Ethicon recalled thousands of defective surgical staplers after patients were injured or died.
What You Can Do & How We Can Help
The Schmidt Firm, PLLC is currently accepting Ethicon Surgical Stapler induced injury cases in all 50 states. If you or somebody you know has been injured by a surgical stapler, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.
What is the Problem?
There have been numerous recalls for surgical staplers in recent years. The FDA has also linked surgical staplers to 366 deaths and 9,000 serious injuries from 2011 to 2019, proving just how dangerous these devices really are.
The most commonly reported problems with surgical staplers include:
- Malformation of staples
- Misfiring
- Difficulty in firing
- Failure of the stapler to fire the staple
- User error (e.g., applying staples to the wrong tissue, or using the wrong type of staple)
Ethicon Surgical Stapler Recalled After Death Reported
In October 2019, the FDA issued a Class 1 recall for Ethicon surgical staplers because the devices can fail to properly form staples, which increases the risk of complications during surgery.
One death and 7 serious injuries were reported in the recall notice. The recall involved about 8,250 Echelon Flex™ Endopath® Surgical Staplers.
Ethicon Recalls Circular Staplers
In May 2019, Ethicon recalled Proximate® Endo-Surgery Intraluminal Staplers because they can malfunction and cause serious injury or death.
What Are Surgical Staples?
Surgical staples are used to close incisions during surgery, including internal surgery and external surgery. Staples are commonly used for large incisions that can’t be closed with stitches or sutures. Unlike sutures, staples must be removed by a doctor after the wound heals.
Stomach Staple Lawsuit Ends in $5 Million Award
Patients who have had gastric bypass surgery (“stomach stapling surgery”) have filed lawsuits that accuse Ethicon of selling defective staplers. In 2007, a jury found Ethicon guilty and awarded $5 million to the family of a woman who died when the stapler failed to properly form staples, resulting in her stomach contents leaking out.
What is the Risk?
The recalled Ethicon surgical staplers have been linked to life-threatening injuries and death. Malformed staples that are not fixed can lead to:
- Prolonged surgery
- Leaking from the surgical incision site
- Bleeding
- Major catastrophic internal hemorrhage
- Sepsis (blood infection)
- Intestinal perforation or leakage
- Fistula formation
- Tearing of internal tissues and organs
- Needing another surgery
- Death
Defective Staplers in Stomach Surgery
When surgical staplers malfunction during a gastrointestinal surgery, patients may also develop these complications:
- Need for permanent ostomy “bag”
- Life-long nutritional and digestive issues
- Leak in the closure (anastomotic leak)
- Additional surgeries or closures (anastomoses)
- Need for antibiotics
- Additional imaging studies
Do I have an Ethicon Surgical Stapler Lawsuit?
The Schmidt Firm, PLLC is currently accepting Ethicon Surgical Stapler induced injury cases in all 50 states. If you or somebody you know has been injured by a surgical stapler, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.
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