On October 3rd Johnson & Johnson subsidiary Ethicon issued a Class 1 recall for over 8,200 Echelon Flex 60 Articulating Endoscopic Linear Cutters, more commonly known as surgical staplers. Class 1 is the most serious type of recall and indicates that lives are at stake.
A surgical stapler is a medical device designed to replace stitches, or sutures, and is used primarily in minimally invasive procedures (those involving small incisions and the use of endoscopic devices). Surgical stapling was first developed in Europe in 1908, but the technology was not made practical until the 1950s. Covidien (formerly United States Surgical Corporation) was the first U.S. company to enter the market for surgical staplers starting in 1967. Ethicon entered the market 13 years later. Today, Ethicon and Covidien dominate the market for surgical staplers. Other manufacturers of surgical staplers include 3M and Medtronic.
Surgical staplers offer a number of advantages over sutures, including reduced surgery time and ease of removal. However, they have also been associated with numerous serious complications, such as allergic reactions, infections, and malformed or improper placement of staples. This is the primary issue behind the current recall of the Echelon 60 Flex.
According to the recent FDA announcement, the problem is “...an out of specification component within the jaw of the device, which could lead to malformed staples.” The consequences of this defect can be fatal. As of the date of the recall, there have been reports of 7 serious injuries and one patient death. In addition to the U.S., Ethicon has issued an urgent field safety notice to surgical personnel in several European countries.
This is not the first time Ethicon has had to issue a recall for its surgical staplers. Earlier this year, a Class 1 recall was issued for two models of the company's Curved Intraluminal Stapler for “...insufficient firing and failure to completely form staples.” Two cases of serious patient injury were reported before Ethicon recalled the products.
Nor has problems with surgical staplers been limited to Ethicon products. Shortly after Ethicon recalled its curved staplers in May of 2019, Kaiser Health News reported there were approximately 110,000 adverse events involving these instruments reported to the FDA between 2011 and 2018 – over half of which were filed into a secret database that was never made available to the public – including surgeons.
Over 11,000 patient injuries and 400 deaths were reported to the agency's MAUDE public database; however, fatalities were not included in the “hidden” reports, so the total number of patients killed by these devices is unknown. According to the story, all fatalities were caused by staplers manufactured by Ethicon and Covidien.
According to the ECRI Institute, an organization that tracks and reports dangerous medical technologies, the use of surgical staplers will pose the greatest danger for patients in 2020.