Brazil Recalls Essure and Note to Bayer: Share the Knowledge

Washington, DCBrazil’s National Health Agency has banned sales and recalled Essure, and advocacy groups worldwide are pressuring their governments to follow suit.

Anvisa, Brazil’s top health regulator, announced last month that the largest country in South America with a population of more than 200 million will no longer accept shipments of the permanent birth control device. And it has also recalled all outstanding Essure implants from doctor's offices.

A press release issued by Anvisa and reported by Modernhealthcare (March 6, 2017) said it had “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."

Despite thousands upon thousands of women in the US lobbying Congress to have Essure removed from the market –A Facebook group called “Essure Problems” comprises 30,000 women alone-- the FDA has done little more than slap a black box warning on the device and develop a three-page checklist for doctors, to be signed by both doctor and patient.

As for Bayer, it disagrees “with the decision by health regulators in Brazil which was taken without the knowledge of Bayer,” reported Modernhealthcare.

This comment “without the knowledge of Bayer” is particularly insidious given two surprise investigations carried out by the FDA to the Conceptus facility, which is the company behind Essure and bought by Bayer in 2013. The agency inspected Conceptus in 2003 and 2010 and both times issued the company Form 483, which means the investigator “has observed conditions that may constitute violations of the Food, Drug and Cosmetic Act…or any related acts,” according to the FDA’s website.

In the first investigation the agency found that Conceptus had not disclosed 15,000 reports of Essure injury or illness. In June 2013 investigators found another 16,047 additional complaints and less than 200 adverse events had been forwarded to the agency. In other words, reports without the knowledge of the FDA.

So Bayer, how about sharing your knowledge of adverse events with the world? Thousands of Essure lawsuits have filed against Bayer, and lawyers are expecting more to come.