Mesh use by month and year is represented by dots, with the black dots representing periods before and orange dots representing periods after the latest set of US Food and Drug Administration (FDA) transvaginal pelvic organ prolapse mesh regulatory statements. The lines represent linear regression estimates of mesh use, fit separately for preregulatory and postregulatory cohorts. The period between the 2 FDA regulatory statements (August 2018-March 2019) is represented by shading and was excluded from comparison.
eAppendix. Current Procedural Terminology Codes for Selected Surgical Procedures
eMethods. Rate of Transvaginal Mesh Repair
eTable. Descriptive Analysis for Mesh Use
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Lewicki P, Brant A, Basourakos SP, Qiu Y, Chughtai B, Shoag JE. Patterns in Transvaginal Mesh Surgery After Government Regulation in the United States. JAMA Surg. 2022;157(6):542–543. doi:10.1001/jamasurg.2022.0663
Reports of adverse events from transvaginal mesh for pelvic organ prolapse (POP) repair have prompted study and regulation over the past decade.1 In July 2018 and April 2019, the US Food and Drug Administration (FDA) prohibited sale and distribution of mesh designed for transvaginal repair of posterior and anterior compartment prolapse.2,3 Nonetheless, transvaginal mesh repair of POP remains a treatment option, with qualified recommendations for use,4 and the procedure itself is not banned. We estimated implications of FDA regulation for transvaginal mesh POP repair in a large, national sample and explored surgeon characteristics associated with its continued use.
In this case series study, Premier Healthcare Database, an all-payer, hospital-based sample, was queried for POP procedures using Current Procedural Terminology (CPT) codes (eAppendix in the Supplement) from September 2017 to July 2018 (before the first FDA regulation) and from April 2019 to February 2020 (after the second regulation). As the CPT code for transvaginal POP mesh does not distinguish anterior from posterior compartment repairs, repairs occurring in the months between regulatory statements were excluded. The University Hospital Cleveland Medical Center Institutional Review Board deemed the study exempt from review and waived the consent requirement because the study did not constitute human participant research. The study followed the PROCESS reporting guideline for case series.
Patient- and surgeon-level variables were extracted. Index vs revision repair was defined as first vs subsequent surgery for POP in the previous 5 years. Surgeon volume was calculated as number of POP surgeries per month, with patients grouped into quintiles based on surgeon operative volume (eMethods in the Supplement).
Rate of transvaginal mesh repair of POP was calculated as the proportion of all POP repairs performed with transvaginal mesh. Adjusted odds ratio (OR) of mesh receipt after (vs before) FDA regulation was calculated using a mixed-effects logistic regression model, adjusting for continuous change in mesh use during the study period to best estimate the impact of the latest regulation. Because surgeon characteristics and expertise may alter transvaginal POP mesh use, differential impact of surgeon volume and academic affiliation was investigated through an interaction term (eMethods and eTable in the Supplement). Analysis was conducted using R, version 4.0.2, with 2-sided significance of α = 0.05.
The cohort consisted of 54 037 POP repairs during the study period, representing an estimated 12% of such repairs performed throughout the US during a similar time period.5 Forty-five percent of surgeries were performed at academic centers, and 6% involved transvaginal mesh.
Transvaginal mesh repair for POP decreased significantly after FDA regulation (Figure). Patients undergoing POP surgery after regulation were 29% less likely to receive mesh vs before regulation (OR, 0.71; 95% CI, 0.53-0.95; P = .023).
Change in mesh use after FDA regulation differed significantly between academic vs nonacademic centers (Table). Although a decrease in mesh use was observed across all surgical volume quintiles, ORs suggest an association between higher surgical volume and postregulation mesh use (Table). After regulation, mesh POP repairs were significantly more likely to be revision procedures than before regulation (4.3% vs 2.5%, P < .001).
Although rates of transvaginal mesh POP repair decreased after FDA regulation, academic surgeons used mesh at an unchanged rate. Surgeon volume also likely shaped postregulation mesh use. Furthermore, the proportion of mesh POP repairs that were revision procedures increased after the most recent FDA regulation. These observations might have been a consequence of shifting indications from primary repairs to complex, repeat procedures or a reflection of confidence among expert surgeons.
Study limitations include reliance on CPT codes, which may propagate error. Information on index repairs outside the data set is not captured and likely contributes to an underestimate of revision repairs.
The results highlight the implications of unprecedented FDA regulations on a surgical device, and the subsequent changes in practice patterns might guide future device regulations. Further study is needed to explore whether such measures are associated with improved population-level outcomes.
Accepted for Publication: January 16, 2022.
Published Online: April 13, 2022. doi:10.1001/jamasurg.2022.0663
Corresponding Author: Jonathan E. Shoag, MD, Department of Urology, Case Western Reserve University School of Medicine, 2103 Cornell Rd, Wolstein Research Building 4541, Cleveland, OH 44106 (firstname.lastname@example.org).
Author Contributions: Dr Shoag had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.
Concept and design: Lewicki, Chughtai, Shoag.
Acquisition, analysis, or interpretation of data: Lewicki, Brant, Basourakos, Qiu, Shoag.
Drafting of the manuscript: Lewicki, Basourakos, Chughtai, Shoag.
Critical revision of the manuscript for important intellectual content: Lewicki, Brant, Basourakos, Qiu, Shoag.
Statistical analysis: Lewicki, Brant, Qiu.
Administrative, technical, or material support: Lewicki, Basourakos, Chughtai.
Supervision: Chughtai, Shoag.
Conflict of Interest Disclosures: Dr Shoag reported receiving grants from the Bristol Myers Squibb Foundation and the Damon Runyon Cancer Research Foundation during the conduct of the study and receiving support from the Frederick J. and Theresa Dow Foundation of the New York Community Trust, Vinney Scholars Award, and a Damon Runyon Cancer Research Foundation Physician Scientist Training Award. No other disclosures were reported.