The Medical University of South Carolina says that up to 3,000 patients — including an unknown number in the Upstate — may have been exposed to dangerous bacteria since 2012 during open-heart surgery at the hospital through potentially contaminated equipment.
Though the hospital says there is no evidence that anyone has been infected to date, it is following federal guidance in notifying patients about the possible risks.
An Anderson attorney, meanwhile, has filed a class action suit on behalf of people who have been notified about the potential infection.
The infections involve a heater-cooler device manufactured by LivaNova PLC — formerly Sorin Group Deutschland GmbH - Stöckert — which is used to control blood temperature during open-heart surgery.
The U.S. Centers for Disease Control and Prevention says the devices may have been contaminated with Mycobacterium chimaera during manufacture.
And the agency is warning patients who've had open-heart surgery to seek medical care if they have night sweats, muscle aches, weight loss, fatigue, fever or other symptoms associated with the infection, saying that some patients identified in their investigation have died.
MUSC Health, which said it is working to replace the devices, said it’s among the 60 percent of heart surgery programs in the country that uses this equipment during coronary bypass and heart or lung transplantations.
Mycobacteria are often found in soil and water, where they rarely make people sick, according to CDC. But introduced into a surgical site, it can result in a severe infection that may not develop for up to six years.
More than 250,000 heart bypass surgeries are done in the U.S. each year with devices, according to CDC, which conducted an investigation that revealed the bacteria from the devices matched the bacteria found in patients in several states. Evidence from Europe also shows the bacteria contaminated the devices during manufacture in Germany.
At hospitals where at least one infection was found, the agency reports, the risk of being infected was between about 1 in 100 and 1 in 1,000.
Because the infection is slow growing and difficult to diagnose, symptoms may not develop until years after surgery. So MUSC said any patients who’ve had surgery using the devices should talk to their doctors about symptoms they may have.
A Mycobacterium abscessus outbreak infected 15 patients at Greenville Memorial Hospital in 2014. Four patients died.
Officials at the time said the infection couldn't be traced to one piece of equipment or process as originally thought, but that tests showed the water in various locations inside the hospital contained the bacterium and that tap water the staff used to prepare for surgery was responsible. And the hospital took steps to prevent more infections.
State and federal health officials said that both the isolates obtained from the GHS scrub sink and those from the heater-cooler machine were closely related to the isolates from the cardiac cases, so the source of the infection was inconclusive and the outbreak involved another species of Mycobacteria as well.
GHS used the heater-coolers in question at the time, but has since stopped, as has AnMed Health in Anderson.
Bon Secours St. Francis Health System, which also has not identified any patients who've been infected, has ordered new heater-coolers and while waiting for them to arrive, is following guidelines to ensure the safe utilization of Sorin devices, said Rose Leo, vice president of surgical and women’s services.
Palmetto Health, which sent letters to about 1,800 patients in December, has not identified any patients with infections and also replaced all its heater-cooler devices, spokeswoman Tammie Epps said.
The CDC issued its warning on Oct. 14, saying that hospitals should check to see which type of heater-coolers are in use, ensure that they're maintained according to the latest manufacturer instructions, and alert affected patients and the clinicians who care for them.
The use instructions for the heater-coolers, but not the devices, were recalled in 2015 by the manufacturer to let users know that the bacteria could reach a surgical site through fluid leakage or aerosolization, according to CDC.
Between Jan. 1 2010, and Feb. 29, 2016, the FDA logged 180 adverse event reports about the devices, including 45 patients in the U.S. who contracted infections and at least nine who died, according to Consumers Union.
CDC said that although thousands of patients have been notified about their potential exposure, the number exposed could be much higher.
Meanwhile, J. Stephen Welch, an attorney with McGowan Hood & Felder LLC in Anderson, filed a class action lawsuit against the manufacturer on behalf of patients who had the surgery with the heater-cooler seeking damages and medical monitoring to screen for the infection. Potentially 7,000 people in South Carolina could be impacted, he said.
The manufacturer “knew or should have known that design and/or manufacturing defects in their Sorin 3T system cause bacterial colonization to which patients are exposed during surgery, thus posing a significant risk of bodily injury or death,” according to court records.
In addition, the lawsuit alleges, the manufacturer “concealed from and/or failed to disclose” that to the FDA.
“This class action is on behalf of people getting letters that say you were exposed,” Welch said. “They may not have it, but they may not know for three to five years. And a lot of doctors won’t know what to look for.”
Greenville attorney Blake Smith, who represents eight patients who sued GHS over injuries allegedly related to the 2014 outbreak at Greenville Memorial, also has sued the manufacturer. Two of the clients he represents died, he said, while some of the rest are still being treated for mycobacteria.