Bayer Health Care faces a new lawsuit alleging injuries from the Essure permanent birth control system.
In their lawsuit, an Iowa couple alleges that the wife suffered serious injuries as a result of the birth control device, Top Class Actions reports. Legal documents say Bayer failed to warn the couple of the device’s adverse health effects.
The couple, Andrea and Matthew, filed their Essure lawsuit on July 15, 2016. Andrea has experienced a variety of injuries including uterine perforation, hepatomegaly (enlargement of the liver), and infection. The lawsuit alleges that these injuries were caused by the defective nature of Essure.
Essure is the first birth control device of its kind, a non-surgical form of permanent birth control. Essure can be inserted in a brief procedure in a doctor’s office, without the recovery time or anesthesia involved in surgical sterilization. Essure consists of two small metal coils that are inserted through the vagina into the fallopian tubes. The coils cause scar tissue that blocks the tubes and prevents pregnancy.
Before Essure came to market, permanent birth control required surgery to “tie” the fallopian tubes. But thousands of women have reported serious side effects from Essure and they say Bayer downplayed the true safety risks of Essure.
Essure complications include persistent pelvic pain or cramping, infection, device migration, organ perforation, unintended pregnancy, ectopic pregnancy (pregnancy outside the womb), miscarriage, irregular bleeding, and metal allergy.
The Iowa woman, Andrea, said she chose Essure after reviewing information from Bayer’s and discussing the decision with her doctor. At the time she had Essure implanted, her doctor was not aware of potential Essure injuries. In the lawsuit, Andrea alleges that the complications were not listed on the Essure’s warning label and Bayer did not provide any precautions or relevant studies, according to Top Class Actions.
Essure received Food and Drug Administration (FDA) approval in 2002 and has since become an increasingly popular permanent birth control choice because it does not require surgery. But since Essure’s approval, the FDA has received more than 4,500 adverse event reports involving Essure.
In response to concerns, the FDA “has been examining the growing number of reports of harm with Essure. The adverse events associated with the use of the Essure System include persistent pain, perforation of the uterus and/or fallopian tubes, intra-abdominal or pelvic device migration, abnormal or irregular bleeding, and allergy or hypersensitivity reactions. Some women have had surgical procedures to remove the device.” In addition, because of “incomplete patient follow-up,” some women have become pregnant, the FDA said. A few months after Essure is implanted, the doctor is supposed to do imaging to make sure the woman’s fallopian tubes are blocked and she cannot become pregnant. But unless the blocked tubes are confirmed, the woman could still become pregnant, despite Essure.
In September 2015, the FDA Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee met to hear expert scientific and clinical opinions about Essure. A number of women appeared before the panel to share their experiences with Essure. Earlier this year, the FDA directed Bayer to add a black box warning to Essure’s labeling to advise patients and doctors that Essure could cause serious injury or death. A black box warning is the FDA’s most serious drug or device warning.