- In April 2024, the U.S. FDA completed its evaluation of “522 studies” on stress urinary incontinence mini-slings, confirming comparable effectiveness and safety to traditional mid‑urethral slings over a 36-month follow‑up period. This milestone underscores ongoing regulatory scrutiny aimed at ensuring mesh safety and boosting patient confidence
- In April 2019, the FDA has enforced a ban on surgical mesh for transvaginal repair of pelvic organ prolapse. Following a 2016 device reclassification to Class III (high-risk), major manufacturers such as Boston Scientific, Coloplast, and Ethicon ceased distribution in the U.S. due to concerns over safety and efficacy
- In January 2024, the FDA continues to monitor and analyze adverse event reports and postmarket data for urogynecologic surgical mesh. Its epidemiological reviews and literature assessments ensure ongoing benefits outweigh risks
- In April, 2019 marks the official FDA mandate requiring manufacturers to stop selling all mesh devices for transvaginal POP repair, following an advisory committee’s recommendation. Data demonstrated increased risks of mesh exposure and erosion compared to native tissue repair
