FDA Panel Meeting to Address Surgical Stapler Injuries

Published on May 9, 2019 by Sandy Liebhard

The U.S. Food & Drug Administration (FDA) will convene an advisory panel meeting later this month to address injuries and complications associated with the use of surgical staplers and internal staple systems.

The two-day meeting of the General & Plastic Surgery Devices Panel will begin on May 30^th. The FDA wants input on its recent proposal to shift internal surgical staplers from the Class I (low risk) to Class II (moderate risk) medical device category.

The agency also plans to issue new draft guidance to surgical stapler manufacturers.

Surgical Stapler Injuries

Surgical staplers for internal use are deployed in a range of surgeries, including gastrointestinal, gynecologic and thoracic procedures. These devices can remove parts of an organ, cut through organs and tissues, and make connections between structures in the body.

According to the FDA, however, internal surgical stapler systems were implicated in more than 41,000 adverse event reports from January 1, 2011 through March 31, 2018, including 366 patient deaths, 9,000 serious surgical stapler injuries, and 32,000 malfunctions. Some of the most commonly reported problems included:

• Opening of the staple line or malformation of staples.
• Misfiring, difficulty in firing or failure of the stapler to fire the staple.
• The application of staples to the wrong tissue or using the wrong size staples.

The agency attributed many of the problems to the staplers themselves because proper staple formation depends largely on proper function and use of the device.

FDA Plans to Reclassify Internal Surgical Stapler Systems

Surgical stapler injuries and malfunctions can prolong procedures, result in additional surgeries and other unplanned medical interventions, and ultimately lead to bleeding, sepsis, fistula formation, tearing of internal tissues and organs, and an increased risk of cancer recurrence.

Reclassifying the devices would subject surgical staplers to greater regulatory oversight, as products in the Class I category do not require FDA approval before coming to market.

“Reclassification of surgical staplers for internal use as a Class II device would allow the agency to require premarket review and allow us to establish special controls, such as mandatory performance testing of various mechanical features, demonstration of usability and labeling comprehension such as assessing health care professionals’ ability to properly select and use the device according to the labeling, and specific labeling elements supporting the safe use of the device,” Jeffrey Shuren, M.D., J.D., Director of the FDA’s Center for Devices and Radiological Health said in a statement published in March.