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 information 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.Coloplast has not been provided any corroborating evidence to verify the information contained in this report.
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As reported to coloplast, though not verified, the patient experienced serious bodily injuries, including but not limited to: foreign body reaction, chronic inflammation, excessive scarring, contraction, erosion, dysuria, bladder pain, pelvic pain, dypareunia, and other injuries.Cystocele was also reported.Physical exam revealed erosion of the altis midurethral sling, protruding from the vaginal epithelium.Transvaginal excision of the eroded vaginal mesh, anterior colporrhaphy, and cystoscopy under general anesthesis took place.
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