The Bleeding Edge

By

Leonard Zwelling

https://www.nytimes.com/2018/07/26/movies/bleeding-edge-review-medical-devices.html?smprod=nytcore-ipad&smid=nytcore-ipad-share

And you think the drug companies are corrupt.

Check out The Bleeding Edge directed by Kirby Dick, a documentary about the medical device industry, its oversight (or lack thereof), and who is making money off the patients, despite the large number of these people being harmed by the devices.

The primary focus of the documentary, available on NetFlix, is Essure, a small metal coil that was designed to be inserted into the fallopian tubes in an office procedure. The devices create an inflammatory response and functionally sterilize the recipient. That’s the purpose of Essure—to sterilize women who no longer wish to have children.

The film documents the huge complication rate with the device and the network of victims who establish a Facebook community, lobby Congress and eventually get Bayer and the FDA to withdraw Essure from the market as of the end of 2018.

Other devices touched upon in the film are the metal-on-metal hip implants that caused cobalt toxicity as the artificial joints leaked metal into the systems of the implantees. And there’s the vaginal mesh which has resulted in myriad numbers of law suits (check any cable station any time of day for the ads from the mesh lawyers) also comes under scrutiny, mostly because it was never really tested for use as a vaginal support and repair device before the FDA approved it using the 510(k) process which allows the approval of any device that is similar to another approved device, even if the approved device has since been taken off the market.

Finally, the DaVinci robot comes under scrutiny, not because it harms people, but because surgeons are inadequately trained in its use and they harm people. Apparently there was a huge number of complications from DaVinci hysterectomies that probably was caused by the fact the needed training on the device was not obtained by the operators. I actually explored this one on my own several years ago when it came to removing cancerous prostates. My guide at the time, a highly skilled and experienced surgeon, thought that at least 50 procedures were needed before competence is acquired. It is not at all clear that the robot actually improves overall outcomes from invasive surgery. It is pricey though.

Proton therapy was not dealt with in this documentary, but could have been. My guess is that many of the devices that are currently on the market are no better than older ones, and may be riskier. I am quite certain that few of them have undergone the rigorous testing to which we have come to expect the drugs we use have been subjected.

This is a chilling film because it makes the generalization less important than the personal stories of hardships that patients have had to endure at the hands of doctors, the FDA and the device companies.

So much conflict. So much interest, but so little of that interest is in the well-being of the patient.

Leonard Zwelling