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 excessive amount of vaginal discharge as well as a small bulge of her posterior compartment of her vagina, mass extrusion at the anterior portion of vaginal cuff, 1 cm mesh extrusion on the anterior compartment, pain out of patient's right avaulta arm, mesh erosion, left lower quadrant pain, hematuria, painful intercourse as well as some tenderness in her vaginal region, detrusor instability, suspect interstitial cystitis, small erosion was noted at the 12 o'clock on mid urethral portion, granulation tissue, depression, anxiety, mesh exposure, scar tissue, pure hypercholesterolemia, mixed hyperlipidemia, chronic constipation, vaginal wall prolapse - chronic mesh exposure, headache, chest pain, abnormal glucose level, disorders of urogenital prostheses or implants, infective hepatitis immunization, incontinence with bladder spasms, nausea and constipation, dyspareunia, arthralgias/joint pain., vaginal wall prolapse, vaginal pain.The patient required additional corrective surgeries, and non-surgical interventions.
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