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What Are the FDA Guidelines for Essure®?

February 3, 2017 · FLEMING | NOLEN | JEZ, L.L.P.

Since its release in 2002, women across the United States have suspected Essure®, a supposedly less invasive surgical sterilization procedure, of not only being ineffective but dangerous. The FDA first approved it on November 2002, based on short-term safety studies. None of the original 745 women in the premarket studies were followed up after 3 years. Two post-market studies were also conducted, one of which was never published and the other released 13 years after approval of the device’s use.

In June 2015, after 16,000 women experienced side effects, the FDA decided to investigate Essure®, and in February 2016 the FDA’s final decision wasnot to remove Essure® from the market. Instead, it mandated a black-box warning label. While this is one of the most severe types of drug labels the FDA can issue, it’s only a recommendation, and nonbinding at that. Essure® continues to be sold by Conceptus, Inc. (a subsidiary of Bayer), despite the 7 deaths associated with it and the numerous side effects experienced by many women who have used the device, only some of which are listed on the FDA website.

Side effects of Essure® include:

  • Essure® poking through fallopian tubes or uterus
  • Consistent pain following the procedure
  • Menstrual cycle changes
  • Allergic reaction symptoms
  • Autoimmune disease-like symptoms (such as joint pain and fatigue)
  • Necessary surgery to remove the device

Many people continue to be disgusted by the FDA’s conclusion and its initial decision to release the product in 2002 without sufficient data to prove the birth control’s efficacy and side effects. If you’ve used the device and have had complications or injury, or know someone who has, you may need legal representation to receive the compensation you deserve.

If you’re considering a lawsuit, contact one of our lawyers at (713) 621-7944 or use our online form for a free consultation. We also have more information available on our Essure® Lawsuit page.