On March 8, 2019, the FDA released a letter to Health Care Providers stating their growing concern with the two-fold medical devices and their plans to address their concerns. Surgical staple/stapler defective product lawsuits have been around for quite some time, but the FDA's recent release expresses the mounting concern of how widespread issues with these medical devices have become.
“The U.S. Food and Drug Administration (FDA) is concerned by the increasing number of adverse events associated with surgical staples and staples for internal use and is providing additional recommendations for heatlth care providers to help protect patient safety and reduce the risk of adverse events associated with these devices,” stated William Maisel, MD MPH, Chief Medical Officer in the FDA’s Center for Devices and Radiological Health.
Additionally, the FDA disclosed their findings after examping medical device reports submitted to the FDA for both surgical staplers and implantable staples. Their results completely shocked the public. The FDA found that after combing through over 41,000 individual medical device reports recorded from January 1, 2011 to March 31, 2018, surgical staplers and staples for internal use caused the following grievous incidents:
In response to the serious nature of their findings, the FDA plans to discuss reclassifying surgical staplers as Class II medical devices, meaning that they would require premarket submission to the FDA for approval. Surgical staples for internal use are already classified as Class II medical devices. But the FDA plans on holding a discussion about how these medical devices are marketed to the public with adequate warning and instructions.