Essure received pre-market approval in 2002 from the Food and Drug Administration (FDA). The contraceptive implant was designed to be a permanent and effective method of birth control. However, since its release into the market, the Essure device has proved to be neither permanent nor safe. The Essure device itself is responsible for just over 300 fetal deaths, and there are reports of well over 10,000 instances of women suffering adverse side effects.
Initial reports submitted by Bayer, the manufacturer of Essure, showed no signs that such drastic complications would result from the device. The FDA called upon Bayer to conduct surveillance that will assess “risks of the device in a real-world environment,” and said the agency will use the results of that study to “determine what, if any, further actions related to Essure are needed to protect public health.”
The company is required to follow more than 2,000 women for at least three years. The study will not be limited to women being implanted with Essure but will be comparing women with Essure to women who select other methods of sterilization.
The FDA expects Bayer to submit a study protocol within 30 days, and the company is required by law to begin the study within 15 months. If Bayer does not, the FDA can declare the device misbranded.
When reached for comment, Bayer provided the following response: “Essure is an important permanent birth control option with a positive benefit-risk profile. Bayer will continue to work closely with the Food and Drug Administration to support the continued safe, effective and appropriate use of Essure.”
Unglesby + Williams is at the forefront of Essure litigation. While fighting Bayer in the courts on behalf of over 1000 women, we have continued to uncover more and more alarming data about Essure, Essure Problems, and how Essure Problems are being reported by Bayer to the FDA. If you or someone you know has been injured or experiencing side effects from the ESSURE Birth Control Implant, contact Unglesby + Williams or call 844-ESSURE-LAW today.