Essure Birth Control Complications
Essure Safety Alert: On July 20, 2018, Bayer announced they will discontinue sales of Essure birth control implants by end of the year.
Thousands of women have come forward against Bayer alleging that the permanent birth control device is causing severe and painful injuries which often may require a hysterectomy to remove the device. We are experienced in helping women who have experienced an injury from a medical device. We are discussing legal options with women who have experienced Essure complications. Call us at 1.800.887.8029 and tell us your story.
Essure is the only non-surgical, permanent birth control device for women on the market. Specifically, the Essure medical device is a small nickel titanium coil that is placed in the fallopian tubes. The 10-minute procedure is done in the doctor’s office by inserting the metal coil into each fallopian tube. The Essure device expands upon release and anchors into the tubes, causing inflammation resulting in scar tissue building up over the coils to block fertilization.
Essure was developed by Conceptus, a subsidiary of Bayer, and conditionally approved by the Federal Drug Administration (FDA) in 2002. It is estimated that the device has been implanted in more than 750,000 women and the FDA has received more than 4,800 adverse event reports. However, the FDA maintains that the product is safe and 99.83% effective, despite numerous reports of significant injuries and even pregnancies. Even its own former celebrity spokesperson became pregnant after being implanted with the Essure device.
As a result of the premarket approval by the FDA, Bayer is shielded from product liability litigation, called preemption. However, there are currently several lawsuits filed against Bayer challenging the FDA’s premarket approval of Essure. The lawsuits allege that Bayer violated the conditions of their premarket approval and should no longer receive that protected status. One complaint alleges the premarket approval became invalid when Bayer failed to meet regular reporting requirements and failed to report known hazards to the FDA. Any failure to comply with the FDA’s conditions of approval could invalidate the approval order. A judge is scheduled to rule whether the FDA’s premarket approval of Essure should be invalidated, which would allow for the thousands who may have experienced complications from Essure to seek appropriate compensation for their injuries from Bayer.
Bayer Plans to Discontinue Essure
In late July of 2018, Bayer announced it would stop selling its permanent contraceptive device Essure at the end of the year, as reported by the New York Times. This news comes amid thousands of injury reports and repeated safety restrictions from regulators. The FDA found that between 2002, when Essure was approved, through the end of 2017, there had been 27,000 reports of complications from patients and physicians alike. Side effects ranged from hair loss to chronic pain, severe bleeding, and sometimes even death. In 2016, the FDA had ordered Bayer to issue a black-box warning.
Women nationwide have experienced a wide range of complications as a result of their Essure implant, including:
- Autoimmune Development
- Inflammation of Joints
- Painful Intercourse
- Sharp Cramping Pains in Lower Abdomen
- Uterine or Bowel Perforation
How We Can Help
If you or a loved one experienced any injuries from your Essure birth control device, we want to hear your story. For more information, or to speak with someone about your potential case, please call us at 1.800.887.8029. You can also fill out our free case review form. Zimmerman Reed is experienced in helping individuals injured by a defective medical device and we welcome your questions.