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The protracted, piece-meal demise of Essure continues. On September 30, 2017, Australia’s Therapeutic Goods Administration issued a “hazard alert” telling patients and physicians that the contraceptive device will no longer be implanted in the country, the Herald Sun reports. At the behest of Australasian Medical and Scientific Limited, implants that have already been sold are being recalled. A similar recall for New Zealand has not yet been announced.
Essure Recall Issued By Australian Health Agency
Essure’s manufacturer, Bayer, decided on May 31 to discontinue all Australian distribution of the device, according to the country’s federal health agency. As in previous withdrawals, Bayer has cited “business reasons” to explain its exit from the Australian market. The German pharmaceutical giant’s decision interrupted the efforts of Australia’s own healthcare regulators, who had recently decided to adopt many of the safety measures established by the US Food & Drug Administration.
In its press release, the country’s Therapeutic Goods Administration said a number of changes were in the works. An updated label would “provide[…] warnings about potential adverse events and situations where device removal may be necessary.” A patient information brochure would guide safety conversations between patients and physicians.
“There Will Be No Further Implantations Of Essure In Australia”
In the wake of Bayer’s withdrawal from the market, none of these measures will be necessary, although updated patient information booklets will be available for current Essure patients. Now, Essure’s entry in the Australian Register of Therapeutic Goods, a list of all the devices and drugs that can be legally distributed in the country, will be deleted. A search of the database now yields only a copy of the TGA’s warning:
Leaving no room for interpretation, the agency ends its hazard alert with the sentence: “there will be no further implantations of Essure in Australia.”
Declining Essure sales across the globe can be attributed to the immense amount of public outrage and advocacy generated by the implant, which has been linked to horrific side effects, life-changing removal procedures and, in recent reports, suicidal ideation.
The Slow Death Of Essure
The world’s supply of Essure implants is literally dwindling. This is a victory for patients, and one nearly unprecedented in the history of medical technology. Bayer has already pulled out of most major markets, including Canada, the United Kingdom, Finland and the Netherlands. Brazil took matters into its own hands, recalling the implants unilaterally in February, but chose to lift the ban five months later.
Perhaps most significant, however, were the recent actions taken by the European Union, where, inspired by the strong criticism of Ireland, Essure’s commercial license has been suspended for at least three months, preventing all sales and distribution in EU member states until a full scientific review can be completed. Bayer’s troubles have only been compounded by the recent announcement that European Union financial regulators have opened an “in-depth” investigation into the company’s proposed acquisition of global agriculture giant Monsanto.
Where Essure is concerned, America now stands as the developed world’s last remaining hold-out. While experts at the US Food & Drug Administration have deemed Essure a “high-risk” device, issued a host of dire warnings and asked physicians to provide patients with a detailed check list of the implant’s potential side effects, no direct actions have been taken to limit the circulation or implantation of the device in the United States.