Objective
Limited data exist on the rates of pelvic organ prolapse procedures utilizing mesh. The objective of this study was to examine trends in vaginal mesh prolapse procedures (VMs), abdominal sacrocolpopexy (ASC), and minimally invasive sacrocolpopexy (MISC) from 2005 to 2010.
Study Design
We utilized deidentified, adjudicated health care claims data from across the United States from 2005 to 2010. Among women 18 years old or older, we identified all mesh prolapse procedures based on Current Procedural Terminology codes (57267 for VM, 57280 for ASC, and 57425 for MISC). VM procedures included all vaginal prolapse surgeries in which mesh was placed, whether in the anterior, apical, or posterior compartment. We estimated rates per 100,000 person-years (100,000py) and 95% confidence intervals (CIs).
Results
During 78.5 million person-years of observation, we identified 60,152 mesh prolapse procedures, for a rate of 76.0 per 100,000py (95% CI, 73.6−78.5). Overall, VMs comprised 74.9% of these surgeries for an overall rate of 56.9 per 100,000py (95% CI, 55.0−58.9). Rates of ASC and MISC were considerably lower at 12.0 per 100,000py (95% CI, 11.6−12.5) and 9.5 per 100,000py (95% CI, 9.2−9.9), respectively. Among sacrocolpopexies, ASC was more common than MISC in 2005-2007; however, since 2007, the rate of MISC has increased, whereas the rate of ASC has decreased. Regarding trends by age, VM was considerably more common than sacrocolpopexies at all ages, and ASC was more common than MISC in women older than 50 years.
Conclusion
From 2005 to 2010, the rate of mesh prolapse procedures has increased, with vaginal mesh surgeries constituting the vast majority.
The recent Food and Drug Administration (FDA) safety communication regarding vaginal mesh for pelvic organ prolapse has drawn attention to the surgical management of this highly prevalent condition. In the July 2011 update on the original 2008 public health notification, the FDA stated that “based on an updated analysis of adverse events reported to the FDA and complications described in the scientific literature, the FDA identified surgical mesh for transvaginal repair of POP [pelvic organ prolapse] as an area of continuing serious concern.” The American Congress of Obstetricians and Gynecologists (ACOG) and the American Urogynecologic Society (AUGS) have recognized the critical importance of complications such as mesh exposure, erosion, and contracture and the symptoms associated with these complications.
For Editors’ Commentary, see Contents
The first mesh kits to aid in the insertion of vaginal synthetic graft material for prolapse were cleared by the FDA in 2004 and marketed by American Medical Systems (San Jose, CA) under the names Apogee and Perigee systems. Since then, there has been an influx of new prolapse mesh devices introduced in the United States. Sales data from manufacturers indicate that 300,000 women underwent pelvic organ prolapse surgery in 2010. Of these, one-third utilized mesh (∼100,000), and three quarters of these mesh procedures were transvaginal surgeries. Thus, approximately, 75,000 procedures involved transvaginal placement of mesh. Despite these estimates, population-based estimates of vaginal and abdominal mesh prolapse surgeries are extremely limited. Furthermore, utilization of mesh for prolapse repair categorized by age and region is lacking.
Several studies have evaluated national trends in prolapse surgeries overall, but these estimates provide limited information regarding mesh prolapse procedures specifically. One reason is that International Classification of Diseases , Ninth Revision, Clinical Modification (ICD-9-CM) codes for prolapse graft materials (ie, codes 70.53, 70.54, 70.55, 70.94, and 70.95) were not introduced until 2007.
Another limitation is that ICD-9-CM procedure codes, which are utilized by a majority of national databases, do not incorporate the more specific Current Procedural Terminology (CPT) codes. Because of these limitations, the rates of specific mesh procedures have not been reported, and the impact on rates of transvaginal mesh procedures after the 2 recent FDA notifications in 2008 and 2011 is relatively unknown. It is critical to understand whether the FDA safety notifications have translated into changes in the rates of transvaginal mesh procedures.
Given the knowledge gaps in the existing literature, we sought to use the more informative CPT codes in a population-based analysis to estimate trends in prolapse mesh procedures from 2005 to 2010. Furthermore, we wanted to estimate the rates of specific prolapse procedures, such as vaginal mesh procedures (VM), abdominal sacral colopopexy (ASC), and minimally invasive sacrocolpopexy (MISC) and to estimate the trends in these surgeries based on age and region of the United States.
