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Despite the fact that thousands of women continue to suffer as a result of TVM, the FDA has yet to recall the product, and surgeons may continue to use the product in surgeries. But due to the massive number of complaints that the FDA was receiving, it undertook a systematic review of the scientific literature to evaluate whether or not TVM was safe and effective. The review revealed the following:
The FDA has noted a five-fold increase in deaths, injuries, or malfunctions tied to vaginal mesh for prolapsed organs, leading to an advisory panel pushing the FDA to classify transvaginal mesh as a high-risk device needing human testing.
On January 4, 2012, the FDA released a safety update based on an assessment of Medical Device Reports, also known as Adverse Event Reports (AERs) submitted to the FDA, evaluation of the published literature, and the September 2011 ObGyn Devices Panel meeting. This indicated that the FDA is considering reclassifying urogynecologic surgical mesh used for transvaginal mesh repair of pelvic organ prolapse (POP).
Moreover, the FDA indicated that it would continue to investigate defective surgical mesh, by: