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Lawsuit Alleges Surgical Warming Blanket Introduced Infection During Surgery

Aug 3, 2015

A lawsuit has been filed against Arizant, a wholly owned subsidiary of 3M, manufacturer of the Bair Hugger forced-air surgical warming blanket.

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 a 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.

A deep joint infection-or septic arthritis-is difficult to treat, and the plaintiff needed six additional surgical procedures in less than eleven months to remove his hip implant and clean the infected area. The surgeries themselves were painful and the patient needed lengthy recovery time, and the man suffers permanent physical damages-including the inability 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 from another part of the body. Septic arthritis can also occur when a penetrating injury or surgical procedure introduces germs directly into the joint. Infants and older adults are most likely to develop 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 within the joint. Prompt treatment is crucial, and the treatment involves draining the joint with a needle or via surgery. 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 of surgical complications from the plaintiff, other consumers, and the medical community. The law firm representing the injured man says Arizant failed to conduct adequate surveillance once the Bair Hugger was on the market. Concerns about the Bair Hugger were discussed in a 2010 interview the New York Times with Dr. Scott D. Augustine, who developed the Bair Hugger in the late 1980s. Dr. Augustine said in the interview that although the Bair Hugger is an improvement over earlier patient warming equipment, 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.

The attorney who filed the legal complaint said, "A joint infection following a hip or knee replacement surgery can result in multiple follow up surgeries leaving a patient with truly catastrophic injuries." The attorney said the plaintiff's injuries could have been prevented by the use of a warming method that does not introduce bacteria from the operating room floor into the surgical field. The attorney asserts that manufacturers of medical products have a duty to thoroughly investigate safety concerns about their products and recall devices when necessary.

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