Bair Hugger systems are used to keep a patient’s body temperature normal before, during, and after surgery. These warming systems are designed to effectively filter the air inside operation theatres and force the warm air into the disposable blanket.
In this article, we will articulate the necessary information that would help you be aware of the harmful effects of this system and discuss the efforts that are being made at different levels to get justice to those who have suffered from the ill effects of Bair Hugger system. The article contains the medical studies and different viewpoints of various manufacturers along with alternative ways of keeping the patients warm before, during, and after surgery.
Bair Hugger Blanket – The History Behind the Therapeutic Technology
Invented by Dr. Scott D. Augustine in 1987, the idea came into fruition because of the continuous problem of keeping the body temperature of patients normal during surgeries. Almost every patient undergoing surgery becomes Hypothermic – a condition that causes the body to lose the core heat way faster than it can produce. Mild hypothermia during operation has been reported to have resulted in blood loss, infections, and increase the duration of a patient’s stay at the hospital.
Thirty years ago, Dr. Scott started selling the blankets through his company Augustine Medical, which was later renamed Arizant in 2003 after it was reorganized under new owners. In 2010 another budding manufacturer, 3M paid 810 million dollars to buy the ownership rights to Arizant. Since then, the company has been marketing the Bair Hugger products, mostly to hospitals all across the US.
How does Bair Hugger System work?
Bair Hugger Blankest technology is a Normothermia System that uses forced-air warming (FAW) mechanisms to help prevent hyperthermia by keeping the core body temperature normal. It is mostly used on patients during all three phases of orthopedic surgeries, i.e., preoperative, intraoperative, and postoperative periods. Since 1987, hospitals are using this system on more than 200 million patients. More than 50,000 units of the models 505, 750, and 775 have been installed in hospitals all across the United States.
The air in the room is filtered by the warming units and is then forced into the blankets that cover the patients, during all phases of the surgery. The pressure points of a patient’s body are used by Bair Hugger Warming Blankets to prevent the heat from penetrating areas of the body, which are at high risk for pressure sores or burns. It has drain holes that allow the fluid to pass through its surface and onto the linen that is placed underneath it. The linen reduces the risk of skin softening and heat loss due to evaporation. These can be disposed to reduce the risk of transmission of infection from one patient to another.
FDA’s Take on the Warming System
The year it was invented, Bair Hugger Warming System got immediate clearance from the U.S. Food and Drug Administration (FDA) through the premarket clearance program 510 (k), stating it as a substantially equivalent technology. Under this 510 (k) program, the FDA is liable to give clearance to a medical device without any clinical proof. The consent is solely given on the basis that is it similar to the tools out there are is therefore safe to use. An additional number of 12 clearances were also given from 1990 through 2002 to Augustine Medical devices under the 510 (k) program.
After Arizant occupied the ownership of the firm, the Bair Hugger products got two more clearances for medical devices under the 510 (k) from the year 2004 to 2006. Within 30 years, the FDA has reported numerous incidents that involved patients who suffered severe side effects after they were put under the blankets. Most cases involved burns due to exposure to heat for prolonged periods during surgery and incidents that included equipment malfunctions due to the circulation of cold air under the circulating under the blanket.
Severe Health Risks Caused by Bair Hugger
Through data from multiple sources, Blair Hugger warming blanket has been found to have distributed the hospital bacteria into surgical sites that are open. Due to the hot air escaping underneath the surgical table, warm airflow currents are generated that transport the bacteria from the floor and deposits it in the open surgical site. This has resulted in contaminated air to be blown directly on the plastic and metal knee or hip implants.
Below are the significant health effects that have been reported by the FDA and certain manufacturers throughout the years:
- Deep Joint Infections
- Fever and Chills
- Night Sweats
- Wound Drainage
- Increased Stiffness
- Redness or Warmth on the Location of the Surgery
MRSA - Methicillin-Resistant Staphylococcus Aureus
A typical ‘superbug’ bacteria, MRSAhas high resistance to antibiotics. In every 2 out of 10 people, the bacteria are present all the time while 6 out of 10 carry it in their body from time to time during their life. Staphylococcus Aureus is a common bacteria that generally go unnoticed, but would trigger an infection in case a person undergoes surgery.
The cause of MRSA includes prolonged hospitalization, living in a care facility for a long time, participating in sports that involve too much contact, implanting medical devices, and living in unhygienic or crowded spaces. The infection can be drained out by doctors without using drugs only if it is detected at an early stage. However, the Centers for Disease Control and Prevention (CDC) suggests doctors initially use the laboratory test reports to find the exact strain of the MSRA bacteria in patients so that to choose the right antibiotic medicinefor its treatment. For patients with severe cases, implant removal, joint fusion, even limb amputation, two-stage revision surgery, and joint fusion is required.
Complications Caused by MRSA Infections
There are life-threatening complications caused by MRSA infections and are capable of overcoming a patient very quickly. You should immediately discuss it with your doctor if you feel any kind of discomfort or unusual appearance of the part that was operated. Through lab tests and identifying certain symptoms, doctors can gauge whether the bacteria infect you or not. There are many instances where the condition of the patient becomes fatal due to severe infections like pneumonia, sepsis, skin infections, and pneumonia that get inside the core of the body.
