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Gastrointestinal Surgery Wasn’t Supposed to Lead to More Surgery

Surgical Stapler Malfunctions Following Gastrointestinal Resections and Bariatric Surgeries Send Patients Back to the Hospital

If you or a family member were rushed to the hospital soon after a colorectal resection or bariatric surgery in 2015 or later, it may have been the result of a recalled internal surgical stapler.

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Surgical Stapler Malfunctions

Surgical Staplers Recalled

No one wants to hear that a device used during surgery was recalled. Unfortunately, if you had one of the following surgeries since 2015 and experienced serious complications within two weeks of the surgery, the internal stapler likely caused your injuries.

  • Colorectal Cancer Resection
  • Bowel Resection for Diverticulitis
  • Sigmoidectomy (sigmoid resection)
  • Colectomy (removal of infected colon)
  • Gastric Bypass Surgery
  • Removal of Colon or Intestinal Polyps
  • Endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD) or endoscopic full thickness resection (EFTR) for polyps or Barrett’s Esophagus
  • Other Resection of the Gastrointestinal Tract

The staplers were recalled after links to serious health problems, including death, occurred soon after the original surgery.

Complications caused patients to become very sick within a couple of weeks, requiring re-hospitalization and repair surgery. Most notably, a defect leading to recalls caused the staples to fail and come out. When the staples fail, it leads to internal bleeding and anastomotic leak (think: fluids leading out of your digestive system into places they aren’t supposed to be) which, in turn, can cause infection, sepsis and even death. No one should get out of the hospital only to have to be rushed back for emergency surgery!

If an internal surgical stapler caused you or your family to have emergency post-operative surgery since 2015, contact us now to learn how you can take part in a lawsuit.


FDA Warning Letter

Prior to the voluntary recall by the manufacturer, the FDA sent a letter to health care providers in May 2019 about concerns connected to the stapler. According to the letter, between January 1, 2011 and March 31, 2018, the FDA received more than 41,000 adverse reaction reports for surgical staplers, including:

  • 366 deaths
  • Over 9,000 serious injuries
  • Over 32,000 malfunctions

Per the letter, one of the most commonly reported problems was “opening of the staple line or malformation of the staples” which can cause:

  • Bleeding
  • Sepsis
  • Fistula formation
  • Tearing of internal tissues and organs
  • Increased risk of cancer recurrence
  • Death

No one should get out of the hospital only to have to be rushed back for emergency surgery!