A St. Clair County man says he suffered severe injuries after an unapproved device was implanted into his lower back during a procedure he allegedly did not know was experimental. Gregory Andersen and Karen Andersen filed a lawsuit on Sept. 14 in St. Clair County Circuit Court against Anulex Technologies Inc. and Protestant Memorial Medical Center Inc., doing business as Memorial Hospital. Dr. William W. Sprich and MSA Alliance LLC, doing business as Neurological Surgery of Southern Illinois, are also named as defendants. Gregory Andersen underwent surgery on his back in December 2009, according to the 27-page petition. During the procedure performed at Memorial Hospital, Andersen says neurologist Dr. William W. Sprich placed a prostethic device known as the Xclose Plus Tissue Repair System into the patient's lower back. The Xclose was manufactured and sold by Anulex, the complaint says.
Andersen claims the lumbar implant caused him severe pain. He says he underwent surgery again in September 2010 during which doctors removed pieces of the implant. Andersen contends it was after that second surgery that he first learned the Xclose Plus Tissue Repair System had never been approved by the Federal Drug Administration. Andersen contends Anulex marketed and distributed the device to spinal surgeons and hospitals, "knowing its use in spinal surgery was prohibited by federal law and FDA regulations." He says the defendants failed to notify him and other patients that they were undergoing experimental surgical procedures. The patient says the unapproved device did not correct his condition but instead caused additional damage to the tissue in his back.
Andersen says he has suffered severe and permanent injuries to his low back and spinal cord as a result of the implantation. He says he continues to suffer pain, mental anguish and loss of enjoyment of life. Andersen and his wife are asking to be awarded more than $500,000 in damages for medical expenses, products liability and loss of consortium. Attorneys Terry Brown of Belleville, Staci Yandle of O'Fallon and David Nelson of Belleville represent the plaintiffs. St. Clair County case number 12-L-482.