As reported to coloplast though not verified, patient's legal representative stated severe pain, vaginal prolapse, urinary incontinence, physical deformity, the loss of the ability to perform sexually, serious and permanent physical and emotional injuries, erosion of the vaginal wall and other tissues, infection, permanent and substantial physical deformity.
A revision surgery occurred to excise and remove a portion of the restorelle mesh.
Patient also had restorelle directfix anterior and altis single incision sling system reported under 2125050-2020-00705 and 2125050-2020-00706.
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