Surgical Staplers and Staples for Internal Use Lawsuits.
For a seven-year period spanning from January 1, 2011 to March 31, 2018, the FDA conducted extensive research on surgical staplers and staples for internal use and ended up finding some devastating numbers. From 41,000 medical device reports, there were over 32,000 malfunctions with 9,000+ serious injuries and 366 deaths reported. Further, the FDA identified that the primary causation stemmed from surgical staplers used for internal purposes.
With all this information, the FDA released a letter to health care providers and additional guidelines and warnings to doctors, patients and product manufacturers. Since the initial data was reported on March 8 this year (2019), an increase in awareness has spread across the nation and potential lawsuits have been filed. Here’s why.
What Surgical Staplers and Staples are Used For
Certain injuries often result in external or internal wounds with deep cuts or openings that need closing. The individuals with sustained injuries then must rely on the work of professional doctors to close up the wound with stitches or staples. Surgical staplers are usually preferred over stitches because they are usually more efficient and take less time.
Problems Stemming from Surgical Staplers
While the intent behind closing up open wounds may be genuine, the FDA reports that the most common problems include the following stapler-related events:
- Malfunctioning staples or staple lines opening
- Staple misfires
- Difficulty in firing
- Failure for the stapler to fire the staple
- Doctors stapling to the wrong tissue
- Doctors using the wrong staple size on a specific tissue
These issues are found throughout the 41,000 reports and happen enough for there to be serious concern.
Side-Effects from Surgical Stapler Problems
The reason for concern in the event of these kinds of problems is the grievous side-effects that may occur. In addition to prolonged medical procedures and previously unneeded surgeries, the following complications may arise:
- Internal bleeding
- Fistula formation
- Tears in organs and tissue
- Organ failure
- Increased risk of cancer reoccurrence
- Leaking fluids
Obviously, the worst-case-scenario is death, but any of these side-effects can have major and lasting impacts.
There are a lot of reasons as to why you might need the assistance of a medical professional to apply staples to an injury or other health concern, but any malfunction should not come at your own expense. The FDA is doing what they can to help resolve the issue by providing draft guidance for public comment, meeting with medical committees, providing labeling recommendations and even recalling certain staplers from manufacturers, but that might not be enough for the time being.
If you or someone you know has suffered from insufficient surgical stapler use, you may be entitled to financial compensation. To review whether or not you have a case, contact one of our experienced lawyers at 801-699-9999 or fill out our form online.