Last month, the Brazilian government removed Essure from the market. On February 17, 2017, ANVISA, the Brazilian equivalent of the USA’s FDA, issued Resolution 457/17, suspending the importation, distribution, marketing or use of Essure in Brazil. The Brazilian safety agency took this action in response to the FDA’s actions in reviewing the safety of Essure and imposing additional labeling requirements, which in turn was spurred by thousands of complaints of injuries caused by the birth control device.

Essure, marketed as a permanent birth control device, consists of a set of micro-coils, which are inserted into the fallopian tubes. The device is intended to cause inflammation and scarring of the tubes, permanently preventing pregnancy. Numerous women have filed lawsuits across the country, complaining of various injuries caused by Essure. Some women have suffered perforation or migration of the device—the metal coils allegedly move around, poking holes in various internal organs. Other women have suffered auto-immune and other disorders apparently caused by chronic device-induced inflammation.

Essure Still Legal in USA

The FDA originally approved Essure for sale in 2002. All along, Essure was intended to be permanent, yet at the time of its approval by the FDA, its long-term effects had never been studied. After receiving numerous reports of injury, as well as a citizen petition, the FDA initiated a safety review in 2015. Ultimately, the FDA declined to pull Essure from the market, and it is still legal in the United States. However, the FDA required Bayer, the device manufacturer, to add additional warnings. On November 15, 2016, the FDA mandated that Bayer add a “black box” warning, the strictest warning the FDA can impose. Bayer is now required to warn potential Essure customers that the product can cause “perforation of the uterus or fallopian tubes” as well as “persistent pain” or “allergic or hypersensitivity reactions.”

Essure Lawsuits Continue

Hundreds of Essure lawsuits are proceeding in California state courts, as well as in courts throughout the country, including Missouri. While some cases have been dismissed due to federal preemption, other cases have survived this challenge and are proceeding towards trial. More Essure cases continue to be filed every month.

Despite the mountain of lawsuits, as well as adverse action taken by regulatory agencies in the United States, Brazil, and elsewhere, Bayer stands by its product and continues to sell it. Bayer continues to proclaim that Essure is an “appropriate option for a majority of women seeking a permanent form of birth control.”

In 2016, Bayer said that about 750,000 women used Essure, and about 70% of those were in the United States. Reports suggest that the black box warning has depressed sales of Essure, but it has proven to be a blockbuster moneymaker for Bayer. The company, unsurprisingly, has resisted efforts to remove it from the U.S. market.

Those harmed by Essure may have a claim for damages. Typical cases involve women who suffered a perforation of internal organs because of Essure, or required surgery in order to remove the device. Each case is different—if you or a loved one suffered injury from Essure, discuss the facts with an attorney in order to assess whether you do have a claim. Essure cases, like all litigation, are governed by strict deadlines—the sooner you take action, the better your chances of securing a recovery for the harms you have suffered.

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