New studies by the U.S. Food and Drug Administration have linked nontuberculous mycobacteria (NTM) infections to the heater-cooler devices that are used in cardiopulmonary bypass or open-heart surgeries. Although the symptoms of an NTM infection may take months or years to manifest, the infection can result in illness and ultimately lead to death.
The FDA issued a statement in October 2015 regarding the potential dangers of using these devices. Now, heater-cooler lawyers are aiding patients by investigating the link between the use of these devices and NTM infections as well as filing lawsuits for patients affected.
Heater-cooler devices serve the purpose of keeping the patient’s body temperature and blood cool during a heart operation by using water that is temperature-controlled. However, water may be contaminated, allowing the device to spread this harmful bacteria into the air. While a patient’s chest cavity is open during surgery, this infection can then easily enter their body. Many lawsuits have already been filed against the manufacturers of these devices as the result of unsafe products being sold that allow this bacteria to enter the body during an operation.
An estimated 250,000 heart bypass surgeries are performed annually in the United States. 60 percent of these heart bypass surgeries use the Sorin Stockert 3T. The CDC has stated that the chances of a patient contracting NTM during a procedure which uses this model are between 1 in 100 and 1 in 1,000. As a result, the CDC as well as the FDA have issued warnings about the risk of using this particular model.
NTM infections have killed several people and caused serious illness in many others. Investigations have found a link between these cases and the use of heater-cooler devices that use contaminated water. Two hospitals in Pennsylvania have informed patients that thousands of people who have received heart surgery on their premises may have been exposed to NTM as the result of the heater-cooler devices used.
Those who contract an NTM infection have a 50 percent chance of surviving. The symptoms are incredibly hard to treat and can take several years to manifest. Patients who have contracted NTM infections are filing lawsuits against the manufacturers of contaminated heater-cooler devices.
Should I File a Heater-Cooler Device Lawsuit?
Those who are infected with NTM may find it difficult to pay for medical bills. Sometimes surgery is required to eradicate tissue that has become infected. Treatment may lead to further complications. The FDA has found a strong link between NTM infections and the use of contaminated devices. After several studies, the FDA has discovered that heater-cooler devices use air filters that may not adequately capture NTM bacteria.