You may not want to know the answer to that question. A Consumer Reports investigation confirms what many patient safety advocates have long suspected: Most implanted medical devices go to market without being tested even once. Manufacturers file a few forms and pay a few thousand dollars with the Food and Drug Administration, and the product is in operating rooms in no time.
Patient advocates say it is time both manufacturers and the government are held accountable for the rush to market. The manufacturers, according to Consumer Reports, do as little as they can. In the few categories that do require testing before FDA approval is granted, the companies submit studies that lack both scope and rigor. At the same time, government rules allow the studies to suffice while safety standards that "don't make sense," as one researcher put it, remain in place.
Congress is well aware of the medical community's concerns. Last year, the Institute of Medicine recommended the FDA completely overhaul its regulatory system, if for no other reason than the current system doesn't ensure patient safety either before or after the devices hit the market.
The bill now in front of Congress, however, would leave the system in place. The main thrust of the proposed law is to speed up the process, to move medical devices from development to market even faster.
The FDA's argument is first that the system has served Americans well. Second, the agency says it doesn't make sense to eliminate one system before another is there to take its place.
The challenge for patients, then, is how to avoid becoming an unwitting participant in an unofficial, after-market clinical trial. Except, of course, the results of clinical trials are gathered and analyzed, and that isn't the case with real-life patients. One of the major challenges with the non-system is that there isn't a way for patients and their doctors -- much less the government -- to learn about problems with the product.
We'll continue this in our next post.
Source: Consumer Reports, "CR Investigates: Dangerous medical devices," May 2012