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Tag: Medical device

  • Beware of medical devices that the FDA has recalled

    Beware of medical devices that the FDA has recalled

    David Hilzenrath reports for KFFHealth News on how defective medical devices end up remaining in use. Even when the FDA sends out notices about medical devices that can cause serious injuries or even death, physicians might be using them. Inexplicably, manufacturers and the FDA do not end their use or effectively recall them from use.

    In most cases, when an agency recalls a product, be it food or an automobile or a crib, it asks that customers return the product to its place of purchase for repair or to discard it. But, an FDA medical device recall does not mean that the product is actually recalled. Rather, a recall could mean something other than an end to a product’s use. It can mean a fix of some sort, be it a repair or adjustment or inspection of a device.

    In one case, Abbot, a medical device manufacturer, explained that instead of removing a defective implanted medical product from the market, it changed instructions on how to use it and required physicians to get training before implanting it.

    Of 338 medical device recalls between 2019 and 2034, 164 were “corrections.” Only 174 products were actually taken off the market. When it does not remove a medical device from the market, the FDA says it is because the frequency or severity of the bad consequences from the product is not great or that the fix is effective and the benefits to patients are greater than the loss of the product.  To be sure, there are risks from removing implanted devices from patients.

    The takeaway: Be sure to look into any medical device your doctor recommends before agreeing to it. I have reported several times, including here and here and here, on dangerous medical devices that the FDA has failed to remove from the market, to the detriment of patients, allowing manufacturers the ability to “fix” the defects at some risk to patients.

    Here’s more from Just Care:

  • Dr. Oz’s heart valve: A cautionary tale about medical devices

    Dr. Oz’s heart valve: A cautionary tale about medical devices

    Dr. Oz proudly endorses an implantable heart valve that he had a role in inventing, which won FDA approval in 2013. Yet, David Hilzenrath and Holly Hacker report for KFF Health News that the valve might be hurting more people than it’s helping. Overall, the FDA does a poor job of monitoring medical devices on the market and warning people of malfunctions.

    MitraClip, the brand name for the heart valve, is intended to allow patients to avoid open-heart surgery. It could treat tens of thousands of people with mitral regurgitation, a condition in which blood flows backwards through the heart. But, thousands of people have reported that it often doesn’t work and can harm patients. Eleven hundred people have died from the device, according to FDA records.

    The MitraClip is manufactured by Abbott and costs $30,000. As of 2019, it had been inserted in 200,000 people worldwide. And, Dr. Oz has received hundreds of thousands of dollars in royalties from the MitraClip. Yet, one FDA outside adviser said that the data showing clinical benefits of the MitraClip was “poop.”

    In March 2013, the FDA reported to its outside advisors that “approval is not appropriate at this time as major questions of safety and effectiveness, as well as the overall benefit-risk profile for this device, remain unanswered.” In a close vote, the majority of the committee determined that the MitraClip was not effective, but they overwhelmingly thought it was safe and risks were minimal as compared to benefits. And, the FDA approved the device shortly thereafter for a limited group of patients.

    Since its approval, the FDA has recalled MitraClip products three times. One recall warned of “potentially deadly consequences,” but Abbott continued to promote the MitraClip. A pending lawsuit claims that Abbott illegally persuaded doctors and hospitals to use the device. How did the FDA allow this device get to market?

    Bottom line: You should not trust the FDA to protect you from medical devices that are unsafe. The FDA acts extremely slowly and, in some cases, does not act in the interest of Americans. Consequently, thousands of patients are harmed or die needlessly. The FDA and Abbott continue to say that the MitraClip is safe and effective.

    Here’s more from Just Care:

  • Medical device corporations and physicians harm patients through artherectomies and gouge Medicare

    Medical device corporations and physicians harm patients through artherectomies and gouge Medicare

    The New York Times reports that Medicare’s outpatient payment system has led to many people receiving unnecessary and often harmful medical procedures. Medical device manufacturers receive millions of dollars from Medicare to cover the devices used to perform artherectomies, a medical procedure intended to open up blocked arteries in people’s legs. But, people can lose their legs as a result of this procedure.

    In one case, a patient had a wound on her foot and ended up having her leg amputated after 18 procedures “to improve blood flow” over a year and a half.  According to one insurance company, 45 people who received this treatment in the last four years lost a leg.

