WASHINGTON — “The Bleeding Edge,” the new documentary from Amy Ziering and Kirby Dick, examines the medical device industry and the government approval process that has allowed an array of innovates to hit the market without a thorough safety examination.
One of them is Essure, a Bayer birth control device that is the subject of thousands of lawsuits from women who claim it caused them injury.
With Netflix set to debut the documentary this weekend, Bayer announced last week that it was phasing out the device in the U.S., but denied that it was due to concerns over safety.
“We don’t think it’s coincidental that they did it just a week before the release of the film on Netflix,” Dick tells Variety‘s “PopPolitics” on SiriusXM’s political channel POTUS. “I think they knew that the public would be outraged at the fact that they still had this product on the market.”
“The Bleeding Edge” follows a group of women who say they suffered serious injuries from the device as they seek to get the Food and Drug Administration to take action and the company to take it off the market.
“We are completely elated,” Ziering says. “It is like what you always dream of. You go down this rabbit hole and are in this horrific nightmarish scenario and you go, ‘Oh my god, could anything possibly change?’ Then you find your film, coupled with the work of these amazing advocates, has moved the needle, which is tremendous.”
The movie also probes other medical device products on the market, including metal hip replacements and a robotic surgeon called Da Vinci.
“If a multibillion dollar corporation backed down in this way, just think of the implications this has for about all the devices out there that no one knows the story about, no one knows the back story,” Ziering says.
Dick and Ziering’s 2012 documentary “The Invisible War,” about the systemic problem of sexual assault in the military, led to changes in government policy on how it treats cases of rape in the armed forces. They hope that “The Bleeding Edge” generates a reaction from Capitol Hill lawmakers to improve the scrutiny of the the medical device industry.
On Friday, Bayer issued a statement in which it said that the movie “presents an inaccurate and misleading picture of Essure by relying almost entirely on anecdotes, cherry-picking information to fit a predetermined conclusion, ignoring the full body of scientific evidence that supports the Food and Drug Administration’s (FDA) determination that Essure’s benefits outweigh its risks and disregarding the appropriate warnings that accompany the device.”
“This does a disservice to the thousands of women who rely on Essure for their reproductive health, as it may encourage them to pursue risky and unnecessary surgery to remove the device,” the company said.
Listen to the interview with Dick and Ziering here.
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“PopPolitics,” hosted by Variety’s Ted Johnson, airs from 2-3 p.m. ET/11 a.m.-noon PT on SiriusXM’s political channel POTUS. It also is available on demand.