Abstract
Objective
To analyze utilization of, and payments for, pelvic organ prolapse procedures after the 2011 U.S. Food and Drug Administration (FDA) communication regarding transvaginal mesh.
Methods
This is a retrospective cohort study examining private claims from three insurance providers for inpatient and outpatient prolapse procedures from 2010 to 2013 in the Health Care Cost Institute. Primary outcomes were the change in utilization of prolapse procedures, with and without mesh, before and after the July 2011 FDA communication. Secondary outcomes were the changes in payments and reimbursements for these procedures. Utilization rates and payments were compared using generalized linear models and interrupted time series analysis.
Results
Utilization of prolapse procedures decreased from 12.3 to 9.7 per 10,000 woman-years (p=0.027), with a decrease of 30.7% (3.9 to 2.7 in 2013, p=0.05) in number of mesh procedures and 16.6% (8.4 to 7.0 in 2013, p=0.011) for non–mesh procedures. Quarterly utilization of mesh procedures was increasing prior to the FDA communication, then significantly declined after its release (slope=0.024 vs. −0.025, p=0.002). Non–mesh procedures, however, were already slightly decreasing prior to July 2011, and continued to decline at a more rapid pace after that time, although not significantly (slope=−0.004 vs −0.022, p= 0.47). Inpatient utilization decreased 52.2% (p=0.002), while outpatient utilization increased 18.5% (p=0.132). Payments for individual inpatient procedures, with and without mesh, increased by 12.0% ($8,315 in 2010 to $9,315 in 2013, p=0.001) and 15.6% ($7,826 in 2010 to $9,048 in 2013, p=0.005), respectively, while those for outpatient procedures increased by 41% ($4,961 in 2010 to $6,981 in 2013, p=0.006) and 30% ($3,955 in 2010 to $5,149 in 2013, p=0.004), respectively.
Conclusion
Use of prolapse surgery declined during the study period. After the 2011 FDA communication regarding trans-vaginal mesh there was a significant decrease in the utilization of procedures with mesh but not for those without mesh. A shift toward outpatient surgeries was observed, and payments for both individual inpatient and outpatient cases increased.
Introduction
The lifetime risk of surgery for pelvic organ prolapse (POP) is 12.6%.1,2 Given the aging population in the United States., Dieter et al. estimated that surgery rates for POP are to increase by 48% by 2050.3,4 Conversely, several studies have reported a decrease in POP procedures following the 2008 and 2011 U.S. Food and Drug Administration (FDA) Advisories regarding the use of mesh for prolapse.2,5–8 Studies examining POP procedures at a national level have focused on either inpatient or outpatient procedures alone, which may underestimate the true prevalence by failing to account for both settings.9–12 There are limited data assessing trends in utilization of both inpatient and outpatient surgeries for POP that span the time before and after the 2011 FDA Safety Advisory.
The Health Care Cost Institute is a non-profit organization that collects inpatient and outpatient claims data from three large commercial insurers across the United States. Our primary aim was to use this data to assess changes in surgical management of prolapse for inpatient and outpatient prolapse surgery, with and without mesh, between 2010 and 2013. Our secondary aim was to analyze changes in inpatient and outpatient hospital payments and patient cost share over time. We hypothesize that during the time of the FDA safety communication on vaginal mesh, procedures for prolapse with mesh decreased, but those without mesh remained stable. Due to the reduction in procedures with a graft, adjusted payments for these procedures are hypothesized to remain stable or decrease.
Materials and Methods
A retrospective cohort study was performed using data from the Health Care Cost Institute between January 1, 2010, and December 31, 2013. The institute includes private payer data from Aetna, Humana, and UnitedHealthCare, and is standardized using multiple quality control and validation checks, including an actuarial validation to ensure the data set is consistent with each insurer’s claims experience(http://www.healthcostinstitute.org). This study was a secondary data analysis and deemed “not regulated” by the University of Michigan Institutional Review Board (HUM0114432). Patients with employer-based insurance plans and those on the individual market were included. The geographical distribution and market share of these insurance providers by state is provided in Appendix 1, available online at http://links.lww.com/xxx. Inpatient and outpatient claims were analyzed to assess utilization and payment variation within each respective setting. Current Procedural Terminology (CPT) and International Statistical Classification of Disease, Ninth Revision (ICD-9) codes were used to identify procedures performed for prolapse, as well as to identify cases involving a graft or prosthesis (i.e., “mesh”) (Table 1). All concurrent prolapse repairs on the same day were counted as one procedure. An individual woman may have had more than one surgery on distinct dates during the study period which would be counted as separate procedures. The primary outcome was to assess the change in utilization of prolapse procedures, with and without mesh, before and after the July 2011 FDA safety communication. The secondary outcome was to assess the changes in payments and reimbursements for these procedures.
