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After 16 years and nearly 30,000 adverse event reports, more than 20,000 complaints, and FDA actions, the Essure permanent birth control device will finally be removed from the U.S. market. Women across the country who suffered severe injuries after receiving the device may be entitled to file an Essure injury lawsuit seeking justice from manufacturer Bayer and compensation for the injuries they suffered and losses they incurred.
What’s Going On?
The Essure birth control device was approved for sale in the U.S. in 2002 by the FDA. Since that time, the government watchdog agency has received close to 30,000 adverse event reports including injuries such as
- Tooth and hair loss
- Chronic pain
- Debilitating fatigue
- Severe bleeding
- Fallopian tube perforation
- Fallopian tube removal
- Uterine perforations
- Uterine removal
- Migration of the device to elsewhere in the body
- Unplanned surgeries
- And the list goes on and on.
And while Bayer maintains the device is safe and effective, women who received the device and then had to endure unplanned surgical procedures to repair damage or remove body parts say the risks of Essure far outweigh any benefit. Women typically chose Essure because it can be implanted in a doctor’s office without the use of general anesthesia. But studies have shown that more often than not, general anesthesia is used, and women who are implanted with the device are 10 times more likely to have to endure unplanned surgical procedures because of complications than women who undergo surgical sterilization such as tubal ligation.
FDA Weighs the Risks
After so many adverse event reports were received, the FDA decided to tune into social media to see what women were saying about Essure. The agency discovered tens of thousands of complaints about serious side effects, complications and severe injury. This prompted the agency to require Essure to carry a Black Box warning alerting patients to the risks of fallopian tube and uterine perforations, device migration, and chronic pain.
Health Advocates Want More
But many complained that they had no idea about an Essure black box warning or the complications that had been associated with the device. So, women’s health advocates continued to ring the warning bell and do what the FDA and Bayer failed to do – put the lives of women before sales and profits.
Finally, a Victory
In July 2018, citing decreased sales, Bayer made the decision to pull Essure from the U.S. marketplace. Now understand, by this time, the U.S. was the only country still selling the device. It had already been pulled in Brazil, England, Canada, and France.
By the time Bayer made the announcement, more than 16,100 Essure injury lawsuits had been filed in state and federal courts across the country. Most of those cases have since been moved to federal court, where Bayer will eventually have to stand in front of judge and jury to explain why they failed to warn women and their doctors about the risks and dangers of the device, why they kept the device on the market while removing it from the markets of other countries, and why after tens of thousands of complaints and injuries, Bayer continued to put profits before people.
These lawsuits will hold Bayer accountable for the injuries their product caused and get justice for victims. If you or a woman you love suffered Essure complications, adverse events and injuries, contact us today to learn if you are entitled to seek compensation.