Two patients who had hip replacements are among the hundreds who report they contracted a serious infection because of the surgical warming blanket used during their surgery.
Both people have endured repeated surgeries to treat devastating infections. One of the two is able to walk, but the other does not expect to walk ever again, Houston television station KPRC reports.
An attorney, for the two patients said the Bair Hugger, the warming blanket made by 3M, used during their hip replacement surgeries caused extreme infections.
The Bair Hugger is used in hospital operating rooms to keep patients warm during surgery because anesthesia drugs lower body temperature. The Bair Hugger blows warm air through a quilted blanket to warm the patient. The blanket increases the patient's comfort, reduces bleeding, and reduces the risk of infection and post-operative heart attack, Law360 reports. But according to the (Minneapolis) Star Tribune, heat from the Bair Hugger's warming unit can build up under the operating table, creating air currents that blow contaminants from the operating room floor onto open incisions during joint-replacement procedures.
Dr. Lisa Mouzi, an anesthesiologist with the American Society of Anesthesiologists, explains that low body temperature during surgery can increase the chance of infection, heart attack, and even death. Low body temperature increases "rates of post-operative wound infections (and) delayed wound healing," Mouzi said. Patients who have low body temperature tend to bleed more during surgery, which means the patient may be more likely to need a blood transfusion.
The American Society of Anesthesiologists said the device is necessary, according to KPRC. "Patients lose heat dramatically within the first 30 minutes of anesthesia, so our standard of care is to keep a patient warm," Dr. Mouzi said. Mouzi said she believes the device is important even during brief surgeries.
Over the past 16 years, the Food and Drug Administration (FDA) has received 300 reports of adverse reactions involving the Bair Hugger. Manufacturer 3M expressed sympathy for patients who have experienced infections, but the company says there is an infection risk in any surgery that "causes a break in the skin." Many factors increase the risk of surgical site infections, 3M says, including medical conditions such as diabetes, high blood pressure or heart disease, being elderly or overweight, and smoking, according to 3M. The company says there is no scientific evidence that the Bair Hugger "causes or contributes to surgical site infections." But in a December 2010 interview with the New York Times, Dr. Scott Augustine, the Bair Hugger's inventor, raised questions about possible increased infection risk. Dr. Augustine said that although the Bair Hugger is an improvement over earlier patient warming equipment, he believes the Bair Hugger creates a danger of infection when used on a patient receiving a joint implant or a heart valve. Augustine feels 3M should recall the device.