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Bair Hugger

Reports of serious joint infections have been linked to the Bair Hugger, a forced-air warming system frequently used during hip and knee replacement surgeries. The forced-air warmers can carry airborne bacteria and other particles to the sterile surgical site causing catastrophic infections.

What is Bair Hugger?

The Bair Hugger is what is known as a forced-air warming system (FAW). It contains a portable heater/blower unit with a flexible hose that is hooked up to a disposable blanket that is positioned over surgical patients.

The Bair Hugger delivers warm air to keep a patient’s temperature stable during surgery by cycling the air under the blanket. This helps to:

  • Reduce wound infections (soft tissue)
  • Reduce blood loss
  • Reduce cardiac events
  • Lower mortality rates
  • Shorten recovery times

Other common methods of patient warming include: resistive electric warming and water-based systems.


More Than 50,000 Bair Huggers in Use

The Bair Hugger has been used in many orthopedic joint replacement surgeries over the past 30 years. Today, more than 50,000 Bair Huggers are in use and it is estimated they are used in more than 80% of all hip and knee replacement surgeries.

The device, manufactured by 3M, was approved through the FDA’s fast-track approval process, which allows medical devices to enter the market as long as they are sufficiently equivalent to products already available.


What is the issue with the Bair Hugger?

The Bair Hugger has been linked to an increased risk of infection when used in knee and joint replacement surgeries.

Forced-air warming systems have the potential to disrupt the airflow in the operating room, resulting in bacteria and other particles being carried into the sterile area around the patient’s incision. This can result in serious infections known as periprosthetic joint infections (PJIs). Even with additional surgeries and weeks of antibiotics, patients never regain their full capacity after catastrophic PJIs.


Bair Hugger May Increase Risk of Serious Infection After Surgery

A study in Bone & Joint Journal documented over 2,000 times more bacteria in the air over the wound with a forced-air warmer than alternative warming methods.

Other relevant findings identified in studies include:

  • Patients were 3.8 times more likely to develop sepsis in the new joint when FAW blankets were used
  • Deep joint infections dropped by 74% when an alternative to the device was used
  • Three studies have found that FAW blowers are a breeding ground for contaminates.

Serious Infection Problems & Risks

Airborne bacteria and particles can lead to serious deep joint infections. Hip and knee replacement patients where the Bair Hugger has been used have experienced severe infections requiring repeat surgeries and replacement of the artificial joint.

Treatments for knee or hip replacement infections may require:

  • Multi-stage revision surgery
  • Placement of an antibiotic spacer, which can severely limit mobility
  • Lengthy physical therapy

Bacteria entering the surgical area may result in:

  • Methicillin-resistant Staphylococcus aureus (MRSA)
  • Sepsis or septic hip/knee
  • Deep joint infection
  • Amputation
  • Wrongful death

3M and Arizant Healthcare Facing Product Liability Lawsuits

3M and Arizant Healthcare have been accused of:

  • Knowing about the infection risks yet failing to make design changes or provide adequate warnings about the potential risk of joint infections
  • Lying to the FDA about the device’s effectiveness in filtering out and trapping bacterial contaminants, saying it meets HEPA standards when it doesn’t
  • Failure to issue a Bair Hugger recall after the risk of infection became known

Individuals who have experienced infections or post-surgical complications after hip or knee replacement surgeries in which a Bair Hugger was used are beginning to file product liability lawsuits based on these allegations.

It is anticipated that the number of complaints will continue to rise over the coming years.


Receive a Free Evaluation

If you developed a serious post-operative infection following a hip or knee replacement surgery that involved a 3M Bair Hugger forced-air warming system, we want to talk with you.

Treating a deep joint infection is a painful, lengthy and expensive process. You may be entitled to compensation for medical expenses, lost wages, pain and suffering, and more. Let us help you obtain the compensation you deserve. Contact us for a free, no-obligation review of your case.

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Bair Hugger in the News


FAQ

What does HEPA refer to?
Q
A

HEPA stands for High Efficiency Particulate Air. These are standards that require an air filter be capable of removing 99.97% of all particles 0.3 microns or larger.

One of the allegations against 3M is that they told the FDA that the Bair Hugger met this standard when it does not.

What studies link the Bair Hugger to a higher risk of infection after surgery?
Q
A

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