As early as 2004, the medical community was aware of the potential of staple line leaks seen in stomach stapling gastric bypass surgery.

In an article published in the peer-reviewed medical journal Obesity Surgery in 2004, researchers performed a meta-analysis, a type of research paper in which researchers compare the results of previous studies, pooling their data for new insights or greater statistical power. In this study, researchers studied other studies on gastric bypass to try and find patterns underlying staple line leaks in gastric bypass surgery.

Researchers found that the rates of reported surgical staple leakage varied between different authors’ studies, but that choosing the appropriate size of staples could reduce the risk. Researchers characterized surgical staple line leaks as “an unwanted, yet seemingly unavoidable complication of stapling associated with bariatric surgery.”

More recently, Ethicon, a subsidiary of medical giant Johnson & Johnson, recalled its Echelon 50 mm surgical staples over concerns that the staples could misfire or break. Echelon staples are often used in gastric bypass surgeries, like stomach stapling surgery. The recalled staples could allegedly make it more likely that patients experienced severe complications like leaking from the staple line, sepsis, and even having the staple line coming apart.

During this same time frame, the U.S. Food and Drug Administration (FDA) received more than 8,000 reports of adverse events associated with surgical staples. Many of these included misfiring, the same issue cited in the class-2 recall of Ethicon’s Echelon staples. Many of these involved gastric bypass surgery.

Gastric bypass surgery is a type of surgery designed as an extreme measure to treat obesity. While gastric bypass surgery is quite effective, the procedure is a serious surgery, with about 15 percent of patients experiencing complications. As such, physicians typically only recommend it as a last resort for obese patients for whom diet and exercise has failed.

In gastric bypass surgery, the stomach is surgically altered to reduce its size. In one form of gastric bypass surgery, a line of staples are used to partition off the stomach. By decreasing the effective size of the stomach, the surgery lets the patients feel full and unable to eat larger portions, contributing to radical weight loss. However, under certain circumstances, the staple line can leak, leading to life-threatening complications.

Lawsuits have been filed by patients who experienced serious complications from gastric bypass surgery. Lawsuits over gastric bypass surgery allege that the makers of surgical staples have produced a dangerous product, endangering patients undergoing gastric bypass surgery. These lawsuits may be filed by patients who experienced serious complications after having their stomachs stapled or their next of kin.