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.

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.

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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?

The hidden cost of tort deform

General Motors knew that its ignition switches were faulty but allowed people to continue to drive Chevy Cobalts and other cars for years.  To date, 49 of those people have died in crashed related to the defective switches, and many more suffered horrific injuries.

burningcar

However, many families of these innocent victims have not been able to obtain justice.  Many states, including Ohio, place a limit on the amount of compensation injury victims and their families can get under the guise of “tort reform.”  As pointed out in this recent New York Times piece, it simply becomes too expensive to bring a case, in light of what the law allows to be recovered.  Said another way, by the time experts are hired to prove the case, the value of the injuries and suffering is not enough to obtain a successful result.

In fact, Ohio even takes the added step of cutting off the right to bring a case after the product is 10 years old.  This “statute of repose” applies even if it is defective and dangerous and even if the manufacturer knew of the problem.

What does this mean to you:  

No one would dispute that frivoulous lawsuits have no place in our legal system. The dispute is, what constitutes “frivolous” and who gets to decide?  Politicians or a jury of your peers?

Where there’s smoke, there’s fire

When I was growing up, my grandfather was a smoker.  As entertainment for the grandkids when we’d go to visit, grandpa Harris would stand up on a chair, hold his lit cigarette up to the smoke detector, and set off the alarm.  Now that’s fun.

smoke detectorBut its only fun as long as the smoke detector works.   It was revealed this week that as many as 150,000 smoke detectors made by ESL and Interlogix have been recalled.  According to the Consumer Product Safety commission, radio interference can cause the detectors to fail.  Most were installed commercially in schools, apartments, hotels, and dorms. 

What does this mean to you:

Call your security or fire system company to see if you have one of the recalled units.  If you do, you can find out more by calling Edwards/ESL at (800) 655-4497 or Interlogix at (855) 286-8889.

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 itsy, bitsy baby climbed out of the high chair

I saw this story in the Columbus Dispatch today noting an increase in the number of injuries to babies caused by high chairs.  On average, 9,400 kids are hurt every year due to high chairs – a number that has been on the rise.

Baby in highchair

To be sure, some injuries were caused by children climbing out, while other are related to defects in the chair itself.

What does this mean to you:

Always register your baby products with the manufacturer so you are kept abreast of recalls.  Or, you can sign up to receive alerts from the Consumer Product Safety Commission.

 

You caught us red – hipped

There are really only 2 reasons a company ever does anything.  The first, and most pervasive reason, is to make money.  The second is when it forced, kicking and screaming, to take responsibility through the justice system for its own products or conduct.

money in trap

The latter was the case this week when Johnson & Johnson agreed to pay $2.5 billion to settle claims related to its defective metal-on-metal hip implants. The company had known for some time that their devices would fail, but forgot to mention it to anyone.  Oops.

What does this mean to you.

It is not too late to make a claim if you had a hip implant made by Johnson & Johnson or DePuy.

The cure may be worse than the symptoms

Thousands of women across Columbus, Ohio, and the country have had vaginal mesh, or bladder sling, surgically implanted in an attempt to repair pelvic organ prolapse (POP) and stress urinary incontinence (SUI).

tired woman

Unfortunately, mesh can erode and fail, causing bleeding, pain during intercourse, vaginal scarring, and urinary tract infection, among other symptoms.  The FDA not admits that mesh failures are “not rare.”

Mesh implants were mainly manufactured by four companies – American Medical Systems, Boston Scientific Corp., Johnson & Johnson’s Ethicon and C.R. Bard.

What does this mean to you:

Sometimes, a product which is meant to help, only hurts, and makes things worse.    If we can help or answer any questions, please do not hesitate to contact us.

 

 

The dangers of drop-sides

Drop-side cribs have been outlawed in the US since June 2011.  Infants’ heads can become trapped in the gaps around the drop-side.  While no new drop-side cribs are being made, plenty are still in use around the country.

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A recall was issued this week for drop-side cribs made by PT Domusindo Perdana.  The cribs were sold at JC Penney from January 1998 through December 2008.  The drop-side can detach or fall off, causing a fall hazard.

What does this mean to you:

You can learn more about the recall here.  If you have one of these cribs, or any drop-side crib, contact the Consumer Product Safety Commission.