Table 1.
Prolapse ICD-9 and CPT codes
| Procedure | ICD-9 Procedure Codes | CPT Cocdes |
|---|---|---|
| Anterior vaginal wall | 70.51–Repair of cystocele | 57240–Anterior colporrhaphy |
| Posterior vaginal wall/perineum | 70.52–Repair of rectocele | 45560–Repair of rectocele 56810–Perineoplasty, repair of perineum 57210–Colpoperineorrhaphy 57250–Posterior colporrhaphy |
| Combined anterior & posterior repair | 70.50–Repair of cystocele and rectocele | 58260–Combined anteroposterior colporrhaphy |
| Colpopexy–vaginal | 70.77–Vaginal suspension and fixation 70.78–Vaginal suspension and fixation with graft or prosthesis |
57282–Colpopexy vaginal extraperitoneal approach (sacrospinous, iliococcygeus) 57283–Intraperitoneal approach (uterosacral, levator myorrhaphy) |
| Colpopexy–abdominal | 70.77–Vaginal suspension and fixation 70.78–Vaginal suspension and fixation with graft or prosthesis |
57425–Laparoscopic surgical colpopexy 58400–Uterine suspension with/without shortening of round ligaments 57280 Colpopexy abdominal approach |
| Obliterative procedure | 70.4–Obliteration and total excision of vagina, vaginal obliteration 70.8–Obliteration of vaginal vault |
57120–Colpocleisis (LeFort type) |
| Enterocele repair–abdominal | 70.92–Other operations on cul-de-sac 70.93–Other operations on cul-de-sac with graft or prosthesis |
57270–Repair of enterocele, abdominal approach |
| Enterocele repair–vaginal | 70.92–Other operations on cul-de-sac 70.93–Other operations on cul-de-sac with graft or prosthesis |
57265–With enterocele repair 57268–Repair of enterocele, vaginal approach |
| Paravaginal defect repair–abdominal | 57284–Paravaginal defect repair including repair of cystocele, abdominal approach 57423–Paravaginal defect repair, laparoscopic approach |
|
| Paravaginal defect repair–vaginal | 57285–Vaginal approach | |
| Other procedures | 70.61–Vaginal construction 70.62–Vaginal reconstruction 70.63–Vaginal construction with graft or prosthesis 70.64–Vaginal reconstruction with graft or prosthesis 70.79–Other repair of vagina 70.91–Other operations on vagina |
|
| Mesh/graft used | 70.53–Repair of cystocele and rectocele with graft or prosthesis 70.54–Repair of cystocele and rectocele with graft or prosthesis 70.55–Repair of rectocele with graft or prosthesis 70.63–Vaginal construction with graft or prosthesis 70.64–Vaginal reconstruction with graft or prosthesis 70.78–Vaginal suspension and fixation with graft or prosthesis 70.93–Other operations on cul-de-sac with graft or prosthesis 70.94–Insertion of biological graft 70.95–Insertion of synthetic graft or prosthesis |
57267–Insertion of mesh or other prosthesis for repair of pelvic floor defect 57425–Laparoscopic surgical colpopexy |
| Revision of mesh/graft | 57295–Revision of prosthetic vaginal graft 57426–Revision of prosthetic vaginal graft laparoscopic approach |
ICD-9: International Statistical Classification of Disease and Related Health Problems, Ninth Revision
CPT: Current Procedural Terminology, 4th Edition
Number of women enrolled per year, age, procedures of interest, and payment data were all obtained from the database. Inpatient and outpatient utilization was calculated both quarterly and per calendar year and was defined as the number of prolapse procedures performed per 10,000 woman-years. This was obtained by calculating the total number of inpatient, outpatient, and overall prolapse procedures divided by the total number of unique women that have at least one month of enrollment for the calendar year. Trends in utilization and payments for procedures in each year were analyzed using generalized mixed models. A multiple group, single intervention interrupted time series analysis using ordinary least squares regression was performed to compare the utilization rates of prolapse procedures with and without mesh prior to and following the FDA safety communication. P-values of <0.05 were considered significant.
