A 2004 stomach staple complications case involving a pregnant woman demonstrates how a botched gastric bypass surgery due to a defective stomach stapler can pose risks not only to the patient, but to a patient’s fetus.

This stomach stapling pregnancy complications case was published in the New England Journal of Medicine and raised concerns of patient pregnancy after a gastric bypass surgery.

In August 2004, an obese Massachusetts woman who was eight months pregnant died from stomach stapler complications approximately 18 months after she underwent gastric bypass surgery. According to USA Today, this stomach stapler pregnancy death case was the first of its kind and led to multiple medical and stomach stapler manufacturing warnings concerning risks of getting pregnant soon after a stomach stapling surgery.

This stomach stapler pregnancy incident raised an alarm in the medical community, since the majority of the 110,000 people who receive gastric bypass surgery every year are women of child-bearing age. The 41-year-old pregnant woman was taken to the hospital after allegedly complaining of pain in her upper stomach.

Once hospitalized, the doctors discovered that her small intestine had slid through a tear in nearby membrane, possibly due to the gastric bypass defect. Because of the tear, blood had been blocked to this section of the intestine, and as a result the intestinal tissue turned gangrenous.

While the doctors attempted to repair the intestinal tissues and save the patient, the fetus died. A few hours later, the woman died. The attending physicians and doctors who have studied this case have not concluded whether the tear in the membrane near the gastric bypass surgical area occurred solely from a stomach stapler defect, from the fetus pressing on the intestinal tissue, or a combination of both.

Because of this case and studies on pregnancies post-gastric bypass surgery performed before and after this stomach stapler complication, doctors have assessed the risks of pregnancy soon after a stomach stapler surgery and have recommended that female patients use contraception for up to two years after a gastric bypass operation.

Ethicon Echelon Gastric Bypass Stomach Stapler

One gastric bypass product that has come under fire for high rates of stomach stapler defect complications, injuries, and even death, is the Ethicon Echelon 60mm Black Reload. The Echelon stomach stapler, manufactured by Endo-Surgery Inc., was recalled in May 2013 after a high volume of adverse incident reports filed by consumers and surgeons alleging patients died or sustained serious injuries from stomach stapler defects.

Based on these adverse event reports filed to the U.S. Food and Drug Administration (FDA), the Echelon stomach stapler is prone to allegedly break or misfire during use. If a stomach stapler complication occurs during a gastric bypass surgery, the staple may not fully close the suture line or fail to fully puncture the stomach tissue, allowing stomach fluid and blood to leak into the abdominal cavity, possibly leading to death.

Stomach Stapler Problems

There are several gastric bypass complications that could occur should a stomach stapler misfire or if the staples do not fully close the sutures. These side effects include:

• Sepsis
• Infection
• Separation of areas that are stitched or stapled together
• Anastomotic leakage (leakage from blood vessels and intestines)
• Hemorrhage
• Leaks from staple lines
• Re-operation
• Death

Because of the thousands of reported wrongful death cases caused by stomach staplers, many families of stomach stapler victims have filed stomach stapler lawsuits or joined a stomach stapler class action lawsuit.