IT WAS REPORTED BY THE PATIENT'S ATTORNEY THAT THE PATIENT WAS IMPLANTED WITH A TRANS-OBTURATOR URETHRAL SLING AND A COMPETITOR'S ANTERIOR PELVIC FLOOR MESH ON (B)(6) 2008 AND AS A RESULT OF THE IMPLANTS, THE PATIENT HAS BEEN SEVERELY AND PERMANENTLY INJURED. THESE INJURIES HAVE CAUSED AND WILL CONTINUE IN THE FUTURE TO CAUSE EXTENSIVE PAIN AND SUFFERING, DISFIGUREMENT, EMOTIONAL DISTRESS AND HAVE SUBSTANTIALLY REDUCED HER ABILITY TO ENJOY LIFE. THE PATIENT HAS UNDERGONE ADD'L SURGERIES FOR EXPOSED MESH IN (B)(6) 2009.
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Patient 1
A REVIEW OF THE DEVICE HISTORY RECORD FOR THE REPORTED LOT NUMBER FOUND NOTHING THAT WOULD CAUSE OR CONTRIBUTE TO THE REPORTED PROBLEM. THE INSTRUCTIONS FOR USE STATES IN THE ADVERSE EVENTS SECTION THAT COMPLICATIONS ASSOCIATED WITH THE PROPER IMPLANTATION OF THE URETHRAL SUPPORT SYSTEM MAY INCLUDE, BUT ARE NOT LIMITED TO: POSTOPERATIVE HEMATOMA, WHICH MAY OCCUR FOLLOWING THE IMPLANT PROCEDURE, TEMPORARY URINARY RETENTION, BLADDER OUTLET OBSTRUCTION, AND VOIDING DIFFICULTIES ASSOCIATED WITH OVER CORRECTION/TOO MUCH TENSION PLACED ON THE MESH SLING IMPLANT, PERFORATIONS OR LACERATIONS OF VESSELS, NERVES, BLADDER OR ANY VISCERA, WHICH MAY OCCUR DURING INTRODUCER NEEDLE PASSAGE, TRANSITORY IRRITATION AT THE OPERATIVE WOUND SITE, WHICH MAY ELICIT A FOREIGN BODY RESPONSE THAT LEADS TO INFLAMMATION, INFECTION, OR EROSION OF THE IMPLANT. PRECAUTIONS SECTION STATES THAT POST-OPERATIVELY THE PT IS RECOMMENDED TO REFRAIN FROM HEAVY LIFTING AND/OR EXERCISE (I.E., CYCLING, JOGGING) FOR AT LEAST THREE TO FOUR WEEKS AND INTERCOURSE FOR ONE MONTH. (B)(4).