After pulling Essure off shelves around the world and leaving the US as the only country on the planet left selling its sterilization device for women, Bayer has responded to an increase in attention and threats from the FDA by finally agreeing to pull it from US shelves as well.
Bloomberg is reporting that the device’s manufacturer received threats of civil and criminal liabilities from the FDA if it didn’t start fessing up about the risks women face when getting an Essure implant. While repeating previous statements assuring women of the safety of a device currently at the center of close to 20,000 lawsuits over injuries sustained while using it, the company cited declining sales in the only country left selling it as the reason for finally pulling the plug.
The FDA, the agency that initially approved the device for sale in 2002, sought to assure women that they wouldn’t be letting Bayer off the hook just because the corporation finally decided that it was no longer beneficial to market Essure. “For women who have received an Essure implant, the post-market safety of Essure will continue to be a top priority for the FDA,” said the agency’s commissioner. “We expect Bayer to meet its post-market obligations concerning this device.”
Despite an ever-increasing public outcry that eventually led to attention and threats of a ban from the halls of the US Capitol, the FDA would only ever go so far as to recommend a black box warning for the device during its turbulent time on the US market. As a seemingly last-ditch effort to avoid banning Essure outright, the agency also ordered that women seeking an implant were to be shown a brochure that detailed the safety risks inherent to the device. The woman and her provider were then to sign a document that verified that the brochure had been presented and reviewed. The FDA, however, left Bayer in charge of enforcing this roadblock to the sale of its own product and publicly acknowledged that the solution was “unique.”
In the end, however, the market did what the FDA lacked the will to accomplish and killed Essure itself – but not before the agency’s inaction and Bayer’s pursuit of profits caused unfathomable pain and suffering for thousands of American women.
