Vaginal Mesh for Pelvic Organ Prolapse After FDA Recommendations
It is known by many of us that the FDA has recommended to withdraw mesh products for pelvic organ prolapse (POP) since April 20191. This order was not pertained to mesh used for stress urinary incontinence (SUI) or to the transabdominal mesh for POP (eg. sacrocolpopexy). However, most of the medical device reports to FDA from 2000 to 2019 were for SUI products (64.6%) and 1.5% evolved to death, with four of these directly attributed to the initial surgery2. This correlates with the percentage of lawsuits on mesh litigations more focused on SUI than on prolapse3. Moreover, media coverage of these materials did not accurately or thoroughly distinguish the type of mesh discussed4.
These events that occurred in the US were just a reflection on what has happened worldwide regarding the mesh use and raised the discussion about what could have been prevented during the steps for allowing the use of mesh products. A combination of a firm understanding of the biomechanical properties of the vaginal, surgical skills, and patient selection justifies the application of these points plus informed consent and more high-quality research for pelvic organ prolapse5. For slings, we have lots of data – and the support of several societies – regarding the efficacy and safety of the procedure. But now, we need to strengthen data on pelvic organ prolapse, and to understand that we, as physicians, have the power to provide good education and knowledge to our patients. Maybe social media can be a useful tool in this regard if we know how to use it well. Studies focused on patient outcomes are needed.
Although this history is about mesh within POP, the final lesson can be extended to other technologies that are being considered/used as treatment within urogynecology, such as laser and radiofrequency for urinary incontinence, vaginal laxity, genitourinary syndrome of menopause; they also need powered, well-designed, prospective randomized studies to show their role on managing these diseases.
1 – FDA´s activities: urogynecologic surgical mesh. Accessed in Dec 28 2020. https://www.fda.gov/medical-devices/urogynecologic-surgical-mesh-implants/fdas-activities-urogynecologic-surgical-mesh
2 – Sassani JC, Artsen AM, Moalli PA, Bradley MS. Temporal trends of urogynecologic mesh reports to the U.S. Food and Drug Administration. Obstet Gynecol 2020;135(5):1084-1090.
3 – Soulders CP, Eilber SK, McClelland L, Wood LN, Souders AR, Steiner V, Anger JT. The truh behind transvaginal mesh litigation: devices, timelines, and provider characteristics
4 – Shoureshi PS, Lee W, Kobashi KC, Sajadi KP. Media coverage of the 2019 United States Food and Drug Administration ordered withdrawal of vaginal mesh products for pelvic organ prolapse. Int Urogynecol J 2020; https://doi.org/10.1007/s00192-020-04401-6
5 – Karmakar D, Hayward L. What can we learn from the vaginal mesh story? Climacteric 2019;22(3):277-282.