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Ethicon stapler products have been subject to multiple recalls over the past two years after the devices were associated with injuries and even deaths, sometimes resulting in surgical staples lawsuits.
Surgical Staplers: Why Are They Used?
Surgical staplers can be used during surgery to close wounds and even assist in the surgical process. External staples are often used to close large or complex wounds while internal staples can be used to remove tissue (resection), cut through tissues (transection), or create connections between structures (anastomoses).
There are several reasons why a doctor may choose to use surgical staplers. Externally, these staples can help close wounds which are under a high amount of tension. In areas like the torso or scalp, sutures or stitches may not be as effective in closing wounds.
Internally, surgical staplers may be chosen over other closure methods due to their quick placement, minimal tissue reaction, relatively low risk of infection, and strong closure that they provide to wounds.
Despite these benefits, surgical staplers have been recalled due to their suspected role in several injuries and deaths.
Ethicon Stapler Recall
In August 2019, Ethicon recalled two of their endoscopic surgical staplers which were designed to create connections between structures during gastrointestinal surgeries. According to the U.S. Food and Drug Administration (FDA), the Endo-Surgery Curved Intraluminal Stapler with Adjustable Height Staples and Endo-Surgery Endoscopic Curved Intraluminal Stapler with Adjustable Height Staples reportedly failed to achieve their goals and instead harmed patients.
Misfiring of the stapler devices reportedly caused uncut washers and malformed staples to be ejected from the staplers. As a result, staple lines from these devices could be compromised, the FDA reveals. An investigation of Ethicon’s manufacturing process reportedly traced this issue to a shift in the processes which was in effect from March 2018 to March 2019.
Patients may have been harmed by the defective Ethicon staplers. According to the FDA, two patients sustained serious injuries in connection to the devices. Both patients reportedly had to have additional portions of their intestines removed during a resection of a smaller portion of the intestines.
Injuries such as these could reportedly result in bleeding, sepsis, lifelong nutritional issues, digestive problems, closure leaks, and the need for further medical procedures. The FDA notes that these injuries could even result in death.
In October 2019, another Ethicon stapler recall was initiated by the company, this time of their ECHELON Flex Endopath staplers. This device was designed to be used in open or minimally invasive gynecologic, urologic, thoracic, pediatric, and general surgeries.
Reportedly, instead of cutting and stapling tissues as intended, the device allegedly posed the risk of ejecting malformed staples due to an out-of-specification component. If this problem isn’t addressed, serious complications could occur including prolonged surgeries, post-surgery leaks, hemorrhage, hemorrhagic shock, and even death. According to the FDA’s stapler recall announcement, seven serious injuries and one death were reported in connection with the product as of Oct. 3, 2019.
As a result of these injuries, Ethicon initiated a recall of the defective staplers. Items included in the recall were:
- ECHELON Flex 60 Endopath Stapler, Articulating Endoscopic Linear Cutter (EC60A)
- ECHELON Flex 60 Powered Plus Compact Articulating Endoscopic Linear Cutter (PCEE60A)
- ECHELON Flex 60 Powered Plus Articulating Endoscopic Linear Cutter, 44cm Shaft Length (PLEE60A)
- ECHELON Flex 60 Powered Plus Articulating Endoscopic Linear Cutter, 34cm Shaft Length (PSEE60A)
For both Ethicon recalls, the FDA recommended removing the recalled devices from inventories and returning them to the manufacturer.
Following these recalls, Ethicon has continued to manufacturer new surgical staplers, including its Echelon+ device released in 2021. This new and improved stapler aims to improve patient outcomes and reduce complications. Only time will tell if this new model improves on the faults of its predecessor.
Though some defective products are no longer in use, patients may have been seriously injured or even died as a result of the recalled Ethicon staplers. Consumers who were injured by these staplers or whose loved one was killed as a result of the defective products may be able to take legal action against Ethicon.
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