Written by: Heather Helmendach, Legal Assistant
Law Offices of Thomas J. Lamb, P.A.
In May of this year, Health Canada released a Health Product Risk Communication for Essure, a permanent and irreversible birth control system. Essure is a device implanted in the fallopian tubes that prevents pregnancy by causing tissue growth which prevents an egg from being released and fertilized.
While many possible side effects of Essure are listed in Health Canada's warning, perhaps the most serious complications are device migration, organ perforation, and chronic pain. Such complications can necessitate surgical removal of Essure, which may include hysterectomy.
Health Canada also states in their article that "Post-marketing information suggests that some patients may not always be fully informed of the various possible device and procedure-related complications before they choose whether to proceed with ESSURE." As a result, Health Canada states that the following actions are being taken:
- Bayer HealthCare LLC in collaboration with Health Canada is developing a Patient Information Sheet and Checklist intended to be reviewed and signed prior to the use of the device.
- The product labeling for ESSURE will be updated including a new Boxed Warning section to reflect this safety information.
The Modern Healthcare article, "Essure court ruling in California could bring more lawsuits," provides the FDA's perspective on Essure:
The FDA approved Essure as a Class III medical device in 2002. Thirteen years later, its Manufacturer and User Facility Device Experience database had racked up more than 5,000 adverse event reports, from abnormal bleeding to “device migration," linked to Essure.
In September 2015, the FDA convened a panel of independent experts who recommended the agency limit the use of Essure because too little research had been done to prove its safety. In February, it recommended a black box warning for Essure, amid calls for it to recall the device entirely.
On October 31, 2016, the FDA released the document, "Labeling for Permanent Hysteroscopically-Placed Tubal Implants Intended for Sterilization," which provided the following example of a Black Box Warning to be included on Essure's label in the near future:
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 for Permanent Birth Control during discussion of the benefits and risks of the device.
At the present time, lawsuits are being filed against Bayer by women who have experienced serious health complications due to Essure. The FierceBiotech article, "California judge boosts plaintiffs’ cases against Bayer’s Essure birth control device" provides this additional information:
A judge in Oakland, CA, ruled in favor of plaintiffs suing Bayer over its Essure birth control device by granting a motion that coordinates 55 cases currently pending in the state.
Under the pretrial motion approved Friday [October 4, 2016], attorneys for the plaintiffs in each case can now pool their resources in their claims the pharma giant failed to warn women about the dangers of the Essure birth control implant. The suits involve about 900 women.
We will continue to monitor the medical literature concerning the Essure litigation, label changes, and complications.
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