Overview
The objective of this retrospective and prospective, single-arm, observational, multicenter, post-market study is to evaluate outcomes in women who underwent surgery for vaginal or uterine prolapse with a GYNEMESH PS Mesh.
Eligibility
Inclusion Criteria:
Subjects who satisfy all of the following criteria will be considered eligible for enrollment in this study:
- Female subjects who had laparotomic or laparoscopic abdominal sacrocolpopexy, including robotic-assisted, for apical vaginal or uterine prolapse
- GYNEMESH PS Mesh was used as a bridging material according to the IFU.
- Able and willing to participate in follow-up
- Subject or authorized representative has signed the approved informed consent
Exclusion Criteria
Subjects meeting any of the following criteria will be considered not eligible for enrollment in this study:
- Subjects < 21 years of age at the time of informed consent
- Subjects who had transvaginal approach for surgery
- Had undergone a uterus-sparing procedure (sacrohystero or sacrocervicopexy)