A few weeks ago, the Institute of Medicine released a long-awaited report on how to improve the US Food and Drug Administration’s (FDA’s) thirty-year-old system for reviewing and approving medical devices like hip implants, artificial knees, and external heart defibrillators.
The current system, commonly known as 510(k), was never designed to be used for review of new medical devices in the first place.The 510(k) system was actually created in 1976 to ‘grandfather in’ medical devices and surgical implants already in widespread use but which had never been formally reviewed by the FDA.
Back then, it was expected that the FDA would create a new and robust system for reviewing medical devices. Unfortunately this didn’t happen, and the 510(k) system become the standard approach used by government regulators.
That this system is desperate need of improvement should come as no surprise to anyone who reads the newspaper regularly. The list of FDA-approved medical devices that have recently proven to be ineffective, unsafe, or downright deadly is as long as my arm … and growing.
Just this month, for example, the FDA announced that a surgical mesh commonly used to repair pelvic organ prolapse, a common condition in women, has a high rate of erosion and failure.
Up to 10% of women who undergo this gynecological procedure suffer severe complications. They often require additional surgeries to repair the damage and to remove surgical mesh that has disintegrated and become embedded in their organs and soft tissue. Many of these women are left infertile, incontinent and in chronic pain as a result.
The safety and effectiveness of this mesh in gynecological procedures like pelvic organ prolapse repair was never demonstrated in clinical trials. Originally designed to help surgeons repair hernias, this mesh is found to be remarkably safe and effective for certain abdominal procedures. This was proven in rigorously controlled clinical trials, and it underwent full FDA review and approval for that use.
But only truly new, first-of-a-kind medical devices undergo such rigorous review. Once a medical device like surgical mesh is approved for one use, doctors often ‘innovate.’ They begin to use these drugs and medical devices to treat other injuries or ailments, a process known as ‘off-label’ use. The current FDA system allows this, and most of what we consider to be standard medical practice involves off-label use.
The current 510(k) system also allows manufacturers to apply for accelerated review and approval of medical devices if they are: 1) remarkably similar to other FDA-approved devices already on the market, or 2) already approved to treat other conditions. Under this accelerated review system, device manufacturers are not required to demonstrate effectiveness or safety. For example, a manufacturer need show only that a new device is “substantially equivalent” to one already sold to gain FDA approval. No clinical trials are required.
This system does little to ensure the safety of patients. Despite this, it took over thirty years for US regulators to realize that the 510(k) system was broken, and to seek the Institute of Medicine’s advice on how to fix it. The Institute’s surprising recommendation: scrap the current system entirely and start over. Unfortunately, that probably won’t happen.
Even before the Institute of Medicine report was released, the medical device industry went on the attack. They claimed the panel that produced the report was biased, and filed a petition arguing that the FDA was statutorily barred from adopting any of its recommendations.
The truth of the matter is that the medical device industry likes the current system. It requires few medical devices to undergo extensive testing to prove that they are safe and effective. Despite this, industry lobbyists are quick to complain that the 510(k) system is onerous and bureaucratic, slowing the development of new treatments and driving up costs for manufacturers and consumers.
These complaints are, for the most part, crocodile tears. It is hard to feel sympathetic to an industry that routinely engages in unethical testing and deceptive marketing practices, all whilst posting record profits.
Sadly, the device industry’s lobbying efforts appear to have been successful. FDA administrators have summarily dismissed the Institute of Medicine’s report, reiterating their position that the 510(k) system should be reformed rather than scrapped outright. The FDA has been working more almost two years to improve the 510(k) system, they argue, and it is better to continue that process than see these efforts go to waste.
But this decision is misguided. Having read the Institute of Medicine report, I am in agreement that the current system of review is irrevocably broken. It needs to be replaced. Reforming rather than replacing the current system would be like putting lipstick on a pig.
We can make all of the changes we want to the 510(k) system but at the end of the day it still won’t provide any assurance that new medical devices are both effective and safe. We need put patient safety above government process or corporate profit when it comes to reviewing new medical devices, but the FDA and the device industry seem to have forgotten that.
[This blog entry was originally presented as an oral commentary on Northeast Public Radio on August 18, 2011. It is also available on the WAMC website .]