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Did You Suffer a Bacterial Infection Within Four Years of Cardiothoracic Surgery?

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February 2018 Update: 42 federal cases are currently pending against LivaNova PLC alleging the Sorin 3T heater cooler device release aerosolized non-tuberculous mycobacterium (NTM) into the operating theater where it exposed cardiothoracic patients to the bacteria or caused infection. There are three different species of Mycobacterium (M. chimaera, M. fortuitum, and M. abscessus) at issue in the pending litigation, all types of bacteria that have been found in the heater coolers. However, all cases argue similar questions of fact. LivaNova PLC has argued in favor of moving all pending cases to Multidistrict litigation under the Honorable Judge Bruce H. Hendricks in the District of South Carolina.

According to the filing, 30 additional lawsuits have been filed in state courts across the country seeking damages for injury or death and alleging the device maker was negligent and violated consumer protection laws. Plaintiffs in the federal cases opposed centralization in an earlier filing.

Heater- Coolers Linked to Potentially Deadly Bacterial Infections

Cardiothoracic patients may suffer a serious bacterial infection following an operation and it may be because of the warming blankets used during surgery. Because the symptoms of this infection are quite similar to various common conditions, many patients do not even know they are infected. The bacteria, a slow growing non-tuberculous mycobacterium called Mycobacterium chimaera is responsible for a growing epidemic of potentially life-threating infections after heart surgery.

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Complications from M. Chimaera Infections

The FDA has reported infections from across the country, all linked to heater-cooler units. M.chimaera bacteria is a slow and steady attacker that spreads gradually over the course of months or even years. Typically, these infections cause patients to suffer pulmonary and cardiovascular disease, as well as serious complications such as:

  • Abdominal abscess
  • Aortic root abscess
  • Death
  • Decrease in the production of red blood cells, white blood cells, and platelets.
  • Disseminated infection
  • Driveline infection
  • Empyema
  • Enlargement of the spleen
  • Gastroenteritis
  • Hepatitis
  • Infection in the lining of the heart and valves
  • Kidney failure
  • Mitral Valve ring infection
  • Muscle flap
  • Mycotic aortic arch pseudoaneurysm
  • Myocutaneous Thoracotomy Flap infection
  • Pericardial abscess
  • Septic Shock
  • Surgical wound infections

While M. chimaera infections can be treated with antibiotics, it is typically not a quick fix. Some patients will have to remain on treatments for years. But left untreated, the infection can potentially cause death.

Any patients who have been diagnosed with one of the side effects and complications of an M. chimaera infection after undergoing an open-chest procedure may be eligible to seek compensation for the injuries they suffered. Contact us today to learn if you are eligible and to learn more about the compensation you may be entitled to.

More than One Heater Cooler Involved

When a patient undergoes certain procedures, their body temperature must be controlled through the use of various devices. Heater cooler units are often used during open-chest procedures. These units warm or cool water that flows through a blanket that is laid over the patient. Unfortunately, bacteria may develop in the unit and be disbursed into the operating theater through an exhaust vent. The bacteria can then fall through the air and land in the open-chest of the patient. But because of the nature of the bacteria, any infection the patient develops may not present for months if not years after the procedure. And because the early symptoms are so similar to other ailments, the infection may not be diagnosed until damage has already been done.

Investigators have determined that nearly one-third of heater-cooler units tested were positive for M. chimaera, and patients undergoing a wide variety of procedures may be at risk for infection. The FDA has identified numerous surgical procedures where patients have been infected with the insidious bacteria, including:

  • Cardiothoracic surgery
  • Coronary Artery Bypass Grafts
  • Correction of Aortic Anomaly
  • Extracorporeal Membrane Oxygenation
  • Heart transplant
  • Heart valve procedures
  • Lung Resection
  • Lung transplant
  • LVAD (Left Ventricular Assist Device implant)
  • Pulmonary Artery Banding

Be aware that infections have been reported in patients where the procedure they were undergoing was not reported to the FDA.

