FDA Requires Essure Black Box Warning
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- FDA Requires Essure Black Box Warning
March 14, 2016
The Food and Drug Administration (FDA) has announced that yet another product will be receiving a black box warning regarding its safety.
According to the FDA, the permanent female contraceptive device Essure will be required to carry a black box warning to alert consumers about the potentially life-threatening risks of using the product.
Essure is a coil-shaped permanent birth control device that is implanted within a woman’s fallopian tubes.
Once the coil is placed, scar tissue forms around it to block sperm from making contact with eggs. In this manner, the device is designed to prevent fertilization, and therefore pregnancy.
Risks Associated with Essure
The Essure black box warning label requirement was issued by the FDA after more than a decade’s worth of complaints were made by over 5,000 women. The complaints date back to the device’s FDA approval in 2002.
Following the implantation of Essure, women have reported several serious medical issues which include:
- Serious pain
- Unplanned pregnancies
Additional FDA Requirements
In addition to requiring the Essure black box warning label, the FDA is mandating that a patient decision checklist be signed by both the patient and the physician before Essure is implanted.
Patients must also agree to undergo testing three months after the device has been placed to ensure it is in the proper position and functioning correctly.
The FDA has also ordered the device’s manufacturer, Bayer, to conduct a study in order to observe the reported risks in a real-world environment. The study will involve following over 2,000 women who have been implanted with the device for a minimum of three years.
The FDA says it will use the study’s results to help decide if additional action against Essure should be taken in order to better protect the public.
Opponents of Essure have expressed outrage over the FDA’s decision, saying the agency should have taken Essure off of the market. They cited several reports that show the device caused life-threatening injuries to women as well as a substantial increase in fetal deaths.
If you have been harmed by a faulty medical product like Essure, Arizona’s law firm, thePhillips Law Group, will fight for you and work tirelessly to recover maximized compensation for the injuries you have suffered.
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