Brazil Issues Recall For Essure, Suspends Importation & Sales

Brazil has become the first nation to issue a recall for Essure, suspending importation and sales of the controversial birth control implant.

Rio de Janeiro




While US health regulators have chosen to leave Essure on the market, officials in other countries have begun to take a more energetic stance.

Brazilian Regulators Take Essure Off Market

On February 17, 2017, Brazil's National Health Surveillance Agency (Anvisa) announced that the South American nation would no longer be accepting new shipments of the controversial birth implant, which thousands of women say causes severe pain, abnormal bleeding and other devastating side effects. In addition to suspending imports of Essure, Brazil's top health regulator banned sales of the device and recalled all outstanding implants from doctor's offices.

Essure has received strong push-back in the United States, with groups of affected women like those at Essure Problems even lobbying Congress to have the device removed from the market. With Anvisa's sweeping measures in place, Brazil has become the first country to issue a recall of the embattled contraceptive device.

A "Maximum Risk" Contraceptive Device

How sweeping the regulatory agency's decision will ultimately be is still in doubt, Modern Healthcare reports. While invasive, mandated removal procedures are not unheard of in US recalls, but there's still no word on whether or not Anvisa intends to recall Essure implants that have already been placed. The reasoning behind Brazil's decision, however, is fairly clear, as explained in a press release issued by Anvisa:

"Anvisa received technical scientific reports and removed the Essure System product from circulation [...] The contraceptive system is rated at maximum risk [and may] cause changes in menstrual bleeding, unwanted pregnancy, chronic pain, perforation and migration of the device, allergy and sensitivity or immune-type reactions."

Public statements from Bayer, Essure's manufacturer, show that the company was not notified of Anvisa's decision before the public was: "we disagree with the decision by health regulators in Brazil which was taken without the knowledge of Bayer."

Essure Litigation Goes Global

Thousands of women have filed lawsuits against Bayer, accusing the company of concealing Essure's risks from the public. While this litigation has been focused in the United States, two French women became the first international plaintiffs to pursue action themselves, according to Le Monde. Meanwhile, the fight against Essure has gone truly global, with advocacy groups devoted to the device's recall sprouting in South Africa, Australia, Canada, Spain, Finland, Italy and at least 6 other nations.



The Legal Herald
By | 2017-03-06T16:57:47+00:00 March 6th, 2017|Medical Devices|0 Comments

About the Author:

Laurence P. Banville, Esq. is the managing partner of Banville Law. He is a regular contributor on several topics including products liability, nursing home abuse and personal injury.

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