Abstract
Introduction and hypothesis
We sought to examine the change in utilization of the midurethral sling (MUS) for the treatment of stress urinary incontinence (SUI) after the 2011 US FDA communication regarding transvaginal mesh.
Methods
This is a retrospective cohort study evaluating surgical utilization of MUS at a managed care organization of 4.5 million patients from 2008 to 2016. The primary outcome was the change in utilization of synthetic mesh MUS before and after the July 2011 FDA communication. Secondary outcomes were the changes in surgeon level MUS utilization.
Results
MUS procedures decreased from 131 to 116 per 100,000 adult women with a decrease of 11.5% from 2010 to 2012. Year over year utilization of MUS was rapidly increasing (p < 0.01) prior the FDA communication from 116 (in 2008) to 131 (in 2010) per 100,000 women and then significantly declined (p < 0.01) after its release from 135 (in 2011) to 75 (in 2016) per 100,000 women (13% increase vs 44% decrease). The number of surgeons performing MUS increased (p < 0.01) from 172/year to 186/year from 2008 to 2010 (Table 1). This decreased (p < 0.01) from 183/year to 121/year from 2011 to 2016.
Conclusions
MUS for SUI drastically declined after the FDA communication. Despite the 2011 FDA communication concerning only transvaginal mesh for pelvic organ prolapse, there was a significant decrease in MUS with synthetic mesh utilization. Our findings support the importance of continued long-term outcome data regarding the safety and efficacy of MUS and highlight the impact of the FDA warning on MUS utilization.
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References
Ford AA, Rogerson L, Cody JD, Aluko P, Ogah JA. Mid-urethral sling operations for stress urinary incontinence in women. Cochrane Database Syst Rev. 2017;2017(7). https://doi.org/10.1002/14651858.CD006375.pub4.
Considerations about Surgical Mesh for SUI | FDA. https://www.fda.gov/medical-devices/urogynecologic-surgical-mesh-implants/considerations-about-surgical-mesh-sui. Accessed August 2, 2020.
Berger AA, Tan-Kim J, Menefee SA. Long-term risk of reoperation after synthetic mesh midurethral sling surgery for stress urinary incontinence. Obstet Gynecol. 2019;134(5):1047–55. https://doi.org/10.1097/AOG.0000000000003526.
Position Statement. www.acog.org. Accessed August 2, 2020.
Koski ME, Chamberlain J, Rosoff J, et al. Patient perception of transvaginal mesh and the media. Urology. 2014;84(3):575–82. https://doi.org/10.1016/j.urology.2014.03.051.
Nager CW. Midurethral slings: evidence-based medicine vs the medicolegal system. Am J Obstet Gynecol. 2016;214(6):708.e1–5. https://doi.org/10.1016/j.ajog.2016.04.018.
Rogo-Gupta L, Litwin MS, Saigal CS, Anger JT. Trends in the surgical management of stress urinary incontinence among female medicare beneficiaries, 2002-2007. Urology. 2013;82(1):38–42. https://doi.org/10.1016/j.urology.2012.10.087.
Funk MJ, Levin PJ, Wu JM. Trends in the surgical management of stress urinary incontinence. Obstet Gynecol. 2012;119(4):845–51. https://doi.org/10.1097/AOG.0b013e31824b2e3e.
Anger JT, Weinberg AE, Albo ME, et al. Trends in surgical management of stress urinary incontinence among female Medicare beneficiaries. Urology. 2009;74(2):283–7. https://doi.org/10.1016/j.urology.2009.02.011.
Souders CP, Eilber KS, McClelland L, et al. The truth behind transvaginal mesh litigation: devices, timelines, and provider characteristics. Female Pelvic Med Reconstr Surg. 2018;24(1):21–5. https://doi.org/10.1097/SPV.0000000000000433.
Tenggardjaja CF, Moore CK, Vasavada SP, Li J, Goldman HB. Evaluation of patients’ perceptions of mesh usage in female pelvic medicine and reconstructive surgery. Urology. 2015;85(2):326–32. https://doi.org/10.1016/j.urology.2014.08.058.
Palmerola R, Peyronnet B, Rebolos M, et al. Trends in stress urinary incontinence surgery at a tertiary center: Midurethral sling use following the AUGS/SUFU position statement. Urology. 2019;131:71–6. https://doi.org/10.1016/j.urology.2019.04.050.
Brown J, King J. Age-stratified trends in 20 years of stress incontinence surgery in Australia. Aust N Z J Obstet Gynaecol. 2016;56(2):192–8. https://doi.org/10.1111/ajo.12445.
Clemons JL, Weinstein M, Guess MK, et al. Impact of the 2011 FDA transvaginal mesh safety update on AUGS members’ use of synthetic mesh and biologic grafts in pelvic reconstructive surgery. Female Pelvic Med Reconstr Surg. 2013;19(4):191–8. https://doi.org/10.1097/SPV.0b013e31829099c1.
Acknowledgments
The research is supported by a grant from the Regional Research Committee of Kaiser Permanente Southern California, grant no. KP-RRC-20171101. The authors thank Stephanie Tovar for her coordination of support and resources at the regional research committee. The authors thank Zoe Li for her assistance with data management. The authors thank Liz Walton-Paxton and her team for assistance with mesh implant registry applications.
Funding
The research is supported by a grant from the Regional Research Committee of Kaiser Permanente Southern California, grant no. KP-RRC-20171101.
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This work was presented at the International Continence Society Annual Meeting Gothenberg, Sweden, September 2019, and the American Urogynecologic Society Annual Scientific Meeting Chicago, IL, October 2018.
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Berger, A.A., Tan-Kim, J. & Menefee, S.A. The impact of the 2011 US Food and Drug Administration transvaginal mesh communication on utilization of synthetic mid-urethral sling procedures. Int Urogynecol J 32, 2227–2231 (2021). https://doi.org/10.1007/s00192-020-04597-7
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DOI: https://doi.org/10.1007/s00192-020-04597-7