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The FDA Requires a New and Improved Warning For The Essure Birth Control Contraceptive Device

Potential Essure patients are now forced to sign a form stating that they have been informed of the risks of Essure

Tuesday, April 17, 2018 - Women that wish to practice permanent, non-reversible birth control along with their health care advisor will now be required to sign a form designed by the FDA that demonstrates that they have been read and understand the known risks of the Essure birth control device. The FDA is holding Bayer, maker of Essure, responsible for complying with the first of its kind medical device warning procedure. The FDA has threatened imposing fines and possible criminal penalties should Bayer fails to meet the specific standards of the warning. Bayer is also required to restrict sales of Essure Contraceptive only to doctors that agree to inform their patients of the risks.

Thousands of women that have experienced unforeseen complications from Essure have sued Bayer alleging that the company and their doctor failed to inform them of the risks. Plaintiffs suing Bayer say they have experienced severe pain, excessive bleeding, infections, swelling and allergic reactions to the coil's metallic composition. Some have complained that the device never adhered to one fallopian tube or the other and had migrated to their uterus, puncturing it. Surgeons performing revision surgery have reported finding the device as far away as the abdominal cavity.

Years earlier the FDA ordered that the company place a "Black Box" warning on the device's packaging that has today been updated to state, "WARNING: Some patients implanted with the Essure System for Permanent Birth Control have experienced and/or reported adverse events, including perforation of the uterus and/or fallopian tubes, identification of inserts in the abdominal or pelvic cavity, persistent pain, and suspected allergic or hypersensitivity reactions. If the device needs to be removed to address such an adverse event, a surgical procedure will be required. This information should be shared with patients considering sterilization with the Essure System of Permanent Birth Control during the discussion of the benefits and risks of the device."

Prospective Essure patients are also warned to be sure that they are finished having children as the device is permanent and irreversible. Essure stresses that patients make sure to continue to practice birth control for at least 3 months after having the Essure coil implanted as it could take that long for sufficient scar tissue to encapsulate the device and block a man's sperm from reaching the eggs. Essure lawsuits plaintiff's allege they were not warned about the potential for Essure risks and dangers.

Essure was originally heralded as a breakthrough medical device and family planning tool, as effective as its predecessor tubal ligation, yet implanted through the vagina without requiring surgery. Essure was also sold to women as reversible and could be easily removed should a woman decide to get pregnant. Essure consists of two coils that resemble the spring from a ball-point pen and is composed of several metal alloys including nickel, a substance which women are finding to be allergic to. The coils are coated with small fibers that are intended to create inflammation on the fallopian tube requiring the body to produce scar tissue around the device. Unfortunately, the scar tissue buildup can also cause infections and encapsulate the device so effectively as to prevent it from ever being removed.

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Onder Law is a St. Louis personal injury law firm handling serious injury and death claims across the country. Its mission is the pursuit of justice, no matter how complex the case or strenuous the effort. The Onder Law Firm has represented clients throughout the United States in pharmaceutical and medical device litigation such as Pradaxa, Lexapro and Yasmin/Yaz, where the firm's attorneys held significant leadership roles in the litigation, as well as Actos, DePuy, Risperdal and others, and other law firms throughout the nation often seek its experience and expertise on complex litigation.