Payments were analyzed for an episode of care—defined as all claims associated with a patient’s medical services between admission and discharge for their surgery. The patient’s portion of the payment—referred to as the patient cost share—included coinsurance (amount the patient pays for a specific service as defined by their benefit plan(s)), copayment (a fixed amount the member pays for a service as defined by their benefit plan(s)), and deductible (amount of money applied to the patient’s annual deductible if they did not reach maximum annual amount). The insurance payment is the amount reimbursed to the hospital and provider. Total hospital payment is the sum of the patient and the insurance payments. The average per-case patient cost share and insurance payment to the hospitals were calculated. All payments were adjusted for inflation to 2013 dollars using the Bureau of Labor Statistics Medical Consumer Price Index. Statistical analyses were performed using SAS software version 9.4 (SAS Institute Inc., Cary, NC, USA).
Results
The number of procedures performed for prolapse in 2010 was 31,787 and decreased by 19.6%, to 25,570, in 2013 (p=0.026). Utilization rates of prolapse procedures followed a similar trend, with a decrease of 21.1% between 2010 and 2013. The number of prolapse procedures both with and without mesh decreased, although the yearly decrease was almost two times as much for mesh procedures (30.7%, p=0.05 vs 16.6%, p=0.01, Table 2). Analysis of quarterly utilization rates reveals that prior to the FDA safety communication, the use of procedures with mesh was increasing, while utilization of procedures without mesh was decreasing (Figure 1). After the July 2011 FDA safety communication, utilization of procedures with mesh significantly declined (slope pre FDA=0.024 vs post FDA=−0.025, p=0.002). Utilization rates for procedures without mesh fell more rapidly after the July 2011 FDA safety communication but this change was not statistically significant (slope pre FDA=−0.004 vs. post FDA=−0.022, p=0.47).
Table 2.
Utilization and payments for prolapse procedures, Health Care Cost Institute, 2010-2013
| Comparison Variable | 2010 | 2011 | 2012 | 2013 | p-value |
|---|---|---|---|---|---|
| Enrolled women, n | 25,785,209 | 25,098,509 | 25,564,388 | 26,299,751 | |
| Prolapse procedures, n | 31,787 | 29,866 | 26,323 | 25,570 | 0.026 |
| Prolapse procedures with mesh, n | 10,039 | 9,453 | 7,323 | 7,046 | 0.045 |
| Prolapse procedures without mesh, n | 21,748 | 20,413 | 19,000 | 18,524 | 0.019 |
| Overall utilization, per 10,000 woman-years | 12.3 | 11.9 | 10.3 | 9.7 | 0.027 |
| Inpatient utilization, per 10,000 woman-years | 6.9 | 5.9 | 4.5 | 3.3 | 0.002 |
| Outpatient utilization, per 10,000 woman-years | 5.4 | 6.0 | 5.8 | 6.4 | 0.132 |
| Mesh utilization rate, per 10,000 woman-years | 3.9 | 3.8 | 2.9 | 2.7 | 0.050 |
| Non-mesh utilization rate, per 10,000 woman-years | 8.4 | 8.1 | 7.4 | 7.0 | 0.011 |
| Age, utilization per 10,000 woman-years | |||||
| ≤ 35 | 0.5 | 0.5 | 0.4 | 0.3 | 0.053 |
| 35-44 | 1.8 | 1.7 | 1.4 | 1.2 | 0.003 |
| 45-54 | 3.0 | 2.8 | 2.4 | 2.1 | 0.006 |
| 55-64 | 3.2 | 3.1 | 2.7 | 2.5 | 0.044 |
| ≥ 65 | 3.8 | 3.8 | 3.4 | 3.6 | 0.290 |
| Inpatient, % | 56.0 | 49.2 | 43.4 | 33.9 | 0.006 |
| Length of stay, days [95% CI] | 1 [0-2] | 1 [0-2] | 1 [0-2] | 1 [0-2] | 1.000 |
| Prolapse procedures, n (%) | |||||
| Anterior repair | 7,751 (24.4) | 6,973 (23.3) | 5,574 (21.2) | 5,225 (20.4) | 0.014 |
| Posterior repair | 6,736 (21.2) | 6,377 (21.4) | 5,784 (22) | 5,754 (22.5) | 0.017 |
| Combined anterior and posterior repair | 8,940 (28.1) | 8,112 (27.2) | 6,655 (25.3) | 6,138 (24) | 0.008 |
| Enterocele repair | 5,488 (17.3) | 4,715 (15.8) | 3,829 (14.5) | 3,412 (13.3) | 0.001 |
| Obliterative procedure | 800 (2.5) | 840 (2.8) | 891 (3.4) | 929 (3.6) | 0.017 |
| Colpopexy | 8,968 (28.2) | 9,245 (31) | 8,850 (33.6) | 9,453 (37) | 0.002 |
