Articles Posted in Medical Device Safety

davincirobot-300x176The federal Food and Drug Administration finally has pushed back at surgeons and hospitals for experimenting on patients, spending $3 billion a year for surgical robots. The devices should not be used for mastectomies and other cancer-related procedures without caution, regulators warn.

The FDA acted after studies have shown that minimally invasive procedures for early-stage cervical cancer, many robot-aided, were more likely than standard, large-incision surgeries to result in recurrences of the disease and deaths.

Regulators also may have been prodded by their poor history in halting harms to women with so-called keyhole procedures, particularly the nightmares the FDA was slow to react to involving minimally invasive hysterectomies and a tissue-grinding tool called a morcellator.

vamps-300x169Funny the mischief that can happen with a little blood and spit. Seemingly unrelated medical stories last week brought home the lesson of the law of unintended consequences. Those consequences abound everywhere, in health care most especially. So with blood, we’re learning about a bizarre new fountain-of-youth treatment, with echoes of vampires, for seniors who ought to know better.   And with spit, we’re learning how seemingly harmless genetic tests can raise from the dead some disturbing revelations about our deceased family members.

Bunk about blood transfusions

The federal Food and Drug Administration has warned older Americans about a new kind of anti-aging bunk flying out of the Silicon Valley: blood transfusions. Companies, dancing on a fine legal line, have hinted that seniors could benefit by getting transfusions of young people’s blood and blood products.

brady-281x300If you’re such a die-hard fan you slogged through that pro football championship that was perfect for the new Year of the Boar, please don’t be so sheepish in your celebrity adoration as to get gulled by quarterback Tom Brady’s health and diet bunk.

His oddball theories well might go into a flaming dumpster, along with  notions about special drinks and excess hydration, and yet more broadcast goop from that princess of health woo, Gwyneth Paltrow.

Sure, Brady’s Superbowl LIII win may have made him the goat (greatest of all time) in National Football League history with six rings. He got there, and may stay there, not only with rare individual gifts, hard work, and special talents, but also with peculiar practices, as Vox, an online news site reported:

hospitalprices-300x162Patients and reformers attacking skyrocketing health care costs may want to focus less on doctors and more on big, shiny hospitals, where in just five years prices soared by 42 percent for inpatient care versus the still sizable 18 percent price hikes that MDs scored.

Those findings are part of a new study that examined medical costs based on actual payments, focusing on common procedures like deliveries of babies (vaginal and cesarean), colonoscopies, and knee replacements.  “Hospital prices grew much faster than physician prices for inpatient and outpatient hospital-based care in the period 2007–14 … The same pattern was present for all four of our procedures,” wrote the researchers from Yale, MIT, and Carnegie Mellon. They found that hospital costs also spiked for outpatient care, increasing 25 percent, versus 6 percent for doctors.

This meant that for a knee replacement costing $30,000 or so, the doctors’ mean price was almost $4,900, while the hospital price was almost $25,000. For a $13,000 C-section, the doctor’s mean price was $4,600, while the figure for hospitals was $8,300. These numbers were derived from analyzing hundreds of thousands of procedures.

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Tens of thousands of women complain that a surgery to implant mesh to bolster weak abdominal tissue, instead has inflicted on them incontinence, chronic pelvic pain as well as pains in the groin, hip, and leg, and with intercourse. Others say they suffer complications as if they had the immune system attacking disease lupus, leaving them with persistent runny noses, muscle pain, fogginess, and lethargy.

The federal Food and Drug Administration in mid-February will convene its expert panel on women’s reproductive surgeries to see advice on next steps in what has become a legal and medical morass over transvaginal mesh operations.

As many as 4 million women globally have undergone mesh surgeries to treat urinary incontinence and weakening of walls in the abdominal area that causes prolapses, the Washington Post reported, quoting a UCLA reconstructive expert as estimating that 5 percent — or 150,000 to 200,000 — of those patients have experienced complications.

diabetesteststrips-300x200Doctors, hospitals, health officials, and disease advocacy groups race to warn about diabetes’ risks, harms, and increasing prevalence. But why, then, doesn’t modern medicine also do much more to help diabetics with the skyrocketing costs of their care, whether with insulin at excessive prices or with  expensive medical aids?

Ted Alcorn of the New York Times drilled down on one slice of diabetes care to capture how medical profiteering distorts what ought to be a more direct, simple, and less pricey treatment for a disease that afflicts as many as 100 million Americans in varying degree.

He reported on the “strange marketplace” for the chemical-imbued plastic strips diabetics use to test their blood sugar, inserting them into specialized meters for glucose readings. Before diabetics adjust their diet or take insulin, they may test themselves with strips and meters as many as 10 times a day. The costs add up. Diabetics can pay thousands of dollars annually to get test strips over the counter.

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:

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