The Bair Hugger lawsuit claimed the manufacturer of the Bair Hugger warming blanket knew about the potential increased risk of joint infections linked to the use of this medical device during hip and knee replacement surgeries. Yet, the company failed to redesign the product to make it safer, and chose not to warn of the danger.
What Do We Know About the Bair Hugger Lawsuits
Thousands of lawsuits were filed against 3M (the manufacturer of Bair Hugger) by individuals who claimed they suffered infections because of the medical equipment. The lawsuits were combined before a federal judge in Minnesota where all of the national discovery and evidence gathering took place.
In August 2019, the federal judge dismissed virtually all of the cases finding that the plaintiffs' experts did not present enough reliable medical evidence that the bair hugger increased the risk of surgical infections.
Risks Associated with the Bair Hugger Warming Blanket
The most serious risk potentially caused by the use of the Bair Hugger surgical warming blanket is deep joint infections, especially in the hip and knee during replacement surgeries.
Treatment for these infections include a combination of surgeries and antibiotic therapy. In severe cases, amputation, joint fusion, or removal and a two-stage revision surgery may be necessary. Patients who are not able to have a second surgery are usually treated with long-term antibiotics.
Some people are at a higher risk for developing infections after knee and hip replacement surgeries.
|Factors that Increase the Risk|
|Immune deficiencies (such as HIV, lymphoma)|
|Immunosuppressive treatments (such as chemotherapy or corticosteroids)|
|Peripheral vascular disease (poor circulation to the hands and feet)|
When a joint infection is suspected, early diagnosis and proper treatment increase the chances of a full recovery. If you have any symptoms of infection, you should immediately contact your medical provider and seek follow-up care.
|Key Signs and Symptoms of an Infection|
|Fevers, chills and night sweats|
|Increased pain or stiffness|
|Warmth and redness around the wound|
Infections are caused by bacteria. Although we have plenty of bacteria within our body, they are usually controlled by our immune system. However, because joint replacements are made of metal and plastic, it is difficult for our immune system to attack bacteria that make it to these implants.
Additionally, the bacteria forming at the implant can create a film that acts like a shield which is resistant to antibiotics. Thus, patients with infected joint replacements often require surgery in order to cure the infection.
Bair Hugger Recall Information
As of this time, there has not been a recall of the Bair Hugger warming blanket because of deep joint infections. However, in October 2015, the FDA did issue a Safety Alert for all heater-cooler devices, including heat exchangers and warming/cooling blankets such as the 3M Bair Hugger.
The primary issue was a link to nontuberculous mycobacteria (NTM) infections in patients undergoing invasive surgery. During the first eight months of 2015, the FDA received 25 Medical Device Reports of patient infections due to bacterial contamination tied to heater-cooler devices.
Additionally, research published in the Journal of Bone and Joint Surgery found that air circulated by a forced hot air warming blanket system contained 2,000 times more potentially contaminated particles when compared to air circulated by a similar device.
Why is the Bair Hugger Warming Blanket Utilized
The purpose of a warming blanket is to help maintain a patient's body temperature during surgery. Keeping the body at proper temperature has proven to reduce bleeding, speed up recovery time, and provide other benefits.
For this reason, forced-air warming systems, fluid warming systems, intravenous fluid warming, and warming blankets often are used during surgery to help maintain a patient’s body temperature as close to normal as possible.
Surgical warming blankets, such as the Bair Hugger, work like a forced-air heater, pushing warm air through a hose into a blanket covering a patient. The device releases warm air over a patient’s body, but also releases air under the surgical table.
The air released under the table has the potential to cause germs and bacteria to spread throughout the room, landing on a patient's surgical site. This can cause an infection in the patient’s hip or knee, such as sepsis and Methicillin-resistant Staphylococcus aureus (MRSA). Unfortunately, these infections are very difficult to treat when they occur deep in a patient's joint or tissue.
Bair Hugger Lawsuit News
3M prevails in first 'Bair Hugger' lawsuit; verdict could affect thousands more
A federal jury in Minneapolis has sided with 3M Co. in a lawsuit over the safety of its patient-warming device that the plaintiff blamed for his surgical infection. The lawsuit was the first of thousands related to 3M's Bair Hugger device — an operating-room cocoon pumped full of warm air — to reach trial. Reported in Minneapolis Biz Journal - Bair Hugger Verdict
Lawsuits turn up heat on 3M's Bair Hugger warming blankets
3M Co. is battling lawsuits from more than 50 orthopedic surgery patients who say the company's popular "Bair Hugger" warming blankets, used to keep people warm before surgery, circulated contaminants and caused debilitating deep-joint infections. Reported in Minnesota Star Tribune - Bair Hugger Claims
Doctor Says a Device He Invented Poses Risks
Dr. Scott Augustine asserts that his invention is a danger to surgical patients receiving implant devices like artificial heart valves and joints. The forced air, he says, can spread bacteria associated with hospital-acquired infections. Reported in New York Times - Bair Hugger Risks
FDA and Scientific Studies Regarding Bair Hugger
Patient Warming Excess Heat: The Effects on Orthopedic Operating Room Ventilation PerformanceExcess heat from forced air warming resulted in the disruption of ventilation airflows over the surgical site, whereas conductive patient warming devices had no noticeable effect on ventilation airflows. These findings warrant future research into the effects of forced air warming excess heat on clinical outcomes during contamination-sensitive surgery. Reported in International Anesthesia Research Society - Warming Blanket Ventilation
Infection control hazards associated with the use of forced-air warming in operating theatresA review is presented of the published experimental and clinical research into the infection control hazards of using forced air-warming (FAW) in operating theatres to prevent inadvertent hypothermia. This evidence has been reviewed with emphasis on the use of ultra-clean ventilation, any interaction it has with different types of patient warming (and FAW in particular), and any related increased risk of surgical site infection (SSI). We conclude that FAW does contaminate ultra-clean air ventilation; however, there appears to be no definite link to an increased risk of SSI based on current research. Reported in The Journal of Hospital Infection - Warming Blanket Infections
Forced-air patient warming blankets disrupt unidirectional airflow: This demonstrated that waste heat from the poorly insulated forced-air warming blanket increased the air temperature on the surgical side of the drape by > 5°C. This created convection currents that rose against the downward unidirectional airflow, causing turbulence over the patient. The convection currents increased the particle concentration 1000-fold by drawing potentially contaminated particles from below the operating table into the surgical site. To read more, click The Journal of Bone and Joint Surgery - Warming Blankets
Do forced air patient-warming devices disrupt unidirectional downward airflow?: Forced air warming resulted in a significant mean increase in the temperature over the surgical site when compared with radiant warming, which raises concern as bacteria are known to require particles for transport. To read more, click The Journal of Bone and Joint Surgery - Downward Airflow
Forced-air warming and ultra-clean ventilation do not mix: an investigation of theatre ventilation, patient warming and joint replacement infection in orthopaedics: During simulated hip replacement, bubble counts over the surgical site were greater for forced-air than for conductive fabric warming when the anaesthesia/surgery drape was laid down. A significant increase in deep joint infection, as demonstrated by an elevated infection odds ratio, was identified during a period when forced-air warming was used compared to a period when conductive fabric warming was used. Air-free warming is, therefore, recommended over forced-air warming for orthopaedic procedures. To read more, click The Journal of Bone and Joint Surgery - Forced-Air Warming