The Significance of The FDA’s Essure Black Box Warning
Watch virtually any drug commercial long enough and, after the deliriously happy looking actors are done twirling in a meadow, you’ll likely be presented with a laundry list of side effects patients may experience. While these side effects often sound as unpleasant as the issues the drug is meant to treat, only a select few are deemed severe enough to carry a special warning label. Such is the case with the FDA’s recent mandate of an Essure black box warning.
According to the FDA, their black box warning label “appears on a prescription drug’s label and is designed to call attention to serious or life-threatening risks.” It is the strictest warning that a prescription drug product can carry, and serves to alert consumers that there is reasonable evidence of an associated hazard with the labeled drug. Previous examples of the black box warning include antidepressants that may cause dangerous and uncontrollable impulse control, diabetes medicine that can lead to an increased risk of heart failure and antibiotics that could cause tendon rupture and potentially permanent damage to the central nervous system.
For those who are familiar with the recent headlines, it may not come as a shock that the FDA has deemed it necessary to require an Essure black box warning. While the product was hailed as “the next generation of permanent birth control,” the implant has allegedly caused numerous complications including chronic pain, autoimmune disorders and damage to the uterus and other organs due to the device migrating. In a New York Times article on the Essure black box warning, it was reported that in 2015 the FDA was flooded with over 10,000 reports of injuries, pregnancy and even a small number of fatalities associated with the device.
While officials at Bayer maintain that there is no proof their device causes the reported side effects, the FDA’s Essure black box warning would suggest otherwise. Numerous class action lawsuits have been filed around the country, seeking to recover damages for affected patients and hold the manufacturer responsible for their negligence.
Disclaimer: This article has been prepared for general information purposes and does not constitute medical or legal advice, nor does it imply an attorney-client relationship or contract with Wexler Wallace.