Surgical products maker Arizant, a subsidiary of 3M, has been hit with a lawsuit charging that the Bair Hugger surgical warming blanket introduced a serious infection during a patient’s hip surgery.
The complaint alleges that the plaintiff suffered serious injuries when the Bair Hugger introduced dangerous pathogens from the operating room floor into the sterile surgical site during hip implant revision surgery. The bacteria caused a Methicillin-resistant Staphylococcus aureus (MRSA) infection.
The Bair Hugger is used in 90 percent of major surgeries in the U.S., but the complaint alleges that the device is dangerous to use in joint replacement and revision surgeries, and the warming blanket may contribute to thousands of orthopedic implant infections that occur each year, according to a news release.
Septic arthritis—a deep joint infection—is difficult to treat. The plaintiff underwent six additional surgeries in less than eleven months to remove his hip implant and clean the infected area. The surgeries themselves were painful and required lengthy recovery time. The man suffered permanent physical injuries that affected his ability to move freely.
Septic arthritis is an intensely painful infection in a joint. The Mayo Clinic explains that the joint can become infected with bacteria that travel through the bloodstream. Septic arthritis can also occur when a penetrating injury or surgical procedure introduces germs directly into the joint. Infants and older adults are at highest risk for septic arthritis, and the knee and the hip are the most commonly affected joints. The Mayo Clinic says septic arthritis can severely damage the cartilage and bone in the joint. Prompt treatment is crucial. The joint must be drained with a needle or with surgery, and intravenous antibiotics also may be necessary to stop the infection.
The lawsuit alleges that Arizant and its parent company 3M concealed their knowledge of the Bair Hugger’s risks from the plaintiff, from other consumers, and from the medical community. The law firm representing the injured man says Arizant did not conduct adequate surveillance once the Bair Hugger was on the market. Dr. Scott D. Augustine, who developed the Bair Hugger in the late 1980s, discussed these concerns in a 2010 article in the New York Times. Dr. Augustine said the Bair Hugger is an improvement over earlier patient warming equipment, but he believes the forced-air device creates a danger of infection when the Bair Hugger is used on a patient receiving an implant device like an artificial joint or heart valve. He feels 3M should recall the device. Dr. Augustine no longer has a financial stake in the Bair Hugger, and he has a safer alternative, a warming device that works more like an electric blanket and does not use forced air.
The attorney who filed the legal complaint said that an infection following joint replacement surgery can require multiple follow up surgeries and can leave a patient with “truly catastrophic injuries.” The attorney said the plaintiff’s injuries could have been prevented by using a warming method that does not introduce bacteria from the operating room floor into the surgical field.