The sample was not returned.The lot number is unknown; therefore, the device history record could not be reviewed.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 a rectocele, vaginal bleeding, vaginal polyp, splinting with bowel movements, feelings of constant bulge, friable base at left vaginal apex, and an enterocele sac.She has required non-surgical interventions and one surgical intervention.
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