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.

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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?

Guest post: Surgical Mesh and the FDA

 

Although surgical mesh has been in use for decades, it was not until 2002 that the Food and Drug Administration (FDA) approved the use of transvaginal mesh for treatment of pelvic organ prolapse.

Since that time, the FDA has received numerous reports of complications associated with transvaginal mesh. On July 13, 2011, the FDA released a statement that informed consumers that the complications associated with transvaginal mesh are not rare and that traditional surgery methods for the treatment of urinary incontinence and pelvic organ prolapse may be more effective and carry less risk.

For those who have already had transvaginal mesh implanted, or for those considering this treatment, this release from the FDA is cause for real concern. There are, unfortunately, numerous complications and many of these complications are quite severe.

To date, the most common complaints associated with transvaginal mesh include:

1. Protrusion or erosion of the mesh. This complication is very serious. Protrusion means that the mesh works its way through nearby organs.

2. Organ perforation. The surgical procedure or the transvaginal mesh itself can perforate — or puncture — nearby organs.

3. Additional complications. The FDA has received numerous reports of neuromuscular issues as well as psychological trauma following the insertion of transvaginal mesh. Some patients have reported feeling the mesh inside their body; sexual partners may also be able to feel it.

The way the mesh is inserted may actually determine the extent of complications a patient will face. The FDA has stated that proper training can reduce the likelihood of these complications. The FDA reports that mesh inserted transvaginally rather than through an abdominal incision results in a higher risk for complications. Even though there have been serious risk associated with this surgical mesh, the FDA has yet to have a Vaginal mesh recall.

For patients, this news from the FDA is understandably disturbing, particularly if their doctors had not previously informed them of the potential risks they would be facing. If your doctor has recommended this procedure to treat pelvic organ prolapse or urinary incontinence, it is vital to make sure you are fully aware of the risks you are facing. Ask your doctor if they have received the recommended specialized training.

It is also important to get a second opinion, in light of the very real health risks you could be facing as a result of this procedure. The FDA has stated that traditional surgery to repair pelvic organ prolapse or urinary incontinence may actually be more successful than the use of transvaginal mesh and carries much less risk for the patient.

So far, nearly 4,000 complaints have been received regarding the use of transvaginal mesh in these treatments. The FDA continues to monitor the situation, and encourages more education both for surgeons and patients. Even though pelvic organ prolapse is a painful condition, patients need to be aware that they may be facing more pain and more surgery if they elect to go with transvaginal mesh. Transvaginal mesh lawsuits have already been filed due to these severe complications.

Elizabeth Carrollton writes about defective medical devices and dangerous drugs for Drugwatch.com.

 

We don’t know what we – I mean, you – are talking about

Baby Boomers appear to be here to stay.  I mean, they even have their own Association now, so you know they’re going to stick around and ask for stuff.  Stuff like hip implants that don’t fail after being implanted, causing pain, swelling, and metal on metal friction to throw off chromium and cobalt ions in to their blood streams.  Some people!  For what it’s worth, the medical research surrounding metal ions is ongoing, but as far as I know, no doctors have started prescribing chromium and cobalt ions to be taken once daily by mouth along with your Flintstones.

Doh!

But, the maker of many hip implants, a company called DePuy (pronounced “Dapew”) who is owned by Johnson & Johnson, knew for quite a while that its ASR hip implants were failing.  It was recently learned that, rather than tell the FDA of the product’s defects, or make a change to its design, or immediately recall the device, DePuy opted merely to not make any more ASR hips, but continue to sell the problematic hips it had remaining.

What does this meant to you:

Many times, patients may not know the brand or model of the particular implant they have.  That is, a person may have a DePuy ASR and not even know it.  If you’re having problems, its important to check with your doctor to see which type you have, and if need be, discuss it with a lawyer.