The Bair Hugger, which is a warming device used on patients following surgeries, is the focus of a lawsuit brought over allegations of serious infection.
Using forced air, the Bair Hugger brings warmed air through a hose to a blanket that covers the patient. According to some studies, keeping patients warm during surgery affords benefits including less bleeding and speedier recovery. The civil lawsuit alleges that it was the Bair Hugger’s airflow that caused a serious infection in the plaintiff, a 70-year-old man, said TwinCitites.com/Pioneer Press.
Following his surgery in March 2011, the plaintiff underwent 14 surgeries; one surgery was conducted to remove his artificial hip, said Pioneer Press, citing the lawsuit. The air the Bair Hugger uses was released under the surgical table, the lawsuit claims, and picked up bacteria that rose with the heat, re-circulating into the hip replacement device that was used in the man’s surgery, Pioneer Press said.
3M; Arizant Heathcare Inc., which manufacturers the Bair Hugger; and a sales representative who works for 3M and Arizant, are the defendants in this case, wrote Pioneer Press. 3M spokesman, Stephen Sanchez, told Pioneer Press that 3M “is very confident about the safety and efficacy of the Bair Hugger.” The Bair Hugger, a single-use device, was involved in some 22 million surgeries in 2012, said Sanchez.
While the lawsuit is new, problems with the Bair Hugger are not. We previously wrote that Dr. Scott Augustine, an anesthesiologist who helped develop the Bair Hugger about two decades ago, was warning physicians against using the device for some surgical procedures as far back as 2010. According to a prior The New York Times report, Augustine said that the Bair Hugger poses bacterial infection risks in patients undergoing implantation with devices like artificial heart valves and joints.
Augustine, who amassed a fortune from the Bair Hugger, has said the device can spread bacteria related to hospital-acquired infections in people undergoing specific procedures. In fact, Augustine told The Times that he has a safer alternative that operates like an electric blanket without the use of forced air.
Augustine also pointed out that five peer-reviewed studies that were conducted in the past couple of years confirm the Bair Hugger air flow’s so-called “contamination phenomenon,” linking the device to increased risks of developing deep joint infections. Augustine also noted that this lawsuit is distinctive because the plaintiff’s injuries are permanently disabling, thousands of similar infections are seen following surgeries annually, and this lawsuit provides a specific cause to the infection, according to Pioneer Press.
Augustine brought the Bair Hugger to market in 1988, said Pioneer Press. He has spoken against the Bair Hugger at professional medical meetings; has underwritten studies conducted to reveal the way in which the Bair Hugger may pose bacterial threats; and has accused the marketer of the Bair Hugger, Arizant, of hiding the device’s problems.
Critics argue that Augustine has no definitive evidence to back up his safety claims about the Bair Hugger; however, an independent testing laboratory that was sought out by Augustine reached similar conclusions, The Times previously wrote. One infectious disease expert The Times interviewed said he found Augustine’s data to be “compelling”; however, proving a link between a bacterial threat and the device would require the implementation of a large clinical study.
Following a dispute with other Arizant board members, Augustine resigned as chairman and chief executive of the company in 2002. Arizant was previously known as Augustine Medical. Also, after a 2004 guilty plea to a misdemeanor charge over a Medicare fraud investigation, Augustine sued Arizant over allegations that Arizant had to indemnify him. Augustine received about $5 million in the settlement, the Times said.