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.Per additional information received, the patient has experienced pink discharge, pressure, mesh exposure, atrophic vaginitis, a bladder infection, grade two cystocele, and atrophy of rugae.She has required non-surgical interventions but no surgical interventions to date.
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