Materials and Methods
Data source
This analysis is based on Thomson Reuters’ MarketScan Commercial Claims and Encounters database and Medicare Supplemental and Coordination of Benefits database from 2005 to 2010. These data represent the medical encounters of individuals with employment-based insurance including spouses, dependents, and retirees. Specifically, the databases contain deidentified, individual-level inpatient, outpatient, and pharmacy claims as well as detailed enrollment data from approximately 100 payers in the United States. Claims and enrollment data are validated to ensure completeness, accuracy, and reliability. Although the data are deidentified, unique individuals can be followed up over time using encrypted identification numbers. The databases contain adjudicated, paid claims for approximately 28.3 million individuals in 2005, increasing to 48.8 million in 2010. Of note, in 2010, 55.3% of the US population had employment-based insurance. This study was determined to be exempt from further review by the Institutional Review Board at the University of North Carolina at Chapel Hill.
Pelvic organ prolapse mesh surgery rates
The study population included all women aged 18 years or older from 2005 to 2010. We utilized CPT codes to identify any prolapse procedures involving mesh placement. A vaginal mesh procedure was defined by the CPT code 57267 (insertion of mesh or other prosthesis for repair of pelvic floor defect, each site, vaginal approach). Because this code is listed in addition to CPT code(s) for the primary procedure(s), we defined a vaginal mesh procedure if CPT 57267 was listed at least once on a specific surgery date. For example, if the mesh was placed in both the anterior and posterior compartment and CPT 57267 was listed twice, this surgery would be counted as a single VM procedure.
We chose to evaluate trends starting in 2005 because the CPT code 57267 was released on Jan. 1, 2005. We opted to use CPT codes instead of ICD-9-CM codes because ICD-9-CM vaginal mesh codes were not introduced until 2007. For sacrocolpopexies, ASCs were identified using CPT code 57280, which indicates colpopexy, abdominal approach. Minimally invasive sacrocolpopexies, MISCs, were defined by CPT code 57425, a code that was released in 2004. MISC represents both laparoscopic and robotic-assisted laparoscopic sacrocolpopexies because CPT codes distinguishing these 2 types of surgeries do not exist.
Rates were calculated by dividing the total number of surgeries in each category (VM, ASC, and MISC) by the total person-time at risk. To calculate person-time at risk, we summed all periods of time when eligible women were enrolled in a health plan that contributed to the database.
We also evaluated common concurrent procedures with VM, ASC, and MISC. Specifically, we evaluated concomitant sling, CPT 57288, as well as concomitant hysterectomy. We evaluated the type of hysterectomy (total vs supracervical) based on CPT codes. Total hysterectomy included total abdominal (CPT codes 58150, 58152, 58200, and 58210), total vaginal (CPT codes 58260, 58262, 58263, 58267, 58270, 58275, 58280, 58285, 58290, 58291, 58292, 58293, and 58294), and total laparoscopic, which also included laparoscopic assisted vaginal hysterectomy (CPT codes 58545, 58546, 58548, 58550, 58552, 58553, 58554, 58570, 58571, 58572, and 58573). Supracervical hysterectomies included both abdominal supracervical (CPT code 58180) and laparoscopic supracervical (CPT codes 58541, 58542, 58543, and 58544).
Statistical analysis
We estimated the rate of any prolapse mesh surgery overall as well as procedure-specific rates for VM, ASC, and MISC. In addition, we estimated the procedure and calendar year, procedure and location (inpatient vs outpatient), procedure and age, and procedure- and region-specific rates for prolapse mesh surgery. We estimated 95% confidence intervals (CIs) based on the Poisson distribution. Rates and CIs are reported per 100,000 person-years (100,000py).
To adjust for differences in the age distribution over calendar time and across regions, we estimated region-specific and calendar year–specific rates using Poisson regression, adjusting for age using 15 categorical variables (18-24, 25-29, 30-34, 35-39, 40-44, 45-49, 50-54, 55-59, 60-64, 65-69, 70-74, 75-79, 80-84, 85-89, and 90 years or older). Wald χ 2 statistics were used to test the significance of independent predictors with a 2-sided alpha of 0.05. All confidence intervals were estimated and statistical tests were conducted using Poisson regression with the dispersion parameter empirically estimated by the Pearson χ 2 divided by the degrees of freedom to account for overdispersion. The analyses were performed using SAS, version 9.2 (SAS Institute, Cary, NC).
