The U.S. Food and Drug Administration (FDA) has finally announced that consumers will be given the much needed information on the potential risk for complications linked to implantable sterilization, Bayer’s Essure. As reported previously there have been life-changing adverse risks tied to the device, including bleeding, chronic pain, and autoimmune disorders (i.e. lupus, psoriasis, etc.). We also reported that metals engineering consultant, Mark Bell has given the opinion that the Essure device appears to have a manufacturing problem that makes it 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.
The FDA has called for Bayer to provide information regarding risks on its product labels, while also issuing a mandatory clinical study for Essure to continue seeking further research on the product’s safety and effectiveness versus its risks. They also want further study on whether some women are more prone to the complications than others and why. The FDA believes these steps will help informed female patients and medical providers have better discussions on the risks versus the benefits for every individual woman.
As we have reported in the past, women with Essure complications 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.
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.