FDA Recommends the Reclassification of Surgical Staplers and Staples, Which May Prompt Various Recalls Surgical staplers and staples are used for a variety of reasons, both internally and externally. Examples of such uses include, among others, wound closure (typically with scalp or trunk of the body), removal (resection) of part of an organ, cutting through […]
Surgical staplers and staples are used for a variety of reasons, both internally and externally. Examples of such uses include, among others, wound closure (typically with scalp or trunk of the body), removal (resection) of part of an organ, cutting through (transection) organs, and creating connections between structures (anastomoses).
While surgical staplers and staples may be beneficial in certain circumstances, these medical devices have proven to be dangerous for many patients. In a March 8, 2019 letter to healthcare providers, the United States Food and Drug Administration (FDA) warns that surgical staplers and staples used internally have caused patients to sustain injuries and death. Between January 1, 2011 and March 31, 2018, the FDA received more than 41,000 medical device reports for surgical staplers and staples, including the following:
Examples of common adverse events associated with the use of surgical staplers and staples that have caused injuries and deaths include, but may not be limited to, the following:
Because of the substantial number of adverse events associated with surgical staplers and staples, the FDA plans to reclassify the medical devices from Class I to Class II, which would require manufacturers to complete a premarket submission to the FDA. As Class I medical devices, surgical staplers and staples can be sold without a premarket submission, which means there is very little regulation to ensure patient safety. Essentially, there are no rules when it comes to surgical staplers and staples, and this is something the FDA wants and needs to change.
After years of patient injuries and deaths linked to surgical staplers and staples, which currently lack essential regulation, the FDA prepared an executive summary that was presented at a May 30, 2019 meeting of the General and Plastic Surgery Devices Panel. The summary outlines the FDA’s plan to reclassify surgical staplers and staples for internal use from Class I to Class II medical devices. By reclassifying surgical staplers and staples for internal use, the FDA can implement requirements that will significantly help to reduce the incidence of injuries and death.
On April 11, 2019, Ethicon, Inc. issued a recall of its circular staplers following complaints of misfiring that harmed at least two patients. Misfiring of staplers has the potential to cause severe injuries, such as sepsis, bleeding, the need for a permanent ostomy bag, life-long nutritional and digestive issues, the need for additional surgeries, leak in the closure (anastomotic leak), the need for additional closures (anastomoses), and death. The FDA had been investigating Ethicon’s manufacturing practices, which proved to be inadequate and dangerous.
The FDA has categorized the Ethicon recall as “Class I,” which is the most serious type of recall available and is only issued when a medical device has the potential to cause serious injuries or death. The specific device information for the Ethicon staplers subject to recall includes the following:
When medical devices have the potential to cause extensive harm, they should undergo review and scrutiny before they are used on patients. While the FDA’s plan to reclassify surgical staplers and staples is a step in the right direction, far too many patients have been harmed over the past decade because of medical devices that should never have been classified as Class I devices to begin with.