Bayer hits back at Netflix medical device documentary
Bayer has issued a robust defence of Essure after the birth control implant was featured in The Bleeding Edge, a Netflix documentary about the medical devices industry.
The German pharma company said the film, which was premiered on Friday, “lacks scientific support” and added that the safety profile for Essure, which Bayer plans to discontinue later this year, “remains positive and unchanged”.
Bayer said in a statement: “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.”
Produced by Oscar-nominated filmmakers Kirby Dick and Amy Ziering, The Bleeding Edge investigates the US medical device industry, focusing on “lax regulations, corporate cover-ups, and profit-driven incentives that put patients at risk daily”.
In the film, a woman who received Bayer’s Essure, describes the excruciating pain and chronic bleeding she has experienced after using the implant, and several others accuse the firm of concealing information about Essure’s potential risks.
For its part Bayer said it provided The Bleeding Edge’s producers with “extensive scientific information on Essure before the completion of the film”, insisting that they chose to use “cherry-picked anecdotes”.
“The film also relies on many conflicted sources without disclosing their potential biases,” Bayer said. “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.”
Essure was approved by the FDA in 2002, when it became the first and only non-incisional form of permanent birth control.
However, a week before the release of The Bleeding Edge Bayer said it would “voluntarily discontinue” US sales of Essure at the end of this year, citing declining revenues that had made the product unsustainable.