Surgical staplers (and staples) are used to close surgical incisions or wounds that are too big or complex to close with traditional stitches. The devices are frequently used in surgeries involving partial removal of an organ, cutting through organs and tissues, and creating connections between structures.
Common procedures that utilize the devices are gastric bypass surgeries, colostomies, neck or thoracic surgeries, lung surgeries, appendectomies and heart surgeries.
Many law firms are now acquiring surgical stapler cases as the number of adverse events involved with their internal use is increasing. Just last month the Food and Drug Administration (FDA) raised their concerns about the devices. Here’s the latest.
Concern, Recommendations & New Actions from the FDA
The FDA issued a letter to health care providers on March 8, 2019 about the rise of adverse events involved with the internal use of surgical staplers.
In an ongoing analysis, from January 1, 2011 to March 31, 2018, the FDA received over 41,000 individual medical device reports for surgical staplers used internally. This number includes 366 deaths, over 9,000 serious injuries, and over 32,000 malfunctions.
Some of the most commonly reported problems include:
- Opening of the staple line or malformation of staples
- Difficulty in firing
- Failure of the stapler to fire the staple
- Misapplied staples (i.e. user applying staples to the wrong tissue or applying staples of the wrong size to the tissue)
In the letter, the FDA provided recommendations to help protect patient safety and reduce complications, as well as announced new actions the agency plans to take to help ensure safe use of surgical staplers and staples. Read more here.
Use of Surgical Staplers on the Rise
Surgical staplers don’t seem to be going anywhere any time soon.
According to Market Watch, despite the rising number of adverse reports, the market for surgical staplers is forecasted to keep growing. In fact, the continued research and development of new technologies and innovations in the medical device market is boosting the demand for surgical staplers.
Additional factors boosting demand include the increased number of diseases in the United States—such as obesity, cardiovascular problems and cancer—as well as the increased amount of insured Americans under the Affordable Care Act and Medicaid. More people are getting sick and more people are covered by insurance, so more people can afford the necessary surgeries potentially involving devices like surgical staplers.
Join the Growing Litigation
With the sheer amount of adverse reports, and the production and use of surgical staplers still gaining traction, there will be plenty of cases to go around.
Alert is already taking surgical stapler calls and web inquires for many of our mass tort clients. Let us take over your entire intake system, or we can simply handle your overflow or cover your intake during after-hours. We’ve got you covered, and we will make sure you get the best return on investment possible so you capitalize on each and every marketing dollar!