New York, NY (PRWEB) December 18, 2012 - (Attorney advertising. Prior results do not guarantee a similar outcome.) On the heels of lawsuits over its transvaginal mesh products, Ethicon recently recalled two of its surgical aid products. The Rottenstein Law Group, which represents clients with injuries allegedly caused by transvaginal surgical mesh, will keep patients apprised of developments related to these new product recalls.
The packaging breaches in Ethicon’s SURGIFLO Hemostatic Matrix and SURGIFLO Hemostatic Matrix Kit Plus FlexTip with Thrombin could have potentially fatal consequences for patients, according to a U.S. Food and Drug Administration report issued Dec. 14. The packing process, the report said, could lead to a breach of the double Tyvek pouch in products manufactured from Sept. 16, 2011, through July 27, 2012, and distributed from Sept. 29, 2011, through Aug. 7, 2012. This could affect how the products control the flow of bleeding during surgery.
This is not the first time Ethicon has faced controversy over its products. The company is one of six major device manufacturers involved in a multidistrict litigation in United States District Court for the Southern District of West Virginia (MDL No. 2327) because of serious side effects such as excessive bleeding, erosion, pain and bladder perforation from their transvaginal mesh products. Complications from transvaginal mesh surgeries are “not rare,” the FDA said in a 2011 report.