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: ¿potential adverse reactions are those typically associated with surgically implantable materials, including hematoma, seroma, mucosal or visceral erosion, infection, inflammation, sensitization, dyspareunia, scarification and contraction, fistula formation, extrusion and recurrence of vaginal wall prolapse.Perforations or lacerations of vessels, nerves, bladder, bowel, rectum, or any viscera may occur during needle passage." (b)(4).
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The patient¿s attorney alleged a deficiency against the device.Additional information has been requested, but not yet received.Per additional information received, the patient has experienced blood loss, serratia marcescens in urine (bacterial infection), urinary tract infection, incomplete emptying, slow stream, urge frequency, hematuria, urinary frequency incontinence, constipation, interstitial cystitis (inflammation), cystocele (prolapse), pelvic/adnexal pain, atrophic vaginitis (inflammation), urge incontinence, urine urgency (urinary urgency), white blood cells found in urine, burning sensation during urination (dysuria), fever, chills, tender bladder, abdominal tenderness suprapubically, multiple bladder lavages, and required nonsurgical interventions.Per additional information received, the patient further experienced lesions, stress urinary incontinence, female, and required additional surgical interventions with revision of the mesh.
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