If you had open-chest surgery and the heater cooler unit used to maintain your body temperature was contaminated, you may receive a notification from the hospital where the procedure was performed. Not all patients will receive notifications, however, as investigations into unit contamination continue. If you or a family member developed an infection in the 48 months following your open-chest operation, contact us as soon as possible. We can help you learn more about heater cooler contamination, the risks to your health, and the options that may be available to you, including your right to seek justice and compensation for your injuries.

Symptoms of a Mycobacteria Infection

Because these types of bacteria are slow growing, symptoms of an infection may not present for months or even years after having an open-chest procedure. The most common symptoms that patients experience after being infected may include:

  • Abdominal pain
  • Cough with blood
  • Fatigue
  • Surgical wound that is hot, red or has pus
  • Joint pain
  • Muscle pain
  • Nausea or vomiting
  • Night sweats
  • Persistent cough
  • Persistent fever for no known reason
  • Shortness of breath that has no medical cause and that may get worse
  • Unintended weight loss

Patients who have undergone an open-chest operation and who experience symptoms of an infection within approximately 48-months after surgery should speak with their physician as soon as possible. Then call us. We fight for the rights of patients harmed by the same devices that are supposed to help, and we will fight for you. Be aware: diagnosis a mycobacterial infection must be done through cultures or molecular testing, both of which will take time.

Though mycobacteria occur naturally outdoors in soil and water, when it enters the body through a surgical incision, or when it enters someone with a weakened immune system, it can have deadly results. Open-chest surgery patients may be infected when the bacteria are released in heater-cooler steam where it can fall into the abdominal or chest incision.

Hospitals Report Infection Concerns

The level of potential patient infection from steam from contaminated heater cooler units in hospitals across the country is extremely concerning. These hospitals are sending notices to patients warning them that they may have been infected with Mycobacterium during their procedures. Just some of the notices issued include:

2017: 1,500 patients notified from Bon Secours St. Francis.
2017: Children’s Hospital in New Orleans, Louisiana issues notices of 12 child cardiac patient infections.
2017: 3000 Medical University of South Carolina patients notified.
2016: Mercy Medical Center in Iowa issues notices to 2,600 patients.
2016: 1,100 patients at Penn Presbyterian Medical Center issued notices.
2016: University of Iowa issues notices to 1,500 patients.
2015: Penn State Hershey Hospital issues notices to 2,300 patients
2015: Spectrum Health Medical Center in Michigan issues notices to 4,500 patients.
2015: WellSpan York Hospital issues notices to 1,300 open-heart surgery patients.

Some patients who have been infected by Mycobacterium from heater-cooler units are seeking justice and filing lawsuits against heater-cooler manufacturers. These patients allege that the device makers knew or should have known about the risks of bacterial infection, but failed to warn the medical community and patients about the contamination risks.

The Centers for Disease Control and Prevention said that more than 500,000 open-chest surgery patients could be at risk for of bacterial infection from these devices. Patients who had open chest surgeries involving:

  • Heart valves;
  • Heart grafts;
  • Heart transplant; or
  • Left ventricular assist device (LVAD) procedures may have an even greater risk of bacterial infection.

Any patients who underwent an open-chest surgery and experience symptoms of bacterial infection within four years of having the procedure should consult with their medical doctor as soon as possible. Patients who are infected may face a long road to recovery. Experts say that treatment typically involves more than one medication, and some of the drugs are toxic. Some patients, such as those who have heart valves, grafts, and implants, will have to undergo additional surgeries to have implants removed because the bacteria may be growing on it.

We Can Help

Patients across the country are filing lawsuits to hold heater-cooler manufacturers liable for contaminated medical devices that have caused far too many patients to suffer the serious and potentially life-threatening side effects of an M. chimaera infection. Legal experts say that as more people recognize the symptoms of these bacterial infections, and understand that they may have been infected, more lawsuits will be filed.

We want to hear from you and anyone you know who has been infected after undergoing a cardiothoracic procedure. We have spent decades fighting for the rights of patients who have been harmed by medical devices. We have a long record of successfully protecting the rights of patients when medical device manufacturers fail to ensure their products are safe. We are aggressive litigators and skilled negotiators who will fight to ensure you get the compensation you deserve for your injuries.

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