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.

Thanks for nothing

Medical devices are supposed to solve our medical ailments, not cause them.  What am I missing here?

However, the FDA announced last summer that it was concerned about problems caused by surgical mesh – a medical device implanted, usually in women, to repair a hernia or pelvic organ prolapse (POP). Problems can involve bleeding, infection, pain, and urinary problems.  Then, earlier this year, the FDA ordered makers of surgical mesh to more closely study the risks involved with their products.  As of today, Johnson & Johnson, one of several manufacturers, has stated it will no longer sell surgical mesh products.  (Recall that this is the same Johnson & Johnson who also made the now-recalled DePuy ASR hip implants.)

What does this mean to you:

Though surgical mesh has not been recalled, it has caused enough issues to raise serious concerns.  Keep in mind that complications following a surgery are not always “normal,” and may actually be related to a medical device with known problems.