Bayer, a multinational pharmaceutical and life sciences company based in Germany, has shot back after a documentary aired on Netflix took aim its controversial birth control implant, Essure.
The implant, which is highlighted in the film The Bleeding Edge, is a non-incisional form of permanent birth control that blocks the Fallopian tubes and was approved by the FDA in 2002. The film slams the product, along with other medical implants and devices in the $300 billion market, citing stories by women permanently harmed by the device. Filmmakers also questioned the expedited FDA approval process for Essure.
The film was described as a “true-life sci-fi horror film” in a review by Variety.
According to filmmakers, more than 32,000 reports of problems or injuries were attributed to the Essure device between 2008 and 2013. As of April, Bayer faced 16,800 lawsuits related to the device.
Despite announcing it would no longer supply the product on the market after 2018, Bayer defended Essure in a “fact check” statement against the documentary.
“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,” Bayer said in a July 27 statement.
The company stated the decision to pull the product was due to declining sales in the U.S. on July 20, a week before the film was released on Netflix.
Following Bayer’s attack on The Bleeding Edge, filmmakers Kirby Dick and Amy Ziering also responded.
“We are not surprised that Bayer has attacked our film, which reveals the serious complications caused by its flawed implantable birth control device Essure,” they said in a statement. “Bayer has a long history of maligning critics of Essure rather than addressing the harms it has caused to tens of thousands of women.”
Amy joined TriMed Media as a Senior Writer for HealthExec after covering home care for three years. When not writing about all things healthcare, she fulfills her lifelong dream of becoming a pirate by sailing in regattas and enjoying rum. Fun fact: she sailed 333 miles across Lake Michigan in the Chicago Yacht Club "Race to Mackinac."