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FDA to Take a Hard Look at Surgical Staple Risks

The agency released a letter to healthcare providers pointing out the risks and said it would hold a public advisory committee meeting.

FDA is working on measures to help reduce the risks associated with surgical staplers and implantable staples. Late last week the agency said it released a letter to healthcare providers to point out these risks and to offer updated recommendations for the devices.

The letter also includes information about issuing a draft guidance with labeling recommendations for manufacturers and holding a public advisory committee meeting. The agency said the meeting would be to discuss whether the current pathway for manufacturers to market surgical staplers for internal use is appropriate.

As it stands now surgical staplers are regulated as Class I medical devices, which do not require a premarket submission to FDA. The Implantable surgical staples are classified as Class II medical devices and require premarket review before marketing.

FDA has been following the adverse events from surgical staplers and staples for some time now. The agency said from January 1, 2011 to March 31, 2018, it received more than 41,000 individual medical device reportings (MDR) for surgical staplers and staples for internal use, including 366 deaths, more than 9,000 serious injuries, and more than 32,000 malfunctions.

The agency said the commonly reported problems in these adverse event reports include an opening of the staple line or malformation of staples, misfiring, difficulty in firing, failure of the stapler to fire the staple, and misapplied staples.

"The agency's analysis of adverse events associated with surgical staplers and implantable staples is ongoing, but we know these devices provide important benefits for patients undergoing surgery, so it's important for us to continue to educate providers about the devices' safety and risk,” William Maisel, M.D., M.P.H., CMO in the FDA's Center for Devices and Radiological Health, said in a release. “We are asking providers to be aware of the new information and implement the recommendations we're outlining today to help improve the safe use of these devices. Improving the safety of surgical staplers and implantable staples is a top priority for FDA, and we believe our forthcoming draft guidance to industry and planned advisory committee meeting will advance those efforts."


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