Law Office of Jami Angelini Haggerty, P.A. Investigates Potential Essure Claims
Essure is a form of permanent birth control for women that was approved by the Food and Drug Administration (FDA) in 2002. The Essure insert system consists of two coils made of stainless steel, nickel titanium, and polyethylene fibers. The inserts are permanently placed through the vagina and cervix into each of the fallopian tubes. Over a period of about three months, tissue forms around the inserts. The tissue build-up creates a barrier that keeps sperm from reaching the eggs.
Bayer, the current manufacturer of Essure, touts the devices as being the only permanent, non-hormonal birth control that does not require a surgical procedure. However, the FDA has been examining thousands of adverse events that have been reported. The adverse events reported include persistent pain, perforation of the uterus and/or the fallopian tubes, intra-abdominal or pelvic device migrations, abnormal or irregular bleeding, and allergy or hypersensitivity reactions.
On September 24, 2015, the FDA had a meeting with the Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee to hear experts’ scientific and clinical opinions, as well as patients’ experiences regarding the benefits and risks of Essure. In addition, the FDA made available a public docket soliciting comments on the device, which remained open from July 22, 2015 until October 24, 2015.
During that time, in October 2015, the British Medical Journal published a study by the Weil Medical College of Cornell University, concluding patients undergoing Essure had a 10-fold higher risk of undergoing a reoperation when compared with laparoscopic sterilization.
After review of the concerns presented at the September meeting, consideration of the comments in the public docket, and the release of the study, on February 29, 2016, the FDA ordered Bayer to put a Black Box Warning on Essure. The FDA also ordered Bayer to conduct a postmarket surveillance study of 2,800 women, which is scheduled to conclude in September 2023.
Contact Our Personal Injury Lawyers Today
The Law Office of Jami Angelini Haggerty, P.A. is offering free, confidential consultations to anyone who has suffered complications from an Essure birth control device. Our personal injury lawyers are committed to advocating on your behalf if you are one of the many who has suffered at the hands of another’s negligence. No matter the complexities of your case, we want to fight for your rights--don't hesitate to reach out a member of our legal team. We won’t give up on you or your case.
Schedule an initial consultation today by calling (954) 400-5264 or emailing email@example.com.