The sample was not returned.The finished product met all specifications prior to being released for general distribution.The instructions for use which accompanies all devices currently addresses potential risks associated with surgically implanted materials.The instructions for use states in the adverse events: ¿complications associated with the proper implantation of the avaulta solo¿ synthetic support may include, but are not limited to those typically associated with surgically implantable materials, including: postoperative hematoma, seroma, abscess or fistula formation, or scarring which may occur following the implant procedure.Urinary retention, bladder outlet obstruction and other voiding and defecatory dysfunctions.These conditions may be associated with over-correction/too much tension placed on the implant.Perforations or lacerations of vessels, nerves, bladder, bowel, urethra, rectum, or any viscera, which may occur during the implantation procedure.Irritation at the operative wound site which may elicit a foreign body response that leads to wound dehiscence, inflammation and/or infection.Extrusion through vaginal epithelium or erosion into surrounding viscera and/or mucosa.Inflammation, sensitization, pain, dyspareunia, scarification, contraction, device migration and failure of the procedure resulting in recurrence of vaginal wall prolapse.Urinary incontinence (stress and urge)." (b)(4).
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The patient's attorney alleged a deficiency against the device.Per additional information received, the patient has experienced vaginal irritation, chronic vaginal discharge, odor and itching, vaginitis, vulvovaginitis, genital culture with heavy growth of e.Coli, serous drainage, chronic anterior mesh exposure, recurrent cystocele, recurrent rectocele, vaginal infection, dyspareunia, pain deep in vagina, chronic infection, recurrent prolapse, nocturia, difficulty starting stream, slow or weak stream, wear pads all the time, difficulty emptying rectum, alternating constipation and diarrhea, difficulty voiding, vaginal bleeding after sex, vaginal pressure, palpable bulge at introitus, urogenital atrophy, granulation tissue at left vaginal sulcus, blood in urine [hematuria], mesh erosion, chronic pelvic pain, pelvic pressure, sensation of incomplete bladder emptying, mild trabeculations, descent of uterus, left-sided perforation of the dome of the bladder during mesh and sling placement on ((b)(6) 2012), vaginal scarring, stress incontinence, urinary frequency, urgency and required multiple surgical and nonsurgical interventions.
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