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: 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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It was reported by the patient's attorney that as a result of having the product implanted, the patient has experienced injury, pain, disability and impairment.Per additional information received, the patient has experienced erosion, mesh protruding into vaginal wall, vaginal bleeding, pelvic pain, pain with intercourse, urinary tract infections, vaginal discharge, unspecified urinary problems, urinary retention, blood loss, urinary tract infection, discomfort, unspecified problems with sex life, cystocele/rectocele (prolapse), nonsurgical and additional surgical interventions.Per additional information received, the patient has experienced discomfort, left side pain, posterior vaginal mesh erosion, distal rectocele, stress incontinence with intrinsic sphincter deficiency, mesh contracture, bleeding, approximately 4-5 cm mesh was dissected.The patient required additional surgical interventions.
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