After years of efforts by patient advocates to get Essure recalled, Bayer finally withdrew it from the market at the end of last year.
What is Essure?
Essure is a permanent birth control device composed of two metal coils. These coils are inserted into the fallopian tubes through a non-surgical office procedure. According to the National Women’s Health Network, the metal coils were designed to cause chronic inflammation, which induces scar tissue to form, which in turn blocks sperm from reaching eggs, preventing conception.
The metal springs were intended to remain in the woman’s fallopian tubes for life.
But as of July 20, 2018, the device’s manufacturer, Bayer, announced it would be removing Essure from the American market, and after Dec. 31, 2018, it would no longer sell or distribute the product in the United States.
Essure website says that the permanent birth control device is 99.3 percent effective at preventing pregnancy, although patients are cautioned to use a backup birth control method until the success of the procedure is confirmed. But
Medical professionals and industry leaders had high hopes that Essure would be a safe, non-surgical alternative to tubal ligation – the surgical blocking of the fallopian tubes known as having one’s “tubes tied.” But women began filing lawsuits alleging saying they were not warned of the serious complications with the device.
Was Essure recalled?
While there has been no Essure recall notice released by the U.S. Food and Drug Administration, Bayer withdrew Essure from the U.S. market at the end of 2018. Bayer maintains that the decision was made based on declining sales in the United States.
However, some consumer advocates speculate that the decision may have been motivated by the risk profile of Essure and regulatory action against the device.
What are concerns regarding Essure safety?
According to the Mayo Clinic, Essure’s side effects include pelvic pain, an allergic reaction (hives, itching, face swelling), heavy periods, spotting, infection, perforation of uterus or fallopian tubes, migration of the Essure coils, and pregnancy.
These complications prompted women around the country to demand to have Essure recalled. They voiced their concerns on Facebook groups devoted to Essure complications, organized protests and circulated petitions against the sale of the permanent birth control device.
These consumers claimed that Essure is defective and dangerous, causing serious harm to consumers. Women say they were never warned about dangerous Essure side effects, meaning they couldn’t make an informed choice when deciding on birth control.
What has the FDA done about Essure concerns?
The device was first approved in 2002. For years, the FDA did not take any action despite consumers’ Essure concerns. In February 2016, the FDA ordered Bayer to conduct a post-market study on Essure’s success and risks. That same year the FDA approved changes to Essure warning labels to impart “the risks of using Essure and to help women and their doctors be better informed of the potential complications.” The FDA also approved a patient-doctor checklist for women to acknowledge and accept the device’s risk.
In April 2018, the FDA took further action by restricting the sale of Essure. This action was prompted by reports that women were not receiving the proper information before agreeing to the Essure procedure.
“Despite previous efforts to alert women to the potential complications of Essure, we know that some patients still aren’t receiving this important information,” said FDA Commissioner Scott Gottlieb at the time of the agency’s action. “That is simply unacceptable.”
In general, Essure lawsuits are filed individually by each plaintiff and are not class actions.
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