Bayer disputed accusations in a new Netflix documentary that claims medical device makers and the U.S. FDA put profits before patient safety.
The Bleeding Edge documentary, released on Netflix on July 27, claims that the way medical devices make it to the U.S. market is lax and dangerous. The filmmakers interview doctors and patients who say they’ve been personally harmed by an array of devices — including Bayer’s birth control device, Essure.
Essure is the only FDA-approved non-incisional form of permanent birth control.
According to Bayer, “the portrayal of Essure in The Bleeding Edge lacks scientific support, despite the fact that Bayer provided the producers with extensive scientific information on Essure before the completion of the film. The film presents an inaccurate and misleading picture of Essure by relying almost entirely on anecdotes, cherry-picking information to fit a predetermined conclusion…”
The drugmaker insists that the benefit-risk profile of Essure has not changed, and says it stands behind the product's safety and efficacy.
On July 20, prior to the documentary release, Bayer announced that it had made a business decision to voluntarily discontinue sales and distribution of the Essure System for Permanent Birth Control in the United States after December 31, 2018.
Read the Bayer response