There has always been tension between the three groups involved in the sale, use and oversight of medical devices in the United States. While manufacturers, consumers and the federal agency that oversees the development and approval of devices share many goals and concerns, each also has its own agenda. That can prompt conflict among them. Usually, those concerns simmer out of view. No more. An aggressive, well-funded and increasingly successful push from the medical device industry to promote its interests in Congress is making the conflict far more public.
Their goal is straightforward, and self-serving. The makers of devices as varied as artificial joints, coronary stents, assorted plates rods and screws, pacemakers, artificial eye lenses and surgical mesh want to simplify government oversight of product development. The reason is mercenary. Quicker approval means manufacturers can develop and sell more products. That means more money for them. And there's a lot of that involved.
U.S. medical device companies already take in about $85 billion a year, mostly from sales of devices that are implanted into patients. Physicians who implant the devices, and hospitals and surgery centers where the procedures take place, benefit as well. A lot of that money is honorably earned. There's no doubt that many of the devices save and extend lives and improve an individual's quality of life. That's not always the case, though.
A few simply don't work or are no more efficacious than less invasive and more cost-effective treatments. A recent study, for example, indicated that up to 15 percent of recent cardiac stent procedures in the United States were either unnecessary or appeared to be of uncertain medical benefit. Moreover, the number of implant device recalls is growing. The most recent involves the possible recall of tens of thousands of hip joints.
Those are reasons enough to avoid quickly green-lighting industry promoted changes to a federal oversight process that serves the public despite a few flaws. Improving rather than junking the current system is the better option.
Consumer protection groups and other advocates for patient safety have tried to make that case to Congress. They've had little luck.
Bills before Congress or in the legislative pipeline would change the mission statement of the Food and Drug Administration to a more industry friendly standard; would allow outside reviewers to join government agencies in the approval process; and would loosen conflict-of-interest rules for those involved in safety reviews of medical devices. Conversely, a useful, patient-friendly bill that would create an identification system to help in the recall of unsafe devices has stalled, the obvious victim of considerable pressure from industry forces. More balance is needed.
There's nothing wrong with getting useful medical devices to market faster than is currently allowed, but only if it can be done without eroding safeguards that help protect patients from the serious, even life-threatening consequences that occur when a device does not work. At the moment, though, the industry seems intent on sacrificing the latter in pursuit of higher profits. Congress should not abet that effort by purposefully mixing politics and medicine.