February 14th, 2011
06:09 PM ET

Testing was lacking in most recalled medical devices

Most of the 113 medical devices recalled by the FDA from 2005 to 2009 for serious or life-threatening hazards were not subjected to the Food and Drug Administration's more stringent approval process, known as "PMA", or premarket approval, according to a review of the FDA's recall data.

Instead, they were cleared using the 510(k) process, which is less extensive and does not require clinical testing. For consumers, that means some cleared products including artificial hip joints, heart valves, and automated external defibrillators (AEDs) were marketed and used on patients without being tested beforehand.

"Like most Americans, I just assumed that medical products could not be sold in this country unless they were proven safe and proven effective in carefully conducted scientific studies in human beings," says Diana Zuckerman, president of the National Research Center for Women and Families. "And it's just not true."

The FDA classifies medical devices as being in one of three classes, ranging from Class I devices like tongue depressors to Class III devices such as automated external defibrillators, or AEDs. FDA policy states that all Class III devices must go through the premarket approval process, which includes clinical testing, so that there is "sufficient valid scientific evidence that provides reasonable assurance that the device is safe and effective for its intended use or uses." Yet a 2009 Government Accountability Office report found that 66 percent of Class III devices were approved using the "less burdensome" 510(k) process, instead. That means the devices  had to be shown only  to be similiar to other devices already on the market but did not have to be tested.

Zuckerman and her team found that among the 113 medical devices that were recalled from 2005 to 2009 for posing serious public health risks, a whopping 71 percent were cleared via the 510(k) process.

"Things that we all take for granted – like a heart valve, we say 'they must be safe or you couldnt sell them,'" says Zuckerman. "But many of them are not being tested scientifically on human beings before they were sold."

The reason for that, believes Zuckerman, is that the FDA lacks the necessary staff and funds to study every implanted medical device with a clinical trial. While a device's manufacturer pays for some of the costs associated with a PMA approval, most of the burden falls to the under-funded FDA. Approving a device via the 510(k) process is a much less expensive endeavour.

For its part, the FDA has acknowledged that its 510(k) approval process needs to be strengthened. The government agency established a 510(k) Working Group last year to and in a statement to CNN, wrote that it "intends to take 25 actions to improve the 510(k) program in 2011." The agency also says it is "evaluating all remaining Class III 510(k) devices...for either down-classification to Class II or to require PMAs." Plus, last year the FDA asked the Institute of Medicine to conduct its own review of the medical device approval processes. That report is expected to be completed by mid-year.

So what does all of this mean for consumers? Is there any way patients can go the extra mile and ensure that the device being used on them doesn't pose any serious health risks and has been adequately tested?
Zuckerman says the answer is unfortunately, no.

"I can say from personal experience, really there isn't much you can do," she says. "But what we can do as a country is ask members of Congress to strengthen safeguards."

Zuckerman's study can be found in the current issue of the Journal of the American Medical Association's Archives of Internal Medicine.

soundoff (56 Responses)
  1. truth

    In the first half of the article the process of non PMA approval is referred to as a "501K". In the second half of the article, the author get's it right and the process is listed as "510K". Quite clear that the author or editor is not familiar with this process. I routinely find errors in many, many CNN articles. Poor spelling and syntax are pervasive. You know back in the day, editors were good at what they did and they held writer's feet to the flames. I could easily spend my day editing for you guys, maybe then your articles will take on the look of a polished product and not a blog from some dude in his mom's basement. Dissapointing that a news organization can not get the very basics right on an given day.

    February 14, 2011 at 18:48 | Report abuse | Reply
    • Jen

      Or as some like to say ... disappointing.

      February 15, 2011 at 09:36 | Report abuse |
  2. Jason

    You can indeed. In a planned surgery, you can always tell your provider you want a PMA-only tested class III device. The implant rep (who can be contacted day or night) will be able to provide testing information for the product. Note, however, that non-Class III devices will not likely have PMAs done. Also, surgeons have experience with certain devices which they prefer, so the exac device you desire may not be familiar to your surgeon. In that case, you would need to weigh changing caretakers or changing equipment preference, whichever is more important to you.

    February 14, 2011 at 19:24 | Report abuse | Reply
  3. Ray Montgomery

    First, the article did not say that anyone was harmed during the study period of 4 years. Only that "serious or life-threatening hazards" were found. I assume we can add the word "potential" to that phrase. Second, the article did not say how many people's lives were saved by products that got to market sooner than the typical 10 years it takes for the PMA process. Also note that since the 2007 PDUFA that provided new funding through user fees, the approval rate of the FDA has gone down. Apparently giving the FDA more more money will only ensure that no new life-saving treatments will become available.

