It is common practice to use a warming device, such as 3M’s Bair Hugger, during hip and knee replacement surgeries. This is to guard against the risk of hypothermia and to ensure normal blood flow during the operation. The Bair Hugger has been in common use for over 25 years, and 3M claims that almost 180 million operations have been carried out using it during that time.
In fact, the number of hip replacement surgeries has increased substantially over the years in the United States, with the U.S. National Center for Health Statistics (NCHS) reporting that the number of hip replacements more than doubled from 138,700 in 2000 to 310,800 in 2010, with over 95% of those patients being over the age of 45.
This is significant from two standpoints:
- The sheer number of operations where warming devices, such as the Bair Hugger, are used means that any contraindications with it are significant in terms of the number of patients who may be adversely affected.
- The higher general age of hip replacement patients is also noteworthy. One recent 2011 report into the, “Mortality and cause of death in hip fracture patients aged 65 or older – a population-based study” in Finland, concluded that “the risk of mortality in hip fracture patients was 3-fold higher than that in the general population”. If you then add onto the three-fold risk of death a 1000-fold increase in the particle count around the site of the surgery, according to one Nov 2012 study into warming devices, it becomes clear why the Bair Hugger is coming under such scrutiny.
The first civil lawsuit against 3M and Arizant, the current makers and originators of the device respectively, came from Tommy Walton, a 70-year-old who underwent a hip replacement surgery in Texas in March 2011 where the Bear Hugger was used. He claims that the expelled air from the device caused him to have an infection which has meant a subsequent 15 surgeries and ultimately required his artificial hip to be removed. He is suing for more than $1 million in damages.
The case is significant for 3M as the devices are a major profit center. While 3M’s own sales literature claims that, the device has been used in ‘almost 180 million operations’ in the last 25 years. The recent numbers are even more impressive, with the company claiming in April 2012 that the Bair Hugger warms over 50,000 patients every day, and that it is in use by more than 80% of the hospitals in the United States.
Given these numbers, it is no wonder that 3M rejects the claims that the device causes bacteria particulates to be more prevalent around wound sites during surgeries. At stake are not only large revenues from the on-going sale of the devices, but also potential damage claims that could run into hundreds of millions of dollars if the initial case is proved.
It remains to be seen which way the Tommy Walton case will be decided, and it may be quietly settled, given how much 3M potentially has to lose. However, for those who have had complications during a hip or knee replacement operation, given the common use of the Bair Hugger device, it may be worth consulting a knowledgeable defective medical device lawyer as to your rights.