Results
From 2005 to 2010, women aged 18 years and older contributed a total of 78,496,836 person-years. Among these women, there were 60,152 pelvic organ prolapse procedures that involved the use of mesh. Table 1 lists the person-time contribution for the population at risk, divided by calendar year, age group (18-29, 30-39, 40-49, 50-59, 60-69, 70-79, 80 years or older), and region of the United States. Furthermore, Table 1 describes the overall number of prolapse procedures with mesh, as well as the specific type of surgery, whether VM, ASC, or MISC.
| Person-years (n = 78,496,836) | Any prolapse surgery with mesh (n = 60,152) a | Vaginal mesh procedures (n = 45,042) | Abdominal sacrocolpopexy (n = 9518) | Minimally invasive sacrocolpopexy (n = 7542) | ||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Characteristic | n | % | n | % | n | % | n | % | n | % |
| Calendar year | ||||||||||
| 2005 | 9,819,195 | 12.5 | 5291 | 8.8 | 3,627 | 8.1 | 1,466 | 15.4 | 424 | 5.6 |
| 2006 | 10,460,669 | 13.3 | 7539 | 12.5 | 5,832 | 12.9 | 1,416 | 14.9 | 541 | 7.2 |
| 2007 | 10,512,203 | 13.4 | 8599 | 14.3 | 6,756 | 15.0 | 1,466 | 15.4 | 625 | 8.3 |
| 2008 | 15,488,086 | 19.7 | 12,050 | 20.0 | 9,244 | 20.5 | 1,776 | 18.7 | 1377 | 18.3 |
| 2009 | 15,418,194 | 19.6 | 12,506 | 20.8 | 9,294 | 20.6 | 1,710 | 18.0 | 1883 | 25.0 |
| 2010 | 16,798,488 | 21.4 | 14,167 | 23.6 | 10,289 | 22.8 | 1,684 | 17.7 | 2692 | 35.7 |
| Age, y | ||||||||||
| 18-29 | 14,145,115 | 18.0 | 490 | 0.8 | 310 | 0.7 | 94 | 1.0 | 97 | 1.3 |
| 30-39 | 14,273,280 | 18.2 | 3807 | 6.3 | 2,394 | 5.3 | 692 | 7.3 | 823 | 10.9 |
| 40-49 | 17,321,528 | 22.1 | 11,326 | 18.8 | 7,644 | 17.0 | 1,983 | 20.8 | 2018 | 26.8 |
| 50-59 | 17,194,089 | 21.9 | 18,653 | 31.0 | 13,994 | 31.1 | 3,021 | 31.7 | 2304 | 30.5 |
| 60-69 | 8,682,445 | 11.1 | 16,337 | 27.2 | 12,754 | 28.3 | 2,487 | 26.1 | 1700 | 22.5 |
| 70-79 | 4,073,367 | 5.2 | 7518 | 12.5 | 6,191 | 13.7 | 1,017 | 10.7 | 524 | 6.9 |
| 80+ | 2,807,011 | 3.6 | 2021 | 3.4 | 1,755 | 3.9 | 224 | 2.4 | 76 | 1.0 |
| Region | ||||||||||
| Northeast | 9,776,689 | 12.5 | 5037 | 8.4 | 3,542 | 7.9 | 866 | 9.1 | 773 | 10.2 |
| Midwest | 20,620,422 | 26.3 | 14,782 | 24.6 | 11,187 | 24.8 | 2,476 | 26.0 | 1596 | 21.2 |
| South | 33,707,919 | 42.9 | 30,291 | 50.4 | 22,583 | 50.1 | 4,920 | 51.7 | 3827 | 50.7 |
| West | 13,917,189 | 17.7 | 9686 | 16.1 | 7,455 | 16.6 | 1,205 | 12.7 | 1300 | 17.2 |
| Unknown | 474,617 | 0.6 | 356 | 0.6 | 275 | 0.6 | 51 | 0.5 | 46 | 0.6 |
a Number of specific prolapse mesh procedures does not total 60,152 because some patients had more than 1 type of procedure.
