The Surgical Stapler lawsuits claim that surgical staplers have been malfunctioning and causing injuries such as infections, internal bleeding, and organ damage.
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What Do We Know About the Surgical Stapler Lawsuits
Surgical staplers (also called “skin staplers” or “wound staplers”) are medical instruments commonly used by surgeons as a substitute for sutures in order to close lacerations and incisions as well as connecting internal organs. These devices have been used for over 50 years. They have been marketed as time savers.
However, a review of the FDA's Manufacturer and User Facility Device Experience (MAUDE) database has found more than 41,000 adverse event reports filed between January 1, 2011, and March 31, 2018. According to this review, surgical staplers have malfunctioned approximately 32,000 times. There have been 9,000 serious patient injuries. More than 350 patients are known to have died as a result of surgeons employing surgical staplers.
These numbers represent only what the FDA has publicly admitted. On May 30, 2019, Kaiser Health News reported that over 56,000 additional reports had been submitted over the same time period. However, these reports were never disclosed, nor even made available to the public.
Surgical Stapler Injuries
Due to malfunctions, misuse, and defective design of surgical staplers, patients have suffered numerous types of injuries and complications, often with long-term or permanent consequences and/or requiring additional surgeries and treatments. These injuries include:
- internal bleeding
- organ damage
- fistula (abnormal connection between organs and blood vessels)
According to adverse event reports, the most common surgical stapler malfunctions are:
- misfiring or difficulty in firing
- failure to fire staples
- using the incorrect staple for a given surgery
- leaks in the staple line (the wound or incision closure)
- staple malformation
FDA and Recalls Regarding Surgical Staplers
On April 24, 2019, the FDA issued a “Draft Guidance” that includes recommendations on labeling for surgical staplers and staples. Approximately two weeks earlier, the FDA initiated a recall of Ethicon Intraluminal Staplers used in gastrointestinal surgeries after receiving reports of problems with staples. On May 16, 2019, the recall was designated as Class I, meaning there is a high probability that the device will cause serious injuries or death. The recall has affected well over 92,000 units sold in the U.S. over a one-year period starting in March of 2018.
The medical device manufacturer Covidien initiated two recalls of surgical staplers on April 9, 2018, for EEA Hemorrhoid and Prolapse Stapler Sets. The stated reason for the recall was: “There is a potential for improper welding of the yellow staple guide to the instrument. Use of a device with an improperly welded staple guide may result in improper staple formation potentially leading to bleeding or anastomotic leak.”
On April 26, 2018, Covidien initiated recalls on 40 GIA surgical stapler devices and components, stating: “Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents.”
Another 14 recalls were initiated on May 22, 2018, for Covidien GIA staplers and components for the same reasons cited in the April 26 recalls.
A recall was initiated on August 17, 2018, for Covidien’s EEA Circular Stapler with Tri-Staple Technology due to “the potential for a device to have an incorrect tissue gap. Use of a device with an incorrect tissue gap may result in incomplete staple formation and/or the inability to remove the device from tissue following application potentially leading to bleeding, anastomotic leak or tissue trauma.”
Another 12 recalls were initiated on May 17, 2019, for Covidien GIA staplers and components. The company stated: “The device may be missing one of two pin components that maintain alignment of the device jaws, resulting in incomplete staple formation which may lead to bleeding, anastomotic leak, peritonitis, or pneumothorax which can result in the potential for infection and/or sepsis”
Other manufacturers of surgical staplers include:
- 3M Corporation
- Stryker Medical
- Tyco Medical Group
- U.S. Surgical
A number of staplers in the past were approved through the questionable 510(k) Premarket Notification process. However, because the FDA determined these devices to be “low risk,” surgical staplers designed and manufactured more recently were given “Class I exemption,” meaning that the manufacturer did not even have to provide notification. In either case, the staplers were not subject to normally rigorous clinical studies and safety testing.