Heater and cooler in one

During many surgeries, including open-heart surgery, a medical device called a heater-cooler is used to raise or lower the body temperature of the patient.  However, heater-coolers made by Sorin, now LivaNova, called the Stockert 3T, can spread infection to patients.  If they become contaminated, these devices can pass mycobaterium chimaera, or M. Chimaera for short, which can cause nontuberculous mycobaterium infections, or NTM.

bacteria

Both the FDA and CDC have issued warnings about the risk of mycobateria infections while using Stockert 3T heater-coolers.

These devices may have been in use at Adena Hospital in Chillicothe, Ohio, among other hospitals in Central Ohio.

What does it mean to me:

Symptoms of mycobaterium infection may not show up for several weeks, but include fatigue, cough with blood, difficulty breathing, joint or muscle pain, nausea, vomiting, night sweats, and weight loss.

Knowing when to leave is half the battle

We all know the type: the person at the party who cannot bring themselves to leave. Whether they just like the sound of their own voice or fear of facing what is at home is just too much, knowing when your time is up is critical.  (Watch this segue.)  And the same goes for IVC filters.

Oh geez.  Its time to go.

Oh geez. Its time to go.

After surgery, the risk of blood clots forming goes up.  If one of those clots makes it into the lungs, it can be bad.  Like, pulmonary embolism-bad.  So, surgeons can place a metal cage or filter in a vein, called the inferior vena cava, to trap blood clots to prevent them from reaching the lungs.  

The problem is that, if these IVC filters are left in too long, they tend to not stay in place. That is, they can move or tilt, causing perforation or tearing of the vein.

These filters have several metal spines, and in a pinch, can also be used to catch bass and stripers.  (This statement has not been evaluated by the FDA.)  What has been stated by the FDA is that leaving an IVC filter in too long can be dangerous.

What does this mean to you:

It can sometimes be as important to know when to stop using a particular medical device as it can be to know when to start.

Sooner or later, they’re going to get one right

When I was growing up, Dad always had workshop.  One of the mantra’s I heard him repeat (and find myself repeating to my kids) is “measure twice, cut once.”  That is, make sure the part fits before you make it permanent.  The parents of the good people of Zimmer apparently never imparted such wisdom to their kids.

41Z6K8E2MNL._SX300_

Zimmer has now had to recall a part of its Persona artificial knee implant, specifically, the Persona porous coated, uncemented trabecular metal tibial plate.  Say that three times fast.  It seems that Zimmer began selling its knee implant without doing any clinical trials first.  This is the same problem Stryker had with its hip implants recently.

Zimmer Persona knee components can become loose, causing swelling and pain, and develop radiolucent lines – large gaps between the parts of the implant and the bones – which can damage both the bones (called osteolysis) and the device itself.

What does this mean to you:

A couple of rhetorical questions come to mind.  Shouldn’t companies that make products, especially ones that get implanted inside your body, have to test them first?  And how does one actually recall a device AFTER its been implanted?

What did you expect?

Its football season again.  Finally.  But with the season comes the ongoing discussion about concussions, especially repeated ones, and what is and is not an acceptable level of carnage that players endure for our amusement.  The NFL recently settled a lawsuit by former players regarding concussions.  And now comes word that a suit has been filed in California against FIFA attempting to alter rules to curb concussions too.

Brain Trauma

What does this mean to you:

Does everyone know that slamming your head into a 300 lb. hunk of linebacker is probably not good?  Sure.  But if the organizing league had information that the problem is much worse than reported, and refused to take action to fix the problem, all in order to make a profit at expense of the players’ health, that is a problem too.

In addition, Marlboro will sponsor the Komen 5k race

Mark Twain once said that golf is a good walk spoiled.  Truth be told, I  tend to agree with him.  But people nonetheless seem to enjoy the activity, whether they’re out strolling the fairway or going for the long ball.

hip

Hopefully, then, the irony was not lost this week when it was announced that the PGA Tour would be sponsored by – wait for it – Stryker Orthopedics.  Yes, that Stryker Orthopedics.  The one that made 20,000 defective ABG II and Rejuvenate metal hip implants.  The ones that would be bad for golfers (or anyone else who likes to, you know, move) to use.

What does this mean to you:

Remember that advertising and corporate sponsorship can be as much about framing and creating a positive public image as about selling products.

Testing, schmesting.

You would think that medical devices  implanted inside your body would be some of the most highly-tested products in the world.  Not so, though, for hip implants made by the Stryker company, who began selling its hips without going through clinical trials first.

science experiment

Stryker claimed its hips were similar to DePuy’s metal on metal hips that were already for sale.  The fault in this logic, if you can call it that, is that DePuy’s hip implants are the ones having problems with fretting and corrosion of the metal, which causes pain and swelling.  This defect may even lead to metalosis – metal toxicity in the blood stream caused by metal ions and shavings from the implant itself.  This, despite the fact that the industry has known for some time that as much as 40% of metal-on-metal hip implants would fail.

Stryker has since recalled its Rejuvenate and ABG II hip implants.  DePuy has since settled many of the claims against it for $2.5 billion.

What does this mean to you:

Someone with a recalled hip implant probably does not know the make or model they have.  If an implant patient continues to have, or suddenly develops, pain or swelling around their hip implant, they should check with their surgeon right away.

The real stuff is bad enough

Ohio has seen more than its fair share of tort deform laws over the last decade.  These laws have the affect of making it harder for folks who get hurt, through no fault of their own, to be made whole again.

 

 

Man with a broken leg  walking on crutches

As if reality wasn’t bad enough, I saw this post on The Pop Tort about fictitious laws on TV shows written in to scripts to limit fictitious rights of the characters.  Art imitating life indeed.

What does this mean to you:

Know that insurance companies and corporations have lobbyists.  Most of us don’t.  When laws get passed, guess which one they favor?

 

 

The Phantom (Driver) Menace

There seem to be a rash of “hit-skip” incidents going around, like this one just this weekend in Victorian Village.  Luckily, this guy was caught.  But what if they never find the at-fault driver?

Car-smoke

In Ohio, this situation is called a “phantom driver.”  Most insurance policies require there to be some other evidence that a crash happened, other than just the injured person’s word.

What does this mean to you:

If you are hit by another car who takes off, you will either need another person who witnessed the wreck to back you up.  Either that, or show some damage to your vehicle to prove there actually was a wreck.  Believe it or not, sometimes insurance companies don’t believe you!

 

I thought there were supposed to be drugs in my glass

Image

Be advised the Ranbaxy and the FDA have recalled the generic form of the cholesterol drug Lipitor, called atorvastatin, because they found glass particles in the drug.

What does this mean to you:

Obviously, people should stop taking this drug and call their doctor.

 

Everybody gets an award these days!

Most of us have seen the email floating around for the “Stella Awards,” named for Stella Leibeck, the 79 year old woman who had third degree skin burns and skin grafts in her crotch who had the gall to ask McDonalds to help her with her medical bills.  Though these awards are meant to highlight “frivolous” cases, many are actually fictitious or trumped up.

You really are a winner.

Now come the Hazelwood Awards, so named for Capt.. Hazelwood of Exxon Valdez fame.  These awards highlight corporate greed and malfeasance.  This year’s winner is the hospital in Florida that performed unnecessary surgeries in order to bill for them.

What does this mean to you:

Corporations and insurance companies often put profits before people, notwithstanding what their slick commercials and handsome spokesmen would have us believe.