A Texas man who suffered a life-threatening bowel leak and other complications during surgery to repair an umbilical hernia claims a malfunctioning Ethicon stapler was to blame for his injuries.
According a lawsuit filed in the U.S. District Court, Northern District of Texas, on March 19th, the plaintiff underwent a low anterior resection and umbilical hernia repair in February 2019. During that procedure, an Ethicon stapler failed and resulted in an incomplete anastomosis, leading to a bowel leak that required additional repair, including a low anterior anastomosis, colostomy placement, and over sewing of rectal stump.
“The failure of the Ethicon Surgical Stapler resulted in significant injuries with hospitalization that required diverting colostomy,” the complaint states. “These injuries will require additional medical care and significantly impair Robert Ashmore’s overall function.”
The Texas lawsuit involves an internal surgical stapler, a type of device used to cut and then quickly seal tissue and blood vessels during a range of procedures. But malfunctions can cause a surgical stapler to misfire or fail to create a secure seal, leading to massive bleeding, life-threatening infections, and other serious complications.
Last year, the U.S. Food & Drug Administration (FDA) warned doctors that internal surgical staplers had been associated with 41,000 adverse event reports since January 1, 2011. Those reports included 366 patient deaths, 9,000 serious injuries, and 32,000 stapler malfunctions.
Some of the most common adverse events logged with the agency included:
Since then, the FDA has proposed reclassifying internal surgical staplers as Class II (moderate to high-risk) medical devices, which would subject the products to greater regulatory scrutiny.