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." device evaluated by manufacturer?: sample not received.
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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 blood loss, vaginal mesh and left anterior graft erosion, dyspareunia, pain with palpation of anterior and posterior apical arms, tenderness posteriorly near the introitus at palpation of the mesh, granulation tissue, pelvic pain, left posterior graft constriction and constriction band, urinary tract infection, (b)(6) (bacterial infection), pyelonephritis, back pain, graft had grown into the surrounding tissue and became very fibrotic (fibrosis, foreign body in patient), failed graft (failure of implant), extrusion, unspecified urinary problems, unspecified bowel problems, unspecified neuromuscular problems, vaginal scarring, abdominal pain, painful intercourse, vaginal bleeding, scar tissue, recurrence, stress urinary incontinence, migration, mild ecchymosis on bilateral gluteal regions, anemia, dehydration, persistent headache, reflux symptoms, inability to void, foley replacement, urinary retention, neurogenic pain, buttocks pain, vaginal pain, hematuria, urgency, low back pain, right leg pain, cystitis and pyelonephritis, back problems and tenderness, mild diffuse bladder wall thickening, graft erosion, revision of anterior graft, revision of posterior graft, (b)(6) vaginal infection, discomfort in the vaginal area, placement of peripherally inserted central catheter, dyspareunia, vaginal mesh erosion with revision of transvaginal mesh, multiple non surgical and surgical interventions.
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