Temporal Trends of Urogynecologic Mesh Reports to the U.S. Food and Drug Administration

Jessica C Sassani, Amanda M Artsen, Pamela A Moalli, Megan S Bradley, Jessica C Sassani, Amanda M Artsen, Pamela A Moalli, Megan S Bradley

Abstract

Objective: To compare temporal trends of urogynecologic mesh medical device reports with sentinel U.S. Food and Drug Administration (FDA) notices and to examine all linked reports of patient death.

Methods: The Reed Tech Navigator is an online tool used to extract and analyze data in the Manufacturer and User Facility Device Experience database. We used FDA product codes to search for reports of synthetic mesh for stress urinary incontinence (SUI) and pelvic organ prolapse (POP). Reports with "death" listed as a patient event were queried further.

Results: There were 43,970 medical device reports involving urogynecologic mesh reported to the FDA between August 2000 and January 2019, with most occurring after the 2011 FDA communication (n=43,018, 97.8%). Of these medical device reports, 64.6% (n=28,422) were for SUI products, 27.0% (n=11,876) were for transvaginal POP products, and 8.4% (n=3,672) were for transabdominal POP products. Peak reporting occurred in 2013, which corresponded with the first major plaintiff verdicts and class action vaginal mesh settlement. There were 645 (1.5%) medical device reports of death, with 49.3% (n=318) having no cause of death identified. Only four (0.6%) could be directly attributed to the initial surgery.

Conclusion: Since 2011, urogynecologic mesh has been the focus of thousands of medical device reports annually, although the data submitted are often incomplete. Few reported deaths are directly attributable to mesh products, and the majority lack sufficient information to draw causal conclusions. A high-quality registry is necessary to improve our understanding of the patient effect from urogynecologic mesh products.

Figures

Fig. 1.
Fig. 1.
Adverse events by date and U.S. Food and Drug Administration (FDA) advisory reports. Sassani. Urogynecologic Mesh Reports to the FDA. Obstet Gynecol 2020.

