Bayer ends U.S. sales of Essure permanent birth control implant
Posted in Drug & Medical Devices on July 24, 2018
Image: Bayer Healthcare Pharmaceuticals, Inc.
Pharmaceutical giant Bayer recently announced it would no longer sell its controversial Essure® contraceptive device in the United States. The decision follows years of concerning reports of dangerous complications and injuries.
Essure, a permanent birth control implant, is a small, flexible coil inserted into a woman’s fallopian tubes. As the devices expand after placement, polyethylene (PET) fibers cause scar tissue, which eventually blocks the tubes and prevents fertilization and pregnancy.
The device was considered a breakthrough alternative to surgical sterilization when it was first introduced in 2002, but over time Essure became the subject of thousands of injury reports and repeated safety restrictions. In recent years, the FDA received more than 10,000 complaints, and in 2016 a “black box warning” label was added to Essure.
Complications linked to Essure include:
- Perforation of the uterus or fallopian tubes or organs in the lower abdomen and pelvis
- Chronic and severe pelvic/lower abdominal pain
- Migration of the device
- Removal of the device (with or without hysterectomy)
- Unintended pregnancy, including ectopic (outside the uterus) pregnancy
- Stillbirth
- Severe nickel allergies and infections
- Severe menstrual cramps and/or persistent, abnormal increase of menstrual flow
- Autoimmune disease
- Death
Prior to the announcement, the U.S. was the only country where the device was still available. Sales in all other markets were halted last fall. Bayer stands by the safety of its device, citing weak sales as the driving factor in the decision.
Did you or a loved one suffer one of the complications listed above after receiving the Essure permanent birth control implant? Elk & Elk’s experienced team of medical device attorneys will aggressively pursue your case and help you receive maximum compensation for your injuries.
Call 1-800-ELK-OHIO or fill out our online contact form for a free, no-obligation case review.