No conclusions can be made.The patient's attorney alleges adverse patient outcome associated with the hernia mesh used to treat the patient including intestinal perforation, sepsis, fistula and disability; however, no details have been provided.The adverse reaction section of the instructions-for-use (ifu) supplied with the device states "if the recoil ring is cut or damaged during insertion or fixation, additional complications may include bowel or skin perforation and infection" and lists fistula as a possible complication.In regard to the infection, the warning section of the ifu states "if an infection develops, treat the infection aggressively.The prosthesis may not have to be removed.An unresolved infection, however, may require removal of the prosthesis." no lot number has been provided; therefore, a review of the manufacturing records is not possible.Should additional information be provided, a supplemental emdr will be submitted.Note, the date of implant is estimated as (b)(6) 2006 based on the information received, as a specific implant date is not provided.Not returned.
|
It is alleged that the patient underwent hernia repair surgery on or about 2006.During that surgery, an unspecified bard/davol composix kugel hernia patch, which included dual mesh technology and a memory recoil ring, was surgically implanted into patient's body.Subsequently, the memory recoil ring broke while inside patient's body and/or became twisted or migrated within the abdominal cavity, causing patient to suffer from intestinal perforations, ring migration through the abdominal wall, abscess formation, bowel obstruction, migration of the hernia patch, sepsis, and chronic intestinal fistulae.It is alleged that the patient has suffered and continues to suffer from serious injuries, including, but not limited to, pain and suffering, physical injuries, disability, significant disfigurement, embarrassment, mental anguish, expenses of hospitalization, medical and nursing care treatment.It is also alleged that the patient is likely require significant additional medical treatment, further surgeries and hospitalizations.It is also alleged that the device was defective.
|