References

    1. U.S. Food and Drug Administration. Urogynecologic surgical mesh: update on the safety and effectiveness of transvaginal placement for pelvic organ prolapse. 2011. Available at: . Retrieved July 26, 2019.
    1. Trabuco EC, Linder BJ, Klingele CJ, Occhino JA, Weaver AL, et al. Two-year results of Burch compared with midurethral sling with sacrocolpopexy: a randomized controlled trial. Obstet Gynecol 2018;131:31–8.
    1. Maher C, Feiner B, Baessler K, Schmid C. Surgical management of pelvic organ prolapse in women. The Cochrane Database of Systematic Reviews 2013, Issue 4. Art. No.: CD004014. DOI: 10.1002/14651858.CD004014.pub5.
    1. Sohlberg EM, Dallas KB, Weeks BT, Elliott CS, Rogo-Gupta L. Reoperation rates for pelvic organ prolapse repairs with biologic and synthetic grafts in a large population-based cohort. Int Urogynecol J 2019;31:291–301.
    1. Nygaard I, Brubaker L, Zyczynski HM, Richter H, Gantz M, et al. Long-term outcomes following abdominal sacrocolpopexy for pelvic organ prolapse. JAMA 2013;309:2016–24.
    1. Hammett J, Peters A, Trowbridge E, Hullfish K. Short-term surgical outcomes and characteristics of patients with mesh complications from pelvic organ prolapse and stress urinary incontinence surgery. Int Urogynecol J 2014;25:465–70.
    1. Liang R, Knight K, Abramowitch S, Moalli PA. Exploring the basic science of prolapse meshes. Curr Opin Obstet Gynecol 2016;28:413–9.
    1. Zhu LM, Schuster P, Klinge U. Mesh implants: an overview of crucial mesh parameters. World J Gastrointest Surg 2015;7:226–36.
    1. Linder BJ, Occhino JA, Habermann EB, Glasgow AE, Bews KA, Gershman B. A national contemporary analysis of perioperative outcomes of open versus minimally invasive sacrocolpopexy. J Urol 2018;200:862–7.
    1. U.S. Food and Drug Administration. Urogynecologic surgical mesh implants. 2019. Available at: . Retrieved August 8, 2019.
    1. Souders CP, Eilber KS, McClelland L, Souders AR, Steiner V, et al. The truth behind transvaginal mesh litigation: devices, timelines, and provider characteristics. Female Pelvic Med Reconstr Surg 2018;24:21–5.
    1. Perkins CE, Warrior K, Eilber KS, McClelland L, Anger JT. The role of mid-urethral slings in 2014: analysis of the impact of litigation on practice. Curr Bladder Dysfunct Rep 2015;10:39–45.
    1. Kirby AC, Luber KM, Menefee SA. An update on the current and future demand for care of pelvic floor disorders in the United States. Am J Obstet Gynecol 2013;209:584.e1–5.
    1. LexisNexis. Reed Tech Navigator for medical devices. Available at: . Retrieved March 21, 2020.
    1. Koski ME, Chamberlain J, Rosoff J, Vaughan T, Kaufman MR, Winters JC, et al. Patient perception of transvaginal mesh and the media. Urology 2014;84:575–82.
    1. Dessie SG, Hacker MR, Haviland MJ, Rosenblatt PL. Attitudes toward transvaginal mesh among patients in a urogynecology practice. Int Urogynecol J 2015;26:865–73.
    1. Holt E US FDA rules manufacturers to stop selling mesh devices. Lancet 2019;393:1686.
    1. Skorupska K, Rechberger T, Bogusiewicz M, Adamiak-Godlewska A, Kwiatkowska A, Miotla P. Current trends in urogynecological surgeries in Poland. Int Urogynecol J 2019. Jul 31 [Epub ahead of print].
    1. van IJsselmuiden MN, Detollenaere RJ, Kampen MY, Engberts MK, van Eijndhoven HW. Practice pattern variation in surgical management of pelvic organ prolapse and urinary incontinence in The Netherlands. Int Urogynecol J 2015;26:1649–56.
    1. Brown LK, Fenner DE, Berger MB, Delancey JOL, Morgan DM, Patel DA, et al. Defining patients knowledge and perceptions of vaginal mesh surgery. Female Pelvic Med Reconstr Surg 2013;19:282–7.
    1. American Urological Association. AUA position statement on the use of vaginal mesh for the surgical treatment of stress urinary incontinence. Available at: . Retrieved August 13, 2019.
    1. American Urogynecologic Society, Society for Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction. Position statement: mesh midurethral slings for stress urinary incontinence. Available at: . Retrieved March 21, 2020.
    1. Masoomi R, Lancaster E, Robinson A, Hacker E, Krajcer Z, Gupta K. Safety of EndoAnchors in real-world use: a report from the manufacturer and user facility device experience database. Vascular 2019;27:495–9.
    1. Khalid N, Javed H, Ahmad SA, Edelman JJ, Shlofmitz E, Chen Y, et al. Analysis of the Food and Drug Administration manufacturer and user facility device experience database for patient- and circuit-related adverse events involving extracorporeal membrane oxygenation. Cardiovasc Revasc Med 2019. Nov 20 [Epub ahead of print].
    1. Patel NH, Schulman AA, Bloom JB, Uppaluri N, Phillips JL, Konno S, et al. Device-related adverse events during percutaneous nephrolithotomy: review of the manufacturer and user facility device experience database. J Endourol 2017;31:1007–11.
    1. U.S. Food and Drug Administration. Manufacturer and user facility device experience database–(MAUDE). Available at: . Retrieved August 13, 2019.
    1. American Urogynecologic Society. PFD research registry. Available at: . Retrieved August 13, 2019.
    1. Sandberg JM, Gray I, Pearlman A, Terlecki RP. An evaluation of the manufacturer and user facility device experience database that inspired the United States Food and Drug administration’s reclassification of transvaginal mesh. Investig Clin Urol 2018;59:126–32.
    1. Kavanagh KT, Brown RE, Kraman SS, Calderon LE, Kavanagh SP. Reporter’s occupation and source of adverse device event reports contained in the FDA’s MAUDE database. Patient Relat Outcome Meas 2019;10:205–8.

Source: PubMed

赞助者和合作者

医疗条件

药物干预

3
订阅