The sale and implantation of Essure in the United States is facing a new set of federally-mandated restrictions, and the government has left the enforcement of that mandate to the company that manufactures the device being restricted.
In response to a decline in demand for its female sterilization solution that quite literally spans the globe, Bayer ceased sales of Essure in every market on the planet except the United States late last year. Here in the U.S., Essure remains available, although the device does come with an FDA-mandated black box warning. As the strongest warning the agency can issue, a black box is used when the product in question could cause serious and/or life-threatening risks to the consumer.
The warnings come as a result of the outcry of tens of thousands of women who say that Essure has introduced unbearable levels of pain and suffering into their lives. They have petitioned not only the FDA but Congress itself to intervene in its continued sale and availability.
In the latest round of Essure restrictions, women seeking to be implanted with the device must be shown a brochure by their healthcare provider that details the risks that Essure presents. After reviewing the information, the patient and her provider must then both sign a document indicating the review has taken place.
The FDA has left Bayer in charge of implementing these restrictions on the sale of its product as well as making the checks necessary to ensure that procedure is being followed. Acknowledging that this is not a normal action generally taken by the FDA, the agency itself has described this solution as “unique.”
One has to wonder how many more “unique” solutions will be developed to protect the profits of the manufacturer of something that has caused considerable pain and suffering not only throughout the United States, but the world over.