Nontuberculous mycobacteria (NTM) are a group of very common bacteria found in dirt and water around the world. For most people, NTM does not pose a threat, but some people can develop life-threatening lung diseases if the bacteria is inhaled. NTM can also cause systemic bacterial infections if it enters through a wound or incision during surgery in a non-sterile environment.

In recent years, the U.S. Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) have become concerned because of NTM infections caused by certain types of heater-cooler devices used in open-heart surgery. Thousands of contaminations of M. chimaera and M. abscessus at hospitals in several states have led to the filing of dozens of heater-cooler infection lawsuits, and that number could grow much larger.

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Why Consumers Should Be Aware of Nontuberculous Mycobacteria

cases of Mycobacterium chimaera infections associated with heater-cooler devices occur globally each year. As many as 80 cases occur in the United States alone.CDC

NTM bacteria are prevalent all around the world. They’re abound in water, soil, and places where dirt or moisture are likely to accumulate – such as pools, hot tubs, and shower heads. Even so, most people do not get an NTM lung infection or other infections. So why should consumers be aware of the potential dangers of these mycobacteria?

Over the last decade or so, there has been a noticeable increase in hospital-acquired infections from NTM. After multiple adverse event reports and a handful of studies, the FDA and CDC traced many of these infections back to a specific medical device used during open-heart surgery, known as a “heater-cooler system.”

A particular manufacturer, Sorin Group USA – owned by Germany-based Sorin Group Deutschland GMBH, which in turn is owned by LivaNova PLC in the UK – has seen a greater share of problems than others. According to the CDC, the company’s Stöckert 3T Heater-Cooler Systems were shown to have been contaminated with a particular NTM known as M. chimaera during the manufacturing process.

Because of this contamination and other potential design flaws, bypass surgery patients are at a higher risk of developing a postoperative NTM infection. The CDC estimates that the risk of such a bacterial infection could be as high as 1 in 100 open-heart surgery patients – and with nearly a quarter of a million cardiac surgeries performed each year, that’s potentially thousands of people who have been affected.

NTM Contamination Notices

Hospitals in some states have issued notices to thousands of their patients in recent years about the potential contamination of M. chimaera, M. abscessus and other nontuberculous mycobacteria.

Hospital Notifications of NTM Contamination

  • Mercy Medical Center (2,600)
  • University of Iowa Hospital (1,700)
  • Children’s Hospital of New Orleans (55)
  • University of Michigan Medicine (7,000)
  • Saint Louis University Hospital (unknown)
  • BJC HealthCare (unknown)
  • Allegheny Health Network (3,000)
  • Penn State Hershey Medical Center (2,300)
  • York Hospital (1,300)
  • Penn Presbyterian Medical Center (unknown)
South Carolina
  • Medical University of South Carolina (3,000)
  • Palmetto Health (1,800)
  • Greenville Memorial Hospital (at least 15)

The list above may not be complete. If you or a loved one experienced an infection after open-heart surgery and received a notice about NTM contamination, you should talk to a legal expert to understand your rights.

NTM Infections

According to some studies, the number of mycobacterial infections has been increasing in recent years, leading to concerns over the effectiveness of antibiotics in treating nontuberculous mycobacteria infections. That said, despite the prevalence of these bacteria in the environment, most people are unlikely to get an NTM infection from their everyday activities.

The people most likely to develop an NTM lung disease or infection are those who have some other compromising health condition, such as one or more of the following underlying lung diseases:

  • Bronchiectasis
  • Chronic obstructive pulmonary disease (COPD)
  • Cystic fibrosis (CF)
  • Emphysema
  • HIV infection
  • Rheumatic pulmonary disease
  • Tuberculosis (TB)

Individuals who have recently undergone surgery may also have compromised immune systems and may be more susceptible. Infections at hospitals, nursing homes, and other healthcare facilities have been shown to be higher in patients with certain types of invasive procedures, such as open-heart bypass operations.

Other less common risk factors include post-transplantation immune system suppression, postmenopausal women who are slender, mitral valve prolapse, and a anti-tumor necrosis factor therapy.

Common Mycobacterium Infection Symptoms

  • Fever
  • Muscle aches
  • Night sweats
  • Chronic cough
  • Unexpected weight loss

Because NTM are slow-growing bacteria, it can sometimes take months for these or other symptoms to develop. It may not always be clear that the infection is related to your surgery, and you may need to undergo several diagnostic tests, such as CT scans and sputum cultures, to determine the cause of the infection.

If you experience any of these symptoms after undergoing open-chest surgery, you should seek medical help right away, as it may be a sign of mycobacterium infection.

Treating Nontuberculous Mycobacterial Infections

Treatment for NTM infection typically consists of some type of antibiotic. However, the specific drug chosen depends on a number of factors, including the type of mycobacterium infecting the patient and its level of resistance to antibiotics. Infection type (lung tissue, soft tissue, systemic infection, etc.), patient allergies, and potentially adverse side effects will also be taken into account by your healthcare provider.

Effective treatment can often take months or even a year or longer to completely remove all traces of NTM from your system. Over time, bacteria can also become more resistant to some antibiotics, requiring a change in regimen or the introduction of other treatments, such as surgery.

Commonly used antibiotics to treat NTM infections include:

  • Azithromycin
  • Amikacin
  • Bedaquiline
  • Clarithromycin
  • Clofazimine
  • Linezolid
  • Rifampin
  • Rifabutin
  • Tigecycline

Again, the specific drug used will change based on the different species of NTM involved and where the infection is located. Your doctor will provide you more information about the recommended drugs for your situation, and whether you might need ongoing treatment.

Types of Nontuberculous Mycobacteria

The Mycobacterium class includes more than 150 types of bacteria, including the bacteria that cause tuberculosis (TB) and leprosy. By definition, the subclass of nontuberculous mycobacteria includes all bacteria except Mycobacterium tuberculosis, Mycobacterium leprae, and a handful of related bacteria.

Some NTM can cause lung infections with symptoms very similar to tuberculosis, such as Mycobacterium avium complex (MAC) infections, which cause lymphadenitis (inflamed lymph nodes).

Most Common NTM Species

  • M. abscessus
  • M. avium
  • M. bolletii
  • M. buruli
  • M. chelonae
  • M. chimaera
  • M. duvalii
  • M. flavescens
  • M. fortuitum
  • M. gilvum
  • M. gordonae
  • M. intracellulare
  • M. kansasii
  • M. marinum
  • M. massiliense
  • M. obuense
  • M. paratuberculosis
  • M. scrofulaceum
  • M. smegmatis
  • M. szulgai
  • M. terrae
  • M. ulcerans
  • M. xenopi

Heater-Cooler Lawsuits Due to NTM Infections

Dozens of people have filed lawsuits against Sorin Group, claiming that their postoperative infections were caused by the company’s 3T Heater-Cooler devices. These lawsuits claim that the company should have known the devices could increase the risk of NTM disease, and they seek damages for the cost of additional treatments, pain and suffering, and other expenses related to their infections.

If you or a loved one had an infection after receiving heart surgery, contact a medical device lawyer to see if you might be eligible for compensation.

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