A number of lawsuits have been filed against Bayer Healthcare Pharmaceuticals, maker of the Essure permanent contraceptive device, over adverse effects that can occur after the device has been implanted, including perforation of the uterus or fallopian tubes, persistent pain and device migration.
According to the Food and Drug Administration (FDA), more than 4,500 consumer complaints have been filed with the agency. The lawsuits allege that the device should never have received premarket approval, which the complaints state was based on faulty research.
Earlier this year, the FDA ordered Bayer to conduct a post-market safety study on Essure. The study will monitor 2,000 women implanted with the device for at least three years. In addition, the FDA ordered Bayer to include a warning on its packaging stating that physicians should warn patients about the potential risks of implanting the device.
Essure was first introduced in 2002 as a form of permanent, non-hormonal birth control. The device's coils are implanted into each fallopian tube through the uterus. As inflammation and scaring occur, the fallopian tubes are sealed off and conception is prevented. Essure has been marketed as an alternative to tubal ligation.
The first Essure lawsuit was filed in 2014 by a woman in Florida who alleged that the device migrated from her fallopian tubes to her uterus, causing a perforation that ultimately required her to obtain a hysterectomy.
The Essure lawsuits have been consolidated in multi-district litigation in a Philadelphia federal court.
If you have suffered injuries from an unsafe or defective medical product, the experienced product liability legal team at Roberts & Roberts is here to help with compassionate, aggressive representation. Please call 800-248-6000 or contact us for a free consultation.