Did FDA actions lead to Bayer removing Essure from U.S. market?

by Paula A. Wyatt | September 11, 2018 | Blog, Defective Products | 0 comments

Did FDA actions lead to Bayer removing Essure from U.S. market?

More than likely, Bayer, the Food and Drug Administration, and doctors all had high hopes for Essure, a non-surgical, permanent method of birth control after its release into the U.S. market back in 2002. The device promised to allow women to never again worry about pregnancy without undergoing surgery, which was the only other way to achieve the same promised results.

Sadly, the device failed to live up to the manufacturer's promises. Women began lodging complaints with the FDA, and now, approximately three years after the agency began taking decisive action to protect consumers, Bayer announced recently that it would discontinue selling Essure here in the United States on Dec. 31, 2018. Even though many advocacy groups believe this is a step in the right direction, it probably won't let the company off the hook for the harm done to at least tens of thousands of women across the country.

If you have suffered harm as the result of using Essure, you may be eligible for compensation. Speak with an experienced personal injury attorney to learn about your legal options.

Some facts about Essure

The primary reason for Essure's popularity was that it was a vaginal implantation into the fallopian tubes. There it would create scar tissue that would block sperm from reaching the woman's eggs, thus preventing pregnancy. The problem is that, almost immediately, women began suffering some severe health issues attributed to Essure:

  • Perforation of the uterus
  • Perforation of the fallopian tubes
  • Chronic pain
  • Abnormal uterine bleeding
  • Migration of the coils into the abdomen or pelvis

Women reported other side effects as well, but these contributed to the most common and most severe. Some women required surgery in order to rectify their health issues caused by Essure.

The FDA response

As the number of complaints continued to mount each year, the FDA realized that it needed to take some action to protect consumers. Investigations began in Sept. 2015. Thereafter, the following occurred:

  • Bayer conducted a post-market (522) study in Feb. 2016 on orders from the FDA.
  • At that same time, the FDA required Bayer to put better warnings on the product's label regarding the potential risks associated with the device.
  • In Oct. 2016, the FDA concluded its initial investigation.
  • In Nov. 2016, the agency required Bayer to add additional warnings to the product. Patients were also to receive a Patient Decision Checklist that a woman must acknowledge and sign before undergoing the procedure to implant the device.
  • As the FDA continued to talk with injured patients, it discovered that not enough women were receiving the Patient Decision Checklist, which should have alerted them to the potentially severe side effects of the device.
  • The FDA then discovered that those warnings and consultations regarding the product failed to happen as intended. By March, the number of reports regarding Essure had risen, and around 90 percent of those complaining discussed removal of the device.
  • By April, the FDA restricted the sale of Essure.

It may be safe to say that the FDA played a large role in the removal of this device from the U.S. market. Bayer says it has nothing to do with safety concerns but is in response to substantial drops in sales - possibly attributed to FDA and advocacy involvement.

Even after removal of the product from the market, women in Texas and elsewhere could continue to suffer harm from these devices and may need further medical intervention such as surgery. It may be beneficial for these women to explore their legal options at the same time.


"*" indicates required fields

I have read the disclaimer.**