    The doctor who performed the surgeries on people with peripheral artery disease received payments from medical device companies. Peripheral artery disease leaves plaque in people’s arteries that can stop their blood from flowing. But, peripheral artery disease is usually symptom-free and does not need to be treated.

    People with peripheral artery disease can improve their conditions with exercise and blood-thinning medicines rather than surgery. It is common for them to also have heart disease or diabetes, which are risky conditions. Treatments include insertions of stents or balloons into the arteries. They also include atherectomies, which involve cutting out the plaque. But, artherectomies are risky and can lead to amputations. Even so, more people are getting these surgeries.

    Why are artherectomies more common than they should be? Money. As of 2011, Medicare pays physicians thousands of dollars for artherectomies in outpatient settings. So, medical device companies have a financial incentive to design devices physicians can use for these surgeries. Medical device companies help train physicians to use their devices, as well as how to get loans to pay for them, and how to bill for their procedures.

    Medical device companies also often reward physicians who use their medical devices when they perform artherectomies. Not surprisingly, artherectomies are costing our health care system $2 billion each year.

    Is there good evidence that artherectomies can be beneficial? Not a lot. They can inflame people’s arteries and worsen their conditions. Lifestyle changes,, such as quitting smoking and exercising are often what’s needed to treat peripheral artery disease.

    What’s the FDA’s role? The FDA tends to approve new medical devices without evidence that they are beneficial. So long as the medical device manufacturer shows that they are “similar” to other devices, the FDA approves them.

    What’s the government doing? Too little, too late. Sometimes, the government imposes small fines on physicians. In May, the Justice Department sued one physician for performing several hundred unnecessary procedures. Who knows how the suit will be resolved.

    Here’s more from Just Care:

  • What’s wrong with market innovations in health care?

    What’s wrong with market innovations in health care?

    Our government counts on market innovations in health care. It also allows companies to abandon these innovations as they please, with little concern for the harm it can cause Americans who depend on them. In an op-ed for Stat News, Claudia Jazwinska explains how the health care marketplace and our government can fail Americans who rely on health care innovations.

    Thousands of different implantable devices are in use around the globe, helping people. But, market pressures mean that these devices might not be reliable over the long-term. For example, hundreds of Americans rely on an implanted medical device in order to see. The Argus II is a retinal implant. But, its manufacturer, Second Sight, has stopped manufacturing it to avoid possible bankruptcy.

    When Second Sight discontinued the Argus II, people using it were left without vision and with an extremely expensive implant in their brain. They had no clue whether the device should be removed and, if so, who had the skills to remove it. They were left at serious risk because they had opted to use cutting edge technology, and the government did not step in to protect them.

    No one wants to inhibit meaningful innovation, which regulation can do. But, people who rely on medial innovations also need protections.

    The National Institutes of Health is continuing to support research from Second Sight even though it failed to continue the Argus II. The NIH is not supporting the patients who relied on its implantable device. It does not seem concerned about investing in companies that are not able to continue to service innovations that Americans rely upon them.

    Jazwinska asks why does our government allow companies to sell costly devices to Americans and then abandon them, especially when these devices are implanted into their bodies? At the very least, companies should be held accountable for doing so. Isn’t it negligence or malpractice to leave these people in the lurch?

    One solution would be to require these companies to make their proprietary devices open-source if they are discontinuing them. Other companies should be allowed to replicate them. Americans should not bear the burden of a company’s inability to continue a valuable technology.

    Here’s more from Just Care:

  • FDA hides information on deadly heart pump and threatens patient safety

    FDA hides information on deadly heart pump and threatens patient safety

    Neil Bedi reports for ProPublica on the FDA’s failure to protect patient safety in allowing a sometimes deadly heart pump to remain on the market and a new congressional investigation of the FDA. The FDA has let a number of unsafe products remain on the market after being made aware of grave patient safety issues with them, hiding information from the public. Never allow any device to be implanted in your body or the body of someone you love without first learning how long it has been on the market and your options.

    The HeartWare Ventricular Assist Device, HVAD, which is intended to help people with severe heart failure has not met federal standards since 2014. Because the FDA did not act to take it off the market, thousands more people received the device.

    At least 3,000 people with the device are known to have died because of it. In some cases, its pump was faulty. In others, it simply would stop working. Finally, in June 2021, Medtronic stopped marketing it.