| Hysterectomy, n (%) | 12,103 (38.1) | 11,301 (37.8) | 10,652 (40.5) | 10,414 (40.7) | 0.118 |
| Vaginal | 6,623 (20.8) | 5,822 (19.5) | 5,078 (19.3) | 4,630 (18.1) | 0.031 |
| Laparoscopically assisted vaginal | 2,661 (8.4) | 2,365 (7.9) | 2,088 (7.9) | 1,927 (7.5) | 0.054 |
| Laparoscopic | 1,508 (4.7) | 2,005 (6.7) | 2,548 (9.7) | 3,066 (12) | 0.003 |
| Abdominal | 1,311 (4.1) | 1,109 (3.7) | 938 (3.6) | 791 (3.1) | 0.027 |
| Payments* | |||||
| Patient cost share, mean U.S. dollars ±SD | $592±842 | $606±902 | $650±983 | $674 | 0.017 |
| Insurance payment, mean U.S. dollars ±SD | $5758±6708 | $5911±6923 | $6055±6824 | $6,154 | 0.004 |
| Cost share + insurance payment, mean U.S. dollars | $6,350 | $6,517 | $6,705 | $6,828 | 0.003 |
| Total patient cost share, sum U.S. dollars | $18,815,137 | $18,098,657 | $17,114,007 | $17,239,659 | 0.074 |
| Total insurance payment, sum U.S. dollars | $183,019,632 | $176,523,362 | $159,384,088 | $157,358,223 | 0.041 |
| Total cost share + insurance payment, sum U.S. dollars | $201,834,768 | $194,622,019 | $176,498,095 | $174,597,882 | 0.041 |
Statistical analysis performed using generalized linear models
CI=confidence interval; SD=standard deviation
All cost share and payments are adjusted for inflation to 2013 dollars, using the Bureau of Labor Statistics Consumer Price Index
Figure 1.

Health care cost institute quarterly utilization of prolapse procedures with and without mesh before and after the July 2011 U.S. Food and Drug Administration (FDA) safety communication on mesh. The orange bar represents the FDA safety communication on transvaginal mesh, issued in July 2011. Q1, January 1–March 31; Q2, April 1–June 30; Q3, July 1–September 30; Q4, October 1–December 31.
Table 2 is a comparison of yearly enrollment, age of enrollees, and utilization of prolapse procedures over the study period. Overall, utilization of prolapse procedures was highest among patients over age 65, which remained stable, and utilization decreased in all other age groups over time. In evaluating procedure types, combined anterior and posterior repair decreased by 31.3% (p=0.008), vaginal and abdominal colpopexy procedures increased by 5.4% (p=0.002), and obliterative procedures increased by 1.6% (p=0.017). Overall, the number of hysterectomies performed for POP was relatively stable over the time period; however, laparoscopic cases more than doubled (p=0.003), while those done vaginally decreased by 34% (p=0.031). Utilization of inpatient procedures decreased by 52.2% (p=0.002) and outpatient procedures increased by 18.5% (p=0.132). Length of stay remained unchanged.
Figure 2 shows changes in hospital payments for individual prolapse procedures by year. Patient cost share and insurance payments were higher for inpatient procedures, both with and without mesh. After adjustment to 2013 dollars, mean hospital payment (patient and insurance portion) for individual inpatient procedures increased by 12.0% for inpatient procedures with mesh ($8,315 in 2010 vs. $9,315 in 2013, p=0.001) and by 15.6% for those without mesh ($7,826 in 2010 vs. $9,048 in 2013, p=0.005). The majority of this increase was driven by increases in the insurance payment, as patient cost share remained relatively stable ($681-$707 for procedures with mesh, $710–$772 for procedures without mesh). In the outpatient setting, total hospital payment increased by 40.7% for procedures with mesh ($4,961 in 2010 vs. $6,981 in 2013, p=0.006) and by 30.2% for procedures without mesh ($3,955 in 2010 vs. $5,149 in 2013, p=0.004). Outpatient insurance payments increased by 40.8% for procedures with mesh ($4,490 in 2010 vs. $6,321 in 2013, p=0.011) and by 28.8% for procedures without mesh ($3,511 in 2010 vs. $4,522 in 2013, p=0.003). Patient cost share increased by 39.9% for procedures with mesh ($471 in 2010 vs. $659 in 2013, p=0.45) and by 41.2% for those without mesh ($444 in 2010 vs. $627 in 2013, p=0.16, Figure 2, Table 3).
