On March 8, the U.S. Food and Drug Administration (FDA) issued a letter to healthcare providers expressing concern about an increasing number of adverse events involving surgical staples and staplers. The letter included clinical recommendations to maximize patient safety by reducing the frequency of adverse events with surgical staples, among other proactive efforts that should be taken.
Between 2011 to 2018, there were 41,000 adverse events reported, including 366 deaths, more than 9,000 serious injuries, and more than 32,000 malfunctions liked to surgical staples, according to the FDA’s ongoing analysis.
“These reports can be primarily attributed to surgical staplers for internal use,” claims the FDA, “because proper staple formation is largely contingent on proper function and use of the stapler.” Problems with staplers include difficulty in firing, misfiring, using the wrong size staples, and insertion of staples into the wrong body tissue.
Stapler malfunction and misuse can result in prolonged surgical times and the need for additional surgical interventions which in turn can create complications such as bleeding, sepsis (a potentially life-threatening condition resulting from the body’s response to infection), fistula formation (an abnormal connection or pathway between two body cavities), increased risk of cancer recurrence, and death.
The FDA said it will issue draft guidance for public comment on proposed recommendations for surgical staples product labeling information. The agency also plans to hold an open public meeting to discuss the reclassification of internal-use surgical staplers from Class I to Class II medical devices. The change would subject staplers to a more stringent approval process and enable the FDA to issue mandatory “special controls” to reduce the potential risk of injuries from surgical staples.