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When a patient goes through a surgical procedure, the last thing they expect is complications caused by the very medical tool that was built to close the surgical site. However, that is exactly what is happening to many colon cancer patients and other gastrointestinal patients according to shocking new reports from the FDA that reveal over 56,000 incidents of surgical stapler and suture malfunctions.

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Surgical Stapler Injury Attorneys

GIA Aperta

Belluck & Fox is currently filing and taking on surgical stapler cases using its decades of experience in fighting for patient justice from medical device companies. Settlements and verdicts for these kinds of medical device lawsuits have ranged from $5 million all the way up to $80 million.

If you or a loved one had surgery for colon cancer, or another gastrointestinal or rectal problem, and have had continuing problems such as bleeding, sepsis, an anastomosis or colostomy that has failed to close, or been affected by a malfunctioning surgical stapler or suture, please reach out today for a free consultation so that our team can get you the information and support you need.

How can staplers hurt patients?

Surgical staples and sutures are often used in gastrointestinal surgery; colorectal cancer surgery; bariatric surgery; endo-related surgery; gynecologic & urologic surgery; thoracic surgery; and more.

According to a memo from the FDA, injuries reported to be caused from these malfunctioning surgical staplers and sutures include:

  • Anastomosis that fails to close;
  • Colostomy that fails to close;
  • Death;
  • Bleeding;
  • Torn or damaged internal organs and tissues;
  • Sepsis, a potentially fatal reaction to infection;
  • Increased risk of cancer recurrence; and
  • Fistula formation, an abnormal connection between organs or other tissue in the body.

These injuries can result from the staplers and sutures placing faulty staples into the body, or failing to fire staples altogether.

Who makes these staplers?

Nearly 80 percent of surgical staplers and sutures used in American hospitals are manufactured by Johnson & Johnson with its subsidiary Ethicon, and by Medtronic with its subsidiary Covidien.

Other manufacturers include 3M; B. Braun; Cardica; Care Fusion; CONMED; Frankenman; Meril Life Science; Purple Surgical; Smith & Nephew; Stryker; U.S. Surgical; Welfare Medical; Reach Surgical; and Zimmer Biomet.

Why are we just learning about this now?

While manufacturers are required to report serious injuries and deaths to the FDA, the majority of those submissions go to a secret database. With the data of both public and hidden databases combined between 2011 and 2018, the FDA was aware of 412 deaths and 11,181 injuries caused by these staplers and sutures. All this from an astounding 97,000 malfunctions reported to both databases.

Thanks to reports from organizations like Kaiser Health News, the FDA was forced to release the hidden records to the public and tighten regulations, including reclassifying the tools from low-risk to moderate-risk.

Is there any accountability?

The other factor driving new public awareness of the risk these staplers and sutures pose have been massive recalls – with more than 3.4 million units and components from the two major manufacturers alone recalled since 2013.

Manufacturer Year Number Recalled Products Included Reason for Recall
Ethicon 2019 92,496 Endo-Surgery Curved Intraluminal Stapler with Adjustable Height Staples

Endo-Surgery Endoscopic Curved Intraluminal Stapler with Adjustable Height Staples

Two patients were injured after devices misfired, cutting portions of their rectums.
Medtronic 2019 3,113,280 Endo GIA Articulating Reloads with TriStaple Technology Missing components could affect staple alignment.
Medtronic 2018 171,271 Endo GIA “Auto Suture” Universal Articulating Loading Unit Five people were injured related to missing components that could affect staple alignment.
Ethicon 2015 6,744 Endopath Echelon Flex Powered Vascular Staplers with Advanced Placement Tip and White Reloads Inspections found certain staplers may not insert a full line of staples when fired.
Ethicon 2013 57,540 ECHELON 60mm Endoscopic Linear Cutter Reloads Black Manufacturer identified a potential for reload damage that would prevent a complete line of staples firing.

Medtronic Endo GIA single-use loading units, Tri-Staple 2.0 intelligent reloads, and cartridges with the following product codes distributed between April 2014 and April 2019 were also included in recalls: EGIA30AMT; EGIA45AVM; EGIA45CTAMT; EGIA60AXT; EGIA60CTAMT; SIG30AMT; SIG45AXT; SIG45CTAMT; SIG60AXT; SIG60CTAMT; EGIA45AMT; and EGIA60AMT.

Altogether, these recalls covered manufacturing defects, missing components, and failed staples that all had the ability to cause pain, bleeding, leaks, infection, and sepsis throughout the body. They could also cause the need for permanent ostomy bags, antibiotics, additional imaging studies, and even surgery, as well as life-long nutritional deficiencies and life-long digestive issues.

What can affected patients do?

By working with Belluck & Fox to hold stapler companies accountable, patients can get the justice and compensation they deserve.

An $80 million verdict was awarded by a California jury to a former police officer when it was discovered after surgery that an Ethicon PPH 03 surgical stapler which had been recalled was responsible for her bowel being stapled against her rectal wall, causing a life threatening infection.

A husband in Illinois was awarded $5.5 million in a settlement over the death of his wife due to a surgical stapler injury.

Patients are entitled to file suit for compensation including but not limited to:

  • Infections caused by stapler injuries;
  • Pain and suffering, both physical and mental;
  • Lost wages;
  • Loss of enjoyment of life; and
  • Punitive damages to punish the manufacturer.

These kinds of lawsuits are complex, involving intricate knowledge of medicine, engineering, manufacturing and liability law. They require a legal team that specializes in standing up for the rights of patients in medical device cases and has a proven track record of success for its clients.

Personal. Professional. Proven. Belluck & Fox.