Sepsis is a condition that, if not given immediate attention, would escalate to causing fatal outcomes. The body responds to the infection in a life-threatening manner,organ failure, tissue damage, and even death. The Centers for Disease Control and Prevention (CDC) has listed staphylococcus aureus the most common types of bacteria responsible for causing Sepsis.
Common Symptoms Include:
- Short breath
- Chills or fever
- Fast heartbeat
- Discomfort and extreme pain
- Disorientation and confusion
- Sweaty and clammy skin
Pneumonia by MRSA
Various types of bacterias and viruses, along with fungi, contribute to causing pneumonia. However, pneumonia due to MRSA can immediately advance to the level of severity that can cause death. MRSA pneumonia caused 7 out of 10 people to die, as the bacteria are tough to kill.
Bacterial Pneumonia Symptoms Include:
- Chest Pain while Coughing Or Breathing
- Cough with Green, Bloody or Yellow Mucus
Skin infections due to MRSA can cause extreme pain and can also lead to the development of deep abscesses that need surgery to be completely drained. If left unattended, the abscesses can spread from the skin to joints and bones, and the bloodstream. In case the infection spreads into the blood, it can cause damage to the heart, lungs and may also disrupt the functioning of heart valves.
MRSA Skin Infection Symptoms Include:
- Warm skin
- A swollen, red or painful area on the skin
- Skin infection accompanied by fever
- Cuts, pimples or irregularities filled with fluids
You or the caretaker should make sure that the infection is covered with a proper bandage. You should wash your hands with soap and water before and after every time you touch the infection or apply the dressing on it.
Incidents of Deep Joint Infections Reported Over the Years
Over the years, there have been many cases where patients have reported deep joint infections that occurred post-surgery due to Bair Hugger. Many have sued the manufacturers like 3M because of their failure to issue proper warnings to surgeons about the side effects of Bair Huggers and the health risk associated with it.
- In 2015 a native of Alabama, Barbara Libby sued 3M due to severe infection in her right hip. As a result of this infection, Barbara had to undergo an additional seven surgeries to relieve herself from the pain and suffering caused by Bair Hugger’s side effects. Libby’s attorney stated that she suffered permanent injuries, and her mobility, was reduced.
- 70-year-old Tommy Walton from Texas filled for a product liability lawsuit against Bair Hugger manufacturer 3M in 2013 after he started suffering from serious health complications post the hip replacement surgery he got done in 2011. Tommy had to undergo 15 more surgeries to treat the debilitating deep joint infection. The operations even included artificial hip removal, which added to the deterioration of his health condition. He is seeking 1$ million in compensation from 3M as the surgeries have drained him financially over two years.
- During his hip revision surgery in May 2013, Renny Schackmann was placed under the Bair Hugger warming blanket to keep his body temperature normal, which in turn caused a severe post-arthroplasty MRSA infection. To treat the infection, Schackmann had to go under the knife for an additional six times a year. The surgery caused permanent mobility impairment, which compelled him to file a lawsuit against the manufacturer and seek compensation.
- One of the most severe cases reported across the States is of 52-years-old Timothy Johnson from Kansas who underwent an arthroplasty surgery for her right knee in 2010. Johnson was also kept under the warming blanket, which caused him to develop a deep joint infection that eventually evolved into MRSA. Johnson’s leg had to be amputated after multiple unsuccessful surgeries. He filed a lawsuit in which it stated that the Bair Hugger was the reason that the bacteria go circulated “from the floor of the surgical room into the surgical site.”
The Inventor Speaking Up
Over the years through feedback and his own study, Dr. Scott D. Augustine came up with the fact that the Bair Hugger warming device is not safe to use in most scenarios, specifically patients who underwent joint replacement surgery. Augustine resigned from his position as the chairman and chief executive of Arizant which was acquired by 3M in 2002. He openly campaigned against 3M’s promotion of the Bair Huggers. In response to 3M’s widely publicized claims of the benefits of using the blankets, Augustine launched his own device, called HotDog in 2010 and warned professionals and surgeons against buying Bair Hugger Blankets because of the high risk it poses in causing infections during all stages of surgery.
With evidence-based statements given by Augustine, cases have been filed by various patients. Most lawsuits against 3M include evidence based on the statements from Dr. Johnson admitted that Bair Hugger is responsible for the deposits of infectious bacteria on the surgery site as it circulates the contaminated air on the surgery floor. 3M still claims that warming blankets are beneficial to use during surgery. However, Augustine was clear that the company was lying and there was no analysis done on their part.