    February 15, 2011 at 01:32 | Report abuse | Reply
    • Lizabeth M.Temple, Esq.

      Hundreds of lives have been lost and hundreds of people have been "harmed" by the FDA's continual and long time practice of "short cuts" and rush approvals. The FDA frequently bends to the pressure of manufacturers and drug companies who wish to rush their products to market to begin earning profits before the next guy gets there. Has everyone forgotten about Thalidomide, Oroflex, and the hundreds of drugs that killed due to rush approvals based upon manufacturer's "manufactured" test reports? This is why Lilly's CEO and two top corp. officials WENT TO JAIL for refusing to recall Oroflex that killed people. Here's just one example of how ineffective and useless is the FDA. The FDA CANNOT RECALL ANY PRODUCT, DEVICE, OR DRUG ON THEIR OWN! THEY DO NOT HAVE THE AUTHORITY. ONLY the manufacturer can recall their own products. Is there any wonder why they delay? They can make millions just by delaying a recall for two months while even more lives are lost. What kind of a governing deparatment can the FDA be without any authority to recall? It's so outlandish that it's a joke! LEAVE THE POLICING UP TO THE BUY WHO MAKES THE PRODUCT? The FDA is far too broken to be fixed. Like the USDA, it needs to be abolished and re-created. It's hopelessly and dangerously behind the times, and rife with corruption.

      February 26, 2011 at 09:34 | Report abuse |
    • dom625

      Yes, hundreds of people have been harmed/died from these devices, but an exponential number of people have been saved by them. Americans are of the instant-gratification frame of mind; they want things *now*. And that includes medicine and medical care. The fact is that no matter how much testing a product goes through, there will always be side effects and possible negative outcomes. It is up to the patient and his/her doctor to determine whether the possible risks negate any benefits.

      March 9, 2011 at 11:42 | Report abuse |
  4. Tina

    Nobody was harmed? Try having to have hip revision surgery because your 9 year old prosthesis breaks! It's horribly painful and almost 2 years later, I still have a limp and pain.

    February 15, 2011 at 07:09 | Report abuse | Reply
  5. Jim

    This article is incredibly misleading; to imply that medical devices released via 510(k) are 'untested' is just absolutely false. Even the 510(k) process requires structured, detailed testing and the FDA frequently denies applications for more testing. If every device required an individual PMA, it would drastically increase the cost of medical devices and in case no one has heard, our health care system is already the most expensive in the world. The last thing we need is more red tape in order to get products to market. This is a truly infuriating article for anyone employed in the medical device manufacturing or R&D industry. Shame on CNN.

    February 15, 2011 at 08:20 | Report abuse | Reply
    • Sarah

      Good point, Jim, and the best way to ameliorate the cost of the American healthcare system is to get people to make choices that will NOT lead them to needing faulty stents to begin with. We both know that's not going to happen any time soon, so I think the FDA must step up. We can run over a breast implant with a bulldozer and if it doesn't break we call it safe. Put it in a human–warm, moist environment with multiple stressors–and it disintergates and leaks. I'm not sure the 510k is adequate.

      February 15, 2011 at 16:18 | Report abuse |
  6. MD

    I agree with Jim – this article is unbelievably one-sided. A 510(k) undergoes rigorous testing prior to clearance, and FDA reviews these devices with the same scientific rigor as a PMA device. The reality is that a very small minority of devices (or drugs, for that matter) cause unforeseen problems that are not detected during the submission testing and review process. Clinical trials that are large enough or long enough in duration to detect such problems are simply not practical, which is why the FDA requires post-market surveillance on all products. The irony is that if a life-saving device was not available in a time of need due to a longer review process, publicity hounds like Ms. Zuckerman would be the first in line at the plaintiff's bar.

    February 15, 2011 at 09:03 | Report abuse | Reply
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  8. Sarah

    I think the point of the study was to reveal truth about FDA testing regulations. If they don't work properly, fix them, so that we won't have to deal with faulty devices. It's not right to put the onus on the consumer (in this case patients) to verify the safety and efficacy of a stent or a hip replacement. We created the FDA to hold manufacturers accountable. If they are underfunded and disorganized, let's fix it.

    February 15, 2011 at 16:07 | Report abuse | Reply
    • Lizabeth M.Temple, Esq.

      Short and to the point and very well said. Thank you.

