One of the earliest notable instances in this wave of bad PR could be attributed to a 60 Minutes story that focused on transvaginal mesh from Boston Scientific. The news was limited to that program and didn’t really garner major attention, but it could be argued it was the first domino to fall.
Soon thereafter, the documentary The Bleeding Edge premiered in April 2018 before quickly making its way to Netflix. As has been discussed within MPO as well as in the Mike on Medtech podcast, the film is a scathing examination of the flaws within the medical device industry and its pathway for getting products to market. While it only highlighted a handful of medical device horror stories, it certainly put the spotlight on the industry and called attention to several manufacturers’ troublesome practices and the FDA’s oversight of those practices.
Then, about a month before the end of the year, the findings of an investigation led by the International Consortium of Investigative Journalists was released. Its reports detailed the analysis of approximately 10 years of data from the FDA and identified 1.7 million injuries and 83,000 deaths that could be linked to medical devices that had been cleared or approved for market release.
At the start of May 2019, more fuel was added to the fire. This time, the attack wasn’t as much against the industry directly, but rather an indictment against the job the FDA was doing in its mission to protect patients. I’m referring to a published opinion issued by The Editorial Board of The New York Times.
For those who haven’t read the actual statement (read it yourself at http://bit.ly/mpo190699), it presents highlights of some of the products that have caused issues for patients on a rather significant scale. Technologies such as vaginal mesh, breast implants, the Essure device, implantable defibrillators, artificial heart valves, and others are mentioned. The opinion piece then goes on to suggest potential ways the regulatory pathway to market could be improved.
The first suggestion is the subject of my focus—tightening approval standards. This is primarily tied to the 510(k) pathway. The piece refers to the 510(k) as a “ regulatory loophole” that was not meant to be permanent. It mentions that the process allows for technologies to be compared to previously released devices that could be “decades old or were subsequently pulled from the market.” It also cites an Institute of Medicine recommendation to abolish the 510(k) pathway. Finally, the opinion piece insists any device intended for permanent residence inside a human body be subject to rigorous testing before hitting the market.
While I can’t help but see validity in several points being made, I do question if some of the suggestions aren’t more knee-jerk type reactions responding to the negative news flooding the industry. There are portions of the 510(k) process that should be questioned and perhaps revised, but to abolish a regulatory review pathway that has seen tens of thousands of products enter the market safely does not seem like a practical way to address the concerns. Perhaps implantable devices that will remain in the body for the patient’s lifetime shouldn’t be allowed to go through the 510(k). Then again, what if the product is simply a revision in a family of products that address similar conditions? Does it make sense to completely retest each product in the family under a PMA, for example? Again, the process certainly can be revisited, but knee-jerk reactions should not be the answer.
There’s another aspect to this discussion—the bigger picture for medical device manufacturers and the direction in which healthcare is moving. This is a factor I’ve mentioned in previous Letters. As medicine moves to a value-based system, will medical devices that are “substantially equivalent” to another product already on the market gain any traction? If a new product offering doesn’t provide a significantly more efficient method for treating a patient by reducing the time required or improving the outcome, why would a physician or surgeon select it? Given that value-based healthcare still has not taken hold in a major way across healthcare, it remains to be seen how medical professionals will react to new “substantially equivalent” products that enter the marketplace.
For financial reasons, it may be in manufacturers’ best interests to attempt to differentiate their products from similar technologies on the market; in that effort, they just may do so enough that they’re unable to use the 510(k) pathway anyway. Perhaps that’s how the true transformation regarding device approvals arrives.
Sean Fenske, Editor-in-Chief