Heater-cooler devices are an integral part of open-heart surgical procedures. No, it appears they could be a deadly part of them, too. During a Special Session at the Society of Thoracic Surgeons’ annual meeting, Dr. Keith Allen of St. Luke’s Hospital in Kansas City claimed that “We’ve only begun to scratch the surface, even though it has been going on for 2 years,” according to MedPage Today. Dr. Allen believes that the number of cases of infection related to heater-coolers could be underreported for a number of reasons:
- The infection has a long latency period, meaning that a person may not develop symptoms of the infection for a while.
- There is no way to screen for the infection before symptoms arise, nor any “true surveillance” in terms of the devices.
- These devices are used all over the globe, making it virtually impossible to calculate just how many people have developed an infection related to a heater-cooler device.
LivaNova/Sorin 3T heater-coolers are not the only ones that pose a risk
In the original warning put forth by the Food & Drug Administration, back in 2015, the LivaNova/Sorin 3T heater-coolers were the source of the infections, believed to be related to “source contamination” at the plant where the devices were made.
It now appears that most Heater-Cooler devices pose a risk to patients: “all five manufacturers’ heater-cooler units commercially available worldwide have had reports of contamination sent to the FDA through the mandatory or voluntary reporting. Four of the five have had patient infections reported; three have had associated deaths.” The Sorin may be the only one, however (though it is unknown at this time time) where shoddy sterility and disinfectant protocols at its manufacturing plant were later related in genetic testing to the same strain of mycobacteria in affected patients. That may later be discovered as this burgeoning investigation unfolds.
Next steps for patients and families
If you or a loved one has had open-chest procedure at any time between 2008 and now, and developed an infection from Mycobacterium chimaera or Mycobacterium abscessus bacteria, you may be able to file a claim or lawsuit for compensation. If you have received a letter from a medical facility that you may have been exposed to a potential mycobacteria contamination during an open-chest procedure (yet have not yet suffered from the infection), you may be eligible to be part of a lawsuit. McGowan, Hood & Felder, LLC has successfully represented both individual and class-action plaintiffs in defective medical device lawsuits in South Carolina, North Carolina and throughout the country. Our skilled team of attorneys has a reputation for tackling the most complex medical products liability and wrongful death cases, and we may be able to help you, too.
For more information about our experience and our services, or to schedule a free initial consultation with one of South Carolina’s most aggressive teams of mass tort attorneys, we invite to you to fill out our contact form or to contact us at 888-302-7546. We are already representing numerous victims throughout the area, and would be honored to represent you in the fight for justice.