In March 2019, the FDA announced that it received over 41,000 adverse event reports associated with surgical staplers and internal staples. These reports may cause the FDA to assign a stricter product classification for the devices.
What’s the Problem?
The adverse event reports come from January 2011 to March 2018. Over the span of seven years, about 9,000 serious injuries, 32,000 malfunctions, and 366 deaths have been reported. However, there are also “many more” surgical stapler and internal staple malfunction reports that are inaccessible to the public.
The most commonly reported problems are:
- Rupture of the staple line or malformation of staples
- Misfiring, difficulty in firing, or failure of the stapler to fire the staple
- The application of staples to the wrong tissue or using the wrong staple size
These problems can lead to:
- Tearing of internal tissues and organs
- Increased risk of cancer recurrence
What’s the FDA Doing About This?
The FDA sent a letter to healthcare practitioners outlining several safety recommendations for the use of surgical staplers. The FDA plans to hold a public meeting to discuss whether to reclassify surgical staplers as Class II medical devices. A Class II medical device is the strictest classification. This would allow the FDA to establish mandatory controls to help mitigate the known risks of the surgical staplers.
If you or a loved one experienced a severe injury from a surgical stapler or internal staples, please contact GoldenbergLaw. We deliver the Gold standard advocacy you deserve.