Joint implant patient? Post-surgical complications suffered by hip & knee replacement patients have have been caused by the forced-air warming blanket used during your operation. Hip and knee infections are among claims made in recent lawsuit complaints brought against 3M and their Bair Hugger patient warming device. If you suffered a deep joint infection, it can require multiple revision surgeries to ex-plant the contaminated device, result in loss of mobility, amputation and even death. In the following guide we rundown the case infection lawsuit attorneys are making against in court, what some of the important research on the matter says, and review the case against liability being made. If you suffered a serious infection post-surgery, we encourage you to come forward and share what happened, adding your voice to the ongoing investigation. Review the information in the guide, and then share what happened with our Bair Hugger attorneys to learn your legal options now.

1. Hip and Knee Infection
Lawsuit Information
(Post Joint Replacement Surgery Complications)

2. A patient whose temperature drops 2º C during
surgery is likely to lose twice as much blood as
one who is kept warm. The Bair Hugger
warming device is used to normalize
temperature.
Q: Why Are Warming Blankets
Used During Implant Surgery?
Source: Maintaining Intraoperative Normothermia
https://www.aana.com/newsandjournal/Documents/maintainingintraoperative_0499_p155-164.pdf
A: to prevent hypothermia
“The complicationsinclude reducedresistance
to surgicalwound infection,protein wasting,
decreasedsynthesisof collagen, reduced
platelet function,increased intraoperativeloss
of blood and need for allogeneic transfusion
during elective primary hip arthroplasty, and
metabolismof most drugs. A prospective
randomized studyfound that a core temperature
drop of 1.5°C tripled the incidenceof ventricular
tachycardia and morbid cardiac events.”

3. The Bair Hugger warming system is a blanket
that functions similarly to a forced-air heating
system in your home.
Warm air is sucked through a hose and into
the blanket, and pushed out vents on the
other side.
It is used to maintain an optimal temperature
in surgical patients during the operation.
How The Bair Hugger Warming
System Works?

4. Bair Hugger Product
FDA History
The first Bair Hugger warming system
was cleared through the 510(k)
premarket clearance program
1987
1990 -
2002
12 additional clearances cleared through the
510(k) program
2004 -
2006
2 more clearances via 510(k)
** Under the 510(k) program, the FDA can clear a medical
device without clinical proof that it is safe if it is similar
enough to a previous device that is already on the market.** Source: FDA Safety Filing
2011 -
Today
At this time, numerousadverse events have
claims have been reported to the FDA

5. Bair Hugger Complaints
Court documents reveal:
“Tommy Walton, a 70 year old man residing in
Hemphill, Texas, underwent total hip replacement
surgery at a Houston orthopedic hospital. A deep joint
infection followed, requiring 15 surgeries, including
removal of the artificial hip.”
“A complaint filed in Kansas Federal
Court, spread Methicillin-resistant
Staphylococcus aureus (MRSA), causing
an orthopedic infection and amputation
of the Plaintiff's leg.”
“There are more than 10,000 orthopedic
implant infections a year in the United
States, most of them in hospitals.”
Source: https://www.lawsuitlegal.com/blog/complete-hip-knee-infection-lawsuit-
info-bair-hugger-joint-contamination/

6. Grounds For Injury Claims?
Recent Research:
(Bone and Joint Journal)
“…intraoperative forced air warming systems to increase
airborne contaminants by as much as 1000-fold, with up
to 2000x the airborne contaminant particles when used.”
Dr. Scott D. Augustine has said the following
about his invention.
“I am very proud of the old technology,” he said in a New
York Times article. “But I am also proud to spread the
word that there is a problem.”

7. Both Sides of The Story
The device’s manufacturer points to 170 studies that
found forced-air warming to be beneficial to
maintaining normal body temperature. However,
Augustine argues that none of those studies analyzed
forced-air warming during orthopedic surgery.
A HAI Antimicrobial survey of
U.S. hospitals revealed:
“One out of every 25 patients has a hospital-acquired
infection at any given time. In 2011 alone, more than
722,000 patients contracted an infection while in the
hospital. About 75,000 of these patients died before
they could be released.”
- CDC.gov

8. Leading Attorney Speaks Out
From the Interview with Attorney Gabriel
A. Assaad on Bair Hugger Infection Litigation:
“…the hip or knee replacement joint is not necessarily
contaminated immediately prior to being implanted. It is
certainly possible that dirt particles can be disturbed and
settle on the components themselves as they are laid out
in the operating room awaiting installation, leading to an
infection.
Additionally, infections can occur when those particles
find their way into the open surgical site during an
operation. We suspect this latter situation is how most of
these infections develop.”
- Attorney Gabriel A. Assad
Interview Source: https://www.lawsuitlegal.com/blog/interview-gabriel-assaad-
kennedy-hodges-bair-hugger-litigation/

9. The Case for Safety: Two Forced
Air Warming Infection Studies
A study by Sessler et al.
A study by Huang et al.
Source: fawfacts.com
The investigators tested the air quality in
laminar flow equipped ORs with a FAW
device under three settings: device
turned off, device delivering ambient air
and device delivering warm air.
The study:
• No deterioration in the air quality
with the use of Forced-Air-Warming
blankets with ambient or warm air.
• No induced upward draft or
disruption in normal downward
movement of sterile air.
This study was conducted on 16 consecutive
patients undergoing aortic surgery with graft
insertion.
The study found:
REDUCTION in the bacterial count in the OR
(operating room) air at completion of surgery
performed with the use of Forced-Air-Warming
blankets

10. A Guest Editorial written by Paul N. Austin, CRNA, PhD for
the American Association of Nurse Anesthetists has called
for a more definitive “randomized controlled trial with
appropriate blinding,” and we agree.
The issue deserves more study, and compelling evidence
has been brought forward on both sides. A definitive study
on possible complications and joint infection rates is called
for.
Some reported the air currents produced by FAW could
foster the flow of dust particles possibly containing bacteria
towards the surgical site. Other authors did not observe
this unwanted airflow.
Do We Have A Clear Answer?

11. Deep joint infections can lead to:
• Implant Revision Surgery
• Severe Mobility & Functionality Issues
• Amputation
• Permanent Disability
• Hospitalization
• Death
The War Against Infection: A
Reminder on Why It Matters
Following replacement surgery, a joint
infection can remain dormant, presenting
symptoms months after the procedure.
It can lead to intense pain, loss of mobility in
the affected joint and require revision
surgeries and possible explant of the implant.
In severe cases, an out of control infection can
require amputation of the limb and even be
fatal for the victim.

12. Pending Bair Hugger Litigation:
Plaintiffs Complaint Seeks
Bair Hugger Lawsuit Seeks Damages &
Financial Recovery for:
• medical expenses
• pain and suffering
• lost wages
• punitive damages

13. Top Bair Hugger Attorneys
Reviewing Patient Claims

14. So, What Now?

15. Considering suing for compensation?
Connect with a qualified lawsuit attorney who will
make sure you are aware of your legal rights, and
ensure your voice and needs are not ignored.
www.LawsuitLegal.com
Connecting people with legitimate legal claims to
attorneys nationwide who can help, Lawsuit Legal
makes it simple and easy to acquire award-winning
legal assistance when it's needed most.
About LawsuitLegal.com
401 E. Las Olas Blvd, Suite 130-484, Ft. Lauderdale, FL 33301
Phone (Toll Free): (888) 713-6653 | Connect with Us on Facebook
Source: https://www.aana.com/newsandjournal/Documents/maintainingintraoperative_0499_p155-164.pdf