It was reported to boston scientific corporation that a xenform was implanted during a pelvic floor reconstruction with xenform including cystocele repair procedure performed on (b)(6) 2015.
The procedure was completed without complications.
According to the complainant, the patient experienced sensation of bulge related to the posterior and apical vaginal compartments on (b)(6) 2015.
A pessary was placed to treat the event on (b)(6) 2015 and (b)(6) 2015, and was subsequently removed on (b)(6) 2015 and (b)(6) 2015.
On (b)(6) 2015, the patient underwent retreatment for prolapse including laparoscopic total hysterectomy, apical vault suspension, rectocele repair, and enterocele repair with xenform graft.
During the procedure it was noted that there were severe left hemipelvic adhesions encompassing the left adnexal strictures including ovary and tube, creating significant scar tissue that the left ovary and tube were barely visible.
The event resolved on (b)(6) 2015 and the patient was discharged on the same day.
The event was assessed as probably related to the index procedure, and probably related to the study device.
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