The purpose of this clinical investigation is to collect clinical data about the ProGYNious Mesh based on a prospective clinical investigation. The primary objective is to verify the treatment outcome and success of the ProGYNious mesh implant in pelvic organ prolapse repair. The secondary objective is to confirm the safety, risks, complications and quality of life of ProGYNious as an implant for pelvic organ prolapse repair.
Subject is a candidate for surgical repair of pelvic organ prolapse by ProGYNious implant according to the indication of the product under evaluation
Symptomatic pelvic organ prolapse with POP-Q >= 2
Age >18 years and ≤ 80years
Subject is willing and able to cooperate with follow-up examinations
previous or concurrent cancer which may affect the successful treament with laparoscopic mesh
known or suspected hypersensitivity to ProGYNious mesh or a component of ProGYNious mesh (Polypropylene)
known severe osteoporosis
pregnancy, suspected pregnancy and breastfeeding
A.M.I. Agency for Medical Innovations GmbH
Lead sponsor