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FDA Issues Essure Black Box Warning, But is it Enough?
On February 29, the U.S. Food and Drug Administration announced that it was mandating stronger warnings for the Essure permanent birth control device as well as further studies regarding the safety of the product. However, critics believe the agency’s actions don’t nearly go far enough.
Black Box Warning
The FDA issued its strongest warning, known as a “black box” warning, to inform patients of the risks associated with the Essure device. The device is inserted into the fallopian tubes, where it stimulates the growth of scar tissue to block sperm from being able to reach a woman’s eggs. However, serious complications have been reported. These include painful menstruation, severe pain during intercourse, perforation of the uterus and fallopian tubes, and others.
In addition, the agency is mandating that Bayer, the manufacturer of Essure, perform a clinical study in order to determine the heightened risk for some women using the device. The company must submit a plan for the study within 30 days and start the study within 15 months.
U.S. Congressman Mike Fitzpatrick said in a statement that he finds it unbelievable that the agency would do so little while keeping the device on the market. He is the sponsor of the E-Free Act, which calls for the revoking of Essure’s FDA premarket approval and for the device to immediately be removed from the market.
If you have suffered harm after use of the Essure permanent birth control device, you may be able to take legal action against Bayer for the suffering you have experienced. Please call Baron & Budd at 866-750-3386 or complete our contact form to learn more about your potential legal options.