New research indicates that the Bair Hugger forced-air warming system used during orthopedic surgery may be associated with a high risk of bacterial contamination at the surgical site, allegedly putting patients at risk for MRSA and other infections. As a result, the manufacturers of the Bair Hugger warming device are being sued by patients who suffered deep joint infections after undergoing hip or knee replacement surgery where the forced-air warming blanket was used. If you believe you have been harmed by side effects of Bair Hugger forced-air warming, contact a reputable product liability lawyer to discuss the possibility of filing a Bair Hugger infection injury lawsuit against 3M.
The potential for Bair Hugger to cause deep joint infections in surgical patients is due to the fact that forced-air warming may allow contaminated air contained under the anesthesia drape and on the operating room floor to be blown over top of the patient and into the surgical site. Some possible alternatives to forced-air warming products like Bair Hugger for keeping patients warm during hip and knee replacement surgery include the following:
The following are some warnings that have been issued recently regarding the potential risk of infection injuries from Bair Hugger devices:
April 2009 – The inventor of the Bair Hugger device writes a letter to Arizant, the maker of the forced-air warming system, accusing the company of concealing information about the risks associated with the medical product.
June 2010 – The FDA issues a warning letter to the President and CEO of Arizant Inc., detailing the company’s “failure to report to FDA no later than 30 calendar days after the day that you receive or otherwise become aware of information of any source, that reasonably suggests that a device that you market may have caused or contributed to a serious injury.”
December 2010 – The inventor of the Bair Hugger device advises hospitals to stop using the warming machine due to the risk of MRSA and other deep joint infections.
Nearly two decades after the FDA approved the Bair Hugger warming system through its 510(k) fast-track approval process, researchers have finally begun to examine the possible risk of side effects from the medical device. The following are some of the most recent studies highlighting the potential for Bair Hugger to cause infections and other injuries in patients:
July 2011 – Researchers involved in a study published in The Bone and Joint Journal indicate that “a significant increase in deep joint infection, as demonstrated by an elevated infection odds ratio, was identified during a period when forced-air warming was used compared to a period when conductive fabric warming was used.”
March 2013 – The Bone and Joint Journal publishes another study in which researchers found that “waste heat from the poorly insulated forced-air warming blanket increased the air temperature on the surgical side of the drape by > 5˚C. This created convection currents that rose against the downward unidirectional airflow, causing turbulence over the patient.”
August 2013 – A study published in Anesthesia & Analgesia finds that “excess heat from forced air warming resulted in the disruption of ventilation airflows over the surgical site,” and calls for further research into the potential risk of infection from forced-air warming.
The inventor of the Bair Hugger system, Scott Augustine, has been very vocal about his opinion that the surgical device may expose patients to a risk of serious infections, and in April 2009, he wrote a letter to 3M’s Arizant subsidiary, accusing the company of covering up the risks associated with the medical device. Lawsuits brought against 3M recently over infection injuries allegedly caused by Bair Hugger forced-air warming have also accused the company of a number of things, including:
Approximately one in one hundred patients undergoing joint replacement surgery develops an infection, which sometimes requires multiple surgeries to replace the infected implant, followed by ongoing medical care and rehabilitation. If you underwent hip or knee replacement surgery with the Bair Hugger forced-air warming device, and you have since suffered MRSA or another severe joint infection, consult an experienced Bair Hugger attorney today for legal help. You may have grounds to file a Bair Hugger lawsuit against 3M, in order to pursue financial compensation for your injuries, medical expenses, and pain and suffering.