The number of lawsuits filed recently against 3M over the Bair Hugger warming blanket has grown to nearly 200. The lawsuits allege that in joint replacement surgery in which the device was used, some patients developed catastrophic injuries, including infections, repeated joint surgeries, immobility and in severe cases amputations of knees and legs. The lawsuits also claim that 3M knew about the hip and knee surgical infection risk for many years, but failed to make design changes or warn the doctors and hospitals.
Approved by the FDA in 1988 the Bair Hugger warming blanket consists of a perforated blanket connected to a forced-air heating unit that rests on the floor near the operating table. The unit carries heat via forced air to the blanket, with the warm air transferred to the patient through the blanket.
Doctors use the warming device on patients during joint replacement surgery to guard against the risk of hypothermia and to ensure normal blood flow during the operation. After the Bair Hugger warming blanket came on the market it has become one of most popular devices of its kind and been used in an estimated 200 million surgeries.
Almost as soon as the device was introduced there were reports of infections in surgeries using Bair Hugger, especially in invasive joint replacement surgeries where the introduction of any infectious germs can have devastating consequences. The configuration of the floor-situated Bair Hugger has been suspected of compromising the carefully controlled ventilation systems common in operating theaters that help maintain the sterile environment. In a recent report in the Journal of Hospital Infection, no fewer than 10 peer-reviewed studies were referenced that suggested use of forced-air warming systems such as the Bair Hugger succeeded in the introduction of contamination to the operating field.
I expect the number of cases against Bair Hugger to continue to grow. There are still an estimated 50,000 Bair Hugger devices still in use across the U.S. and patients need to be aware of the suspected risks associated with this device, especially if they are undergoing hip or knee replacement surgery.
At Saunders & Walker we continue to represent clients harmed by dangerous and defective medical devices. If you suspect that you or a loved one has suffered a dangerous infection following a surgery in which a Bair hugger warming blanket was used, please do no hesitate to contact our office for a consultation.