      February 26, 2011 at 09:42 | Report abuse |
  9. Jim

    I just cannot agree that more testing is really the answer. Sarah, you touched on the crux of the issue previously by stating that you truly CANNOT guarentee the safety and efficacy of every device 100%. As draconian as it sounds, there will always be failures and the only way to prevent them 100% is to outlaw medical devices. There are too many variables to account for. Proving equivalence in a statistically significant manner is a viable way to bring a device to market which will work for 99% of the people – there are too many variables to be perfect. Having said this, I agree with another thing you said Sarah: we should focus on solving the problems before a stent or new hip is necessary! Even though that would put those of us in the medical device industry out of business, it is a much more elegant solution to all of these problems.

    February 16, 2011 at 10:29 | Report abuse | Reply
  10. Jim A Different One

    I agree with Jim and MD
    What makes this “study” so inaccurate is that it (obviously and intentionally) ignores the percentage of devices that are approved by the processes. The vast majority of devices are cleared through the 510(k) process (about 47,000 versus 2800 for PMAs, since 1998). When you look at the percentages, recalls for 510(k) devices are lower than those of PMAs. One study shows 0.16% for 510(k) devices versus 0.85% for PMA devices.
    There have been other studies with similar conclusions. PMA devices are more risky so a direct comparison is not necessarily fair but 0.16% is a low percentage and it is hard to imagine that more regulatory oversight would reduce it.
    The implication that 510(k) device require little or no testing is absurd and ridiculous.
    There are many, many other things that are wrong the in the study. There is a nice analysis of the problems on AdvaMed’s website http://www.advamed.org somehow they limited their analysis to 6 pages.
    I am shocked that “Archives of Internal Medicine” would publish such drivel. Less shocked that CNN, WSJ, NYT, CBS and others would blindly regurgitate it. Whatever happened to journalism?

    February 17, 2011 at 15:45 | Report abuse | Reply
  11. Robert Mostow

    Don't forget...numbers and statistics are, in actuality, people. Just because a device is approved does not mean it is effective, nor does it mean that it is safe. Watchdog groups such as this one are our only hope against mega-businesses that put profit before performance. Going to advamed for an "unbiased report" is like asking the fox what it feels about being given the keys to the henhouse. My hip has been hurting for a couple of months. I'm going to take some Advil now.

    February 27, 2011 at 19:33 | Report abuse | Reply
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  14. Bad Patient

    Now he's trying to tell us that radiation is not a dirty word. I went through radiation and I assure you it's still a dirty word. I'm not convinced that I needed it (but whoever sells these machines lies to them and makes them believe this stuff is saving lives...mostly they are getting their machines paid for...at the expense of my life. I don't appreciate that. And they shouldn't be required to lie to people like they do.

    March 25, 2011 at 08:58 | Report abuse | Reply
    • Bad Patient

      I don't believe for a second that my doctor believed what she was saying to me when she told me that if I only have the lump removed, I "have to have radiation...that's the rule". Her eyes diverted to the ground. I believe she knew full well that she was lying to me. And probably thought she would lose her license if she didn't. Medicine is a business. By having radiation as I was told that I have to...I eliminated a choice to just have the lump removed if I got another one. The quality of my life definitely declined after radiation. No lung power...possibly hit my heart.

      March 25, 2011 at 09:03 | Report abuse |
  15. Bad Patient

    They recalled my Mom's pacemaker after it was installed. I'm not convinced she really needed it. Possibly dehydrated and highly likely that she is allergic to corn.

    March 25, 2011 at 09:06 | Report abuse | Reply
    • Bad Patient

      The quality of her life has declined dramatically as she went to doctors also. Shoe-boxes full of pills. She is all over the place just dealing with the drug interactions.

      March 25, 2011 at 09:11 | Report abuse |
  16. Bad Patient

    They put the wrong sized heart valve in my mother in law. The quality of her life dropped to the point that she died. (The FDA is like the kiss of death...more reason not to believe what they are saying...like they are protecting the industry, not the actual humans.)

    March 25, 2011 at 09:08 | Report abuse | Reply
  17. Bad Patient

    Health care in the US is a crock. It's set up for them to make maximum dollar. People would do better to pitch the lousy food and water supply that we have and all of these agencies that are supposed to be protecting us and start over. The actual humans need someone on their side and we would have to start our own agency to do that (EWG?), but don't we already pay taxes for that? so...we would have to pay twice to get actual protection for that actual humans.

    March 25, 2011 at 09:15 | Report abuse | Reply
    • Bad Patient

      They use our money against us.

      March 25, 2011 at 09:15 | Report abuse |
  18. Bad Patient

    We are nothing to corporations anymore. if you have money...they will figure out how to get every last dime...and if you have a house they will go after that too. (nobody has a house anymore...so they will just throw us away) does it bother anyone that they can look at your bank account first? are wealthy people sicker? (yes, according to studies...that tells you something)

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