Surgical staplers are used in a number of routine surgeries, but what happens when a routine surgery becomes a matter of life and death? That is exactly what has happened for thousands of patients, but the adverse events went unreported, at least that’s how it would appear as the reported injuries and deaths were housed in an FDA secret database, referred to as “alternative summary reporting.”
In a damaging report released by Kaiser Health News on Friday, the FDA supposedly has created and expanded a “vast and hidden repository of reports on device-related injuries and malfunctions.” Included in that hidden database are reports of injuries or deaths caused by surgical staplers.
What are Surgical Staplers and Staples?
Used in “gastrointestinal, gynecologic, thoracic, and many other surgeries”, surgical staplers are used both externally and internally. Removable skin staples, for external use, “close wounds under high tension, including wounds on the scalp or the trunk of the body.” Internally, surgical staples “deliver compatible staples to internal tissues during surgery.”
But, thousands of reports of surgical staplers malfunctioning during surgery have been recorded. In one such instance, a surgical stapler misfired during a man’s liver surgery, severing a vein. CPR was performed for 22 minutes. The individual was in a coma for two weeks, and when he woke, he was unable to walk. His surgical stapler injury story is one of many – men and women injured or killed by surgical stapler malfunctions.
If you were to look up reports of injuries in the public database in 2016, 84 adverse events were reported. The FDA secret database paints a different story. Nearly 10,000 malfunctions were reported to the hidden database – an alarming difference.
Surgical Stapler Lawsuits
In 2012, a Pennsylvania family alleged the death of their loved one was caused by a defective stomach stapler during gastric bypass surgery. The Ethicon stapler, according to the lawsuit, failed to properly seal the surgical area which then allowed the stomach contents to spill into the intestines. A jury awarded the family $5 million in damages. In May 2013, the surgical staplers, like the one used in the botched gastric bypass surgery, Ethicon Echelon 60 mm and Echelon Flex were recalled due to the high adverse events reported.
In another surgical stapler incident on January 2012, Florence Kuhlmann alleged that an Ethicon proximate surgical stapler misfired and sealed her anal cavity-causing two weeks of hospital care and the permanent use of a colostomy bag. A California jury awarded her $80 million, including nearly $70 million in punitive damages. In October 2012, Ethicon recalled over 157,000 of the hemorrhoid staplers.
What Causes Surgical Stapler Injury?
While the issue of how injuries are reported is recent, complications as a result of surgical staplers are not and have been occurring for years. Most commonly, injuries and death are caused by:
- Device malfunction, including misfiring
- Design defect, which is when the design of the stapler is at fault for an injury
- Manufacturing defect, which is when the device was assembled incorrectly
- Complications with surgical staples
- A failure to warn, which is when the manufacturer failed to warn consumers of risks associated with the stapler
Many lawsuits claim error by the surgeon caused injuries or death of patients, but there have many, many reports of defective surgical staplers that misfired provoking questions of fault.