Ethicon Surgical Stapler Recall
In April 2019, the FDA identified a Class I Ethicon surgical stapler recall — the most serious type of recall – after reviewing more than 41,000 adverse events related to surgical stapling devices from January 2011 through March 2018. The use of these devices “may cause serious injuries or death,” warns the FDA.
Which Products Were Involved In The Ethicon Surgical Stapler Recall?
The Ethicon surgical stapler recall pertained to Ethicon Endo-Surgery Curved or Endoscopic Curved Intraluminal Staplers with Adjustable Height Staples used to create connections between structures in the gastrointestinal tract. Product codes, located on the front of the single unit carton, are as follows:
The 92,496 affected products — manufactured from March 6th, 2018 to March 6th, 2019 — were distributed from March 15, 2018 to March 8th, 2019. The recall was initiated on April 11, 2019.
Reason for the Surgical Suture Recall
Following numerous complaints and returned products, Ethicon discovered that a shift in their manufacturing process from March 2018 through March 2019 was creating uncut stapler washers, which in turn caused insufficient firing and malformed staples.
The line was shut down once the problem was discovered, but at least two patients suffered serious injuries, Ethicon has confirmed. One of the patients suffered an additional resection of the middle rectum, and the other patient suffered an additional resection in the lower rectum during planned re-sectioning of the upper rectum.
According to the FDA, “Potential risks to patients include death, sepsis, bleeding, the need for permanent ostomy ‘bag,’ life-long nutritional and digestive issues, leak in the closure (anastomotic leak), additional surgeries, need for additional closures (anastomoses), need for antibiotics, and the need for additional imaging studies.”
What Should Surgeons Do Next?
Surgeons who use these staplers should consider other options – like manual staplers from other manufactured or less invasive surgeries. Medical facilities with the affected staplers should remove the product at once. The deadline for obtaining a replacement device has already passed as of June 30, 2019, but Ethicon can answer any questions at 1-877-384-4266 Monday through Friday from 7:30 am to 6:30 pm EST. The FDA would also like information regarding adverse events reported to 1-800-FDA-0178 or online.
Does The Ethicon Surgical Stapler Recall Go Far Enough?
The Ethicon surgical stapler recall is a substantial move to get dangerous medical devices off the market. However, patient advocates are calling for more action by the FDA, such as tougher regulation of surgical staplers, new label warnings, and public advisory meetings that incorporate expert input into proposed reclassification and draft guidance.
Many others are calling for greater transparency from the FDA. Surgeon Dr. Douglas Kwazneski said he turned to the public database after a surgical stapler he was using to seal appendix tissue “locked up,” instead of cutting and sealing as it was designed to do. “There was nothing,” he said. Yet, when he surveyed his colleagues, he found that two-thirds of them had similar experiences.
He later learned the FDA allowed surgical stapler manufacturers to submit reports of malfunctions to a hidden database, known only to regulators, and inaccessible to doctors or their patients. Since 2016, over 1.1 million incidents involving over 100 devices have been internally recorded. “I don’t want to sound overdramatic here, but it seemed like a cover-up,” Dr. Kwazneski told The Huffington Post.
Will The Endo-Surgery Stapler Recall Trigger A Rash of Lawsuits?
Any time we see a major event like the Endo-Surgery Stapler Recall, the lawsuits soon follow. As of August 2019, we are in the early stages of litigation, with no consolidation of similar claims in Multi-District Litigation proceedings just yet. While a recall is not necessary to file a surgical stapler lawsuit, it certainly helps build a substantial case for manufacturer negligence when more than 366 patients have died and over 90,000 patients have been injured by surgical stapling devices since January 2011. While not all of these incidents can be traced back to Ethicon’s devices, Ethicon is one of the leading manufacturers of surgical staplers.