Articles Posted in Medical Device Safety

ivf-300x271Equipment failures in two clinics in Cleveland and San Francisco not only resulted in the loss of thousands of frozen human embryos and eggs, the incidents also have raised new concerns about safeguards and regulation of booming and costly fertility programs.

Experts said the mishaps were uncommon, and they were hard pressed to explain how advanced refrigeration systems, with rigorous checks and back-ups, could have malfunctioned at large, respected facilities, leading to a likely boom of lawsuits by women and couples against the University Hospitals Ahuja Medical Center’s Fertility Center in Cleveland and the  Pacific Fertility Center in San Francisco.

The centers serve different types of women and couples, with the San Francisco facility dealing with younger, career-driven, and international patients eager to freeze eggs and embryos in hopes of starting families later in life. It has attracted public notice, partly because high-tech firms in the nearby Silicon Valley offer financial assistance to women employees who want to freeze their eggs. The Cleveland center, meantime, seeks to assist women and couples in the city’s western suburbs with infertility issues, especially through in vitro fertilization.

frail-300x150Although patient advocates long have pressed Big Medicine to eliminate unnecessary care — waste in the health care system that some experts estimate adds as much as $765 billion annually in needless costs — it may be past due for a public condemnation of a notably extreme example of this practice: The all too frequent, unhelpful surgeries for the old, many of whom are at the end of life.

Liz Szabo of the independent, nonprofit Kaiser Health News Service, and National Public Radio deserve credit for their report, detailing how 1 in 3 Medicare patients undergoes a serious procedure, “even though the evidence shows that many are more likely to be harmed than to benefit from it.”

As the story explains:

danger-194x300jeanne_lenzerJeanne Lenzer, a seasoned medical investigative reporter, points out that 32 million Americans — about one in 10 of us — have at least one medical device implanted in our bodies. These include artificial joints, cardiac stents, surgical mesh, pacemakers, defibrillators, nerve stimulators, replacement lenses in eyes, heart valves and birth control devices.

Most patients — indeed most of the public — may think federal regulators subject all this hardware to rigorous quality and safety testing.

That’s a wrong assumption. And though medical devices may be helping change and save many lives, Lenzer also warns they are harming and even killing too many patients. In a new book (The Danger Within Us), interviews, and in a recent Op-Ed in the New York Times (“Can Your Hip Replacement Kill You?”), she has argued that:

precise-223x300Although billions of dollars and lots of positive public attention have been lavished on the promise of genetic-based “precision medicine,” this therapeutic approach to treating cancer and other serious diseases may need more scrutiny for basics of quality control.

National Public Radio deserves credit for airing some less-heard experts’ worries about the roles of at least two groups of little-seen and often-ignored medical specialists — pathologists and med techs — and how their common practices may undercut the potential of efforts to target disease treatments to individual patients based on maps of their genes.

Despite its powerful and progress-promising name, precision medicine relies on some old-fashioned, unchanged, and possibly problematic medical techniques, experts told NPR. Blood and tissue samples, which later will be analyzed with costly and supposedly state-of-the-art equipment, still get taken by med techs with limited training. Little attention typically gets paid to how they collect samples and how carefully they get handled before arriving in labs. They may sit on carts for hours, and they may be dragged through different parts of hospitals where temperatures vary widely and can hit extremes.

spanking-187x300Kids can be a major part of what makes the holidays special. But if a house full of the little darlings hasn’t already driven the grown-ups around them to total distraction, parents, grandparents, and uncles, aunties may want to consider a few ways to ensure youngsters stay healthy and wise in the days ahead, including:

Spare the rod so children don’t get spoiled

If the kids get naughty during the winter break, their parents might find themselves agreeing with a controversial view: Two-thirds of Americans, when asked in surveys, say that misbehaving children younger than 7 need a “good, hard spanking” on occasion when they’re very bad.

gottliebThe  Food and Drug Administration has closed out the year by issuing a new white paper reaffirming the agency’s three-year-old warning to surgeons and women to avoid in general the use of a surgical device called a morcellator in “key-hole” or laparoscopic gynecological operations.

It wasn’t a surprise that the FDA retained this caution. That’s because the Wall Street Journal, back in 2014, had published a major investigative series linking morcellators to increased cancer incidences, recurrences, and risks in women. Researchers found that the popular surgical tool, by grinding up tissues such as those found in common female fibroid tumors, purportedly to permit their easier, faster removal, spread cancerous tissues throughout the body. The FDA has taken major, deserved criticism for failing for two decades to better protect thousands of women from harms caused by this medical device.

But what else did the agency do in its busy December? Scott Gottlieb, the FDA commissioner, also has reaffirmed that the FDA is motoring ahead with a stepped program to speed up an already loose approval and oversight process for medical devices like the morcellator.

soccerknee-300x97Here’s another painful reminder to grownups about youngsters and sports: Moderation matters, and youthful games are supposed to fun, diverting, and character building—and most definitely should not leave today’s aspiring athletes as tomorrow’s hobbled adults.

The New York Times has reported on what a pediatric sports medicine expert has described as a “dirty little secret” of orthopedics, which is “the chance of getting arthritis within a decade of tearing a tendon or a ligament in the knee is greater than 50 percent.” And more and more youths, as they participate aggressively and frequently in sports programs, are undergoing surgeries on damaged or torn anterior cruciate ligaments, a procedure well-known as the ACL repair.

The sports medicine doc says he is gathering data for a study that will show that patients at 26 children’s hospitals he has focused on underwent 500 ACL repairs in 2005, but by 2014, more than 2,500 youths had these surgeries.

epipen-300x119Big Pharma’s rapacious profit-seeking can seem to hit no bounds, even if it afflicts millions: Just consider what federal and state regulators are mulling about the makers of a popular anti-allergy therapy and those who supply a critical diabetes medication.

The federal Food and Drug Administration has replied to Bloomberg News Service that, so far, in 2017, it has recorded 228 reports of EpiPen or EpiPen Jr. failures, and the failure of EpiPens to deploy correctly has been cited in seven deaths through mid-September.

The agency said it is monitoring closely these “adverse event complaints.” These are unconfirmed reports that do not necessarily tie a product to a harm. But they might constitute sufficient grounds to investigate further and to potentially order product recalls, though, so far, the FDA says it believes patients can keep using EpiPens on the market without worry.

pacemaker-300x186Big medical device makers, like Big Pharma, have complained relentlessly that Uncle Sam hamstrings them with red tape and bureaucracy that slows or prevents innovative, life changing and lifesaving products from reaching the public. Most of this criticism has been targeted at the federal Food and Drug Administration, which under the Trump Administration, has promised to speed and ease its industry oversight.

But internal watchdogs for the Health and Human Services department have provided a rebuke to the move-faster crowd, detailing the costly cleanup—paid for by taxpayers like you and me— that results from defective medical devices.

The HHS inspector general’s office, in what some patient advocates are calling “a drop in the bucket” of the magnitude of this concern, has found that Medicare paid “at least $1.5 billion over a decade to replace seven types of defective heart devices [that] apparently failed for thousands of patients,” according to a story by Pro Publica, the Pulitzer Prize-winning investigative reporting web site.

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