The film from Oscar-nominated documentary filmmakers Kirby Dick and Amy Ziering (“The Invisible War,” “The Hunting Ground”) investigates the $400 billion medical-device industry, “examining lax regulations, corporate cover-ups, and profit-driven incentives that put patients at risk daily,” according to a Netflix description.
Bayer, in a statement issued Friday, said the film “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 [FDA’s] determination that Essure’s benefits outweigh its risks and disregarding the appropriate warnings that accompany the device.”
Netflix reps did not respond to a request for comment.
Bayer currently faces more than 16,000 lawsuits in the U.S. related to Essure by women who claim the implants caused injuries such as excessive bleeding, abdominal pain and allergic reactions, according to the New York Times.
Last week, Bayer announced that it would discontinue sales and distribution of Essure in the U.S. at the end of the year. The company cited declining interest in Essure among women, which it attributed to factors including decreased use of permanent contraception overall, as well as negative publicity about the device including the accounts in “The Bleeding Edge.”
“The Bleeding Edge” launched on Netflix on Friday (July 27). Bayer said its critique of the film is based on a review of the film’s premiere at the Tribeca Film Festival in April.
In the film, one of the women who received an Essure implant, Ana Fuentes, describes excruciating pain and chronic bleeding she has experienced because of the device. Eventually, because of her medical complications, she was no longer able to work or pay her rent and was forced to place her four kids in foster homes.
Essure was approved under the FDA’s Premarket Approval program for medical devices in 2002. “The Bleeding Edge” includes video footage of the FDA’s approval hearing for Essure, revealing that the agency panel’s questions about the safety of the product are barely addressed.
“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,” Variety‘s Owen Gleiberman wrote in his review. “Think ‘Frontline’ meets David Cronenberg.”
According to Bayer, the company provided the producers of “Bleeding Edge” with “extensive scientific information on Essure before the completion of the film.” The pharma giant also alleged that several sources interviewed for the film have potential conflicts of interest that are not disclosed. The movie “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,” Bayer said.