German drugs and pesticides group Bayer said on Thursday it will pay around $1.6 billion to settle the majority of U.S. claims involving its Essure birth-control device.
The agreement follows a $10.9 billion settlement in June of U.S. lawsuits claiming the company’s weedkiller Roundup caused cancer.
Essure is a permanently implanted birth control device for women (female sterilization). Implantation of Essure does not require a surgical incision. In the procedure, a health care provider would place flexible inserts through the vagina and cervix and into the fallopian tubes – the tubes that carry the eggs from the ovaries to the uterus. Over a period of about three months, tissue forms around the inserts. The build-up of tissue creates a barrier that keeps sperm from reaching the eggs and prevents conception.
On December 31, 2018, Bayer stopped selling and distributing the Essure device in the United States. Health care providers could implant Essure up to one year from the date the device was purchased. As of December 31, 2019, all unused Essure units should have been returned to Bayer.According to the FDA, short-term risks to women with Essure as reported in clinical trials include:
- Mild to moderate pain during and immediately following the Essure placement procedure.
- Cramping, vaginal bleeding, nausea, vomiting, dizziness, lightheadedness, pelvic or back discomfort immediately after the procedure.
Longer-term risks to women with Essure as reported in clinical trials include:
- Abdominal, pelvic, or back pain
- Tear or hole (perforation) of the uterus or fallopian tubes
- Unintended pregnancy
- Allergy or hypersensitivity reactions
- Essure inserts unexpectedly moved to the abdominal or pelvic cavity
- If a patient and health care provider decide to remove Essure, another surgery may be required.
Essure was a dangerous contraceptive device because of manufacturing defects. The metal parts of the device could break off and pierce the fallopian tubes and migrate to other parts of the anatomy.