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The North American headquarters of Bayer based in New Jersey.
Photo: Julio Cortez (AP)

A controversial contraceptive method that is said to have injured thousands of women over the past two decades is now being finally closed. On Friday, the pharmacy Bayer announced it would stop selling its Essure birth control implant in the US by December 31 of this year. It follows a similar step by the company to end sales in 2017 across the world, including Europe.

Approved in 2002 by the Food and Drug Administration, Essure prevents pregnancy through the use of two metal coils, each inserted into each fallopian tube of the uterus. It is believed that the coils irritate uterine tissue, creating scars that prevent sperm from reaching the egg.

When it debuted in 2002, Essure was marketed as a durable, drug-free and safe birth control with a 90 percent pass rate. But people have reported serious complications with its use. The implant can cause punctures in the fallopian tubes or other parts of the uterus; It can also leave the uterus and get stuck on the pelvis or stomach, causing pain or triggering allergies. Both types of complications typically require surgical removal.

Following an outcry from patients and doctors, the FDA asked Bayer in 2016 for a black box warning for its product. In April, after more discussions with Essure critics, the agency followed took things one step further. They asked Bayer to create a label that would ask health care providers to deliver the implant only after discussing the risks with their patients for the first time. Both the patient and the doctor would then have to sign a document confirming that they have spoken.

Emagazine.credit-suisse.com/app/art … = 157 & lang = DE The bad publicity and the tires that Bayer had to endure in order to resell Essure proved to be too tedious: the company cited the dramatic decline in sales US sales in recent years as a reason for cessation of the Essure production FDA, sales have dropped by 70 percent since the black box warning was added). However, Bayer has refused to admit any misconduct in the marketing of Essure and to adhere to its safety record.

"The health and safety of patients who rely on our products is our top priority," the company said. "Most of all, we want the many women who have selected Essure for their reproductive health to know that our decision to stop selling is for business reasons, and not for the sake of the safety or efficacy of Essure."

Along with the change in FDA labeling in 2016, the agency also requested that Bayer conduct a post-market study with Essure patients. And despite the imminent end of Essure sales, Bayer said it will continue to include patients in the study. Originally, the study looked at the health of 2,000 women who received an implant for three years.

"Because Bayer can not reach its expected registration numbers for this study," said FDA chief Scott Gottlieb in one statement"We will work with the company to determine how we can evolve to answer the critical questions we have about specific patient complications that can occur in patients with Essure."

Women who are currently using Essure to successfully prevent pregnancy without serious health problems, said Gottlieb, should feel confident to continue to do so. Women who may have related symptoms, such as chronic pain, should consult a physician to decide their next step, he added.

According to Bayer, more than 200,000 women worldwide have used Essure since their availability.

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