Two dangerous varieties of bacteria—Mycobacterium chimera and Mycobacterium abscessus—that have been causing infections in South Carolina and several other states appear to have arisen from the use of a particular surgical medical device. The Sorin 3-T operating room (OR) device is used in various kinds of open-chest (cardiothoracic) procedures, such as during a coronary bypass, open-heart surgery, and heart or lung transplants. It is conjectured that the devices were shipped from a German manufacturing plant already contaminated with the bacteria. Issues also exist concerning the spread of bacteria by the device’s exhaust, meaning that bacteria-laden air is blown near or over the surgical site.
The Sorin 3-T is a heater-cooler device, meaning that it is used in the OR to warm or cool patients as needed during surgery. These devices are especially vital and are used routinely for open-chest surgeries. Heater-cooler devices have tanks containing temperature-controlled water performing the heating or cooling as needed. Over a quarter-million heart bypass procedures in the U.S. employ such devices every year, and about 60 percent of such procedures have used the Sorin 3-T. Chances of infection from the bacteria run between 1 in 100 and 1 in 1,000. To lend some perspective, you have less chance of dying in a SC vehicular crash—1 in 6,225.
These mycobacteria exist routinely in water and soil, rarely sickening healthy people. However, when such bacteria contaminate a surgical site, the resulting severe infection might take as many as six years to develop. Because of the extremely long time period before a full-blown infection could make itself known, the Centers for Disease Control and Prevention (CDC) has recommended that a letter be sent to every patient who underwent surgery that used the Sorin 3-T, or who were operated on in the same OR where the device had been used, during the past three years.
Locally, Medical University of South Carolina (MUSC) Health has said it is attempting to replace the named devices. Greenville Health System has used the heater-coolers in the past, but does not use them anymore. At Greenville Memorial Hospital in 2014, a Mycobacterium abscessus outbreak killed four patients, infecting 15 in all.
Palmetto Health sent letters to approximately 1,800 patients at the end of 2016. They have not encountered any patients with mycobacterial infections but have replaced all their heater-cooler surgical devices. Bon Secours St. Francis Health System has also not found any infected patients. They are waiting for new heater-coolers to be delivered as of late January, 2017.
The CDC has issued warnings to those who have undergone open-heart or open-chest surgeries to seek medical care if they experience the following symptoms:
- Muscle aches
- Night sweats
- Weight loss
- Similar symptoms related to infections.
The CDC believes that some infected patients have already died.
Medical device manufacturers are required by law to make products which are safe and which will provide the intended benefit. When they fail to safely design or manufacture the product or properly package or label it, they may be held accountable in a court of law. With that in mind, if you or a loved one had open-chest surgery where a Sorin 3-T was used, or in an OR where the device was used, and were diagnosed with Mycobacterium chimera or Mycobacterium abscessus, you might want to seek legal advice, even if the patient in question has died. Likewise, if you or a loved one had open-chest surgery where a Sorin 3-T was used, or in an OR where the device was used, and were sent a letter from the hospital alerting you to possible mycobacteria infection, you might think about exploring your legal options. It is always possible that, if you had or have an infection, it was misdiagnosed as something other than mycobacteria.
Seeking truth. Securing justice.
The Columbia defective medical device lawyers of the Louthian Law Firm can help you obtain compensation for your injuries, pain and suffering, medical expenses, rehabilitation, loss of income and reduced quality of life. We will investigate every aspect of the product’s development and application to make sure all appropriate defendants are named in the lawsuit. This could include the laboratory which failed to conduct adequate pre-market testing, the manufacturer who failed to maintain quality control, the doctor or hospital which failed to warn of possible complications or give adequate instructions, and others whose negligence contributed to your injury.
We’ll fight for your right to safe and appropriate medical care with discipline, diligence and dedication. For a free consultation, call the Louthian Law Firm today at 1-803-454-1200, or fill out our confidential online case evaluation form.