Published Studies That Point Out the Health Hazards of Bair Hugger
In 2011, the Journal of Bone and Joint Surgery published a study that simulated lumbar spinal and hip replacement procedures using conductive fabric warming and forced-air-warming. The simulation involved a manikin to compare the Bair Hugger forced-air-warming device with a separate warming device that did not have a forced-air mechanism. Hip-replacement surgery was simulated, which helped researchers find out the forced-air device was generating air currents that were responsible for the floor air to be transmitted inside the surgical site. In conclusion, the researchers recommended the use of air-free warming procedures during surgery.
The same year, other researchers carried out a similar type of study in which they released detergent bubbles that were neutrally buoyant during a simulated surgery to track if the bubbles were movingtowards the incision. During the test, they used the forced-air-warming system that helped them find out a significant mean value increase in particle number. The forced-air warming system was reported for releasing more than 275 times the bubbles during the simulation of an incision.
The UK journal Anaesthesia, in 2012, came up with similar results but issued a statement that said that the tests were not accurate. The researchers were not able to perfectly recreate the airflow that generally gets affected by health professionals who are working in the operating theatre. They mentioned that the choice of device for warming a patient should be based on the airflow and other external factors that most contribute to infections. The waste heat from the device was creating convection currents. Due to the turbulence, damaging particles got transferred to the surgery table and eventually to the surgical site, eventually triggering an infection.
The Bone & Joint Journal published a study in 2013, which found that the reason behind post-surgery infections was the waste heat from forced-air-warming blanket like the Bair Hugger. The airborne particles had a higher temperature and concentration in environments where the device was used. Researchers conducted simulations that replicated a knee-replacement surgery, which helped them find out that turbulent air over a patient contained more than 2 million particles per cubic meter that were airborne. This is in comparison to other devices which only caused 1,000 particles to be transferred to the patient’s body. In conclusion, the researchers pointed out the risk of potential infections and warned that the airflow in some room set-ups could be disrupted significantly, which might draw in particles to the surgical site.
Large Scale Lawsuits
With more than 4,000 lawsuits filed over the Bair Hugger devices, many cases were combined in Multidistrict Litigation (MDL) for speedy action and to save the money of the plaintiffs. A judicial panel pushed an MDL in a Minnesota federal court that contained claims against the device, about the infections caused by its use during surgeries of different types. These mass tort/class action trials have so far not reaped any of the victims any kind of justice; instead, 3M managed to win the first bellwether trial that was held in May 2018. Here is the status of the 14 bellwether cases that have been selected in the mass tort litigation:
- 3M won the first
- Out of the 14, nine have been withdrawn
- One got dismissed by a federal district court
- One got dismissed by a Minnesota state court
- One was deselected and was sent back to the broader pool.
- The remaining one has been postponed
The Big Rollback
After the humongous amount of pressure from the lawsuits and the medical fraternity, more than 165,000 units of Bair Hugger blankets were recalled in January 2018 because of the defect in their design. However, 3M did not state the recall a result of the infection risks and instead said that the changes in design would prevent the blankets from inflating.
Also, the FDA was submitted with a report of a blanket that was not successful at fully inflating. This caused the patient’s temperature to drop to 95° while the surgery was going on, resulting in hypothermia. The patient was immediately moved to the ICU to normalize the body temperature. 3M was compelled to recall the lot along with the blanket that was used during the surgery.
The recall ended up affecting more than 33,000 cases of Bair Hugger blankets with each case containing five blankets. After October 26, 2017, the lots were shipped by the distributors all across the U.S. and 17 other countries.
There have been many inventions and updates to the forced-air warming blankets. One of the alternative technologies that are being commonly used are the conductive fiber blankets featuring at least a single layer of resistive polymer. One such product is the HotDog warming system designed by Dr. Augustine. Another type of warming method for patients is by using garments or mattresses with warm water circulating in it. Using a mattress with a conductive heating surface like Inditherm is also an alternative option to keep the patients warm during surgery.
Filing for a Mass Tort
Mass tort lawsuits are civil actions that involve many plaintiffs against a single or multiple defendants or corporations. With new and developing tort litigation practices, distribution and production have become more comfortable, making the filing process much more convenient for the plaintiffs. This type of litigation allows victims who have gotten injured to have their collective voice and experience heard and tried in the court of law. These types of lawsuits cover product liability claims, man-made disasters, and broad antitrust claims against businesses.
There are attorneys and law firms who work solely for helping victims in filing the critical paperwork before the expiration date of state or federal statute of limitations. They aggressively and accountably work on your behalf to get you the deserving compensation.
Finding Help to File a Lawsuit Near Me
If someone you love has undergone orthopedic surgery and has been suffering from side effects of some kind of infection, you can reach out to Consumer Alert Now to get help in filing for a claim. The dedicated team of attorneys will give a free-of-cost review of your case and will work with other litigators from all over the country to get you the best compensation from the court of law. You can call our class action law firm at 800-511-0747 to discuss your case regarding the suffering and complication that the Bair Huggers have caused you so that we can work out things in your favor.
The damages we file for you generally include the cost you paid for your surgery, medication, the loss of wages in case you had to leave your job, and the pain, emotional, mental distress, along with disability that hampered with your daily life. We also make sure that the plaintiff’s family gets compensated in case he/she has passed.