Due to problems with 3T Heater-Cooler Systems used in many operating rooms, a number of open heart surgery patients have developed a severe and potentially life-threatening infection, known as M. Chimaera or Mycobacterium chimaera.
This slow growing infection, which is a type of nontuberculous mycobacteria (NTM), may not result in systems until months, or even years after surgery. However, it can result in severe disability and wrongful death.
Treatment typically involves a combination of antibiotics. However, in some cases the infection is so deep that it can take months or even years of antibiotic treatment to cure. If untreated, these infections can be fatal.
While 3T Heater-Cooler Systems are commonly used during heart valve surgery, vascular grafts and other cardiac procedures, certain devices manufactured prior to September 2014 may have become contaminated. This may result in the release of vapor into the air of the operating room, where exposure to the open chest cavity may cause a Mycobacterium chimaera infection.
Contact the M. Chimaera Infection Lawyers at Saiontz & Kirk, P.A. to determine whether you or a loved one may have a lawsuit.
M. Chimaera Infection Risk Following Heart Surgery
While it appears the manufacturer of the 3T Heater-Cooler System knew or should have known about the risk of problems following heart surgery, information is just now being discovered by many doctors and patients.
In June 2013, a case report published in the Journal of Clinical Microbiology detailed instances where two heart surgery patients who had procedures years apart from each other each developed bloodstream infections caused by Mycobacterium chimaera. Researchers concluded that M. Chimaera infections should be considered during differential diagnosis of patients with biomechanical or mechanical heart valves who present with symptoms similar to endocarditis or septicemia. However, a clear connection to the heater-cooler systems used during these heart procedures was not made at that time.
It was not until M. chimaera bacteria was found in the production line and water supply at the 3T manufacturing facility that the connection started to become more clear for federal health investigators. This resulted in a “corrective action” by the manufacturer, providing instructions for medical providers about how to determine whether the device was contaminated in July 2015. The FDA later classified this action as a 3T Heater-Cooler recall, although the devices remained in place in many operating rooms nationwide.
In another study published in the medical journal Open Forum Infectious Disease in June 2016, researchers noted that ten case reports of disseminated M. chimaera infections linked to heart surgery were published from Europe, and three new cases were described involving infections following aortic graft or valvular surgery within the United States.
That same month, the FDA issued a Safety Communication about the Mycobacterium chimaera infection risk with 3T Heater-Cooler systems used during open heart surgery. The agency confirmed that it has received reports of U.S. patients infected with M. chimaera after cardiothoracic surgery involving the device.
As a result of the investigation, the FDA issued an update regarding M. chimaera infections following heart surgery on October 13, 2016, indicating that hospitals should take several steps, including:
- Immediately remove heater-cooler devices, accessories, tubing and connectors that have tested positive for M. chimaera;
- Direct and channel heater-cooler exhaust away from the patient and into the operating room exhaust vent;
- Limit use of 3T Heater Cooler Systems manufactured prior to September 2014 unless it is an emergency or life-threatening sitiation and no other heater-cooler system is available;
- Monitor patients who have undergone coardiopulmonary bypass for signs and symptoms of M. chimaera infections, or nontuberculous mycobacteria (NTM) infections.
3T Heater-Cooler Heart Surgery Infection Class Action Lawsuits
The Mycobacterium chimaera infection lawyers at Saiontz & Kirk, P.A. are reviewing potential individual cases, as well as 3T Heater-Cooler class action lawsuits for individuals who may have been exposed during heart surgery.
Since these heart surgery infections may not appear for several months or years after the procedure, M. chimaera infections may continue to be diagnosed amony individuals who were exposed to these unreasonably dangerous and defective devices. In addition, since individuals and families had no way of discovering the cause of their surgical infection, or even that it may have been caused by the heart surgery, wrongful death lawsuits and prior infection claims can still be brought.
Financial compensation may be available through an open heart surgery infection lawsuit for any individuals who have suffered severe injuries or lost loved ones due to these infections. All cases are handled on a contingency fee basis, which means that there are no fees or expenses unless a recovery is obtained. Request a free consultation and claim evaluation.