Negative Pressure Wound Therapy Lawsuit

Pritzker Olsen Law Firm is representing several clients who have suffered injury from medical products. If you are interested in a free consultation regarding a negative pressure wound therapy lawsuit, please contact Pritzker Olsen toll free at 1-888-377-8900 or complete the firm's online-consultation form. We are not paid unless you win.

The Food and Drug Administration (FDA) has received reports of 6 deaths and 77 injuries associated with negative pressure wound therapy (NPWT) in the last two years.

Most of the deaths reported to FDA occurred at home or in a long-term care facility (nursing home).

Bleeding Associated with Negative Pressure Wound Therapy

Bleeding was the most serious complication and was reported in six death and 17 injury reports. Extensive bleeding occurred in patients with vascular grafts (such as femoral and femoral-popliteal grafts), in sternal and groin wounds, in patients receiving anti-coagulant therapy, and during removal of dressings that adhered to or were imbedded in the tissues. Patients with bleeding required emergency room visits and/or hospitalization and were treated with surgical procedures and blood transfusions.

Infection Associated with Foam Dressing

Twenty-seven reports indicated infection from original open infected wounds or from retention of dressing pieces in the wound. Retention of foam dressing pieces and foam adhering to tissues or imbedded in the wound were noted in 32 injury reports. The majority of these patients required surgical procedures for removal of the retained pieces, wound debridement, and treatment of wound dehiscence, as well as additional hospitalization and antibiotic therapy.

Legal Rights of Those Injured and the Families of Those Killed

All cases of injury and death should be reviewed to determine if there are claims against the manufacturer of the negative pressure wound therapy used, a hospital, a doctor and/or a nursing home.

According to the FDA warning, NPWT systems using foam dressings have been associated with infections due to foam pieces adhering to tissues or becoming embedded in the wound. Each case would have to be reviewed to determine if the manufacturer of the foam dressing, the manufacturer of the NPWT system involved and others are liable.

NPWT systems are contraindicated (should not be used) for certain wound types, including the following:

necrotic tissue with eschar present
untreated osteomyelitis
non-enteric and unexplored fistulas
malignancy in the wound
exposed vasculature
exposed nerves
exposed anastomotic site
exposed organs

In addition, there are several known patient risk factors that a doctor should consider before using a NPWT system:

patients at high risk for bleeding and hemorrhage
patients on anticoagulants or platelet aggregation inhibitors
patients with:

friable vessels and infected blood vessels
vascular anastomosis
infected wounds
osteomyelitis
exposed organs, vessels, nerves, tendon, and ligaments
sharp edges in the wound (i.e. bone fragments)
spinal cord injury (stimulation of sympathetic nervous system)
enteric fistulas

patients requiring:

MRI
Hyperbaric chamber
Defibrillation
patient size and weight
use near vagus nerve (bradycardia)
circumferential dressing application
mode of therapy- intermittent versus continuous negative pressure

If the NPWT system was used for the above contraindicated wounds or on a patient at high risk for serious injury, there may be issues of both medical malpractice and product liability. A careful review of the facts will be necessary to determine who may be liable, if anyone.

Manufacturers of Negative Pressure Wound Therapy Systems

Blue Sky Medical Group - now owned by Smith & Nephew, Inc.
Boehringer Wound Systems, distributed and marketed by Conva Tec
Innovative Therapies, Inc.
Kalypto Medical
KCI USA, Inc.
Medela Healthcare/Medela, Inc.
MediTop BV/The Medical Company
Premco Medical Systems, Inc.
Prospera
Smith & Nephew, Inc.
Talley Group, Ltd.

To contact a lawyer at Pritzker Olsen for a free consultation about a negative pressure wound therapy lawsuit, please call toll-free at 1-888-377-8900 or submit the firm's online form for a free consultation.

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