Serious Injuries and Deaths Linked to Surgical Staplers and Staples
Surgical staplers and staples are used both externally and internally after surgical procedures to close skin wounds and to connect and remove organs, including parts of the bowels and lungs.
In March 2019, the U.S. Food and Drug Administration (FDA) published a letter to healthcare providers describing an increasing number of risks and complications associated with the use of surgical staplers and staples.
From January 1, 2011, to March 31, 2018, the FDA analyzed 41,000 medical device reports for surgical staplers and staples and found the following adverse effects:
- 366 deaths
- More than 9,000 serious injuries
- More than 32,000 malfunctions
Why Are Surgical Staplers and Staples Linked to Injuries and Deaths?
In its letter to healthcare providers, the FDA indicated that many adverse effects caused by surgical staplers and staples are due to device malfunctions or user error of the devices when they are used internally. The devices are prone to many reported problems, including:
- Opening of staple lines
- Malformation of staples
- Difficulty in firing
- Failure of staplers to fire staples
- Misapplied staples
What Health Problems Are Associated with Surgical Staplers and Staples?
When surgical staplers malfunction or surgical staples are applied improperly, surgical procedures may become prolonged, putting patients at greater risk. In addition, some patients may require unplanned surgical interventions and additional surgery. Those adverse events can lead to serious health problems and complications, such as:
- Fistula formation
- Tearing of internal tissues and organs
- Sealing of untargeted tissues
- Increased risk of cancer recurrence
We’re Here to Help If You Were Hurt by a Surgical Stapler or Staples.
Because surgical staplers and staples can cause injuries due to both malfunctions and user error, the risk of complications is high. At Ferrer, Poirot & Wansbrough, our defective medical product lawyers are here to help anyone who was harmed by these potentially dangerous medical devices.
If you or someone you love suffered complications after a surgical procedure that required the use of surgical staples, we want to hear from you. Contact us today for a free consultation.
Ferrer, Poirot & Wansbrough is not associated with, sponsored by, or affiliated with the U.S. Food and Drug Administration.