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GYNEMESH PS Mesh Post Marketing Clinical Follow-Up Study

GYNEMESH PS Mesh Post Marketing Clinical Follow-Up Study

Recruiting
21 years and older
Female
Phase N/A

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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:

  1. Female subjects who had laparotomic or laparoscopic abdominal sacrocolpopexy, including robotic-assisted, for apical vaginal or uterine prolapse
  2. GYNEMESH PS Mesh was used as a bridging material according to the IFU.
  3. Able and willing to participate in follow-up
  4. 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:

  1. Subjects < 21 years of age at the time of informed consent
  2. Subjects who had transvaginal approach for surgery
  3. Had undergone a uterus-sparing procedure (sacrohystero or sacrocervicopexy)

Study details
    Pelvic Organ Prolapse

NCT04829058

Ethicon, Inc.

18 August 2025

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