Figure 2.

Patient and insurance payments for individual prolapse procedures by setting, 2010–2013. All payments adjusted to 2013 dollars using the Bureau of Labor Statistics Medical Consumer Price Index. Mesh includes prolapse procedures performed with mesh or graft implant. Nonmesh includes prolapse procedures performed without mesh or graft implant.
Table 3.
Payment for inpatient and outpatient procedures with and without mesh, 2010-2013
| Prolapse Procedures | 2010 | 2011 | 2012 | 2013 | p-value |
|---|---|---|---|---|---|
| Inpatient Procedures, n | 17,809 | 14,693 | 11,427 | 8,663 | 0.001 |
| Prolapse procedures, n | 6.9 | 5.9 | 4.5 | 3.3 | 0.002 |
| Utilization, per 10,000 woman-years | 5,609 | 4,569 | 3,171 | 2,396 | 0.005 |
| Prolapse with mesh, n | $681 | $707 | $704 | $687 | 0.848 |
| Patient cost share | $7,634 | $7,957 | $8,319 | $8,628 | <0.001 |
| Insurance payment | $8,315 | $8,664 | $9,024 | $9,315 | 0.001 |
| Total | 12,202 | 10,125 | 8,257 | 6,268 | <0.001 |
| Prolapse without mesh, n | $710 | $722 | $717 | $772 | 0.173 |
| Patient cost share | $7,116 | $7,515 | $7,816 | $8,276 | 0.003 |
| Insurance payment | $7,826 | $8,237 | $8,533 | $9,048 | 0.005 |
| Total | 17,809 | 14,693 | 11,427 | 8,663 | 0.001 |
| Outpatient Procedures, n | 13,978 | 15,173 | 14,896 | 16,907 | 0.102 |
| Prolapse procedures, n | 5.4 | 6.0 | 5.8 | 6.4 | 0.132 |
| Utilization, per 10,000 woman-years | 4,430 | 4,884 | 4,152 | 4,650 | 0.970 |
| Prolapse with mesh, n | $471 | $531 | $652 | $659 | 0.045 |
| Patient cost share | $4,490 | $4,998 | $5,464 | $6,321 | 0.011 |
| Insurance payment | $4,961 | $5,528 | $6,116 | $6,981 | 0.006 |
| Total | 9,551 | 10,294 | 10,745 | 12,257 | 0.031 |
| Prolapse without mesh, n | $444 | $483 | $583 | $627 | 0.016 |
| Patient cost share | $3,511 | $3,863 | $4,262 | $4,522 | 0.003 |
| Insurance payment | $3,955 | $4,346 | $4,845 | $5,149 | 0.004 |
| Total | 13,978 | 15,173 | 14,896 | 16,907 | 0.102 |
Payments adjusted to 2013 dollars using Bureau of Labor Statistics Medical Consumer Price Index
Statistical analysis performed using generalized linear models
Hospital payments were higher for procedures with mesh compared to those without mesh. The relative increase in reimbursement over time for procedures with mesh differed based on inpatient status. The addition of mesh to an outpatient case increased the hospital payment by $1,006 in 2010 and by $1,832 by 2013. Conversely, an inpatient procedure with mesh added $489 to the hospital payment in 2010, and only $267 in 2013. (Figure 2, Table 3).
Figure 3 and Table 4 show the change in total annual payments for prolapse procedures over time. There was a 13.5% decrease in total annual payments (from $201 million to $174 million) from 2010 to 2013. The largest decrease was seen in inpatient procedures performed with mesh, which saw a 57.3% decrease in number of procedures, while inpatient procedures without mesh declined by 48.6%. The downward payment effect is offset by the increasing reimbursements for both inpatient and outpatient procedures described previously.
Figure 3.

Total annual payments for inpatient and outpatient prolapse procedures, with and without mesh, 2010–2013. All payments adjusted to 2013 dollars using the Bureau of Labor Statistics Medical Consumer Price Index. Mesh includes prolapse procedures performed with mesh or graft implant. Nonmesh includes prolapse procedures performed without mesh or graft implant.
