Hip and Knee Infection

Lawsuit Information

(Post Joint Replacement Surgery Complications)

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 Normothermiahttps://www.aana.com/newsandjournal/Documents/maintainingintraoperative_0499_p155-164.pdf

A: to prevent hypothermia

“The complications include reduced resistance to surgical wound infection, protein wasting, decreased synthesis of collagen, reduced platelet function, increased intraoperative loss of blood and need for allogeneic transfusionduring elective primary hip arthroplasty, andmetabolism of most drugs. A prospective randomized study found that a core temperaturedrop of 1.5°C tripled the incidence of ventricular tachycardia and morbid cardiac events.”

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?

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, numerous adverse events have claims have been reported to the FDA

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/

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.”

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

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/

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

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?

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.

Pending Bair Hugger Litigation:

Plaintiffs Complaint Seeks

Bair Hugger Lawsuit Seeks Damages & Financial Recovery for:

• medical expenses• pain and suffering• lost wages• punitive damages

Top Bair Hugger Attorneys

Reviewing Patient Claims

So, What Now?

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Source: https://www.aana.com/newsandjournal/Documents/maintainingintraoperative_0499_p155-164.pdf