Essure Lawsuit Filed over Complications Following Fallopian Tube Perforation

A South Carolina woman is pursuing a product liability lawsuit over complications from Essure birth control, indicating that she suffered severe pain and bleeding after receiving the controversial implant.

The complaint (PDF) was filed by Tanya De La Paz in the U.S. District Court for the Northern District of California on September 1, indicating that her doctor discovered part of the Essure birth control implant was broken or stretched, resulting in the need for removal of the device and her right fallopian tube.

De La Paz indicats that she first attempted to have Essure implanted in July 2012, but the procedure had to be stopped after the doctor pierced her fallopian tube, resulting in bleeding. She returned that September for a second attempt, which appeared to be successful. However, after she began experiencing severe bleeding and daily pain, she returned to confirm placement of the device in December. The doctor discovered that the right Essure micro-insert was stretched or damaged, resulting in the removal of the device and her right fallopian tube in February 2013, on advice from Bayer, the manufacturer of the device.

Essure is an implant offered as an outpatient procedure by many medical facilities to provide long-term birth control. During the surgery, a doctor inserts bendable coils into the fallopian tubes, passing through the vagina, cervix and uterus. The process thus causes scar tissue to form around the coils over several months, which blocks the tubes, preventing insemination.

In recent years, concerns have emerged about the risk of Essure complications, with the FDA receiving more than 5,000 adverse event reports involving the device between it’s approval in November 2002 and May 31, 2015. Most of those reports were voluntary from women who received the implants.

The FDA has scheduled an advisory committee meeting on September 24 to discuss the safety and risks of the Essure implant. Following the hearing, the agency will determine what, if any, additional regulatory actions are needed to address Essure safety issues.

According to the FDA adverse event reports, 3,353 of the reports it received were of abdominal pain, 1,408 were of menstrual irregularities, 1383 involved headaches, 966 were reports of fatigue , and 936 were reports of weight fluctuation.

The Essure lawsuit alleges that Bayer knew about the risk of perforation and failed to adequately warn the medical community and patients about the risk of problems, which have been linked to severe injuries and deaths. De La Paz is pursuing claims against Bayer for manufacturing and designing a defective device, negligence, failure to warn, strict liability, breach of warranty, negligent misrepresentation, fraudulent misrepresentation, and fraudulent concealment. The lawsuit seeks both punitive and compensatory damages.