It was reported to boston scientific corporation that the patient had recurrent cystocele and recurrent vaginal vault prolapse.
She was implanted with a xenform device during a procedure for sacrospinous ligament fixation, with concomitant revision of a previously-implanted non-bsc mesh device.
As reported by the patient's attorney, on (b)(6) 2015, the patient underwent a procedure for cystocele repair with native tissue due to recurrent cystocele, recurrent infections, and incomplete bladder emptying.
Boston scientific has been unable to obtain additional information regarding the event to date.
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