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When Bayer announced in July 2018 that it would stop selling the permanent birth control device Essure, the U.S. Food and Drug Administration (FDA) required the company to continue to evaluate long-term safety information in women who received the device.

According to the latest analysis from Bayer covering the period of June 1, 2020, through August 31, 2020, there were an additional 7,509 events related to the Essure reported to the FDA’s medical database, including 7,332 serious injury reports, 104 malfunction reports, and 73 death reports. The most common patient problems reported included pain, perforation, foreign body/device fragment in the patient, pregnancy, and heavier periods.

The FDA added that the limited information on the reports provided by Bayer “prevents the ability to draw any conclusions as to whether the device or its removal, caused or contributed to any of the reported deaths or other events in the reports.”

Essure Designed to be a Permanent Birth Control Device

The Essure device is a permanent form of birth control that is inserted into a woman’s fallopian tubes. There, it elicits scar tissue inside the tubes that develops until it creates a blockage, preventing any eggs from being released. The barrier also keeps sperm from reaching the eggs, preventing pregnancy.

The Essure was sold as a minimally invasive alternative to permanent birth control and was designed to stay inside a woman’s body indefinitely. However, thousands of women have suffered complications with the device, which sometimes require the device to be removed. Because the Essure is not designed to be taken out, removal can be difficult and complicated and may result in further health problems.

Between November 4, 2002—the date the device received FDA approval—and December 31, 2017, the FDA received 26,773 medical device reports related to Essure. The most frequently reported problems were abdominal pain, heavier menstrual periods and menstrual irregularities, headaches, fatigue, and weight fluctuations.

Bayer Denies Any Wrongdoing, but Will Pay a $1.6 Settlement

Though Bayer waited until 2018 to halt Essure sales in the U.S., it had already done so in other countries the year before. In September 2017, Bayer AG said in a statement that they were no longer going to sell Essure in countries other than the U.S., adding that the change was being made for commercial reasons and denying it had anything to do with any safety issues related to the product.

The FDA continued to put pressure on the company, however. Considering the tens of thousands of reports received concerning problems with the device, the FDA:

  • required a new clinical study on it in 2016,
  • made Bayer include a boxed warning to increase awareness of the product’s risks,
  • and required the company to create a “decision checklist” that patients were meant to review before implantation.

When even these steps didn’t stop the influx of adverse event reports, the FDA announced in April 2018 that it was restricting sales of Essure only to doctors and healthcare facilities who required patients to review and sign the “decision checklist” before going ahead with implantation.

A few months after that final restriction was put into place, Bayer announced it would no longer sell the device in the U.S. At the time, it faced thousands of Essure lawsuits filed by plaintiffs claiming to have been injured by the device.

In September 2020, Bayer agreed to pay $1.6 billion to settle about 90 percent of the 39,000 Essure cases pending against it.

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