Cincinnati, Ohio Medical Device Attorney reviewing the recent Ethicon Surgical Stapler Recall, and injuries and deaths linked to defective surgical instruments
Patients undergoing surgery assume the medical instruments that surgeons use during operations are effective and have been properly tested. But that is not always the case, as medical device companies often recall defective medical tools, as seen in the most recent surgical stapler recall initiated by Ethicon, a subsidiary of Johnson & Johnson.
Ethicon recalled the ECHELON FLEX™ ENDOPATH® staplers after they were found to fail to completely form staples. The FDA has been concerned with Ethicon surgical staplers for quite some time.
In May, the FDA decided to require a pre-market review of surgical staplers used in internal procedures, due to a poor safety record of surgical staplers. From 2011 to 2018, the FDA received 412 reports of surgical deaths and around 110,000 malfunctions linked to surgical staplers. About a third of the reported device failures were related to malformed staples, the same safety issue that led to the Ethicon surgical stapler recall.
Earlier in 2019, the FDA recalled 92,000 circular staplers in a Class I event, meaning the agency believed the devices had the potential for serious harm or death. Ethicon warned of an “out-of-specification component” that may misform staples. The malformed staples could lead to a range of severe complications, from prolonging operations to death.
Ethicon has asked doctor and surgeons to check their stocks of affected Echelon Flex Endopath staplers. The 60mm staplers are meant to be quarantined and returned to the manufacturer. The poor safety history of surgical staplers makes them one of the top health technology hazards.
The Echelon Flex Endopath staplers are single-use devices that cut and staple internal tissue. The stapler is designed to simultaneously cut and staple tissue back together during surgery. But the misformed staples fail to properly close incisions.
The stapler defect involves a defective component within the jaw of the device, leading to malformed staples. The company has said the stapler defect could lead to prolonged surgery, post-op connection leak, hemorrhage, or death. At least seven serious injuries and one death have been reported to Ethicon.
Last year, the FDA sent a letter to health care providers and hospitals after discovering more than 41,000 medical device reports that describe adverse events and deaths linked to the use of surgical staplers.
Johnson & Johnson faces a mind-blowing 100,000 lawsuits, with injured plaintiffs suing the company over a range of dangerous products, including opioids, baby powder, surgical devices and other medications.
If you or a loved one has suffered a surgical stapler injury, and have questions about the legal remedies available to improve quality of life and medical care in Ohio, contact The Lyon Firm (800) 513-2403. You will speak directly with Mr. Lyon, an Ohio medical device recall attorney, and he will help you answer critical questions regarding surgical stapler injury lawsuits.