Essure lawsuits are being filed as complaints of injuries continue to mount and the public outcry over Bayer’s medical device grows even louder. Essure has been the subject of scrutiny for a number of years; however, Essure victims have continued to encounter obstacle after obstacle in their pursuit of justice. The legal options for Essure victims may finally be presenting themselves in light of some recent court rulings.
What is Essure?
Essure is a nonsurgical form of permanent birth control consisting of two-inch long flexible coils wound with synthetic fibers which is inserted into the fallopian tubes via the vagina. Scar tissue forms around the fibers and coils, thereby preventing sperm from traveling down the fallopian tubes and inseminating an egg in the uterus.
Thousands of Reported Essure Injuries
The Essure device was first approved in the United States in 2002. As of the end of 2015, the FDA had received nearly 10,000 reports of injuries associated with the device. Associated injuries may include:
- Need for surgical removal of the device or surgery to repair damaged organs;
- Migration of the device;
- Perforation or tear of organs such as the uterus or colon;
- Autoimmune responses such as fatigue, rashes, hair loss, and weight gain;
- Ectopic pregnancy; and
Essure’s History of Controversy
From the time Essure was approved by the FDA in 2002, the agency has being receiving reports from doctors and women that the permanent birth control device has caused serious side effects, including 11 deaths. Five of those were for fetal deaths that occurred in women who became pregnant after the Essure procedure.
On Sept. 24, 2015, the FDA held a public meeting of the Obstetrics and Gynecology Devices Panel “to discuss the risks and benefits of Bayer HealthCare’s Essure System for permanent female sterilization.” The panel heard from medical experts as well as from women who have been implanted with the device.
More recently, in what many would consider a long overdue move, the FDA has recommended a black box warning for Bayer’s Essure contraceptive device. In addition to the proposed warning, Bayer has been ordered to conduct additional clinical studies on the safety of Essure as well as include a “patient decision checklist” in the product’s packaging. The goal of the checklist is to “ensure women receive and understand information regarding the benefits and risks of this type of device.”
To the disappointment of many however, the FDA has not required a recall of Essure nor did it remove legal protections to the product that clear the way for Essure lawsuits. As public and Congressional pressure continue to grow, a future recall is not out of the realm of possibilities.
Are you or a loved one an Essure victim?
If so, consider contacting the attorneys at Lopez McHugh, LLP to discuss your legal options.