What Are the Unexpected Dangers of Medical Devices

Joe and Terry Graedon, People’s Pharmacy Podcast: May 24, 2018

One in ten Americans has some kind of medical device implant in their body. In a recent NPR podcast, NCHR president Dr. Zuckerman warns that the FDA standards for approval of implants are much less rigorous than for prescription drugs. Most medical devices do not have to even be proven to be safe or effective! Don’t buy into the hype about the “latest and greatest” medical product because new ones may not be as safe or as effective as the older ones. Dr. Zuckerman urges listeners to ask doctors questions about the scientific evidence that the device is good for them, and let Congress know you support better safety testing for new devices. (the podcast is 60 minutes of interesting information; Diana is featured for the last 20 minutes)



Interviewer: Well, Dr. Zuckerman, I wonder if you can give us your perspective on the scope of this problem.

It’s an almost overwhelming issue when you consider how many thousands of medical devices that there are on the market that are being sold in the United States and other countries, and that about 95% or more of them have not been required to be proven safe or effective in clinical trials. And for those who don’t know, clinical trials are studies of human beings. So you want — whether it’s a hip implant, or a breast implant, or certainly a cardiac implant — you would want to assume those have been studied in patients to make sure that they’re safe and that they work. But that isn’t the case.

Interviewer: Now, a lot of patients like the idea of new and improved, so if they’re going in for an implant, whether it’s a joint implant or maybe it’s a new mesh to repair a hernia, the surgeon might very well say, “Well yeah, yeah there were some problems 10-15 years ago, but this is the new and improved mesh, this is the new and improved hip transplant. There’s nothing to worry about the new devices. They’re much better and safer.” Can we rely on that?

Unfortunately, we can’t. I think that almost any doctor who says that believes it, but the doctors don’t realize how little research has ever been done on these new products. So it’s very important for patients to realize (and it’s very important for us as family members) to ask those questions of doctors and ask, “Well what is the evidence that this product is better than the older product?” or whether this product is even as good as the older product. And yes, we have evidence that the older product has had problems, but what’s the track record of the new device, the new and improved and more innovative device? What’s really the evidence to show that it’s been studied in human beings and that we can rely on it to be better?

Dr. Zuckerman, one thing that patients have learned over the last probably 5-6 years, maybe a little longer, that has made many people cynical is that doctors sometimes are being paid by the company, whether it is the drug company or the device company, to look favorably upon the product. Is there any way that patients can find out whether their doctors are on the payroll?

That’s such a great question, and I’m glad to say there is a way to find out. There’s a website that the government actually provides; it’s called openpayments.com. I would suggest you to put that in your search box in your computer or your phone, and go to the part where they allow you to do a search– there’s something called the ”search tool” on openpayments. You can put in the name of a doctor (you need to know what city and state they’re at) and they do ask for zip code and what their specialty is, and you can put in the name of the doctor you’re considering or doctor that you’re going to, and you will get information about where they have received money, from which pharmaceutical or device company, and how much money they’ve received by year. The one thing I have to say that’s difficult about using this is that what happens if you find out that your doctor does take money? And maybe it’s not a million dollars, maybe it’s $5,000, does that mean that the doctor’s going to make a bad decision? That they’re going to suggest a device that’s not as good as another device? We don’t know. It gives us that information but sometimes it’s very difficult to figure out what to do with it.

In summing up Dr. Zuckerman, what would you like our listeners to take away from our conversation from Jeanne Lenzer — “The Danger Within Us,” her new book — and from your research and your organization going forward?

I think the most important thing is that we really need to question. Unfortunately, it’s a little bit of a “let the buyer beware” — you can’t just assume that because a product is sold in the US and it’s got an FDA approval, you can’t assume that it’s going to be safe and effective. And you especially can’t assume it’s going to be safe and effective for you. So be a little bit more skeptical, look for the information as best you can, and also I would say think very carefully about what it means when something is advertised or promoted or described as “new” or “innovative” or “break-through.” You know, all of those terms are really public relation terms. They’re not scientific terms. […]

Listen to the rest of the podcast above or here.


Note: The openpayments.com link that Dr. Zuckerman refers to is provided by the Centers for Medicaid and Medicare (CMS).