As reported to coloplast, though not verified, legal representative stated the patient with this device experienced pelvic pressure, vaginal bulge, frequent constipation, chronic pain, pelvic pain, abdominal pain, weight loss, loss of appetite, nausea, diarrhea, vaginal pain, spotting, vaginal discomfort, foreign object under the vagina, ongoing pelvic discomfort, discomfort in the lower abdomen, discomfort in suprapubic region, interstitial cystitis, pelvic fullness, bladder instillation, inconsistent voiding, self-catheterization, palpation consistent with residual device that was removed several years ago, dyspareunia, bleeding after intercourse, circumferential pain at the introitus, a small tear at the posterior aspect consistent with vulvar vestibulitis, poor wound healing, self-catheterization, pain below the urethra, tearing along the urethra, bleeding after intercourse, throbbing sensation in the pelvis, post-coital soreness, urinary hesitancy, vaginal injections in office, and post void residual volume.Patient had explantation of vaginal device, urethrolysis, posterior repair, and cystoscopy under general anesthesia.Patient had robotic assisted sacrocolpopexy with pelvic organ prolapse device, midurethral device from another manufacturer, lysis of adhesions and cystourethroscopy under general anesthesia.Patient had an abdominal and pelvic mri for possible device infection.Impressions noted postsurgical changes related to sacral colpopexy with mesh extending from the vaginal cuff to the left aspect of sacrum.No abnormal fluid signal / collection surrounding the device to suggest infection / inflammation and no pelvic fluid collection/abscess.Mild presacral edema, likely postsurgical.No acute abnormality is seen within the abdomen.Patient had a cystoscopy and laparoscopy under general anesthesia.Patient had harvest of fascia from abdomen for midurethral device from another manufacturer and explantation of midurethral device from another manufacturer under general anesthesia.Patient had abdominal wound separation with sutures placed in office.Patient passed the device out of the vagina and it was sent to pathology.The patient's doctor noted pictures she took of the device were consistent with the pelvic organ prolapse device.Pathology report noted a minute fragment of benign keratinized squamous epithelium.No dysplasia or malignancy identified, and 1 cm of translucent tissue.The pathologist thought that the material was part of a sponge or something else that was used to transport a fragment of epithelium.Patient had a pelvic ultrasound with transvaginal.Findings noted that with the residual small fragments of vaginal device in the anterior and posterior wall of the vagina as described with findings concerning protrusion into the lumen.
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