Mesh Debate Awareness Among Non-urogynecologists. A Practical Survey Study.
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Complication of Surgical Procedure
- Pelvic Organ Prolapse
- Urinary Incontinence
- Type
- Observational
- Design
- Observational Model: OtherTime Perspective: Other
Participation Requirements
- Age
- Between 30 years and 75 years
- Gender
- Both males and females
Description
There has been a great deal of discussion about mesh complications in urogynecology. During the following decade, vaginal mesh operations for pelvic organ prolapse increased exponentially all over the world, particularly in the United States. Once the complications started to increase, the publicati...
There has been a great deal of discussion about mesh complications in urogynecology. During the following decade, vaginal mesh operations for pelvic organ prolapse increased exponentially all over the world, particularly in the United States. Once the complications started to increase, the publication of mesh-related complications on social and broadcast media and the increase of medico-legal claims the United States led to an extensive FDA (Food and Drug Administration) restriction on vaginal mesh procedures in 2013. On January 5, 2016, the FDA reclassified surgical mesh for transvaginal repair of the pelvic organ prolapse into class III, which require premarket approval. Finally, on April 16, 2019, the FDA ordered all manufacturers of urogynecological mesh intended for transvaginal repair to stop selling and distributing their products immediately. However, awareness of the other doctors in branches of medicine outside of gynecology and urology is unknown.
Tracking Information
- NCT #
- NCT04010162
- Collaborators
- King's College Hospital NHS Trust
- Investigators
- Study Director: Kemal Ozerkan, M.D. Uludag University