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 antibiotics.

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 product 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

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.