The U.S. Food and Drug Administration sent a letter to healthcare providers on March 8, 2019 alerting them to identified risks of surgical staplers and implantable staples. The FDA stated in the letter that it was receiving a rising number of adverse event reports on the devices and that it planned to create new labeling guidance and hold a committee meeting about reclassifying surgical staplers.
The FDA stated that it had reviewed medical device reports for both surgical staplers and implantable staples because the two are used internally as a system. Analyzing reporting for both, the FDA counted 41,000 reports describing complications from the staplers or staples for internal use between January 1, 2011, and March 31, 2018. The reports included 9,000 instances of serious injury and 366 patient deaths. The FDA noted that it had received many additional reports regarding staplers and staples as “Alternative Summary Reports,” which it is still analyzing.
It is important to note that while the FDA reviewed the devices together as a system, the agency has assigned different device classifications to the two. Surgical staplers are a Class I device, and implantable staples are a Class II device. Class I devices are not subject to the premarket requirements placed on other medical devices.
Part of the reason the FDA reviewed the devices together might be because of difficulty ascertaining which reports are specific to staplers and which are specific to staples. Reports describing stapler injuries might not come up under “stapler” because they were submitted as adverse events for staples, and vice versa, that’s why we have Surgical Staples Misfiring and Implantable Staples Malformation Attorney Lawsuit.
However, the FDA explained in its letter that it believed the majority of issues could be attributed to the staplers, as proper staple applications are largely dependent on proper function of the staplers. Still, defects could be present in the staples themselves, not just the staplers. The FDA noted that it had predominantly identified issues related to staple lines, staple malformation, misfiring or fire failure, and incorrect staple application.
Complications from staplers or staples could lead to longer duration of surgery and further, unplanned surgery. The FDA states that longer surgeries and additional surgeries could then lead to serious complications, including fistulas, bleeding, organ or tissue tearing, cancer recurrence, sepsis, and death.
The FDA recommended that physicians adhere to all instructions for use and have several sizes of staples and cartridges prepared for surgeries. The agency advised surgeons to not use staples on tissue that was too thick and to consider different options for patients who have swollen tissue, dead tissue, or tissue prone to tearing. The staples are less likely to work correctly in these patients, the FDA said.
Additionally, the FDA advised surgeons in its letter to pay attention to their staple lines, avoid using staples on large blood vessels, and avoid use on delicate tissues. Clamping the stapler on fragile tissue can result in injuries, the agency wrote.
The FDA further informed doctors that it planned to draft guidance in 2019 regarding new information manufacturers should place in their stapler and staple labeling. The guidance will be available for public comment this year.
The FDA also plans to call a meeting of the General and Plastic Surgery Devices Panel from the Medical Devices Advisory Committee sometime this year to address whether surgical staplers should be reclassified as Class II devices. The reclassification would enable the FDA to implement controls that would reduce the known risks of surgical staplers, it said.
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