The FDA plans review the risks of surgical and implantable staplers after receiving thousands of reports about the medical devices, according to Zenopa.
Three insights:
1. The agency plans to issue draft guidance with labelling recommendations for manufacturers. It will also hold a public advisory meeting to review how manufacturers are permitted to market surgical staplers for internal use.
2. The FDA has already been reviewing the risks associated with surgical staplers and implantable staples. Between Jan. 1, 2011, and March 31, 2018, the agency received more than 41,000 individual medical device reports for surgical staplers and staples for internal use.
3. An assessment of the reports revealed 32,000 malfunctions, approximately 9,000 serious injuries and 366 deaths.
"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," said FDA Center for Devices and Radiological Health Chief Medical Officer William Maisel, MD.