By Kay Van Wey, Board Certified in Personal Injury Trial Law by the Texas Board of Legal Specialization
There is concern in the medical community about Bair Hugger® Therapy used during surgeries involving implants because these surgeries often carry a high risk of contamination. According to multiple studies, the forced-air warming systems could possibly carry a higher risk for contaminating surgical sites than other warming methods.
Litigation against 3M has been consolidated in Bair Hugger – MDL 15-2666 Forced Air Warming Devices Products Liability Litigation.
Bair Hugger Therapy works by using temperature management systems that force warm air throughout to prevent and treat hypothermia in patients during surgery. Hypothermia during surgery can lead to blood loss, infections and prolonged hospital stays.
The blankets were invented by Dr. Scott D. Augustine, and they are sold along with warming units and accessories through his company, Augustine Biomedical and Design. Bair Hugger® Therapy is used on more than 180 million patients since being introduced in 1988. More than 80 percent of hospitals in the United States use them today.
Dr. Augustine now states that the blankets should not be used in patients who have had implants (including knee and hip implants and artificial heart valves) because they can potentially spread bacteria linked to infections.
FDA Not Recalled Bair Hugger® Blankets
The FDA still hasn’t issued a recall of these medical devices even though many adverse effects have been reported to them. Most reports involve burns from prolonged exposure to heat during surgery or cold air blowing during surgery when the device malfunctioned.
Patients who have developed an infection after surgery that involved the use of Bair Hugger® Therapy have filed lawsuits against the manufacturers, claiming they knew about the risk and attempted to conceal evidence. Compensation for damages, medical expenses, pain and suffering, lost wages and punitive damages could be awarded.