Although the U.S. Food and Drug Administration (FDA) has not done it yet, many women are begging the agency to withdraw Bayer’s Essure, a permanent birth control device. Thousands of women thus far have complained that it has caused life-changing adverse side effects, including bleeding, chronic pain, and autoimmune disorders (i.e. lupus, psoriasis, etc.). Facebook even has a site where women impacted by the implant have gone for support called “Essure Problems” and experts have been sought out, including metals engineering consultant, Mark Bell, to analyze and speak out. Mr. Bell has asserted his opinion that he analyzed the Essure device after it was removed from a number of women and found that he saw that there appears to be a manufacturing problem with the device that makes them unsafe. Assertions have also been made that nickel or other metals in such devices can bring on problems with allergic reactivity so that women should at the very least be tested for sensitivity to the metals before the implants are performed.
Women have described problems, such as the coils of the device moving from the fallopian tube into the pelvic cavity or around the bowel, causing significant pelvic pain. Others women have described problems with extreme fatigue that has accompanied symptoms associated with a systemic immune response to the Essure device. FDA panelists have recommended that the product label be improved on Essure to give consumers and medical providers better information about potential side effects and have also recommended that a patient registry be put in place so that patients can register their complaints and the FDA can track them. The panelists also stated that doctors should be trained better in how to remove the Essure coils and to recognize problems earlier in patients so that there is a protocol for the Essure removal from a patient.
If you or a loved one has suffered adverse side effects and has an Essure device implanted, contact your medical provider immediately, and do not hesitate to contact Inserra & Kelley Law Offices for assistance and to see whether you may be entitled to compensation.