“The Bleeding Edge” review by Alex and Nate Blake

Directed by: Kirby Dick

Rated: Not Rated

Length: 99 minutes


Considering the world we live in, you probably don’t need a reality check about where we are as a country. However, if you want to feel really shitty about the state of our medical industry, this documentary is for you. This documentary focuses on the ever-growing industry of medical devices and those who have been wronged by the system. The documentary follows those who have experienced significant side effects from the permanent birth control Essure, vaginal mesh manufactured by Johnson & Johnson, and metal joints constructed from cobalt. The documentary reveals how these devices were approved by the FDA in the first place. It gives you a look into a system that benefits only those that are already on top and is just flat out dangerous for patients seeking relief from their pain.

The director, Kirby Dick, has an impressive film catalog and this is another impressive addition to the list. With hard hitting documentaries like The Hunting Ground, The Invisible War, and This Film is Not Yet Rated under his belt, Dick delivers yet another thought-provoking look into a system our society depends heavily on even though it continues to wrong those who need the its support. Beyond the subject matter alone, the film is shot wonderfully. Often times, I find the use of B-roll in documentaries to be unnecessary and distracting from the matter at hand. However, this film is wonderfully edited and the B-roll served a purpose throughout the entire run time.


Fair warning: at times this film is quite graphic. But the graphic nature is necessary in order to demonstrate the truly horrific side effects these patients have suffered. This film does a great job of weaving together a narrative of real patients, expert opinions, and hard-hitting research. I will definitely be thinking twice the next time I go to the doctor.


The Bleeding Edge is a disturbing look at the medical device industry and the FDA’s flawed approval system. I agree with Alex that this is a stunning addition to Kirby Dick’s canon that makes for uneasy viewing at times. It’s a film everyone should see. It’s guaranteed to make you angry at the FDA, politicians who promote deregulation and companies that rush medical devices to the marketplace. Dick’s main objective however is to reach those memories viewers likely have of instances where a doctor pushed a treatment on them without providing enough information. The film encourages us, when we are patients, to ask questions, get second opinions and do research. It tells us we should not automatically be encouraged when we are told a treatment is “innovative” or “state of the art.”

The narratives focus on patients who had devastating, irreversible and life threatening complications from devices that were approved by the FDA under rules that are more relaxed than those that apply to medications, food and beverages. Four recent devices found to be harmful are described by patients whose lives were altered forever by them. A doctor describes how he began suffering psychological effects after receiving a chrome-cobalt hip replacement. Several women detail how Essure, a permanent birth control device from Bayer, caused severe cramping and other symptoms. The devices later splintered into fragments when doctors tried to remove them.  All of the stories are heartbreaking, and also include that of a woman who could not have sex with her husband for eight years after receiving vaginal mesh. After doctors thought they removed most of it, fragments that were still embedded inside her cut her husband’s penis during an intimate moment. Another woman recounts how her colon began sliding out of her body after she had a hysterectomy that was performed using the Da Vinci Surgical System.


Inter-cut with these patient stories are interviews with medical experts, including those who worked for the FDA and were pressured to keep quiet about potential issues with various devices. Dick also relies heavily, as he has in the past, on graphics and text. I was happy to see that he uses the former with a little more restraint than he did in The Hunting Ground. All of it adds up to a very damming indictment and an incredible viewing experience. Here is a director who cranks out documentaries at a fairly rapid pace, and yet they never seem like the same film. There are trademark flourishes of course, but unlike Michael Moore, Dick doesn’t seem to hit the same beats every damn time. This is one of the most difficult to watch films of the year, but also one of the most important. Miss this at your own risk.


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