Table 4.
Total payments for inpatient and outpatient procedures, with and without mesh, 2010-2013
| Prolapse Procedures | 2010 | 2011 | 2012 | 2013 | p-value |
|---|---|---|---|---|---|
| Inpatient Procedures, n | 17,811 | 14,694 | 11,428 | 8,664 | 0.001 |
| Total inpatient payment | $142,138,970 | $122,983,443 | $99,069,506 | $79,032,166 | 0.001 |
| Prolapse with mesh, n | 5,609 | 4,569 | 3,171 | 2,396 | 0.005 |
| Total payment | $46,640,942 | $39,585,301 | $28,613,617 | $22,319,037 | 0.005 |
| Prolapse without mesh, n | 12,202 | 10,125 | 8,257 | 6,268 | <0.001 |
| Total payment | $95,498,028 | $83,398,142 | $70,455,888 | $56,713,128 | <0.001 |
| Outpatient Procedures, n | 13,981 | 15,178 | 14,897 | 16,907 | 0.103 |
| Total outpatient payment | $59,751,381 | $71,734,939 | $77,452,248 | $95,566,900 | 0.020 |
| Prolapse with mesh, n | 4,430 | 4,884 | 4,152 | 4,650 | 0.970 |
| Total payment | $21,977,470 | $27,000,462 | $25,393,338 | $32,459,709 | 0.118 |
| Prolapse without mesh, n | 9,551 | 10,294 | 10,745 | 12,257 | 0.031 |
| Total payment | $37,773,912 | $44,734,477 | $52,058,910 | $63,107,192 | 0.007 |
| Total inpatient + outpatient procedures, n | 31,792 | 29,872 | 26,325 | 25,571 | 0.026 |
| Total inpatient + outpatient payment | $201,890,351 | $194,718,382 | $176,521,754 | $174,599,066 | 0.041 |
Payments adjusted to 2013 dollars using Consumer Price Index
Statistical analysis performed using generalized linear models
Discussion
Using data from three national private insurers, our analysis reveals a 21% decrease in the annual utilization of all procedures for pelvic organ prolapse from 2010 to 2013. Over the four years, the decrease in the utilization of procedures with mesh was two-fold greater than those without mesh, however the utilization of procedures without mesh also significantly declined. Prior to July 2011, the utilization rate of procedures with mesh was increasing, then sharply declined after the FDA safety communication was released. These findings supports prior studies describing an increase in mesh procedures during the years preceding 2011.13–16 Our findings highlight a previously undescribed decrease in surgical management of prolapse, regardless of mesh use, during a time when the need for prolapse surgery on a national level was projected to rise.3,4,17
There are several possible reasons for the decrease in POP procedures. Hospital policies and physician practice may have changed in response to the reports of complications from mesh and the FDA Safety Communications in 2008 and 2011.2,8 The number of physicians privileged to use mesh may have changed when hospitals reacted to guidelines regarding surgeon privileges, the consent process, and outcomes reporting.18,19 Simultaneously, subspecialty physicians may have become more selective about mesh procedures and changed the procedures the perform., Physicians have reported that following the 2011 FDA Safety Communication they were less likely to use mesh in a vaginal repair of recurrent prolapse and more likely to use an abdominal approach for primary prolapse repairs.20 Finally, patients may have become more reluctant to consider surgery for prolapse given the media coverage about mesh-related complications.21,22
Claims data from inpatient and outpatient settings allowed us to identify changes in surgical practice for prolapse. Surgery for prolapse is now more often performed as outpatient versus inpatient. Sanses et al. reported a 29% decrease in inpatient procedures in the decade prior to 2011. This change in practice is now occurring at a more rapid pace, with a 52.2% decrease in inpatient procedures and a 18.5% increase in outpatient procedures over a four-year period.10 This outpatient shift may be related to the observed increase in hysterectomies performed laparoscopically. Given the outpatient shift it will be important for future research to utilize datasets that include outpatient claims.
Average expenditures for prolapse procedures continue to increase. We found that prolapse surgery became 7.5% more expensive between 2010 and 2013—a surprising development considering the large shift from inpatient to outpatient surgery, and that outpatient procedures were 40% less expensive than inpatient procedures. The majority of the payment increase was seen in the insurance portion, as patient payments remained stable.
