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:
- When surgical mesh is used in pelvic organ prolapse surgeries, the patient is subjected to additional risks that she would not be at risk for if traditional stitches were used
- Transvaginal placement of mesh leads to higher problem rates than mesh placed abdominally
- Most transvaginal mesh surgeries provide no additional benefit to traditional surgeries
- Even when the transvaginal surgical repair provides better anatomic results, the patient may still suffer more serious and painful symptoms
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:
- Review and analysis of published literature, Medical Device Reports (adverse event reports) submitted to the agency, and post-approval study reports.
- Epidemiological research on safety and effectiveness of surgical mesh, as a part of the FDA’s effort to more clearly understand the possible adverse events linked to surgical mesh for Stress Urinary Incontinence (SUI) and Pelvic Organ Prolapse (POP).
- Collaborations between professional societies and other key opinion leaders to fully comprehend the post-market performance of vaginal surgical mesh devices, as well as the occurrence of and signals and symptoms associated with specific adverse events.
- Collecting and reviewing all available information and marketing data about urogynecologic surgical mesh devices sold in the United States.
- Mandating postmarket surveillance studies (“522 studies”) by manufacturers of urogynecologic surgical mesh devices. On January 03, 2012, the FDA issued 88 postmarket study orders to thirty three different manufacturers of urogynecologic surgical mesh for Pelvic Organ Prolapse and 11 postmarket study orders to seven different manufacturers of single-incision mini-slings for Stress Urinary Incontinence.