A Need for Removal Protocols?

Many of you have likely heard of the controversial medical device industry documentary, “The Bleeding Edge,” recently released through Netflix. If you haven’t yet seen it but you’re reading this column, put the magazine down or step away from your screen. I strongly encourage you to take the first opportunity you have to view it to see how our industry is being presented to the public in this film. In fact, I would recommend a “viewing party” at your location with your colleagues, followed by a group discussion of the presentation. (I mean, someone in the group must have a Netflix account. It’s that important for it to be watched.)

To be fair, some of the criticism is justified and many of the warts exposed in this film are not anything to be ignored. The documentary presents a number of serious industry and FDA-related issues that should absolutely be questioned and potentially revised. Further, the real people presented were harmed by medical technology, destroying their trust in this industry and in the healthcare sector as a whole. For many, lives were irreparably damaged, and that is a travesty.

As my small contribution to help bring to light the troublesome issues featured, I’m using the platform of my regular podcast, “Mike on Medtech,” to discuss many of the points revealed in the film. For those who are unaware of the show, I’m joined each episode by my co-host, Mike Drues, president of Vascular Sciences, to discuss a variety of industry and regulatory issues. For this multi-part series centered around the film, we delve much deeper into many of the points brought up in the documentary. (For anyone interested, you can find Mike on Medtech here: http://bit.ly/mpopodcasts).

The film centers around only a few specific healthcare products that resulted in extremely unfortunate medical situations once in use. Most of these are implantable devices, including vaginal mesh from Johnson & Johnson, the Essure sterilization device from Bayer, and metal-on-metal hip implants from DePuy. Unfortunately, once the problems with each of these devices were discovered, removal was quite challenging. As I watched, the thought emerged, “Should all implantable devices be required to include a removal protocol as part of their clearance/approval submission?” It’s sort of an extension or sub-section of the device’s instructions for use.

The orthopedic industry already deals with this to a degree with revision implant surgeries. That said, I brought this question up to Mike during the first part of the podcast and he provided his own insight on the topic.

“To be honest, this is one of the ideas I’ve proposed over the years, so I’m inherently biased,” explained Drues. “This topic is worthy of having a discussion on. Why? When you think about it, when you have a device that goes inside the body, we obviously have to have an implantation procedure, so why don’t we, if we need to, have a removal procedure?”

And then Mike did what he frequently seems to do when we are having a discussion—he throws me the curveball I hadn’t even considered (or otherwise, forgot) as it relates to whatever topic is at hand. “Having a removal procedure may not be a bad idea, but here’s the irony of that when it comes to the regulatory portion of it. FDA does not regulate either one. FDA cannot regulate an implantation procedure nor can they regulate a removal procedure.”

Then came the phrase I’ve now heard several times in these regular discussions with Mike. “FDA does not regulate the practice of medicine.”

So, perhaps due to the inherent nature of the orthopedic implant industry and the reality that not every implant is going to be a perfect solution for the lifetime of the patient, the current practice of needing revision surgeries negates the need for a specific removal protocol from the manufacturer. Surgeons are already fairly familiar with the procedures of removing part or all of a problematic implant and performing the necessary revision.

Regardless, I did feel it was an interesting point that arose during the discussion that was closely tied to this technology sector. Further, I’d love to hear your thoughts on the removal of implants and suggestions for what implant designers could potentially do to aid in a removal or revision procedure.

This item was just a small tidbit of subjects covered in the documentary that I found worthy of discussion. There’s much more, which again is why I encourage you to listen to the Mike on Medtech podcast series mentioned earlier. Then reach out and share your own thoughts with me concerning my comments, Mike’s points, or the documentary itself.