HOUSTON - Retired and ready to enjoy life, Tommy Walton and Dianne Dunn have both had hip surgery, and since then, they've both endured more than a dozen additional operations to fix a devastating infection.
“Some of the days, I don't remember anything," Walton said. "Then I would start to be coherent again, and whoops, you got to go to another surgery."
Walton now walks with a prosthetic joint. Dunn does not ever expect to walk again, she said.
“I was in bed for six months, you know, and couldn't get out of bed,” Dunn said. “Then I go from that to a wheelchair, and then you have to maneuver and not be able to use my legs and use my arms.”
Their attorney, David Hodges, said a medical device used in his clients' operations caused extreme infections. The device he is referring to is called a Bair Hugger.
The Bair Hugger works like a blanket, keeping the body warm during anesthesia, because anesthesia drugs lower body temperature.
Low temperatures during surgery can increase your chance of infection, heart attack and even death, said Dr. Lisa Mouzi, an anesthesiologist with the American Society of Anesthesiologists and the Harris Health System.
“Other complications that arise from low body temperature are increased rates of post-operative wound infections (and) delayed wound healing," Mouzi said. "Patients who have low body temperature tend to bleed more during surgery, which means they are at higher risk for requiring a blood transfusion."
The Bair Hugger pumps warm air into an inflatable blanket, helping the patient to maintain a normal body temperature, mostly during joint replacement surgeries.
However, Hodges claims that circulating air carries bacteria.
“How does bacteria make its way into this wound? It has to be mobilized in some respect,” Hodges said.
He wants patients to ask their doctor about it before surgery.
“Ask them, 'Are you going to use a Bair Hugger on me? Do you have another device that you can use, or do I really need to be warmed up at all if my physician can do this surgery (in) 45 minutes?” Hodges said.
The American Society of Anesthesiologists said the device is necessary.
“Patients lose heat dramatically within the first 30 minutes of anesthesia, so our standard of care is to keep a patient warm,” said Mouzi, adding that she would use a warming device, no matter the length of a procedure.
In the past 16 years, the Food and Drug Administration has received 300 reports of adverse reactions involving the Bair Hugger.
In that same time span, the device has not been owned by the same company. The company that manufactures it today, 3M, has published websites and videos to convince skeptics the device is safe.
In a statement, 3M said: “3M is sympathetic to patients who experience surgical site infections. Any surgery that causes a break in the skin can lead to a post-operative infection. About one of every 100 patients undergoing a joint arthroplasty procedure develops an infection after surgery. The U.S. Centers for Disease Control notes that the majority of surgical site infections come from bacteria in the patient’s own body. There are many factors that are known to increase the risk of surgical site infections, including having other medical conditions such as diabetes, high blood pressure or heart disease, being elderly or overweight, and smoking. There is absolutely no evidence that Bair Hugger warming therapy causes or increases the risk of surgical site infections. In fact, there is not one scientific study – not even the studies the plaintiffs’ lawyers rely upon to support these lawsuits – that provides scientific evidence that the 3M™ Bair Hugger™ system causes or contributes to surgical site infections. The authors of those studies all explicitly acknowledge that their studies do not establish that the Bair Hugger system causes surgical site infections.
"Two separate clinical studies (Kurz, 1996; Melling, 2001) compared the surgical site infection rates of patients not warmed during surgery to patients warmed during surgery using the Bair Hugger system. Both studies demonstrated more than a 60 percent reduction in surgical site infections for those patients warmed using the Bair Hugger patient warming system.”
Click to read more from 3M.
Walton and Dunn said they are not convinced that it should not be removed from operating rooms.
“You should really investigate what is going to be done to you,” Dunn said.
The best thing to do is have a conversation with your anesthesiologist before surgery, Mouzi said. Other warming devices do exist, but they are not as common.
3M said the Bair Hugger has been used in more than 200 million surgeries.
If you have legal questions about whether an infection you've experienced was related to the device, you can contact Hodges online or call him at 713-523-0001, and toll free: 877-342-202.