The Bleeding Edge: A Documentary Investigates the Safety of Medical Devices

The documentary The Bleeding Edge has just been made available on Netflix in the US and UK (27th July 2018). Described by Netflix as “controversial”, the documentary explores the impact and regulation of medical devices in the US.

Difficult to watch, the film builds its narrative by following the stories of patients who struggle with serious health problems that they say are caused by medical devices.

Women who had been implanted with Essure, a permanent form of birth control sold by Bayer AG, describe the health problems that they have had since the operation, including cramping, fevers, almost continual bleeding, and stabbing pain. One woman, Angie, began a Facebook page to share her experiences, and it quickly grew. According to the film, the website now has thousands of members and eleven sub-groups in different countries.

However, Bayer has responded in a recently released statement. In it, Bayer says that they want to “encourage a science-based conversation” and remind those with Essure “that the safety profile of the device remains positive and unchanged.” The statement also criticises The Bleeding Edge, saying that the way Essure is presented is “inaccurate and misleading” and is based on “anecdotes and cherry-picking.” Cherry-picked data is data that fits one conclusion, but doesn’t accurately represent all available information.

Other medical devices are also brought under scrutiny in the film, including cobalt metal hip replacements that one doctor thinks may have caused him and several of his patients neurological symptoms; a high-tech medical device used in surgery that an attorney says was used by some doctors after limited training (according to Dr Poston: “I was told it takes ten cases to get good at robotics, but […] I didn’t really begin to feel comfortable until I was at around two or three hundred cases”); and vaginal mesh that the film says has been the subject of multiple lawsuits.

The Bleeding Edge is profoundly disturbing because of its implications. If, as the film suggests, medical devices are not as well regulated or controlled as often believed, the consequences are threateningly personal. Medical devices are everywhere; the film cites Jeanne Lenzer’s book The Danger Within Us when it claims that nearly 70 million Americans have been implanted with a medical device over the last ten years.

The documentary itself has also brought attention to the industry, with high profile news sources including the New York Times, Time, and the Guardian writing detailed reviews. Amy Ziering, the producer of The Bleeding Edge, told the Guardian, “My great hope is you watch this film and then you are really, really, really careful and ask a lot of questions and do a lot of research.”

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