As reported to coloplast, though not verified, legal representative stated the patient experienced dyspareunia, urinary urgency, frequency, stress urinary incontinence confirmed with urodynamics, menorrhagia, and intrinsic sphincter deficiency.Patient had a total laparoscopic hysterectomy for markedly enlarged fibroid uterus, bilateral salpingectomy, left ovarian cystectomy, uterosacral ligament vault colpopexy, ureterolysis (complete removal of unknown suburethral device), retropubic device urethropexy, and cystoscopy under general anesthesia.Interoperative findings noted the previously placed sling was very distally displaced and banded, estimated blood loss of 150 ml.Pathology report for explanted unknown vaginal wall device noted fibrosis and foreign body type reaction to birefringent foreign debris.Foreign body material gross examination noted a mesh-like white synthetic foreign object with attached membranous pink tissues, measuring 1.6 x 0.6 x 0.1 cm.
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Coloplast has not been provided any corroborating evidence to verify the information contained in this report.Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence.Should additional facts prompt us to alter or supplement any information or conclusions contained in the original mdr or in any prior supplemental reports, a follow-up report will be submitted.
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