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FDA Approves Bayer’s Essure Study Despite Deaths

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FDA approves Bayer's Essure study despite deaths

Recently, the FDA approved Bayer’s Essure study despite the deaths and permanent injuries to thousands of women. Once the Essure side effects toppled the 10,000 women mark, the FDA insisted that Bayer conduct a study on the safety of their permanent birth control device. This report was released to the FDA in March 2016 and was subsequently approved on September 2, 2016. The final report is due on September 1, 2023.

The Scope Of The Report

Reports of this nature are ordered by the FDA for one of two reasons: either there have been significant adverse effects reported or the device is meant to be permanent. With Essure, we see both. Essure was designed to be a permanent birth control device that is implanted into the fallopian tubes. The tiny coils are inserted, one into each fallopian tube. After around 90 days, scar tissue begins to form around the coils. This is meant to stop the cycle of contraception since the egg should no longer be able to pass. Bayer has stated that they believe that their device is 100% effective and is a direct competitor of the traditional tubal ligation.

Sadly, thousands of women have died, been seriously injured, or become pregnant after the device was implanted. To date, the FDA has received more than 30 reports of death, more than 600 reports of pregnancy, and thousands of reports about side effects such as device breakage, extreme pain, migration of the device in the body, and more.

The purpose of the report is for Bayer to monitor and report on:

  • Pelvic and lower abdominal pain
  • Allergic reactions to the device
  • Hypersensitivity to the device
  • Autoimmune issues that develop
  • The need for invasive surgery to remove the Essure device
  • Abnormal bleeding
  • The number of pregnancies that arise during the use of Essure

It’s also important to note that the above list of Essure side effects are being compared to the side effects experienced by a traditional tubal ligation. They are being directly compared because Essure is being marketed as a permanent method of birth control for women.

Is The Study Truly Necessary?

Is the study ordered by the FDA about Essure side effects truly necessary? It appears to be very little more than a formality since the FDA has already approved Bayer’s initial study despite close to 25,000 women being injured or killed by the device.

U.S. Representative Mike Fitzpatrick (PA) has been leading the fight in Congress to get rid of what he sees as a very dangerous product. Fitzpatrick introduced the E-Free Act in November of 2015. He questioned the true need for further studies stating, “Frankly, I’d contend that the 25,000 women harmed by Essure are the postmarket study that the FDA is ordering. It’s been done. The evidence is all there: tens of thousands of injured women and hundreds of fetal deaths.” Fitzpatrick also believes that, at the very least, the FDA should remove the device from the market during the study.

Did You Suffer Because Of Essure?

If you received an Essure permanent birth control device and you’ve suffered from the side effects or become pregnant, contact Goldwater Law Firm. We stand ready to evaluate your case free of charge. You may benefit from filing an Essure lawsuit. Act now and call Goldwater Law Firm.