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Bayer: Netflix documentary's portrayal of birth control implant 'misleading'

Bayer AG said a recently released Netflix documentary investigating the safety of its birth control implant, Essure, showed an "inaccurate" and "misleading" picture of the medical device.

The German pharmaceutical and chemical giant's device has been associated with serious health risks including persistent pain, bleeding of the uterus, and movement of the device's coils into the pelvis or abdomen.

In a July 27 release, the company issued a fact check based on its review of the film's premiere at the Tribeca Film Festival on April 21.

Bayer said the film, called The Bleeding Edge, relied on selected studies and patient anecdotes while ignoring a large body of scientific evidence backed by the U.S. Food and Drug Administration.

The U.S. FDA had restricted the device's sales in April on reports that women were not being adequately informed about the safety issues associated with the product.

According to Bayer, the film cited an independent study in JAMA: the Journal of the American Medical Association authored by Kim Bouillon in 2018 but ignored 40 other published studies involving about 200,000 women over two decades.

The makers of the documentary, Kirby Dick and Amy Ziering, told CBS News that the studies cited by Bayer were biased and funded by the industry, with most following patients for a relatively shorter time frame of up to a year and a half.

The device, a metal coil that when placed into fallopian tubes is intended to prevent pregnancy and designed as an alternative to tubal ligation, can show side effects after five to 15 years later, Dick clarified to the news outlet in the interview.

Bayer added that the documentary brought Essure under the glare of major media outlets including The New York Times, which wrote that the film highlights the greed for profit within the industry.

The company added that the film relied on interviews from experts with conflicts of interests, including psychologist Diana Zuckerman and Madris Tomes, who had been part of anti-Essure litigation.

As of Jan. 30, Bayer is facing lawsuits from about 16,100 Essure users in the U.S. alleging personal injuries from the use of the device.

The film also raised serious public health issues as it encourages the patients to get the implant removed through a risky and unnecessary surgery, Bayer said.

Bayer in July decided to stop selling Essure in the U.S. from Dec. 31, after regulatory actions resulted in a decline of about 70% in the product's U.S. sales.