Ethicon Recalls Surgical Staplers
On April 11, 2019, Ethicon, a subsidiary of Johnson & Johnson, issued a recall of it intraluminal surgical staplers. The surgical staplers are used in gastrointestinal tract surgeries to fire staples to create connections between structures (anastomoses). The Ethicon surgical staplers may have been used in patients who have undergone gastrointestinal surgery, such as patients with colorectal cancer and bariatric patients. Ethicon issued the recall of its staplers due to reports of malformed staples, resulting in injuries to patients.
On May 16, 2019, the FDA classified the Ethicon recall as a Class I recall, the most serious type of recall issued by the FDA. A Class I recall is issued if the FDA believes there is a reasonable probability that the use of the product will cause serious adverse health consequences or death. FDA has identified the following risks to patients with use of the Ethicon Endo-Surgery Stapler: 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.
The recall affects 92,496 Endo-Surgery endoscopic and non-endoscopic staplers manufactured between March 6, 2018 and March 6, 2019 and distributed for use in surgeries between March 15, 2018 and March 8, 2019.
If you or a loved one suffered complications from a gastrointestinal surgery between March 15, 2018 and March 8, 2019, please contact one of the experienced medical device attorneys at Burg Simpson today. Our award winning lawyers would be happy to discuss your potential claim and the recall of Ethicon intraluminal surgical staplers. Call 1-800-713-9340 or fill out our contact form for a free no obligation consultation today.
By David C. Harman, Burg Simpson Shareholder
David Harman focuses his practice on personal injury, mass tort, and class action litigation. David has considerable experience representing individuals in complex products liability cases against some of the largest pharmaceutical and medical device manufacturers in the world.