Vesna Janic

The Bleeding Edge and 510k approvals

A couple of nights ago I watched The Bleeding Edge on Netflix. It’s a documentary about medical devices, or rather about side effects of medical devices. If you have not seen it yet, I recommend viewing it.

The documentary covers several devices: robotic laparoscopic surgery, metal-to-metal hip replacement, gynecological application of mesh, and birth control.

To say at least, the film is deeply disturbing and pictures the entire medical device industry and FDA as villains. Filled with patient interviews, the stories are tragic and devastating for whole families. Normal lives are destroyed forever.

As a woman, I was deeply touched by the testimonials about Essure –permanent birth control (female sterilization) by bilateral occlusion of the fallopian tubes (blocking the fallopian tubes). I can’t even imagine the pain and suffering that these women endure! Whole families destroyed… However, during the entire documentary, I did not hear one single thing about the other side.  How many women did not have any side effects and improved their lives with this device?

We have to remember that 510K cleared medical devices are clinically proven to actually improve patient outcomes and even save lives. Most of us have been exposed to medical devices. I have several dental implants – and I love them! However, I am sure there are patients with bodies that have rejected dental implants. Should we stop approving devices that may have side effects?

On July 27, 2018 Bayer responded to the release of documentary with a long memo defending the safety and efficacy of the Essure: “The full body of scientific evidence, clinical trials and more than two decades of science and real world clinical experience continues to support the positive benefit/risk profile of Essure and its strong efficacy of 99.3% in patients who chose to rely on Essure for birth control.”

I have always been fascinated by the power of statistics; 99.3% sounds great. As a quality and regulatory professional I would think that is an outstanding outcome. But I still feel for patients that fall into 0.7% with side effects that could ruin their life permanently. I do question – depending on adoption of the device – how many thousands of patients that end up with side effects are morally and ethically acceptable? I am curious to hear what you think.

Vesna Janic is a Director of Quality/Regulatory at StarFish Medical.   She uses her expertise in quality systems and regulatory compliance to guide our QA/RA team and help clients avoid wasting time on their path to market.

Photo credit: Netflix

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