Litigation involving the permanent sterilization device Essure is providing to be expensive for its maker, Germany-based Bayer AG. Over 3,700 women have filed product liability lawsuits in the U.S. against Bayer, alleging harm sustained from the device.
Although Bayer had a record year for earnings in 2016, posting a net income of $4.8 billion on revenue of $48 billion compared with a net income of $4.3 billion on $48 billion of revenue in 2015, the company suffered losses of $413 million in 2016 connected with the Essure device. Those losses resulted in an increase in “special charges” from $316 million in 2015 to nearly $590 million in 2016, based upon the company’s “lower revenue expectations.”
What is Essure?
Essure is a nickel-titanium permanent contraceptive implant that has drawn complaints from thousands of women. They have reported suffering from a variety of serious side effects associated with the device, including:
- Chronic pain
- Unwanted pregnancy
Essure is typically inserted in an OB-GYN’s office in ten minutes or less, without incisions or general anesthesia. One Essure coil is inserted through the vagina and cervix into each fallopian tube. Over the next several months, scar tissue forms around the coils, creating a barrier that blocks the tubes and keeps the eggs from being fertilized or making their way to the uterus, thus preventing conception.
While Essure’s existing label warns about pelvic pain and bleeding immediately after the procedure, many women have said these problems persisted and were so severe that surgery was required to remove the device.
In October 2016, the U.S. Food and Drug Administration (FDA) called for a boxed warning on the label. They also called for a patient checklist to highlight the possible negative effects associated with Essure. These include perforation of the uterus or fallopian tubes, device migration, hypersensitivity reactions to the metal present in the device, and persistent pain.