On May 16th, 2019, the U.S. Food and Drug Administration (FDA) required Ethicon, a division of Johnson & Johnson, to recall more than 92,000 Circular Staplers that are used in gastrointestinal and bariatric surgeries.
The FDA has identified this as a Class I recall, the most serious type of recall. They have stated, “Use of these devices may cause serious injuries or death.”
Who May be Affected
Patients who have had or may undergo gastrointestinal surgery, such as patients with colorectal cancer and bariatric patients.
The FDA Recall Notice states: “The U.S. Food and Drug Administration (FDA) is concerned by the increasing number of adverse events associated with surgical staplers and staples for internal use and is providing additional recommendations for health care providers to help protect patient safety and reduce the risk of adverse events associated with these devices.”
What are the injuries?
Potential injuries to patients include:
- Death
- Infection
- Bleeding
- 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
- Need for additional imaging studies
FDA’s Reason for Recall
The FDA states:
“Complaints of uncut washers in the stapler and malformed staples occur with their intraluminal circular staplers due to insufficient firing, which can compromise staple line integrity. When the washer is cut, confirming completion of the firing cycle, the surgeon experiences an audible and tactile crunch. Failure to cut the washer suggests complete 360-degree staple line failure.
In addition, an investigation of the manufacturing process detected a shift in a process, which occurred in March 2018 and continued through March 8, 2019, at which time the line was shut down.
The use of affected product may cause serious patient harm or death. Ethicon confirmed serious injuries. Misfiring of the stapler resulted in an additional resection — of the middle rectum in one patient and the lower rectum in another patient — during the planned resection of the upper rectum.”
What Should I Do Now?
If you or a loved one has suffered an injury after colorectal, bariatric, or bypass surgery, please contact the Minnesota Defective Medical Device Attorneys at Goldenberg Lauricella. With over 30 years of experience litigating complex medical device case, we will deliver the Gold standard advocacy you deserve.