This event is deemed reportable based on the allegations in a lawsuit which, while unsubstantiated, suggest that a reportable event may have occurred during use of atrium medical's mesh product.Allegedly, following the implant of mesh plaintiff experienced chronic pain, scarification of mesh, failure of mesh to incorporate, hardening and deformation of mesh, seroma of abdominal wall, hernia recurrence and multiple adhesions, including adhesions to the colon.Since this is a legal matter, the case has been turned over to legal counsel and further information obtained through investigation or discovery may fall under the attorney/client and/or work product privilege.However, atrium will supplement this report as appropriate if additional information comes to its attention.
|