    Why didn’t the FDA intervene if it truly believes that patient safety is its “highest priority?” Why didn’t it notify doctors, patients and other federal agencies about the safety issues with the device? Medtronic claims that 90 percent of patients now know it was discontinued.

    Around 2,000 people still have this HeartWare pump. And, they are likely stuck with it because it is extremely risky to remove it. It requires surgery.

    While you might not be able to find evidence on malfunctions with medical devices, it’s a good rule of thumb to ensure a device has been in use for at least a decade. Usually, serious problems come to light by then. You should also talk to your doctor about known side effects.

    Here’s more from Just Care:

  • Beware of faulty medical devices

    Beware of faulty medical devices

    Do not think that the medical device–be it an artificial hip, a pacemaker or mesh–your doctor proposes to implant is safe because the Food and Drug Administration (FDA) has approved its use. As I’ve written before on Just Care, there is a fair chance that you could be at serious risk. Fred Schulte reports for Kaiser Health News on the 28,000 lawsuits against medical device companies for selling faulty products, misleading providers about their products, failing to disclose product defects as required by law, paying physicians illegal kickbacks, and more.

    You rarely read or hear about medical device companies, but many are multi-billion dollar businesses. Like pharmaceutical companies, they are operating in a health care market that allows them to charge exorbitant prices for products that sometimes add little value or worse, cause serious harm. Despite the need for a more stringent FDA approval process of certain devices and a registry to ensure awareness of dangerous medical devices, the industry has done a brilliant job of keeping this from happening.

    One reason dangerous devices are in use lies with the FDA’s approval procedures. It allows medical device companies to design and distribute many new devices without testing. If they are substantially equivalent to another product already approved, they do not need to go through an approval process. But, the line between substantially equivalent and different enough as to be defective is blurry.

    It’s also often hard to know whether a device is safe even though there is a public database that is supposed to store information about faulty medical devices. The problem lies with the FDA, which also keeps a private database of information on medical device malfunctions and injuries that for some reason it does not deem fit for the public database. It literally keeps hundreds of thousands of incident reports secret. Consequently, doctors keep using these dangerous devices–artificial hips, pacemakers, mesh, etc.–on unsuspecting patients.

    And, physicians often rely on medical device salespeople when implanting a device. They often work in tandem with medical device salespeople to learn about them. While that might make sense in theory, it can be harmful to patients if the physician is not super sure of what he or she is doing. The sales reps are not legally required to have medical training or credentials.

    In one case, a surgeon relied on a Life Spine rep’s assurance that the surgeon would have the implants he needed mid-surgery to address a spinal issue, but he did not. The patient is claiming that, as a result, the surgeon implanted the wrong device and she suffered physical harm. Meanwhile, Life Spine, the sales rep and the surgeon are pointing fingers at one another, refusing to take responsibility for the harm.

    It’s still not possible to do the needed research to determine the frequency with which implants cause harm or which implants are dangerous. It’s also not possible to know which implants are the safest. A public FDA website at which reports of serious injuries from a medical device are posted has the following caveat: It could include “incomplete, inaccurate, untimely, unverified, or biased data.”

    Now, six multi-district federal cases have consolidated the more than 28,000 patient suits charging that medical devices caused injuries. For the health and safety of Americans, the federal government should be putting in place a smart and wholly transparent way to track injuries, a more robust approval process for devices, and a means of removing defective products from the market swiftly.

    Here’s more from Just Care:

  • Medical device company gouges hospitals that use its surgical robot

    Medical device company gouges hospitals that use its surgical robot

    Intuitive Surgical, a medical device company, has profited handsomely from the sale of its surgical robots to lots of hospitals. Still, most of the enormous revenue it generates comes from its super expensive maintenance services and replacement parts. Hospitals are now suing the company for using its monopoly power to price gouge.

    Franciscan Health, based in Indiana, and Kaleida Health, based in New York, are two hospital systems that have brought class action lawsuits claiming that they have no choice but to buy maintenance services and replacement parts from Intuitive Surgical for their surgical robots. Intuitive Surgical requires them to do so. The hospitals claim that if they could take advantage of other options, they would spend far less.

    Much like the pharmaceutical industry, the medical device industry has enormous price-setting power. Too much! As a result, Americans pay a lot more for healthcare than people in other wealthy countries .

    What’s worse is that, in this technological era, the medical device companies can often control the devices that they have sold. They can literally keep their surgical robots from working if they choose to. And, sometimes they do.

