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FDA issues Black Box warning for Essure — Lawsuits keep growing

Essure is a medical device manufactured by Conceptus Inc., a subsidiary of Bayer AG. It is a permanent contraception method that gained much popularity among those women who preferred to avoid surgical operations such as tubal ligation. The device consists of two metal coils that are inserted into the fallopian tubes, blocking them as soon as scar tissue forms around them. This type of birth control is permanent and does not interfere with the menstrual cycle or the hormonal balance.

Since Essure was approved by the FDA in 2002 however, many women claimed that the device caused them significant harm and health issues. Many concerning side effects of Essure were reported through the FDA Adverse Event Reporting System (FAERS), including extreme pelvic pain, device migration, and breakage leading to organ perforation. Many women started sharing their experiences through social networks, calling themselves “E-sisters”, and raising public awareness about the purported dangers of the device. Bayer and Conceptus Inc. are shielded against potential Essure lawsuits due to the device being approved via the FDA’s premarket approval program. Nonetheless, in 2014 the famous consumer advocate Erin Brockovich started a campaign against the pharmaceutical giant claiming she’s fighting another battle against women discrimination.

Concerned with the amount of adverse reaction reports reaching over 5,000 cases in just two years, in September 2015, the FDA issued an investigation panel to reevaluate Essure’s risk and safety profile. At the end of February, the U.S. regulatory agency concluded their surveillance assessment and determined that the device showed additional risks in the real-world environment. FDA required a new “black box warning” label to alert patients about the potentially life-threatening complications associated with the use of Essure. The agency also requested Bayer to conduct a study to follow 2,000 women for at least three years, comparing the safety and effectiveness of the device with other surgical birth control methods. Doctors and patients will also be required to sign a decision checklist before Essure implantation, and to give consent to a test three months later aimed at ensuring the device is properly placed and functioning.

In the meanwhile, the Essure lawsuit moves forward as a federal judge from the United State District Court for the Eastern District of Pennsylvania ruled two claims among five to be reasonable. Although Bayer asked the court to dismiss all the five claims filed against them, the judge from Philadelphia ruled that two of them, accusing the company of negligent misrepresentation and negligent failure to warn of the risks, could proceed.

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