FDA Safety Communication: Serious complications have been associated with negative pressure wound therapy systems. To date, at least 12 deaths and 174 injuries have been linked to the devices. Health care providers and patients should weigh risks vs. benefit options carefully before using NPWT.
Free Negative Pressure Wound Therapy System Case Evaluation: If you or a loved one has been injured or otherwise adversely affected by a NPWT device, you should contact our law firm immediately. You may be entitled to compensation by filing a lawsuit and we can help.
Updated Death and Injury Report on NPWT Products
February 28, 2011 – Since 2007, the FDA has received a total of 12 deaths and 174 injury reports related to negative pressure wound therapy (NPWT) systems.
Wound infection occurred in more than half of these cases, with patients experiencing delayed recovery and requiring wound exploration, surgical removal of dead tissue (wound debridement), and drainage.
Bleeding continues to be the cause of the most serious adverse events, and was reported in 12 patients (including three death reports). Bleeding occurred in patients who had blood vessel grafts, wound infection, those receiving medicine for blood clots, and during removal of dressings attached to the tissues. Bleeding contributed to shock, low blood pressure, and swelling containing blood (hematoma). Some of the patients who experienced bleeding required additional surgery to stop the bleeding, blood transfusions, admission to the emergency room and hospitalization.
Need More Info?
If you’d like more information about negative pressure wound therapy systems, please visit the FDA website to view the official safety communication.
Do I have a Negative Pressure Wound Therapy (NPWT) System Lawsuit?
The Product Liability and Defective Medical Device Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in NPWT lawsuits. We are handling individual litigation nationwide and currently accepting new cases in all 50 states.