For thousands of women who have suffered from the contraceptive device Essure, news that a federal judge dismissed a Connecticut woman’s case against Essure’s manufacturer, Bayer A.G., is devastating. Essure is a permanent form of birth control that is non-surgically implanted into the cervix. The device consists of two small coils that are inserted into the fallopian tubes to cause inflammation and benign growth preventing sperm from reaching the egg.
Essure became a popular contraceptive method because it did not require any hospital stays or anesthesia. In 2013, Essure made headlines in the United States when women complained of severe side effects, which led to the medical device having to be surgically removed. The complaints were so numerous that two years later the FDA waged a formal investigation into the medical device and reported over 5,000 complaints from women who had the device implanted.
This past March, the FDA issued a black box warning for the device, the most severe warning issued for medical devices. Women have reported suffering from migraines, vomiting, nausea, and severe allergic reactions. For some women, the Essure device migrated within their bodies and perforated other organs.
April Norman filed a lawsuit against Bayer after she was forced to undergo a hysterectomy to remove her Essure device after suffering from “pelvic pain, weight gain, heavy bleeding, blood clots, painful intercourse, hair loss, and depression.”
Unfortunately for Ms. Norman, Connecticut law does not require manufacturers to report any risks associated with their devices to the FDA, so her case was dismissed. While Ms. Norman’s case has been dismissed, this isn’t the end for Bayer. More than 16,000 complaints of adverse events have been filed against the company, and women who have been affected by Essure have pledged not to go away quietly.
“E-Sisters,” as they call themselves, have found support from several state representatives including Pennsylvania Senator Mike Fitzpatrick, of the U.S. House of Representatives, who has introduced legislation that would help hold manufacturers responsible for defective or dangerous products.