Patterns in Transvaginal Mesh Surgery After Government Regulation in the United States

Abstract

This case series examines whether the rate of transvaginal mesh repair of pelvic organ prolapse changed after US Food and Drug Administration prohibitions on the sale and distribution of the mesh.

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.

Methods

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.

Results

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).

Figure. Pelvic Organ Prolapse Repairs Performed With Mesh During Study Period .

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.

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).

Table. Mixed-Effects Logistic Regression Models Estimating Adjusted OR of Patient-Level Receipt of Transvaginal Mesh for Pelvic Organ Prolapse Repair After Regulations^a.

Characteristic	Mesh receipt after vs before regulation, adjusted OR (95% CI)	P value
		Adjusted OR	Interaction term
Total cohort	0.71 (0.53-0.95)b	.02b	NA
Surgeon volume (procedures/mo), quintilec
First (≥6.20)	0.66 (0.47-0.92)b	.01b	>.99
Second (≥2.94 to <6.20)	0.47 (0.34-0.66)b	<.001b
Third (≥1.42 to <2.94)	0.45 (0.32-0.64)b	<.001b
Fourth (≥0.57 to <1.42)	0.37 (0.25-0.53)b	<.001b
Fifth (<0.57)	0.39 (0.26-0.59)b	<.001b
Center affiliationc
Academic	0.93 (0.68-1.27)	.64	<.001b
Nonacademic	0.52 (0.38-0.71)b	<.001b

Abbreviations: NA, not applicable; OR, odds ratio.

^a Three separate models are represented, each containing terms for before regulation vs after regulation period and months from study initiation to account for continuous changes in mesh use over the entire study period.

^b Value met a predetermined level of statistical significance.

^c Subgroup ORs were ascertained using an interaction term for the variable and before and after the regulation time period, and the statistical significance of differences in ORs by subgroup was ascertained by analysis of variance (P value of interaction term in table).

Discussion

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.

Supplement.

eAppendix. Current Procedural Terminology Codes for Selected Surgical Procedures

eMethods. Rate of Transvaginal Mesh Repair

eTable. Descriptive Analysis for Mesh Use