The group behind “The Bleeding Edge,” the Netflix exposé on questionable practices within the medical-device business, have issued a response to criticisms in regards to the movie’s alleged inaccuracies leveled by Bayer, the multibillion-dollar pharmaceutical large.

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“We aren’t stunned that Bayer has attacked our movie, which reveals the intense issues brought on by its flawed implantable contraception system Essure,” the filmmakers stated in a press release. “Bayer has a protracted historical past of maligning critics of Essure reasonably than addressing the harms it has prompted to tens of 1000’s of ladies.”

“The Bleeding Edge,” which debuted on Netflix worldwide on July 27, comes from from documentary filmmakers Kirby Dick and Amy Ziering (whose earlier credit embody “The Invisible Conflict” and “The Searching Floor”). The assertion on Bayer was from Dick, Ziering, producer Amy Herdy, and the remainder of the filmmaking group.

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Bayer final week accused the movie of presenting “an inaccurate and deceptive” portrayal of Essure, the birth-control implant system that’s the middle of some 16,000 lawsuits towards the corporate by girls who declare it has prompted medical issues together with continual bleeding and extreme ache. On July 20, Bayer introduced that it was pulling Essure from the market within the U.S. by the top of 2018.

The pharma large alleged “The Bleeding Edge” cherry-picked data “to suit a predetermined conclusion, ignoring the total physique of scientific proof that helps the [FDA’s] willpower that Essure’s advantages outweigh its dangers and disregarding the suitable warnings that accompany the system.”

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The filmmakers behind the film stated, “The reality is that Essure was rushed to market underneath an ‘expedited evaluate,’ based mostly solely on two poorly constructed research that weren’t randomized or non-blinded and that lacked comparator teams.”

Selection‘s Owen Gleiberman, in his evaluate of the movie, wrote, “Working alongside his producing associate Amy Ziering, [director] Dick has conceived ‘The Bleeding Edge’ as a type of true-life sci-fi horror movie that spins across the queasy theme of invasiveness. Assume ‘Frontline’ meets David Cronenberg.”

Learn the filmmakers’ full response:

We aren’t stunned that Bayer has attacked our movie, which reveals the intense issues brought on by its flawed implantable contraception system Essure. Bayer has a protracted historical past of maligning critics of Essure reasonably than addressing the harms it has prompted to tens of 1000’s of ladies.

The details set forth in “The Bleeding Edge” are correct and have been rigorously vetted by intensive analysis and a number of specialists.

The reality is that Essure was rushed to market underneath an “expedited evaluate,” based mostly solely on two poorly constructed research that weren’t randomized or non-blinded and that lacked comparator teams. These research adopted most members for less than 18 months, despite the fact that Essure is meant to stay implanted for a girl’s lifetime.

We had been glad to listen to Bayer’s July 20 announcement that it might cease promoting Essure after 2018. Till then, we urge any girl who’s considering Essure to be absolutely knowledgeable of its dangers.

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