Ethicon Recalls Surgical Staplers After Several Reports of Injuries, Death
On October 29, 2019, the U.S. Food and Drug Administration (FDA) announced that Ethicon initiated a recall of several lots of its ECHELON FLEX ENDOPATH® Staplers. The recall was prompted by the manufacturer discovering that some of the surgical staplers distributed may have an out-of-specification part which could lead to malformed staples. If a malformed staple is used during an operation, it could lead to a longer surgery or expose the patient to a post-operative leak in the closure (anastomotic leak), hemorrhage, hemorrhagic shock, additional surgical intervention, or even death. Because of the severity of the injuries involved, FDA has classified the recall of the surgical staplers as Class I, its most serious designation. Indeed, Ethicon has already received reports of at least 7 serious injuries and 1 death associated with the use of the surgical staplers.
The recent Ethicon recall is just one of a string of surgical stapler recalls announced by FDA. An ongoing analysis conducted by FDA has revealed reports of 366 deaths, over 9,000 serious injuries, and over 32,000 malfunctions associated with surgical staplers and/or staples between January 1, 2011 and March 31, 2018. The experienced medical device attorneys of Burg Simpson are currently investigating cases of complications arising out of staple-related issues.
What are surgical staplers?
Surgical staplers are medical devices that are used to deliver compatible staples to tissues inside the body during surgery. They are commonly used during procedures to remove part of an organ (resection), cut through organs and tissues (transection), and create connections between structures inside the body (anastomoses). Depending on the procedure, some surgeons prefer to use staplers over stitches for quicker placement, minimal tissue reaction, lower risk of infection, and secure wound closure.
However, surgical staplers often fail to perform in the way they were intended to perform. Common issues with surgical staplers include the misfiring of staples, difficulty in firing staples, failure to fire staples, applying staples to the wrong tissue, or applying staples of the wrong size to tissue. Malfunctions and/or misuse of surgical staplers can lead to a longer operation or unplanned, additional surgery. Further complications that can arise are internal bleeding, torn or damaged internal organs and tissues, a potentially fatal reaction to infection (sepsis), increased risk of cancer recurrence, an abnormal connection between organs or other bodily tissue (fistula formation), lifelong nutritional deficiencies or digestive issues, and even death.
How would I know if a surgical stapler caused my complications?
Put simply, you may not know that a malfunction or misuse of a recalled surgical stapler caused your subsequent health problems. Sometimes, it is immediately obvious to the surgeon that something went wrong during the stapling process, such as when there are immediate signs of tears within the body. However, oftentimes the complications do not become readily apparent until a scheduled follow-up, or unfortunately, an unplanned visit to the emergency room. Because of the recency of some of these surgical staple recalls, it can be difficult for doctors (and especially patients) to identify that the stapling process was the cause of the later complications, such as internal bleeding or required additional surgery.
If you or a loved one underwent surgery and later experienced complications or underwent additional corrective procedures that you suspect may have been caused by staple-related issues, contact the product liability lawyers at Burg Simpson’s Cincinnati office today. Our experienced medical device team is willing to investigate your potential claim, and fight for the money you need to recover from your injuries. Call 513-852-5600 or fill out our contact form for a free, no-obligation consultation today.