Surgical staples are a near-universal feature of the modern operating room. Offering faster and quicker application than more traditional methods, the staples are marketed and largely perceived as a more efficient and reliable method of post-op wound closure than the precise and honed craft of stitching a patient. Yet for all its modernity, some products, like the Ethicon Intraluminal Stapler, manage to slip into the limelight periodically for some unsettling defects.
About The Ethicon Intraluminal Stapler
The Ethicon Intraluminal Stapler is made by the Johnson & Johnson subsidiary Ethicon, which claims to market a safe and superior product. Some highlighted aspects of the device include audio feedback on staple insertion, increased tissue control, and lessened tension when compared to their competitors. In fact, Ethicon’s claims to have a superior product to its competitors include a head-to-head comparison to its competitor Medtronic published in December 2018 by the peer-reviewed journal Medical Devices: Evidence and Research.
Despite the manufacturer’s confidence in their product, Ethicon released a statement in late March of 2019 about the potential risks of their product in the Eurasian area. According to reports, notices about the Ethicon Intraluminal Stapler were released in Europe, Africa, and the Middle East.
The issues highlighted in the notices were about malformed staples and uncut washers that could put the integrity of the staple line at risk. If left untreated, Ethicon has warned about a number of unpleasant complications. Some of those complications mentioned by Ethicon include:
- Postoperative anastomotic leak
- Gastrointestinal injury
- Hemorrhagic shock
In an effort to prevent these injuries in potentially affected areas, Ethicon has instituted an official medical device field safety corrective action for 378 lots of their Intraluminal Staplers distributed throughout the regions.
Ethicon has also disclosed that much of this action has taken place as a result of persistent consumer reporting. For more information about the dangers of Ethicon and other surgical staplers, visit Parker Waichman’s in-depth page about surgical staplers here.
Past Issues With The Ethicon Intraluminal Stapler
Though these corrective actions may seem removed from American markets, it is important to know that Ethicon has also experienced issues with product safety in the domestic sphere as well. On February 21, 2018, the U.S. Food and Drug Administration (FDA) issued a Class II recall against the Ethicon Intraluminal Stapler. Once again, in this recall from over a year ago, the reasoning for the recall is the presence of malformed staples that fail to adequately secure the integrity of the staple line.
As part of their current notice to consumers overseas, Ethicon is advising consumers to use a stapler not included in the safety notice if possible and requesting the return of identified staplers. For those to whom no alternative is available, specific outlines have been given for using the Ethicon Intraluminal Stapler within a certain degree of safety.
Receiving Compensation For Ethicon Intraluminal Stapler Injuries
While Ethicon is issuing remedies for the affected products of their latest manufacturing error, it should be well noted that this issue was not detected by the manufacturer themselves, but by concerned consumers. Even after a recall in the U.S. there may still be malfunctioning Ethicon Intraluminal Staplers in circulation. If you or a loved one have found yourselves receiving treatment and then suffering complications as a result of the use of one of these faulty devices, compensation may be available to you. At Parker Waichman LLP, experienced teams of trial lawyers can help you recover compensation for the pains and complications that arise as a result of the usage of these unsafe devices. Contact Parker Waichman today for a free consultation and begin your path to recovering your previous life.