Johnson & Johnson Issues Class I of Surgical Stapler Devices Used In Colorectal Surgery
Class I Recall Of Johnson & Johnson Surgical Stapler Devices Used In Colorectal Surgery
On October 26, 2012, the FDA gave its most serious Class I status to a recall initiated by Johnson & Johnson’s Ethicon division of surgical stapler devices used in colorectal surgery.
User difficulty in firing the stapler devices properly has created safety concerns of possible serious adverse health consequences, including death. Such concerns led Johnson & Johnson’s Ethicon division to initiate its recall on August 3, 2012. The recall covers all Proximate PPH Hemorrhoidal Circular Stapler devices and accessories (“Proximate PPH”); Proximate HCS Hemorrhoidal Circular Stapler devices and accessories (“Proximate HCS”); and Transtar Circular Stapler Procedure Sets (“Transtar”) manufactured between April 2011 and July 2012. The recall implicates more than 157,000 devices and accessories, reports The Wall Street Journal.
These systems are typically used in colorectal surgical procedures treating prolapse and hemorrhoids. Reports indicate users having difficulty firing the stapler leading to incomplete staple formation. The misfiring of the staple device and incomplete staple formation can result in severe pain, sphincter dysfunction, rectal wall damage, sepsis, bleeding, occlusion of the rectal canal, and the splitting open of surgical wounds in the rectal wall.
The FDA advises that health care professionals and consumers may report adverse events or reactions to MedWatch.
If you or a loved one has been injured or died after colorectal surgery in which Ethicon’s Proximate PPH, Proximate HCS, or Transtar devices were used, you may be entitled to compensation. Burg Simpson has experience in defective medical stapler litigation and a national reputation as being a leader for plaintiffs and victims in personal injury litigation against medical device manufacturers. We would be happy to review your records to determine if you have a viable case. Call 1-800-713-9340 or fill out our contact form for a FREE no-obligation consultation today.