The Bair Hugger Warming System, a blanket that is used on patients during certain surgical procedures to regulate body temperature, has recently been alleged to have dangerous and potentially life-threatening complications.

Plaintiff Donna Edwards, a resident of Arkansas, has filed a personal injury lawsuit against 3M Company and Arizant Healthcare, Inc. the manufacturers of the Bair Hugger Forced Air Warming System.

Donna underwent right hip replacement surgery in 2011, and the Bair Hugger was used, which allegedly swept contaminants into the open surgical site.

According to the Bair Hugger lawsuit, Donna alleges that the warming system used on her during a hip device implantation surgery directly caused her severe infections which in turn allegedly caused severe and permanently disabling injuries.

3M Aware of Bair Hugger Infection Risks

Donna claims that the defendants were aware of the dangers of the Bair Hugger prior to her surgery, and knowingly concealed this important information from not only her but other consumers and the medical community as a whole.

The Bair Hugger lawsuit claims that the defendants were aware since at least 2009 that the Bair Hugger’s internal airflow becomes contaminated with pathogens. This contamination, the lawsuit states, is due to reduced efficiency of air filtration.

The defendants admitted to the U.S. Food and Drug Administration (FDA) that “air blown intraoperatively across the surgical wound may result in airborne contamination.”

The defendants then assured the FDA that this would not be an issue with the Bair Hugger, because their systems were all designed featuring a tape barrier that prevents this kind of contamination.

However, the Bair Hugger lawsuit claims that this is not true — not all Bair Hugger systems utilize a taped edge. By the defendants’ own admission, these Bair Hugger systems without a taped edge blow contaminated air across the surgical wound and “may result in airborne contamination.”

The Bair Hugger lawsuit further claims that numerous published studies document these adverse contamination effects associated with the Bair Hugger FAW.

The system blows hot air at patients in an attempt to warm their bodies and keep them stable during surgeries.

However, the Bair Hugger’s method of circulating warm air can allegedly force harmful bacteria from nonsterile areas of the operating room into open surgical wounds into the sterile area.

According to patients, this negative side effect to the system has caused, among other things, serious infections during knee or hip replacement surgery.

Donna is charging 3M with negligence, strict liability, failure to warn, defective design and manufacture, breach of express and implied warranty, fraudulent concealment, and others.

If you or someone you know has contracted a life-threatening infection after the Bair Hugger warming system was used during a procedure like knee replacement surgery or hip replacement surgery, you may have cause for filing a Bair Hugger lawsuit.

The 3M Bair Hugger Lawsuit is Case No. 4:15-cv-465-JM, in the U.S. District Court for Western Division of the Eastern District of Arkansas.