Is the Bar for Medical Device Approval Too Low?

by Terry Bryant

The U.S. Food and Drug Administration (FDA) is moving forward with its plans to establish a new medical device approval process in early 2019 which is supposed to make new products available sooner. But a chorus of critics says this is a dangerous move for patients because it makes an already dubious approval system even more questionable.

The FDA says this process modification will require less trial research and, instead, add increased oversight after a device is introduced to the market. Its argument is that this will spur more technological innovation and perhaps help some terminally ill patients sooner.

Even if this new policy seems to reflect FDA Commissioner Dr. Scott Gottlieb’s pro-industry, deregulatory approach, which he championed before being named to his post by President Trump, loosening current approval standards could extract a hefty price in the form of higher patient mortality rates and further erosion of the public’s trust in the U.S. healthcare system.

The typical process for decades has been to thoroughly research devices through laboratory trials before bringing a product to market. It is laborious and can take longer than some may like, especially the device manufacturers which are forced to spend their money on R&D and wait long periods of time before realizing profits after protracted FDA trial periods.

The problem with the new FDA method is this: After a device  with little or no randomized controlled trial data has reached the market, companies have little incentive to do high-quality trials on their own. The theory suggests these manufacturers will ask the question, “Why borrow trouble by risking a study showing that our [stents, surgical mesh, catheters, replacement hips and knees, heart valves and pacemakers, etc.] may have problems when doctors are already using them?” This question brings up others, all having to do with the veracity of the new process and how much the public can trust the device manufacturers and, for that matter, the new “business-friendlier” FDA.

Are Doctors Becoming More Invested in New Medical Devices Than in Our Good Health?

Over the past 25 years, physicians have become much more influential drivers of the overuse of many devices and procedures. Doctors are rewarded on a fee-for-service basis. This means the more “sponsored” procedures they perform, the more they can be “paid” in the form of cash and incentives. In this environment, in spite of their best Hippocratic intentions, such programs make it more difficult for doctors to be objective caretakers of their patients’ health and well-being.

An example of this “push-pull” can be found in the fact that the FDA recently approved a new kind of blood vessel stent to relieve blockages. This type would dissolve in about three years and was developed with the thought that patients would prefer this to having metal placed inside them. And because the device makers began advertising this “new thing” immediately upon FDA approval, patients began demanding these “vanishing stents.”

But longer-term studies revealed that even though these stents were disappearing, they were actually morphing into blood clots, thereby increasing the risk of heart attacks compared with the lower risk to patients with conventional stents. The manufacturer quickly shut down the program.

It is much more difficult to study the effectiveness of medical devices than that of drugs, because most devices involve invasive procedures. Prescriptions are easier to effectively evaluate when you have a comparable control group which is swallowing a placebo.

The most important interest in protecting us from this new FDA device-approval process could be those who pay for these new wonder devices – the insurance industry. Even if the FDA approves a device, insurers can stop paying or reduce how much they do pay for it, until they have their own actuarial data which is compiled over time.

Unfortunately, some medical devices cause patients serious harm. If you or a loved one has suffered serious injuries and want a free consultation, contact Terry Bryant Accident & Injury Law to get started.