Over the years, countless patients have had wounds closed and organs reconnected by surgeons who were using surgical staplers. But between Jan. 1, 2011 and March 31, 2018, the U.S. Food and Drug Administration (FDA) found that out of 41,000 reports of surgical stapler usage, 366 patients died, more than 9,000 were injured, and 32,000 staplers or staples malfunctioned.
That level of risk and product failure is unacceptable. People whose wounds were closed or whose organs were reconnected with surgical staplers faced serious health problems and complications, including:
- Fistula formation
- Tearing of internal tissues and organs
- Sealing of untargeted tissues
- Increasing risk of cancer recurrence
The FDA warned healthcare providers of the dangers of defective surgical staplers and staples in a letter in March 2019, but more patients have been put at risk since then. Unfortunately, some patients who received surgical staples may have yet to experience complications but will in the future, while others are already dealing with side effects and have had revision surgeries and hospitalization.