Bayer Pharmaceuticals announced last week that it will voluntarily withdraw the Essure birth control device from the United States. The company has stated that it will end sales of the device in America after December 31, 2018.
The company claims that the reason for the change is related to degraded sales. Bayer maintains that the device is safe and effective. The pharmaceutical company holds this position despite growing controversy regarding injuries that are alleged to have been caused by its device.
Lawsuits numbering in the hundreds have been filed against Bayer by women who allege the device has harmed them. Some of these lawsuits indicate that the device has caused serious injury and health complications. These injuries include but are not limited to: the implant breaking while inside the body, internal perforation, constant pain, persistent bleeding, unintended pregnancy and injury to child.
The history of Essure is fraught with updates to the information Bayer made available to women considering the device. This led to a large number of patients who received the device without being adequately warned or informed of the risks and complications associated with the device.
According to the U.S. Food and Drug Administration (FDA): “The FDA is aware that some women have received the Essure device without being adequately informed of Essure’s risks.”
In April of this year, the FDA took steps to restrict the sale of the device to only those physicians who used the FDA-approved “Patient-Doctor Discussion Checklist – Acceptance of Risk and Informed Decision Acknowledgement” form.
This latest action by Bayer to withdraw the device from the United States at the end of 2018 marks an important moment in the ongoing struggle those affected by the pharmaceutical giant’s decisions.
If you or a loved one has suffered an injury and you suspect it may be associated with this or another device or drug, please contact our firm today. Initial consultations are always free and we are happy to answer any questions you may have.