Bair Hugger Warming Blanket
Hip & Knee Surgery Infections
Bair Hugger Therapy has been the focus of lawsuits regarding deep joint infections that developed in patients following hip and knee replacement surgeries.
Bair Hugger Therapy is a body-temperature management system that uses a warming blanket and forced air to prevent and treat hypothermia in the operating room. Hospitals have been using this procedure for decades to treat patients undergoing orthopedic surgery.
The litigation claims that the use of Bair Hugger devices is linked to severe post-operative infections, particularly in patients who have undergone hip and knee replacements. It is alleged that these devices allow air to accumulate under the surgical drape, which then escapes below the level of the surgical table, and that escaped air creates warm, rising airflow currents that deposit bacteria from the operating room floor back into the surgical site.
The first Bair Hugger warming system was manufactured by Augustine Medical and approved by the FDA in 1987 through the 510(k) premarket clearance (fast track) program. Twelve more clearances were fast-track issued from 1990-2002. After Augustine Medical changed its name to Arizant, the FDA issued two more 510(k) clearances from 2004-2006. The devices are currently being manufactured by 3M and Arizant.
Patients who suffered infections while exposed to Bair Hugger therapy have filed lawsuits against 3M and Arizant. They claim the companies failed to properly test the products, did not conduct sufficient post-market testing and review, and continued to market Bair Hugger while knowing of the potential for serious adverse effects. Even the inventor of the devices, Dr. Scott Augustine, urged the manufacturers to recall the products because of the risk they pose to implant surgery patients. The lawsuits are challenging the efficacy of the warming devices, stating there is no proof that heating the body during surgery in this manner results in more positive outcomes versus other warming techniques. There are other options like radiant warming which work just as well. Despite the claims, lawsuits and controversy, 3M and Arizant continue to make and market Bair Hugger forced-air warming temperature management systems.
If you or someone you know suffered a joint infection following a hip or knee replacement surgery, call us today. Martin, Harding and Mazzotti LLP and our hip and knee replacement surgery attorneys will investigate your claim. We have locations across New York State and Vermont to serve you. Call 1800LAW1010 (1.800.529.1010).