If you have suffered complications or lost a loved one after gastrointestinal (GI) surgery, such as bariatric surgery or surgery to treat colorectal cancer, a defective surgical stapler may have been the cause. The U.S. Food and Drug Administration (FDA) has announced a Class I recall of Ethicon circular staplers. Endo-Surgery Curved and Endo-Surgery Endoscopic Curved Intraluminal Staplers are used during GI surgery to make connections between sutures. The staples can misfire causing injury and creating malformed staples which can affect the integrity of the staple line. A Class I recall is the most serious class of recall and involves defects which can result in serious injury or death.
The Stapler Recall
The recall was initiated on April 11, 2019. 92,496 units have been recalled. All of the recalled units were manufactured from March 6, 2018 through March 6, 2019 and distributed from March 15, 2018 through March 8, 2019. According to the FDA, there was a shift in the manufacturing process in March of 2018 which continued until the line was shut down on March 8, 2019.
According to the FDA, use of the defective staplers may result in serious complications including:
- Leak in the closures
- The need for additional closures
- The need for additional surgeries
- Life-long digestive issues
- Life-long nutritional issues
- Life-long use of ostomy bag
Ethicon has confirmed serious injury to two patients due to the defect. Both patients were undergoing surgery to remove the upper rectum. In one patient, misfire caused the removal of the middle rectum and in the other, misfire caused the removal of the lower rectum.
If you believe that your injuries or the death of a loved one may have been caused by a defective surgical stapler, please schedule a free consultation with an experienced product liability attorney right away to learn more about your rights