The team behind “The Bleeding Edge,” the Netflix exposé on questionable practices in the medical-device industry, have issued a response to criticisms about the film’s alleged inaccuracies leveled by Bayer, the multibillion-dollar pharmaceutical giant.
“We are not surprised that Bayer has attacked our film, which reveals the serious complications caused by its flawed implantable birth control device Essure,” the filmmakers said in a statement. “Bayer has a long history of maligning critics of Essure rather than addressing the harms it has caused to tens of thousands of women.”
“The Bleeding Edge,” which debuted on Netflix worldwide on July 27, comes from documentary filmmakers Kirby Dick and Amy Ziering (whose previous credits include “The Invisible War” and “The Hunting Ground”). The statement on Bayer was from Dick, Ziering, producer Amy Herdy, and the rest of the filmmaking team.
Bayer last week accused the film of presenting “an inaccurate and misleading” portrayal of Essure, the birth-control implant device that is the center of lawsuits filed against the company on behalf of more than 16,000 women who claim it has caused medical complications including chronic bleeding and severe pain. On July 20, Bayer announced that it was pulling Essure from the market in the U.S. by the end of 2018.
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The pharma giant alleged “The Bleeding Edge” cherry-picked information “to fit a predetermined conclusion, ignoring the full body of scientific evidence that supports the [FDA’s] determination that Essure’s benefits outweigh its risks and disregarding the appropriate warnings that accompany the device.”
The filmmakers behind the movie said, “The truth is that Essure was rushed to market under an ‘expedited review,’ based only on two poorly constructed studies that weren’t randomized or non-blinded and that lacked comparator groups.”
Variety‘s Owen Gleiberman, in his review of the film, wrote, “Working alongside his producing partner Amy Ziering, [director] Dick has conceived ‘The Bleeding Edge’ as a kind of true-life sci-fi horror film that spins around the queasy theme of invasiveness. Think ‘Frontline’ meets David Cronenberg.”
Read the filmmakers’ full response:
We are not surprised that Bayer has attacked our film, which reveals the serious complications caused by its flawed implantable birth control device Essure. Bayer has a long history of maligning critics of Essure rather than addressing the harms it has caused to tens of thousands of women.
The facts set forth in “The Bleeding Edge” are accurate and have been rigorously vetted by extensive research and multiple experts.
The truth is that Essure was rushed to market under an “expedited review,” based only on two poorly constructed studies that weren’t randomized or non-blinded and that lacked comparator groups. These studies followed most participants for only 18 months, even though Essure is supposed to remain implanted for a woman’s lifetime.
We were glad to hear Bayer’s July 20 announcement that it would stop selling Essure after 2018. Until then, we urge any woman who is contemplating Essure to be fully informed of its risks.