    Axios reports on one alleged instance in which Intuitive Surgical shut down its surgical robot “in the middle of a procedure.” The surgeon then had to quickly regroup to undertake the surgery directly. Intuitive was responding to a threat by the hospital to secure maintenance services for the robot from another company.

    Intuitive Surgical is one of those healthcare companies you likely have never heard of that is enormous. It generates $4 billion a year in revenue and has a market cap of $113 billion, more than CVS Health. Its surgical robot does not come cheap. It can cost between half a million and two and a half million dollars.

    The lawsuit alleges that Intuitive Surgical requires hospitals to sign high-priced multi-year services agreements with it when they buy the equipment. The company also requires that hospitals buy new instruments and other accessories after a fixed number of uses, even if they still work well. These requirements generate more revenue for the company than it derives from the equipment itself.

    This hospital systems’ lawsuit against Intuitive Surgical follows antitrust suits brought against the company in the last couple of years from service companies.

    All this said, do we need surgical robots? There is evidence to suggest that they deliver no better outcomes than surgeons themselves.

    Here’s more from Just Care:

  • Warning: Your hip replacement could kill you

    Warning: Your hip replacement could kill you

    Jeanne Lenzer writes for the New York Times about the danger of getting a hip replacement. In some cases, your hip replacement could cause serious harm. In general, as we have reported, FDA-approved medical devices may not be safe.

    Stephen Tower, an orthopedic surgeon, had a metal-on-metal hip implanted, the ASR XL, made by Johnson & Johnson. Dr. Tower specializes in complex hip replacements, but he was not aware that the hip he chose for himself had a serious defect. He ended up needing another surgery because of the pain his artificial hip was causing him.

    Dr. Tower’s artificial hip had turned the tissue around it black. The artificial hip leaked cobalt causing Dr. Tower to suffer from metallosis. Muscles, tendons and ligaments near the hip were destroyed. Worse still, Dr. Tower suffered damage to his heart and brain.

    Afterwards, Dr. Tower warned Johnson & Johnson of the serious defect in the hip but the medical device company did nothing about it. Rather, it continued to market metal-on-metal hips. It finally withdrew the ASR XL model from the market in 2010, but it sold another metal-on-metal hip, the Pinnacle, until 2013.

    Thousands of people received a Johnson & Johnson metal-on-metal hip replacement during this time. Six of them won a $247 million verdict because of the Pinnacle’s harmful side effects and because Johnson & Johnson did not warn doctors or patients about these side effects.

    Unfortunately, these metal-on-metal hips are one of many FDA-approved medical devices on the market that put patients at risk for dangerous side effects.  A provision of the Federal Food, Drug and Cosmetic Act, known as 510(k), allows medical device companies to market many new products without having to do any clinical trials. All that the medical device company need do is claim that the device is “substantially equivalent” to a medical device already on the market.

    While the FDA can recall the product if it is deemed to cause harm, it can take a long time for that recall to happen. Hundreds of thousands of people can end with the device implanted before it is recalled. And removal of the device once recalled can also jeopardize patients’ health.

    In 2016 alone, the FDA recalled 117 medical devices because of a “reasonable probability” that they would “cause serious adverse health consequences or death.”

    Medical devices that undergo clinical trials are also not guaranteed to be risk free. Indeed, the FDA may conditionally approve them even when the clinical trials show potentially harmful side effects, including a high death rate. That’s what happened with a Cyberonics device designed to treat epilepsy. The FDA did not require that patients who received this device be told about the risk of dangerous side effects.

    The FDA’s approval process appears to put profits before patients. Yes, more devices get to market more quickly. But, at what cost to human life and health?

    Here’s more from Just Care:

  • FDA hides data on medical device malfunctions and injuries

    FDA hides data on medical device malfunctions and injuries

    Before you let a doctor insert a medical device into you or someone you love, talk to the doctor about its safety. Kaiser Health News reports that scores of medical devices in frequent use may cause serious harm. And, the FDA hides a lot of the data on device malfunctions and injuries, even when they are serious.

    Medical devices can be anything that a doctor uses in surgery, including surgical staplers, artificial hips, surgical mesh, balloon pumps and mechanical breathing machines. Often, the FDA approves new devices without requiring the device to go through clinical trials. Malfunctions are supposed to be reported into a public database.

