The Bleeding Edge


When rich corporations win, we lose.

(2018) Documentary (Netflix) Stephen Tower, Anna Firmalino, Robert Bridges, Ana Fuentes, Julio Cesar Novoa, Jim Spencer, Rita Redberg, Jeanne Lenzer, Michael Carone, Gaby Avila, Peter Firmalino, William K. Hubbard, David Kessler, Janice Tower, Adriane Fugh Berman, Deborah Cohen, Rodney Evans, Angelia Clark, Bill Vigil, Kemal Malik, Diana Zuckerman, Adam Slater, Tammy Jackson. Directed by Kirby Dick

 

We take for granted that the drugs our doctors prescribe and the devices that they implant in our bodies are meant to make us well. We assume that they have undergone rigorous testing by the government agencies who are supposed to protect the consumer and of course we don’t question that the said devices and drugs won’t make things worse.

But that isn’t the case as this documentary shows. An indictment of the Food and Drug Administration which also grants approval for medical devices, the film concentrates on a loophole that has been exploited by companies that manufacture these devices (companies that included Johnson & Johnson and Proctor & Gamble) that allow them to escape any testing should the devices be based on devices that existed before a more rigorous testing policy went into effect.

The result is that this testing, which is expensive and time-consuming, is these days rarely put into effect as most companies make the case for their product are extensions of existing products. Thus things like vaginal mesh, the Essure permanent contraception device and artificial hips made of cobalt have been put in people’s bodies without any idea of how the products effect the human body long term – or even short term.

Veteran documentary filmmaker Dick illustrates his point with some pretty horrifying stories as we see the absolute worst nightmares of anyone planning to have a medical device implanted. Many of them involve the Essure, which is essentially a tiny coil which implants itself in the Fallopian tube and induces fibrosis and blockage. It was marketed as a less invasive alternative to a tubal ligation. However, many women who had the procedure complained of bleeding, intense pain, and unwanted pregnancies. In some cases, the devices came out of the walls of the Fallopian tube and embedded themselves in the uterus; in others the device splintered, leaving tiny shards shredding the walls of the tubes and uterus.

I won’t go further into the other products mentioned; suffice to say that there were adverse affects for all of them, some gruesome and others startling. In every case no testing was done, leaving those who had the devices implanted as essential test subjects, unknowing human guinea pigs. It is sobering to think that a government agency would allow it but the $200 billion medical device industry is powerful and as they say in Washington, money talks and lots of money legislates.

The film makes the point that the FDA, designed as a consumer watchdog agency, has instead morphed into a corporate advocacy agency. As tempting as it is to blame the Trump administration (and the problems at the FDA have worsened under the “astute” leadership of Scott Gottleib who has industry ties but no medical degree as past administrators have had) this has been going on for more than two decades – the Essure itself was approved in 2002.

The film is an eye-opener. Dick uses the various interviews and stories to alternate the history of the FDA to make a devastating indictment of a government agency that has been hopelessly corrupted from its original purpose. Certainly this should be required viewing for anyone who is preparing to have a medical device put into their bodies (and in the interest of transparency, my own wife is one of these as of this writing). It is also a sobering reminder that the medical industry is often far from benevolent; very often they are more concerned with profits over patients.

REASONS TO GO: The presentation is simple but effective. A movie anyone thinking about getting a medical device implanted should see.
REASONS TO STAY: It feels like a bad attempt to mimic a Disney animated movie from the 70s. The humor is pretty dumb.
FAMILY VALUES: There is some disturbing imagery.
TRIVIAL PURSUIT: A week before the documentary debuted on Netflix, Proctor and Gamble announced their Essure permanent contraceptive device portrayed in the film would be pulled from the market.
BEYOND THE THEATERS: Netflix
CRITICAL MASS: As of 8/8/18: Rotten Tomatoes: 100% positive reviews. Metacritic: 74/100.
COMPARISON SHOPPING: The Big Lie
FINAL RATING: 7.5/10
NEXT:
American Animals

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