Lawsuits have been filed alleging that 3M’s Bair Hugger Forced Air Warming System has the potential to cause severe deep joint infections in patients who have had hip and knee replacement surgery.
The Bair Hugger Forced Air Warming Blanket was initially approved by the Food and Drug Administration (FDA) in 1987, through a 510(k) premarket clearance program that allowed it to be sold without proven evidence of its safety. The Bair Hugger devices have now been used in hospitals on more than 100 million patients since 1988.
What is the Bair Hugger Warming Device?
The device uses forced air to help maintain body temperature during surgery. Maintaining core body temperature around 98.6 degrees during and after surgical procedures has been proven to reduce bleeding and facilitate a faster recovery. The device is intended to force warm air into a blanket and over a patient’s body. However, reports claim that the dispersion of warm air during hip and knee surgery may cause bacteria to circulate and at times contaminate the surgical site.
The Bair Hugger’s inventor, Dr. Scott Augustine has cautioned against the devices’ use during surgery.
Circulating air which has been contaminated with bacteria during a surgery has the potential to cause infection. Documented infections include cases of sepsis and Methicillin-resistant Staphylococcus aureus—commonly known as MRSA.
Occurrence of infection after use of the devices has specifically been reported in patients who underwent knee and hip replacement surgeries. This is due to the fact that the metal and plastic replacements used in such surgeries hinder the immune system’s natural response to fighting bacterial infection. In some instances of the infection, the bacteria has developed a resistance to antibiotics, requiring that patients undergo additional surgeries as treatment.
Severe side effects relating to the bacteria include joint infections. Such infection can require that patients have revision surgery, joint fusion and removal surgery, or in the most severe cases undergo amputation of the infected area when other treatment proves insufficient.
Lawsuits Pertaining to the Bair Hugger Device
Lawsuits have been filed alleging that 3M—the manufacturer of the Bair Hugger Warming Device and related systems—and sales representatives for the company were aware of the increased risks associated with the device’s use. Further, patient attorneys claim that 3M not only failed to redesign the device, but did not warn healthcare providers and patients of the risks, and attempted to discredit evidence of the adverse effects. Current lawsuits claim that patients who have suffered infection resulting from the device have been hospitalized, undergone implant revision surgeries, faced permanent disability, and required amputation. Critics of the device contend that infection related to its use have the potential to lead to death.
If you or a family member suffered a deep joint infection, also known as a peri-prosthetic joint infection, during a hip, knee or other implant surgery, contact the Law Offices of Peter G. Angelos, P.C. for additional information and a no-charge consultation with one of our experienced attorneys.
On December 11th, 2015, the United States Judicial Panel on Multidistrict Litigation ordered the transfer of all 3M Bair Hugger cases to the U.S. District Court, District of Minnesota. There are currently 84 3M Bair Hugger cases pending before this court. Read more about the MDL here.