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Essure sales throughout the European Union have been suspended for at least three months, according to a new report from the Associated Foreign Press. The move comes after Ireland’s national health regulator, the National Standards Authority of Ireland, failed to renew Bayer’s commercial license for the contraceptive device. Pending further review, Essure’s EU license will be reinstated on November 2, 2017.
Essure’s Uncertain Fate In Europe
Bayer’s embattled birth control implant has been dealt a series of major blows this year. Just two months ago, the implant’s manufacturer announced that sales and distribution would be stopped “for business reasons” in Canada, the United Kingdom, Finland and the Netherlands. The three latter nations are member states of the European Union. The United Kingdom’s full withdrawal from the union (commonly known as “Brexit”) is expected to take around two years.
Meanwhile, women across the world continue to organize for a global Essure recall, citing strong links to severe side effects. A major litigation is breaking new ground in California, where thousands of women have joined forces to secure financial compensation from the implant’s manufacturer.
Ireland Lets Essure’s EU License Lapse
Now, the Republic of Ireland has asked Bayer for more information on Essure’s safety and efficacy. The island country’s decision will have widespread ramifications across Europe. Medical devices must obtain CE marking, a commercial license, to be sold within the European Union. This license confirms that the device has met explicit EU standards for manufacturing practices, quality, safety and efficacy.
Companies, however, are allowed to select one member state’s regulatory agency to review licensing applications and renewals. Bayer chose Ireland’s National Standards Authority; the CE mark for Essure was set to expire on August 3, 2017.
Ireland didn’t play ball. The country has decided to postpone the renewal of Essure’s licensing for three months, until all outstanding “questions” have been answered. As Ireland searches for answers, every other European Union state will have to suspend Essure sales and distribution, too. Essure “can no longer be sold in France or Europe during the temporary suspension period,” a representative for the French Agency for the Safety of Health Products told reporters.
EU Member States Recall Essure Implants
Even more impactful, France’s health regulator has advised women throughout the European Union to stay away from Essure “as a precaution.” The regulator has told current Essure patients to consult with their gynecologists to investigate potential alternatives. Likewise, health professionals have been instructed not to implant Essure in new patients.
In Ukraine, the Ministry of Healthcare has asked Bayer to recall all Essure units currently stocked by the country’s healthcare providers, according to The Siver Times. Similar measures have already been taken by France’s regulatory body.
Is this the end for Essure in Europe? Health regulators say that’s not likely. In April of 2017, France’s Agency for the Safety of Health Products convened a committee of experts to analyze the medical literature on the birth control implant’s safety. Relying largely on an epidemiological study that followed 100,000 women, the committee concluded that the research, at this time, did not support a full-on Essure recall. French authorities believe that Ireland’s temporary suspension of the device is unlikely to call the committee’s ultimate findings into question.