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.
|
As reported to coloplast, though not verified, the patient with this device experienced dyspareunia, groin pain, thigh pain, vaginal pain, painful bladder filling and recurring urinary tract infections.Underwent conservative treatment.The surgical mesh was removed (b)(6) 2021.During the explant, the physician noted vaginal, bladder and urethral scarring, found the mesh from the aris sling implanted deeply in the muscles of the groin, and noted that the mesh was at the bladder neck deformed and folded in orientation.The patient continues to experience problems including groin pain, pelvic pain, extrapelvic pain, thigh pain, vaginal pain, painful intercourse and urinary problems.
|