A 37-year-old woman allegedly died after receiving a gastric bypass surgery with a defective stomach stapler.

Boston resident Ann Marie Simonelli had willingly undergone gastric bypass surgery at Brigham and Women’s Hospital where a stomach stapler allegedly misfired, a contributing factor to her eventual death, ABC News reported.

More and more consumers are becoming aware of the potential dangers of gastric bypass surgery, especially with the number of stomach staple lawsuits involving an alleged defect, the main medical device used to perform gastric bypasses.

Simonelli’s 2003 stomach stapler wrongful death lawsuit was one of the first examples of the potential risks of stomach stapler products.

Simonelli’s alleged stomach stapler death occurred during the early popularity of gastric bypass surgery and hers was not the only reported defective stomach stapler incident.

From 2001 to 2003, the U.S. Food and Drug Administration (FDA) received 14 reports of wrongful deaths associated with stomach stapler medical devices. While surgeons are generally able to fix or work around the damage done, a defective stomach stapler that misfires can cause undue harm, pain, and long term damages to a patient.

Ethicon Echelon Gastric Bypass Stomach Stapler

The Ethicon Echelon 60mm Black Reload medical product is one of the stomach staplers involved in wrongful death stomach staple defect lawsuits.

The Echelon 60mm and the Echelon Flex are both manufactured by Johnson & Johnson subsidiary Ethicon Endo-Surgery Inc. Both stomach stapler models were recalled in May 2013. According to FDA reports, the Echelon stomach stapler devices are allegedly prone to breaking or misfiring during use, which can result in serious and often life-threatening complications for gastric bypass patients.

If a stomach staple does not fully close or fails to fully puncture the stomach tissue, stomach fluid and blood will leak form the surgical site and into the abdominal cavity, which will create further complications.

Stomach Staple Complications

Some gastric bypass complications that may arise from a stomach stapler misfiring or from a staple failing to fully close surgical sutures may include.

• Sepsis
• Infection
• Dehiscence (separation of areas that are stitched or stapled together)
• Anastomotic leakage (leakage from tubular structures, such as blood vessels and intestines)
• Hemorrhage
• Leaks from staple lines
• Reoperation
• Death

Since the invention of gastric bypass surgery, the FDA has received 8,000 to 9,000 stomach stapler adverse incident reports each and every year, the majority of which claim that the gastric bypass complications stemmed from a misfired stomach staple or a stomach staple failing to close the suture line.

As a result of the painful and often damaging and life-threatening complications resulting from an allegedly defective stomach stapler, many patients and their families are choosing to pursue gastric bypass stomach staple lawsuits and may join gastric bypass stomach staple class action lawsuits.