Patient-Doctor Discussion Checklist Now Required for Essure Sell
On April 9, the FDA issued an order to restrict the sell of Essure devices. The new restriction allows only doctors and health facilities who use the FDA’s Patient-Doctor Discussion Checklist to sell the device. Further, the new guidelines require both patients and doctors to sign the checklist indicating that the patient is aware of the risks. The checklist ensures that women opting for Essure as a permanent birth control understand the risks associated with the device.
The move comes after 5,000 injuries and complications related to Essure were reported to the FDA. These adverse events have been reported to the FDA since the device’s 2002 approval. In 2016, the FDA required the product’s manufacturer, Bayer Pharmaceuticals, to conduct a mandatory clinical study. Additionally, the FDA required the company to include a “boxed warning” and a checklist of the risks. However, at the time, doctors and other healthcare facilities were not required to review the doctor-patient discussion checklist with patients.
“We’ve been closely evaluating new information on the use of Essure, and based on our review of a growing body of evidence, we believe this product requires additional, meaningful safeguards to ensure women are able to make informed decisions about risk when considering this option,” FDA Commissioner Dr. Scott Gottlieb said in a written statement.
With the inclusion of these warnings, between 2016 to present, sales of the device dropped by 70 percent. Still, even with these measures, women were not receiving information about the known risks.
Since its FDA approval, the risks associated with Essure include:
- Puncturing the uterus or fallopian tubes
- Stomach and pelvis migration
- Abnormal bleeding
- Unplanned pregnancies
Essure’s manufacturer, Bayer, advertised the product as a surgery-free alternative to other methods of permanent birth control. However, there are women who opted for the birth control who have had surgery as a result of the device. Some women reported hysterectomies just to have the device removed. For more than 15 years, these risks were unknown to the many of the women who opted for Essure for birth control.
Has there been an Essure Recall?
No. While other countries like Brazil have recalled Essure, the United States has not issued a recall for the device. The U.S. FDA continues to believe that the benefits of the device outweigh its risks. It also believes that requiring the “Patient-Doctor Discussion Checklist” is enough to protect women looking for permanent birth control.
Update: While the FDA did not force Bayer to recall the Essure device, the company has opted to phase out the sale of the device by the end of 2018.
How The Carlson Law Firm Can Help You
Women who underwent an Essure procedure and experienced health complications should know that they have rights, including the right to take legal action against Bayer. If you or someone you know have suffered these serious injuries from the product, contact our team of defective product attorneys immediately for a free consultation.
- Written by Kazia Conway