The 3M Company is disputing rumors that the Bair Hugger forced air warming blanket is the subject of a “silent recall.” In a statement issued on February 16th, 3M asserted that rumors of a Bair Hugger recall are being driven by a competitor to incite “unease” about the surgical warming system.
The statement was issued in response to mass emails purportedly generated by Augustine Temperature Management, through its OrthopedicinfectionAdvisory.org website.
“Augustine sells a competing product that is not widely used nor accepted in the marketplace,” according to the 3M statement. “The company’s founder, Scott Augustine, has pursued a deliberate business strategy of disparaging and instigating litigation against the 3M Bair Hugger system in an attempt to promote his own competing product. He has a history of making false and misleading claims and has been warned by the FDA to stop.”
3M maintains that the Bair Hugger is safe and effective, and denies that it is subject to recall, silent or otherwise.
The Bair Hugger surgical warming system was brought to market in 1987 by Arizant Healthcare, Inc. Arizant was subsequently acquired by the 3M Company in 2006. Today, the forced air warmer is used by more than 80% of the nation’s hospitals to prevent hypothermia in patients undergoing surgical procedures. During surgery, a single-use, inflatable blanket is draped over the patient. The Bair Hugger’s portable heater then draws in and warms ambient air, which is forced through a flexible plastic tube into the blanket.
Despite 3M’s assertions as to its safety, the Bair Hugger is currently the subject of more than 1,200 product liability lawsuits, all of which were filed on behalf hip and knee replacement infections who allegedly developed post-operative deep joint infections due to problems with the apparatus. These lawsuits claim that the forced air warming system suffers rom a design defect that allows potentially contaminated air from the operating room floor to come into contact with the sterile surgical site, greatly increasing the odds that an infection will develop at the site of the implant. Plaintiffs further allege that 3M and Arizant have been aware of this issue for years, yet have failed to implement appropriate design changes or warn the medical community about this issue.
Federally-filed Bair Hugger lawsuits have been centralized in the U.S. District Court, District of Minnesota, for coordinated pretrial proceedings. The litigation’s first trials are expected to begin in February 2018.