There is some evidence to explain why surgery for prolapse became more expensive. First, the proportion of hysterectomies for prolapse performed vaginally- the least expensive and morbid surgical approach- decreased 34%, while the utilization of more expensive laparoscopic hysterectomy increased 103%.23 Second, the average outpatient cost of a case involving mesh was $1823 (40%) higher than a case that did not utilize mesh. It is possible that a growing proportion of gynecologic surgeons now favor laparoscopic repairs with mesh, which are associated with higher expense, over vaginal surgery. A final factor affecting the changing payments is that hospitals and insurance companies often negotiate payment contracts—which can affect these outcomes, and may be unrelated to clinical factors.
Although the findings among women with private insurance may not apply to women with Medicare, Medicaid, or no insurance, this study’s primary strength is its generalizability, as this database provides data for more than 25 million commercially insured women from all 50 states. The use of de-identified claims data is a limitation. We are unable to distinguish between biologic and synthetic mesh with current ICD9 procedure codes and we are unable to determine if current coding practices accurately distinguish between conventional and robotic-assisted laparoscopy. Therefore, robotic-assisted surgeries were considered as laparoscopic procedures. Additionally, only one CPT code could be recorded per procedure, and as such, we were unable to sufficiently distinguish between vaginal and abdominal colpopexy. Finally, hospital and insurance payments do not necessarily reflect actual cost.
Clinically, the FDA safety communication appears to have led to a change in surgical practice regarding the treatment of pelvic organ prolapse. Future studies are needed to identify the cause of the declining number of prolapse procedures despite an aging population and a projected increase in need, as well as to examine factors that account for the observed rise in hospital payments.
Supplementary Material
Acknowledgments
Grant Support: Investigator support for C.W.S. was provided by the National Institute of Child Health and Human Development WRHR Career Development Award # K12 HD065257 and for J.O.L.D. by Office for Research on Women’s Special Center of Research P50 HD044406.
Footnotes
Presented as a poster at the American Urogynecologic Society meeting in Denver, Colorado, September 27–October 1, 2016.
Financial Disclosure
The authors did not report any potential conflicts of interest.
Each author has indicated that he or she has met the journal’s requirements for authorship.
References
- 1.Wu JM, Matthews CA, Conover MM, Pate V, Funk MJ. Lifetime Risk of Stress Incontinence or Pelvic Organ Prolapse Surgery. Obstet Gynecol. 2014;123:1201–6. doi: 10.1097/AOG.0000000000000286. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 2.FDA Safety Communication: UPDATE on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse: FDA Safety Communication. doi: 10.1007/s00192-011-1581-2. Available at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm262435.htm. Retrieved 2/1/2017. [DOI] [PubMed]
- 3.Dieter AA, Wilkins MF, Wu JM. Epidemiological trends and future care needs for pelvic floor disorders. Curr Opin Obstet Gynecol. 2015;27:380–4. doi: 10.1097/GCO.0000000000000200. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 4.Wu JM, Kawasaki A, Hundley AF, Dieter AA, Myers ER, Sung VW. Predicting the number of women who will undergo incontinence and prolapse surgery, 2010 to 2050. Am J Obstet Gynecol. 2011;205:230.e1–e5. doi: 10.1016/j.ajog.2011.03.046. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 5.Wang LC, Al Hussein Al Awamlh B, Hu JC, et al. Trends in Mesh Use for Pelvic Organ Prolapse Repair From the Medicare Database. Urology. 2015;86:885–91. doi: 10.1016/j.urology.2015.08.022. [DOI] [PubMed] [Google Scholar]
- 6.Younger A, Rac G, Clemens JQ, et al. Pelvic Organ Prolapse Surgery in Academic Female Pelvic Medicine and Reconstructive Surgery Urology Practice in the Setting of the Food and Drug Administration Public Health Notifications. Urology. 2016;91:46–51. doi: 10.1016/j.urology.2015.12.057. [DOI] [PubMed] [Google Scholar]
