Surgical staplers are medical devices often used during surgery, internally or externally to close wounds. However, the FDA recalled certain surgical staplers manufactured by Ethicon Inc., a Johnson & Johnson subsidiary, due to concerns that the staplers may cause serious injuries or death. A Class I recall, the FDA’s most serious type, was issued for Ethicon’s Circular Staplers in May 2019 following reports that the devices caused patients serious harm or even death.
Contact a medical device attorney
If you or a loved one was injured, or tragically died, from complications after having surgery involving a defective surgical stapler, you may have a claim. We understand that you may not be familiar with the specific device used during your medical procedure. Our attorneys have access to the resources needed to thoroughly investigate your situation to determine if you were affected.
Circular stapler gastrointestinal surgery post-op complications
Circular stapler devices were designed for surgical repairs of the gastrointestinal tract for patients with colorectal cancer, bariatric patients and other conditions. Misfiring of the staplers has been reported, however, resulting in malformed staples and other issues that may comprise staple line integrity, according to the FDA. Complications following surgery or a procedure using recalled Ethicon circular staplers may be severe and life altering, including leading to:
- Severe Bleeding
- Need for a permanent ostomy “bag”
- Life-long nutritional digestive issues
- Leak in the closure (anastomotic leak)
- Additional surgeries
- Additional closures (anastomoses)
Echelon Flex™ Endopath® stapler complications
Ethicon announced a Class I recall in October 2019 for these devices due to a defective component within the stapler that may cause malformed staples. If left uncorrected, patients may experience severe complications including:
- Prolonged surgery
- Postoperative connection (anastomotic) leak
- Hemorrhagic shock
- Additional surgeries
As of Oct. 3, 2019, seven serious injuries and one death had been reported to Ethicon, according to the FDA.
Recalled surgical staplers
Products included in the circular stapler recall are:
- Endo-Surgery Curved Intraluminal Stapler with Adjustable Height Staples
- Endo-Surgery Endoscopic Curved Intraluminal Stapler with Adjustable Height Staples
- Products included in the Echelon Flex™ Endopath® stapler recall are: Echelon Flex 60 Endopath Stapler, Articulating Endoscopic Linear Cutter
- Echelon Flex 60 Powered Plus Compact Articulating Endoscopic Linear Cutter
- Echelon Flex 60 Powered Plus Articulating Endoscopic Linear Cutter, 44cm Shaft Length
- Echelon Flex 60 Powered Plus Articulating Endoscopic Linear Cutter, 34cm Shaft Length
Our experience in medical device lawsuits
Our medical attorneys have extensive experience with medical device litigation and have held numerous leadership roles in multidistrict litigations filed for injured patients, including those allegedly harmed by transvaginal mesh and hernia mesh repair products manufactured by Johnson & Johnson and Ethicon. Carmen Scott has been at the forefront of national contraceptive litigation involving products such as Essure®, and served on the Plaintiffs’ Steering Committee in In re NuvaRing Products Liability Litigation, as co-lead counsel in In re Mirena Product Liability state court consolidation in New Jersey, and is co-chair of the AAJ Mirena® IUD Litigation Group. She also represents women who developed ovarian cancer after using talcum member, and is a member of the Plaintiffs’ Steering Committee for the multidistrict litigation In re Power Morcellator Products Liability Litigation and In re Johnson & Johnson Talcum Powder Products Marketing, Sales Practices and Products Liability Litigation.