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Doctors have long realized hypothermia is a concern associated with surgery, and as a result, Dr. Scott Augustine developed the Bair Hugger Blanket in 1988.

Known as a Forced-Air Warming Blanket, or FAW for short, it helps patients stay warm during orthopedic surgery. Early tests also claimed it reduced infection risks. However, more recent data shows that, particularly during joint replacement and heart surgeries, this device might, in fact, be spreading serious infections the body can’t fight off.

Background

Augustine’s FAW has remained a hospital mainstay, supposedly used on about 180 million patients and found in 80 percent of hospitals. Augustine now, however, disowns the system, alleging it can be a danger to certain patients.

On a general level, the Bair Hugger Blanket works by forcing air through a hose as doctors apply the device when the patient is undergoing anesthesia. The blanket stays on before, during, and after surgery, in the process using pressure points to prevent heat from reaching the body’s burn-susceptible areas. At the same time, it’s equipped with drain holes, where fluid then passes through the blanket to the linens below.

As a result of this combination, the FAW reduces skin softening and cooling from evaporation-related heat loss, prevents the patient from bleeding too much, allows for a faster recovery, and prevents hypothermia during surgery.

Yet, even with the blanket’s benefits, a serious flaw remains: The air brings up bacteria from the operating room floor, making it airborne. In the process, bacteria accumulates on an exposed joint during surgery, and afterward, the body has a difficult time defending it against the infection. Its usage has been associated with sepsis and Methicillin-resistant Staphylococcus aureus (MRSA).

Multiple studies further support these results. One found that 96 percent of all Bair Hugger Blankets caused exposed joints to accumulate high amounts of bacteria, while another, a 2012 study published in Bone & Joint Journal, supported Augustine’s 2010 assertions.

Effects

Having to fight off sepsis or MRSA turns into a difficult, life-changing ordeal for patients who have had hip and knee replacement infections. Some treated with an FAW end up developing deep joint infections, which then require multiple revision surgeries and even joint amputations. Patients have needed:

  • Multiple revision procedures.
  • A longer recovery time
  • Physical therapy.
  • Joint implant removal
  • Antibiotic spacers added to the joint.
  • Intravenous antibiotics
  • Amputation

Lawsuits

Even with these risks and its creator disowning the product, this FAW remains on the market, without any recall.

Yet, patients who’ve needed extensive follow-up procedures to remove the contaminated joint have come forward, filing lawsuits against Arizant Healthcare Inc. and current owner 3M. Plaintiffs allege Arizant and 3M provided no warnings about the risks, supplied the product with insufficient instructions, and continue to promote it as a safe product.

Others further allege that Arizant failed to properly test the FAW before releasing it. Data supports this assertion, as the company didn’t include joint replacement surgery in its trials. Along with this point, the plaintiffs further claim it didn’t examine its pre-market and post-market data, and inadequately monitored the product.

Since lawsuits started amassing in 2015, the case has been consolidated as multi-district litigation in the U.S. District Court, District of Minnesota.