    However, Kaiser Health News reports that the FDA keeps two databases for these reports, one of which is hidden from public view. It’s called the “Alternative Summary Reporting Program.” Even your doctor cannot see it. As a result, your doctor cannot rely on the FDA for information on reported medical device malfunctions and injuries.

    Few people had been aware that there are two FDA databases. Experts whose profession it is to educate others about defective medical devices are unaware of the program. Apparently, the alternate confidential database has been in place since 2000. It allegedly was aimed at reducing paperwork say FDA officials who were around when it was put in place.

    The FDA began allowing medical device companies to request exemptions from public reporting without any public notice or regulations. And the FDA has clearly given a lot of medical device companies exemptions. Over the last two years, the FDA has kept 1.1 million incident reports secret.

    Device malfunctions can lead to serious injuries. In 2017, 480,000 injuries or malfunctions were reported secretly. About 100 medical devices have caused serious injuries. It appears that the FDA is doing little if anything to oversee the safety and efficacy of medical devices.

    For example, Medtronic’s surgical staplers malfunctioned almost 10,000 times in 2016 alone, but only 84 injuries have been reported publicly, some of them extremely serious. Since 2001, more than 250 deaths have been reported.  The surgical staplers cut and close tissues, so when they fail at closing a blood vessel, a patient can bleed to death.

    The question remains as to why these critical potentially life-saving reports remain secret. Who has access to them? And, what can be done to make them public immediately?

    Here’s more from Just Care:

  • FDA permits doctors to implant untested medical devices at extreme risk to patients

    FDA permits doctors to implant untested medical devices at extreme risk to patients

    In an op-ed for the Washington Post, Jeanne Lenzer and Shannon Brownlee describe how the FDA permits doctors to implant untested medical devices at extreme risk to patients. Today, 32 million people have one of these devices implanted in them.

    They report that many patients with implantable devices are at risk. They describe, for example, the implantation of a pain-relieving device in the top of patients’ spines that can cause respiratory distress and even death. The FDA approved it in 2003 even though it had never been tested on people. Likewise, artificial hips have been found to cause cobalt poisoning, harming the heart and brain and defibrillators can provide too great a shock to patients.

    Many medical devices have caused harm to patients in the last ten years–1.7 million injuries and more than 80,000 deaths.  And, many hundreds of thousands of people have medical devices implanted in them that have been recalled. But, often these devices cannot be taken out or can only be taken out at severe risk to patients.

    A lot of the blame for these faulty medical devices can be attributed to the FDA’s lax approval process. Acknowledging its responsibility, back in November, the FDA had said it would make changes to the way it approved the vast majority of devices. But, it still is not insisting on testing of these devices in people. Only a small fraction of highly risky heart devices go through stringent clinical trials.

    The issue stems from an old FDA policy to grandfather in for approval all new devices that have “substantial equivalence” to a device that was approved before 1976. As a result, about 80 percent of new devices are approved without testing. If it’s a simple device like a cane or stretcher, automatic approval makes sense. If it’s a highly complex device, such as artificial joints or a pacemaker, it is dangerous.

    Even new surgical mesh implants can be dangerous. Researchers at the University of Oxford determined that about one in eight surgical meshes sold in the US between 2013 and 2015 were like surgical meshes that had been recalled because of the harm they caused. The FDA reports that it does not look at the earlier approved device when approving the new device. And, it is doing nothing to fix this issue.

    A second way medical device manufacturers can avoid clinical trials for new devices is if they tell the FDA that they are updating a device in small ways, a pre-market “supplement pathway.” According to Harvard research, the FDA allowed virtually all “updated” pacemakers and defibrillators to be sold without clinical trials between 1979 and 2012. No surprise, one defibrillator ended up putting people’s hearts into a lethal rhythm. At the time, 250,000 people had the device implanted in them.

    The FDA has done nothing to address the flawed process. As a result of a federal law passed several years ago, MDUFA, the FDA now takes money from the medical device industry to cover its costs. And, it sees the manufacturers as its customers. The FDA head, Scott Gottlieb, supports the FDA’s inaction to correct the medical device approval process saying that “the FDA’s caution is hazardous to our health.”

    What should be done? All new high-risk implanted medical devices should go through clinical trials before the FDA approves them as safe and effective. There should also be a medical device registry that records patient outcomes. And, the FDA should operate with no conflicts of interest. It should not take money from the device manufacturers as the law currently requires, and the head of FDA should have no financial conflicts of interest.

    Here’s more from Just Care: