Pending Lawsuits Allege Surgical Blankets Designed to Regulate Body Temperature during Surgery Increases Risk of Infection
Our experienced defective medical device attorneys are currently reviewing legal claims brought against the manufacturer of Bair Hugger alleging the company knew use of their warming blanket increases the risk of surgical patients experiencing serious infections. Dozens of lawsuits have been filed by patients who suffered joint infections after the Bair Hugger was used during surgery. Among the allegations in lawsuits filed against the manufacturer of the medical device, lawsuits allege 3M was aware the medical device could increase the risk of infection when used during surgery to regulate body temperature, but it failed to warn the medical community and patients of this increased risk of infection.
Why Do Surgeons Use the Bair Hugger?
The Bair Hugger temperature management system was invented by Dr. Scott D. Augustine who was formerly the chief executive of Arizant. The company subsequently was purchased by 3M, the company that manufactures the medical device which is designed to prevent hyperthermia during surgery. The function of the device is to force warm air over the body of a patient. When a patient is placed under anesthesia to undergo a surgical procedure, the body cannot regulate temperature. Many people are unaware that hyperthermia is one of the leading causes of death during surgical procedures.
The Bair Hugger therapy surgical warming blanket operates like a forced-air heater. Heated air is forced through a hose and into a blanket that covers the patient during surgery. The warm air released by the blanket is designed to avoid sudden temperature drops. The company markets the device as accelerating recovery time, minimizing bleeding, and providing other benefits by stabilizing body temperature.
How Extensive Is the Safety Threat?
The medical device has been adopted for use in eighty percent of hospitals since it was first marketed in the U.S. in 1988. The medical device has been used to regulate body temperature during surgery on approximately 180 million patients. While the device is designed to propel warm air over the surface of the body, lawsuits allege the device also forces air under the surgical table, which can cause bacteria and germs to be spread throughout the room. The patient can have the bacteria or other infectious agents settle in the surgical wound causing Methicillin-resistant Staphylococcus aureus (MRSA) or sepsis. Patients are particularly susceptible to infections in the knee or hip.
Nature of the Risks Associated with the Bair Hugger Surgical Warming System
The most compelling risk associated with the Bair Hugger surgical warming blanket involves infections during surgical procedures on the knee or hip. When infections occur in the deep joints during knee and hip replacement surgeries, extensive treatment might be necessary to combat infection. Treatment might entail antibiotic therapy along with surgery. Severe cases might require joint fusion or removal, amputation, and/or a dual stage revision surgery. If patients are unable to tolerate the second surgery, they typically will be treated with long-term antibiotics.
FDA Reports and Medical Research Regarding Adverse Effects of Bair Hugger System
According to research published in a journal article from the International Anesthesia Research Society, forced-air warming systems that propel heated air over a surgical site can disrupt normal ventilation airflows. By contrast, conductive patient warming devices did not exhibit a noticeable impact on ventilation airflow in operating theaters. The researchers concluded the results merit additional studies of clinical outcomes involving excess heat from forced-air warming systems in contamination-sensitive surgical environments.
A review of published clinical and experimental research into potential infection risks from use of forced air-warming (FAW) in operating theaters with ultra-clean ventilation found that FAW does contaminate ultra-clean air ventilation. The study published in the Journal of Hospital Infection recommended further study to determine if this results in a higher risk of post-surgical infection.
Research published in the Journal of Bone and Joint Surgery determined that air warming blanket systems like the Bair Hugger caused the circulation of 2,000 times more possibly contaminated particles when compared to air circulated by an alternative device.
Even the inventor of the forced air warming blanket system has indicated concerns regarding the safety of the surgical heating blankets. Although his critics have charged that his concerns are related to his involvement with a rival company that produces an alternative device, concerns remain regarding the potential for fatal infections.
Free Case Evaluation for Victims of Bair Hugger Forced Air Warming Blankets
At the Stern Law, PLLC, we are currently investigating claims for compensation on behalf of patients who have experienced surgical infections after use of the Bair Hugger temperature regulation system. We invite you to give us a call today to see if you or a loved one is entitled to compensation. Call Stern Law, PLLC today at at 1 (844) 808-7529, or complete an online contact form for assistance. Click here now for more information on scheduling your free case evaluation with one of our knowledgeable defective medical device lawyers.