by Jonathan Abbamonte
Population Research Institute
The U.S. Food and Drug Administration (FDA) has announced that it has approved a boxed warning for Bayer’s controversial Essure® sterilization device. A boxed warning is the strongest warning the FDA can require for drugs and devices and is intended to alert the user to potentially serious, even deadly, side effects that can result from using them.
The Essure boxed warning will alert patients and health professionals to adverse events associated with the device including the possibility for uterine perforation, chronic pain, serious allergic reactions, device migration into the abdominal or pelvic cavity, and the need for the device to be removed surgically if symptoms become unbearable.
More than 10,000 women who have suffered adverse medical events associated with Essure have already filed complaints with the FDA, and the number continues to rise daily. Nearly 5,000 women have filed complaints with the FDA this year alone. Bayer itself has received close to 30,000 additional complaints from users of its device.
The combination of the public outcry and the unusually high number of complaints led the FDA to conduct a hearing on safety issues surrounding the device last September.
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