Articles Posted in Medical Device Safety

jeanne_lenzerbrownlee-150x150Medical devices race onto the market with little or no effective testing or regulatory safeguards, and a proposed “reform” of the oversight system of products that are implanted in tens of millions of Americans is a sham, safety advocates say.

That’s because there are gaping flaws in the proposal to alter the so-called 510(k) procedure under which the federal Food and Drug Administration clears medical devices for sale, say medical journalist Jeanne Lenzer (right) and health care activist Shannon Brownlee (left).

Their Op-Ed in the Washington Post is the latest salvo against FDA Commissioner Scott Gottlieb’s claims of “transformative” changes in medical device regulation by his agency. News organizations around the world in recent weeks have published investigations of how poorly such products are tested, reviewed, and then released on markets, killing and injuring patients as a result.

When doctors, hospitals, insurers, and their captive lawmakers howl about how unfair malpractice lawsuits allegedly can be for modern medicine, patients who have suffered harms while seeking medical services should require loved ones, friends, and members of their community to view Bleed Out.

This new HBO documentary details the decade-long quest by comedian Steve Burrows and his family for justice for his mother, Judie. She was an energetic, retired teacher when she fell from her bike and needed emergency hip surgery. Before she had recovered, she fell again and needed a second operation. But this time, something went wrong: She lost more than half her blood, fell into a coma, and suffered irreversible brain damage that meant that she would spend the rest of her life in institutional care in rural Wisconsin.

davincirobot-300x176When surgeons insist on cutting on patients using the million-dollar da Vinci robot system, patients should demand to know why — and to be skeptical to the nth degree whether the device-based operation will be beneficial to them, or if it is yet another way for doctors and hospitals to make medical care exorbitantly expensive and to boost their profits.

NBC News, as part of a global investigation of medical devices and their harms, deserves credit for adding yet more disturbing disclosures with a detailed story about the da Vinci. The report clearly seeks to be balanced and doesn’t deliver as hard-hitting a point of view as The Bleeding Edge, a recent and important HBO documentary on the surgical robot system.

Still, there are plenty of disturbing items that ought to stop lawmakers, regulators, safety advocates, and patients, and force a hard re-thinking about da Vinci:

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FDA Commissioner Scott Gottlieb

If the federal Food and Drug Administration expected any public goodwill for putting forward long-term proposals to change a fundamental way that medical devices win agency clearance, forget about it.

Instead, FDA Commissioner Scott Gottlieb and lawmakers should be reeling still from a salvo of news organization investigations into unacceptable ways that patients in this country and around the planet suffer pain, injury, and other harms from products that go in or on the body. Under industry pressure and spurred by pro-business lawmakers, the FDA, the investigations show, has exercised a weak, poor, and unacceptable oversight of medical devices, including:

deskstanding-231x300Holiday gift-giving can be expensive, so the health-conscious may wish to exercise skepticism about some potential purchases with dubious or unexpected consequence.

If you’re considering forking over more than a few dollars, think twice about:

  • So-called “tall” or “standing” desks. They were supposed to be a response to growing research about workers’ heightened health risks from sitting all day long. But studies show that standing while working with a computer isn’t as beneficial as some advocates may have claimed. That’s because it isn’t exercise or movement — which was supposed to the point of promoting healthier workplace practices, such as getting up from the desk and walking around every few minutes rather than becoming sedentary on the job. Studies, in fact, show that workers who must stand all day suffer health harms, like varicose veins and more. Some employees with posture issues may benefit some from standing and not scrunching themselves up while sitting at a desk. For most of the rest of us, it does matter to get up, exercise, and move. A fancy desk isn’t necessary for that, right?

hpvshot-300x231Women may need to double-up on their consultations with their specialists about treatment for serious gynecological concerns, as new studies have raised troubling questions about a much-touted minimally invasive surgery for early-stage cervical cancer.

These concerns, in a more perfect world, also would prompt greater questioning and oversight by doctors, hospitals, regulators, and lawmakers of surgical “innovations.”

The procedure now in question removes the uterus, part of the vagina, and other surrounding tissues via small incisions and with special laparoscopic instruments, including robots. Surgeons have advocated for this surgery rather than making a large incision in an “open” procedure, arguing the less invasive approach promotes less discomfort and faster healing for patients.

aspirinDoctors subject older patients to risky, costly, invasive, and painful tests and treatments, perhaps with good intention but also because they fail to see that the seniors in their care are individuals with specific situations with real needs that must be considered.

If  physicians too readily accept conventional wisdom in their field, for example, they may push patients 65 and older to take low-aspirin, with the popular but mistaken belief that this practice will help prevent heart attacks, strokes, and dementia. This doesn’t work, and, it increases the risk in seniors of “significant bleeding in the digestive tract, brain or other sites that required transfusions or admission to the hospital,” the New York Times reported.

The newspaper cited a trio of studies, published in the New England Journal of Medicine and based on “more than 19,000 people, including whites 70 and older, and blacks and Hispanics 65 and older. They took low-dose aspirin — 100 milligrams — or a placebo every day for a median of 4.7 years.”

kaisertavr-300x175When big hospitals and their doctors jostle with competitors in smaller and medium-sized facilities over who gets to perform an important and booming kind of surgery, it’s not a pretty sight — nor might it be obvious with which institutions patients ought to side.

Phil Galewitz of the independent, nonpartisan Kaiser Health News Service does consumers a service with his reporting on recent bureaucratic brawling in Baltimore before federal regulators charged with determining where surgeons may replace leaky valves without open heart procedures.

As Galewitz explains, surgeons and medical device makers for a few years now have worked together to develop a new way to fix defective valves for tens of thousands of patients too frail to undergo open heart operations that, among other things, involve getting their chests cracked open. Surgeons, instead, can snake a catheter through patients’ blood vessels, into their heart, and shove aside the leaking valve, replacing it with a new model.

Robots are the shiny new toys of surgery in American hospitals. They promise ultra-precise, tiny cuts that give patients faster healing and better outcomes. Wherever you live, your local TV news outlets have likely run uncritical, gee-whiz stories about hospitals and surgeons bringing in these robots, featuring glowing patient testimonials.

So what’s not to like? You need to watch a new documentary airing Friday night on Netflix to get the other side of the story, and there’s plenty. And also about other medical devices that promise much but deliver more pain than benefit.

intubation-300x181Grown-ups with the least bit of gray on them may want to step up their thinking on how they want to receive medical care under tough circumstances, especially if they consider a new, clear-eyed and hard-nosed study that dispels any myths about possible life-sustaining “miracles” of artificial breathing machines.

A research team with experts from Boston, San Francisco, and Dallas studied 35,000 cases in which adults older than 65 had undergone intubation and use of mechanical ventilators at 262 hospitals nationwide between 2008 and 2015.

They found that a third of patients intubated died in the hospital.

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