Medical device maker Ethicon is one of the two chief manufacturers of surgical staplers in the U.S. Surgical staplers are widely marketed and used as an alternative to manual sutures made by surgeons to close internal wounds, their greatest benefit being reducing a patient’s time in surgery. However, Ethicon and other stapler makers have long been dogged by reports that their products frequently malfunctioned, causing serious injury and even death to patients.
Now Ethicon has initiated a recall of more than 8,000 of its Echelon Flex Endopath staplers, announced by the U.S. Food and Drug Administration in October. The FDA has identified this as a Class I recall, which indicates the devices could cause life-threatening injuries or death. As of October 3, seven serious injuries and one death had been reported to Ethicon for the affected products.
The Echelon Flex Endopath staplers are designed for use on only one patient, in major or minimally invasive surgical procedures including gynecologic, urologic, thoracic, pediatric, and general surgeries. They were manufactured between July 18 and August 3, 2019, and distributed to healthcare providers between August 1 and September 26.
Ethicon is reportedly recalling these staplers because some of them may contain a component that could lead to malformed staples. A problem with the staple line could result in prolonged surgery, post-operative leaking, internal bleeding (hemorrhage), hemorrhagic shock, the need for additional surgeries, or death.
Ethicon Staplers Subject to Recall
The following Echelon Flex staplers are the subject of the company recall:
- 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)
The recall affects patients who have had or might undergo surgery involving staplers for internal use, and surgeons who have performed or might perform surgeries using the staplers.
On October 3, 2019, Ethicon sent a notice to medical facilities, distributors, and other customers that purchased the affected staplers instructing them to determine if they have the product in their inventory and if so, to remove the product and inform operating room and other relevant personnel in their facility not to use it. In addition, they were asked to post notices of the recall in visible locations and return the recalled products to their distributor.
Of course, there are likely thousands of patients who have already undergone surgery using these staplers. Patients are advised to consult their physicians on the best course of action. Your doctor will likely recommend that you not have corrective surgery as long as you are experiencing no symptoms.
Ethicon Has a History of Surgical Stapler Issues
In May 2019, the FDA acknowledged receiving more than 110,000 surgical stapler failure reports between 2011 and 2018, more than half of which had never been publicly disclosed, involving Ethicon and other medical device companies.
According to the FDA’s “MAUDE” database, which lists adverse events involving surgical staplers going back to 2009, the following Ethicon products have been cited most often in malfunction reports as frequently leading to surgical complications and injury:
- Echelon Flex 60
- Echelon Flex 45
- Echelon 60
- Echelon Endopath
In recent years, patients and their families have successfully filed lawsuits against Ethicon for product liability, which holds the manufacturer of a product responsible for any injuries the product causes when it is used as intended. Patients who underwent a surgical stapling procedure and suffered injuries due to defective staplers may be entitled to receive compensation from the manufacturer for the cost of medical treatment required to correct the issue, pain and suffering experienced, and any other financial losses incurred as a result.
The FDA’s letter to health care providers on surgical staplers and staples from March 2019 includes general recommendations for surgeons.
Health care professionals and consumers can report adverse reactions or problems they experience with these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX to 1-800-FDA-0178.