Bayer Stops Essure Sales Worldwide Except for United States
Bayer announced yesterday that it will cease sales of Essure in "all countries except for the United States" for "commercial" reasons. Bayer insisted that the move to remove Essure virtually worldwide is, "not related to a question of safety or dangerousness of the medical device-whose positive benefit-risk profile remains unchanged." The company continues to stand by its product, despite declining sales and profitability world-wide. According to the french paper, Le Monde, Bayer indicated that an "environment unfavorable" to the prescription of the "innovative solution in contraceptive matter" that constitutes Essure has for several months "a continuous decline in demand in France." Simply stated, the powerful negative publicity from the thousands of ladies worldwide who have been injured by this device is hurting Bayer's bottom line.
This action was not totally unexpected as over the past few months, Bayer has been quietly removing Essure from the market in various countries. The company first voluntarily withdrew the product in Finland and the Netherlands in the Spring. This was shortly followed by a withdrawal throughout the United Kingdom and Canada. The device was recently banned from sale in Australia and then the National Standards Authority of Ireland, the agency responsible for approving CE marketing in Europe, issued a three month ban on Essure sales pending a review of its safety before renewing the CE marking.
Unfortunately, Bayer has steadfastly refused to cease sales of Essure in the United States. However, the market place may be accomplishing what Bayer is refusing to do. Although Bayer has refused to date to provide information regarding US sales, clearly the sales have dropped significantly in the last few years as more women and physicians become aware of the significant dangers of the device. The Essure device is no longer listed as a product on Bayer's website. Bayer's decision to remove the device from all European markets likely signals that Bayer will pull it from the U.S. as well, said Erik Gordon, a professor at the Ross School of Business at the University of Michigan. Art Sedrakyan, a professor of healthcare policy and research at Weill Cornell Medical College who has studied the device, said he wouldn't be surprised if Bayer voluntarily stops selling Essure. The negative publicity and stagnant use around the device might push Bayer to decide its no longer worth it to sell from a financial standpoint.
There is also evidence that physicians are recommending Essure less to patients as news of the health risks grow. "Doctors don' want to be sued," Gordon said. The FDA has been slower to react to negative information concerning the device than other countries' similar government agencies. US women affected by the device are losing patience with the FDA, which was created to protect the consumer and not the pharmaceutical or device manufacturing companies. However, if the world trend continues, Essure will soon be discontinued in the United States as well.