A recent Brazil Essure recall has experts asking whether the U.S. could also pull the controversial device off the market. Bayer, which manufactures the permanent sterilization device, faces hundreds of injury lawsuits from women demanding an Essure recall. Despite the fact that Bayer paid $413 million fighting Essure litigation in 2016 alone, the product is still widely available. And the issue doesn’t look like one that can easily resolve without all involved parties facing off in court.
Brazil’s version of the FDA, the National Health Surveillance Agency (Anvisa), issued the country’s Essure recall on February 21, 2017. In addition to suspending Essure distribution throughout Brazil, Anvisa also suspended importation, marketing use and dissemination of any device-related materials. Anvisa also issued a mandatory Essure recall for any previously distributed devices stored in Brazilian clinics, hospitals, and doctor’s offices. And while it’s unclear whether the Essure recall affects women already implanted with the device, Anvisa could recommend surgical removal.
We’re not sure how many Brazilian women this year’s Essure recall directly affects. However, Bayer officials estimated that about 750,000 Essure devices currently exist worldwide.
Why Brazilian Officials Issued an Essure Recall
Your doctor implants Essure, a permanent birth control device composed of two flexible coils, directly into the fallopian tubes. These coils then induce scarring, which blocks sperm from entering the fallopian tubes and thereby prevents egg fertilization. But American women currently filing Essure lawsuits reported serious problems and injuries to the U.S. Food and Drug Administration (FDA). Adverse events reported to the FDA include:
- Device migration
- Organ perforation
- Autoimmune responses
- Ectopic pregnancies
- Internal tissue adhesions
According to Modern Healthcare, Anvisa released a press release about the February 2017 Essure recall explaining the agency’s reasoning. The statement read, “Anvisa received technical scientific reports and removed the Essure System product from circulation […] The contraceptive system is rated at maximum risk [and may] cause changes in menstrual bleeding, unwanted pregnancy, chronic pain, perforation and migration of the device, allergy, and sensitivity or immune-type reactions.”
Bayer Issues Statement Disputing Anvisa’s Essure Recall Decision
Afterwards, the company issued a statement: “We disagree with the decision by health regulators in Brazil which was taken without the knowledge of Bayer.” Bayer officials will work directly with Anvisa to rectify issues going forward. “Bayer stands behind the positive benefit-risk profile of Essure, the safety, and efficacy of which is supported by clinical trials and more than a decade of science and real-world clinical experience worldwide.”
But some say the $413 million Bayer spent fighting Essure litigation in the U.S. justifies Brazil’s recall decision. With thousands of women given Essure implants reporting devastating side effects, the FDA could pull it from U.S. distribution next.
What Essure Injury Victims Can Do
If you or a loved one suffered serious Essure device complications, you may qualify for a cash settlement. We help women filing product liability or failure to warn claims against Essure to get the justice and compensation they deserve. To see within minutes if you may qualify for financial compensation, get your free Essure claim review today. Once you’ve submitted your information, an experienced mass tort lawyer will call you to discuss your case and compensation options.
Related: Essure Complications Lead to 5,093 FDA Complaints From Women
Mandy Voisin
Mandy Voisin is a freelance writer, blogger, and author of Girls of the Ocean and Star of Deliverance. As an accomplished content marketing consultant, mom of four and doctor's wife, Mandy has written hundreds of articles about dangerous drugs and medical devices, medical issues that impact disabled Americans, veterans' healthcare and workers' compensation issues since 2016.