A black box warning is one of the strictest warnings that the Food and Drug Administration (FDA) can place on a prescription drug or medical device. It is a warning to those who have been prescribed the medication or device that has a black box around the warning, hence the name. The FDA gives out black box warnings when there is serious potential for an adverse reaction when taking the drug or an adverse reaction to the device. One device that has such a warning is Essure, a medical implant that is meant as a permanent form of birth control. CBS News reports on the story.
The Essure device is subject to some 27,000 complaints from women across the country. The device was approved by the FDA in 2002.
More recently, the FDA began requiring physicians with patients who wish to have a device implanted to go over a checklist detailing the possible adverse reactions. The agency also gave the device on of its strictest warnings, a black box warning in 2016.
Women have reported excessive pain, allergic reactions, and in some cases, perforated organs.
Bayer, who manufactures the device, said that there is no way to tell which women will experience the adverse reactions and those who will not experience them.
Dr. Brett Cassidy was once a supporter of the Essure device and implanted it in 114 patients. His opinion changed when that woman came back experiencing migraines and joint pains. The symptoms went away after he performed a hysterectomy, which also removed the Essure device.
In the three years following, Cassidy has since performed more than 100 hysterectomies on women who are experiencing complications after having the Essure device implanted.
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