attorneys and defective medical device lawyers at Jim Adler & Associates can help victims of this harmful product. Contact us today for a confidential legal review of your case. Your case’s review is free, and it comes at no obligation to you.

Call us today, and let’s get started getting you the payments you deserve for your Essure birth control implant injury.

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