- 7.Skoczylas LC, Turner LC, Wang L, Winger DG, Shepherd JP. Changes in Prolapse Surgery Trends Relative to FDA Notifications Regarding Vaginal Mesh. Int Urogynecol. 2014;25:471–7. doi: 10.1007/s00192-013-2231-7. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 8.FDA Safety Communication: Transvaginal Placement of Surgical Mesh. 2008 [Google Scholar]
- 9.Boyles SH, Weber AM, Meyn L. Procedures for pelvic organ prolapse in the United States, 1979-1997. Am J Obstet Gynecol. 2003;188:108–15. doi: 10.1067/mob.2003.101. [DOI] [PubMed] [Google Scholar]
- 10.Sanses TS, NK, Richter HE, Koroukian SM. Trends and Factors Influencing Inpatient Prolapse Surgical Costs and Length of Stay in the United States. Female Pelvic Medicine & Reconstructive Surgery. 2016;22:103–10. doi: 10.1097/SPV.0000000000000225. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 11.Brown JSWL, Subak LL. Pelvic organ prolapse surgery in the United States, 1997. Am J Obstet Gynecol. 2002;186:712–6. doi: 10.1067/mob.2002.121897. [DOI] [PubMed] [Google Scholar]
- 12.Erekson EA, Lopes VV, Raker CA, Sung VW. Ambulatory procedures for female pelvic floor disorders in the United States. Am J Obstet Gynecol. 2010;203:497.e1–e5. doi: 10.1016/j.ajog.2010.06.055. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 13.Funk MJ, Edenfield AL, Pate V, Visco AG, Weidner AC, Wu JM. TRENDS IN USE OF SURGICAL MESH FOR PELVIC ORGAN PROLAPSE. Am J Obstet Gynecol. 2013;208:79.e1–e7. doi: 10.1016/j.ajog.2012.11.008. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 14.Khan AA, Eilber KS, Clemens JQ, Wu N, Pashos CL, Anger JT. Trends in management of pelvic organ prolapse among female Medicare beneficiaries. Am J Obstet Gynecol. 2015;212:463.e1–e8. doi: 10.1016/j.ajog.2014.10.025. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 15.Rogo-Gupta L, Rodriguez LV, Litwin MS, et al. Trends in Surgical Mesh Use for Pelvic Organ Prolapse From 2000 to 2010. Obstet Gynecol. 2012;120:1105–15. doi: 10.1097/aog.0b013e31826ebcc2. [DOI] [PubMed] [Google Scholar]
- 16.Elterman DS, Chughtai BI, Vertosick E, Maschino A, Eastham JA, Sandhu JS. Changes in Pelvic Organ Prolapse Surgery in the Last Decade among United States Urologists. J Urol. 2014;191:1022–7. doi: 10.1016/j.juro.2013.10.076. [DOI] [PubMed] [Google Scholar]
- 17.Wu JM, Hundley AF, Fulton RG, Myers ER. Forecasting the Prevalence of Pelvic Floor Disorders in U.S. Women: 2010 to 2050 Obstet Gynecol. 2009;114:1278–83. doi: 10.1097/AOG.0b013e3181c2ce96. [DOI] [PubMed] [Google Scholar]
- 18.American Urogynecologic Society’s Guidelines Development Committee. Guidelines for Providing Privileges and Credentials to Physicians for Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse. Female Pelvic Medicine & Reconstructive Surgery. 2012;18:194–7. doi: 10.1097/SPV.0b013e31825f36ed. [DOI] [PubMed] [Google Scholar]
- 19.Committee on Gynecologic Practice. Vaginal Placement of Synthetic Mesh for Pelvic Organ Prolapse. Female Pelvic Med Reconstr Surg. 2012;18:5–9. doi: 10.1097/SPV.0b013e3182495885. [DOI] [PubMed] [Google Scholar]
- 20.Myers E, Geller E, Crane A, Robinson B, Matthews C. Estimating the early impact of the FDA safety communication on the use of surgical mesh. South Med J. 2013;106:684–8. doi: 10.1097/SMJ.0000000000000031. [DOI] [PubMed] [Google Scholar]
- 21.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;85:326–31. doi: 10.1016/j.urology.2014.08.058. [DOI] [PubMed] [Google Scholar]
- 22.Brown LK, Fenner DE, Berger MB, et al. Defining patients’ knowledge and perceptions of vaginal mesh surgery. Female Pelvic Med Reconstr Surg. 2013;19:282–7. doi: 10.1097/SPV.0b013e31829ff765. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 23.Aarts JW, Nieboer TE, Johnson N, et al. Surgical approach to hysterectomy for benign gynaecological disease. Cochrane Database Syst Rev. 2015;8:CD003677. doi: 10.1002/14651858.CD003677.pub5. [DOI] [PMC free article] [PubMed] [Google Scholar]
Associated Data
This section collects any data citations, data availability statements, or supplementary materials included in this article.