The overall rate of any prolapse surgery with mesh was 76.0 per 100,000py (95% CI, 73.6−78.5) ( Table 2 ). VM comprised 74.9% of these surgeries for an overall rate of 56.9 per 100,000py (95% CI, 55.0−58.9). Rates of ASC and MISC were considerably lower at 12.0 per 100,000py (95% CI, 11.6−12.5) and 9.5 per 100,000py (95% CI, 9.2−9.9), respectively ( Table 2 ). Although approximately half of the VM and MISC procedures were performed on an outpatient basis, a majority of the ASC procedures were inpatient surgeries ( Table 2 ).
| Any prolapse surgery with mesh (n = 60,152) | Vaginal mesh procedures (n = 45,042) | Abdominal sacrocolpopexy (n = 9518) | Minimally invasive sacrocolpopexy (n = 7542) | |||||
|---|---|---|---|---|---|---|---|---|
| Variable | Rate a | 95% CI | Rate a | 95% CI | Rate a | 95% CI | Rate a | 95% CI |
| Total | 76.0 | 73.6–78.5 | 56.9 | 55.0–58.9 | 12.0 | 11.6–12.5 | 9.5 | 9.2–9.9 |
| Procedure location | ||||||||
| Inpatient | 40.5 | 39.2–41.9 | 27.8 | 26.9–28.9 | 10.2 | 9.8–10.5 | 4.1 | 3.9–4.3 |
| Outpatient | 35.5 | 34.4–36.7 | 29.1 | 28.1–30.1 | 1.9 | 1.8–1.9 | 5.4 | 5.2–5.6 |
| Calendar year | ||||||||
| 2005 | 53.5 | 49.4–57.9 | 36.7 | 33.7–39.9 | 14.8 | 13.5–16.2 | 4.3 | 3.9–4.7 |
| 2006 | 71.5 | 66.3–77.1 | 55.3 | 51.0–59.9 | 13.4 | 12.4–14.6 | 5.1 | 4.7–5.6 |
| 2007 | 81.1 | 75.1–87.6 | 63.7 | 58.7–69.2 | 13.8 | 12.7–15.0 | 5.9 | 5.4–6.4 |
| 2008 | 77.2 | 71.5–83.3 | 59.2 | 54.4–64.4 | 11.4 | 10.5–12.3 | 8.8 | 8.2–9.5 |
| 2009 | 80.5 | 74.5–87.0 | 59.8 | 55.0–65.0 | 11.0 | 10.1–12.0 | 12.1 | 11.3–13.0 |
| 2010 | 83.7 | 77.3–90.5 | 60.8 | 55.7–66.2 | 9.9 | 9.1–10.8 | 15.9 | 14.8–17.1 |
| Age, y | ||||||||
| 18-29 | 3.4 | 3.0–4.0 | 2.2 | 1.8–2.6 | 0.7 | 0.5–0.8 | 0.7 | 0.5–0.8 |
| 30-39 | 26.9 | 25.2–28.8 | 16.9 | 15.7–18.3 | 4.9 | 4.5–5.3 | 5.8 | 5.3–6.3 |
| 40-49 | 65.9 | 63.3–68.5 | 44.5 | 42.5–46.5 | 11.5 | 10.9–12.2 | 11.7 | 11.0–12.5 |
| 50-59 | 107.7 | 104.2–111.3 | 80.8 | 77.8–83.9 | 17.4 | 16.6–18.3 | 13.3 | 12.4–14.2 |
| 60-69 | 178.8 | 171.8–186.2 | 139.6 | 133.8–145.7 | 27.2 | 25.8–28.7 | 18.6 | 17.2–20.2 |
| 70-79 | 182.5 | 175.8–189.4 | 150.3 | 144.6–156.1 | 24.7 | 23.0–26.5 | 12.7 | 11.3–14.3 |
| ≥80 | 68.1 | 65.2–71.0 | 59.1 | 56.6–61.8 | 7.5 | 7.0–8.2 | 2.6 | 2.3–2.8 |
| Region | ||||||||
| Northeast | 51.1 | 47.4–55.1 | 35.9 | 33.1–39.0 | 8.8 | 8.1–9.6 | 7.8 | 7.1–8.6 |
| Midwest | 71.1 | 66.3–76.2 | 53.8 | 49.9–58.1 | 11.9 | 11.1–12.8 | 7.7 | 7.0–8.4 |
| South | 89.2 | 83.2–95.6 | 66.5 | 61.7–71.7 | 14.5 | 13.5–15.5 | 11.3 | 10.5–12.1 |
| West | 69.0 | 64.7–73.7 | 53.1 | 49.5–57.0 | 8.6 | 7.9–9.3 | 9.3 | 8.6–10.0 |
| Unknown | 73.0 | 64.4–82.9 | 56.4 | 49.1–64.8 | 10.5 | 8.2–13.3 | 9.4 | 7.2–12.4 |
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