This event was previously reported to the fda on an alternative summary report (asr approval #: e2013038) which is no longer in effect.
Because of additionally received complaint information, this and all further updates will be submitted through the 3500a form.
If information is provided in the future, a supplemental report will be issued.
|
The patient¿s attorney alleged a deficiency against the device.
The product was used for therapeutic treatment of stress urinary incontinence.
It was reported that after implant, the patient experienced recurrence, pelvic pain, dyspareunia, abnormal uterine bleeding, adhesions, urethral hypermobility and intrinsic sphincter deficiency, defecatory disorder secondary to rectocele, left bartholin gland inflammation, and vaginal scar tissue.
Post-operative patient treatment included video urodynamic evaluation including noninvasive uroflowmetry, cystometrogram, sphincteric emg monitoring, abdominal leak point pressure measurement, pressure flow urodynamics, urethrocystography and video imaging, a transobturator mesh revision and cystoscopy, pubovaginal sling with align retropubic urethral support system, cystoscopy, and posterior colpoperineorrhaphy, an examination under anesthesia, excision of mesh on the left lateral wall of the vagina and left obturator space, excision of left inflamed bartholin gland, and cystoscopy, and laparoscopy with lysis of adhesions.
|