Surgical staple devices manufactured by Johnson & Johnson subsidiary, Ethicon, were recalled because of injury-causing defects. Stapling devices are used for many different types of surgery, for the purpose of connecting body structures during procedures. Surgical staples are sometimes used as an alternative to stitches or sutures. They may provide benefits such as strength, fast application, and minimal infection risk. However, a defect in the manufacturing of Ethicon’s surgical staplers has caused harm to multiple patients.
FDA Class 1 Recall Order
The United States Food and Drug Administration (FDA) ordered a recall of surgical staplers manufactured by Ethicon, a subsidiary of Johnson & Johnson. The recall is specifically related to the company’s circular staplers, of the “Ethicon Endo-Surgery Curved Intraluminal Stapler” and “Ethicon Echelon Flex Endopath Stapler” varieties. The most recent recall was issued in October 2019. A previous recall was issued in May 2019. It is considered a “Class 1”-level recall. Class 1 recalls administered by the FDA are generally related to items that are seen as highly dangerous to users. Ethicon’s circular staplers were recalled due to a defect that causes the device to misfire. The misfire issue was attributed to manufacturing defects in the devices, including uncut washers and misshaped staples. A stapler misfire during surgery can cause severe injury to a patient.
Surgical Staple Injuries
A patient who is harmed by the misfiring of a defective surgical stapler may suffer from complications such as bleeding, sepsis, or death. Victims may require additional surgery, alternative forms of surgical closure, and/or medication to address the issues caused by defective staplers. As a victim of surgical staple injuries, you may be qualified to pursue a lawsuit against Johnson & Johnson Ethicon and other manufacturers to recover damages.
Were You Injured by Surgical Staples?
The damage caused by surgical staples may appear well after a patient has undergone surgery. In many cases, defective Ethicon staplers are not immediately identified as the cause. It is possible that defective staples were used in a surgery before the recall was ordered. People who underwent surgery — including gastrointestinal, gynecologic, colorectal, and other procedures — between the dates of March 2018 and November 2019 may have a case. The legal team of Williams DeClark Tuschman Co., L.P.A. represents people who suffered from injuries caused by surgical staples. If you were harmed by a defective surgical stapler device, contact us for a no-cost consultation. We can discuss the details of your circumstances to determine if your surgery may have involved the defective Ethicon devices. If so, our lawyers can help you speak to your doctor and pursue a case against the manufacturers. To schedule a free case evaluation with our team of attorneys, complete our contact form or call (419) 719-5195.