New restrictions on Essure sterilisation device in the United States, but no recall

Publié le 4 May, 2018

On Monday, the U.S. Food and Drug Administration (FDA) imposed new restrictions on the permanent contraceptive implant following reports of painful complications from thousands of women. Nevertheless, the metal implant made by Bayer is still on the market.


From now on, only women who read and sign a leaflet about the risks associated with the device can be prescribed Essure. The woman’s doctor must also sign a checklist of risks. These new regulations take effect almost two years after stern warnings from the FDA who ordered Bayer to carry out a study on the device’s safety. An agency spokesperson confirmed that, taking these new requirements into account, the device continues “to meet our standards for a reasonable assurance of safety and effectiveness”.


However, questions are still being asked. It is highly unlikely that patients will read the entire 22-page brochure before signing it: “In addition to being much too long and technical, the information provided will be confusing to many consumers”, explained Diana Zuckerman, president of the National Center for Health Research, consumer advocacy group.


Bayer received FDA approval to launch Essure in 2002. Given the number of complaints, Bayer was ordered to carry out a study involving 2,000 patients in 2016. Other studies are needed.


The agency has noted that Essure sales have plummeted by 70% since the earlier FDA restrictions were announced. According to the last annual report of the German conglomerate, Bayer is facing lawsuits from approximately 16,000 U.S. women who used Essure. The complaints “exceed the available insurance coverage”. The company stopped sales outside the United States last year (see Marketing of Essure sterilisation implants halted in Europe). Last month, the FDA announced that it received 12,000 reports of implant-related problems last year (see Essure contraceptive implants: “needle-like pain”, several complaints lodged and Essure: group litigation against Bayer scheduled for September). Most reports come from lawyers representing patients suing Bayer. 90% of these reports were linked to attempts to remove the device.

Medical Press, Matthew Perrone (09/04/2018)

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