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Reports of serious nontuberculous mycobacterium (NTM) infections following heart bypass and other surgical procedures have been linked to the use of certain medical devices, which may release contaminants into the sterile air of the operating room. As a result, heart surgery patients may be left with hard-to-treat and life-threatening infections like M. chimeara and M. abscessus, which could develop months or even years later.
STATUS OF HEATER SURGERY LAWSUIT: Lawyers are no longer reviewing additional product liability lawsuits against the makers of these devices, but potential heart surgery infection lawsuits may provide financial compensation through a medical malpractice claim.
OVERVIEW: Heater-Cooler Systems are medical device commonly used during heart surgery, involving tanks of temperature-controlled water to regulate blood temperature during the procedures. They appear to most commonly be used with heart bypass surgeries, but have also been used during liver transplants and other major operations.
According to the U.S. Centers for Disease Control and Prevention (CDC), the devices are used in about 60% of all heart bypass surgeries in the United States. However, federal regulators have discovered that certain cardiac heater-cooler devices manufactured before September 2014 may have become contaminated with nontuberculous mycobacterium (NTM), and hospitals have been provided critical instructions about the steps that must be taken to reduce the risk of infection.
Following reports of M. chimeara infections and other types of NTM infections among individuals exposed to certain Heater-Cooler System, the FDA has warned that contaminants in the water tanks or lines may be released as vapor through an exhaust fan, entering the sterile surgical site and open chest cavity of patients.
For years, manufacturers and federal regulators have provided hospitals and health care providers with updated instructions to avoid microbial contaminants in the water tanks, and reduce the risk that contaminants may be introduced into the sterile operating field by the devices.
NTM INFECTION RISKS: Nontuberculous mycobacterium (NTM) infections can cause severe and potentially fatal illnesses. They can be difficult to detect, may lie dormant for months before symptoms show, and by that time the infection could have spread to significant parts of the body, making it hard to treat and rid the patient of the infection.
Patients must often go through long, harsh, antibiotic therapy, wound debridement, blood transfusions and may often need repeated surgeries to clear the body of the infection, and in some cases the infections still are not completely removed and return again at a later date.
Symptoms can include:
- Abdominal pain or pain at the surgical site
- Redness or puss at the surgical site
- Inflammation of organs