Pelvic organ prolapse and urinary incontinence are among the most common chronic disorders in women. These disorders affect nearly one quarter of U.S. women and it is estimated that stress urinary incontinence alone results in more than $12 billion in annual expenditures.1–3 Although many nonsurgical treatments exist, 11% of women undergo surgery.4 However, even after surgery, up to one third of women have recurrent symptoms and require an additional operative procedure.5
Surgical mesh has been promoted for the treatment of women with pelvic organ prolapse (POP) to improve long-term outcomes similar to mesh use for hernia repair.6 The first mesh product for urinary incontinence treatment received clearance from the U.S. Food and Drug Administration (FDA) in 1996, and the first mesh product for prolapse followed in 2001.7 The majority of studies examining mesh products were small and demonstrated improvements in short-term anatomic outcomes; however, most did not report long-term outcomes.8 Since 2004, a number of professional societies have called for evidence to determine the appropriate use of surgical mesh.9–11 Despite initial reassuring data, concern regarding the safety of transvaginal mesh arose in October 2008 when the FDA released a public health notification that it had received more than 1,000 reports of mesh-associated complications, some of which may not be correctable surgically.12 In 2011, the FDA released two further communications highlighting the safety concerns surrounding surgical mesh.7,13
The use of surgical mesh for POP repair clearly has become an important public health issue. Despite reports of increased surgical mesh use, little is known about the patterns of use or the factors that influence use. Our objective was to examine the use of surgical mesh for POP repair over the past decade and to explore factors that potentially influence its use, including patient, hospital, and surgeon factors, as well as the publication of safety advisories.
MATERIALS AND METHODS
We analyzed data from the Perspective Database (health care quality and resource utilization database).14 Perspective is a nationwide, voluntary, fee-supported database developed to measure health care quality and resource utilization. The database captures data on clinical and demographic characteristics as well as all diagnoses and procedures recorded with International Classification of Diseases, 9th Revision, Clinical Modification (ICD-9-CM) codes. In addition, it contains a log of all billed services, including drugs, devices, and interventions that a patient receives during hospitalization.15,16 More than 600 acute care hospitals report data to this health care quality and resource utilization database; in 2005, the database recorded approximately 5.5 million hospital discharges, which represents approximately 15% of all hospitalizations in the United States.17 The database has been validated and utilized in a number of outcomes studies.18,19 All data were de-identified and deemed exempt by the Institutional Review Boards at Columbia University and University of California, Los Angeles.
Women aged 18 years and older who underwent POP repair from 2000 to 2010 were analyzed. Participants were included in the cohort if they had an ICD-9-CM procedure code for one or more prolapse-related procedure (Appendix 1). Based on the type of procedure performed, each was classified as anterior repair, apical repair, posterior repair, or multiple compartment repair. Procedures were grouped by prolapse compartment and not by surgical method (vaginal, abdominal, laparoscopic). For each individual, we also recorded the performance of a concomitant incontinence repair or hysterectomy based on ICD-9-CM coding.
Billing records were searched to identify surgical mesh. After identification of potential surgical mesh products, these codes were arranged into product categories and classified by the indication for use (incontinence sling mesh, POP mesh, or mesh usable for multiple indications) using published resources. The mesh billing codes were then merged with the cohort who underwent prolapse repair and women were classified as having undergone a mesh-augmented or nonmesh repair. The cohort was further characterized based on the presence or absence of an incontinence procedure. If a billing record for an incontinence sling mesh was identified without a corresponding procedure code for incontinence, the record was considered discrepant and these women were excluded from the analysis (n=3,496). The remainder of the women comprised the cohort.
Age (younger than 50, 50–59, 60–69, 70–79, 80 years of age or older), race (white, black, other), year of surgery (2000–2010), marital status (married, single, unknown), and insurance status (Medicare, Medicaid, commercial, uninsured, unknown) were categorized for each patient. Comorbidity was estimated using the Charlson index and modified classification system described by Deyo et al.20,21 Based on a summary score, comorbidity was classified as 0, 1, or 2 or more.
Hospital characteristics, including location (metropolitan, nonmetropolitan), teaching status (teaching, nonteaching), size (less than 400, 400–600, 600 or more beds) and region (Midwest, Northeast, South, West), were recorded. For all surgical procedures, the health care quality and resource utilization database reports a unique surgeon identifier. For each prolapse procedure, the attending surgeon was captured and classified as a gynecologist, urologist, or other or unknown.
Annualized surgical volume was calculated for both physicians and hospitals. The total number of prolapse procedures performed by a given physician or hospital was divided by the number of years in which the physician or hospital contributed at least one prolapse procedure. These annualized volumes were then inspected and approximately equal patient-based tertiles were constructed (low, intermediate, high). Applying this model to our cohort, low-volume tertile surgeons performed fewer than seven procedures annually, intermediate-volume tertile surgeons performed between 7 and 23 procedures, and high-volume tertile surgeons performed more than 23 procedures. Similarly, for hospitals, low-volume tertile hospitals performed fewer than 84 procedures annually, intermediate-volume tertile centers performed between 84 and 164 procedures annually, and high-volume tertile hospitals performed more than 164 procedures annually.
Frequency distributions between categorical variables were compared using χ2 tests. Hierarchical mixed-effects logistic regression models were developed to determine predictors of surgical mesh use. These models included all patient, physician, and hospital-level characteristics, as well as a hospital-specific random effect to control for hospital level clustering. Separate models were developed for women with and without incontinence. Results are reported with odds ratios (ORs) and 95% confidence intervals (CIs). All statistical tests were two-sided. All analyses were performed using SAS 9.2.
We identified 273,275 women who underwent POP repair. The cohort included 208,307 (76.2%) women who underwent nonmesh-augmented repairs and 64,968 (23.8%) who had mesh. Mesh use in our cohort increased from 7.9% in 2000 to a peak of 32.1% in the fourth quarter of 2006, and then declined slightly to 27.5% in 2010.
Within the cohort, 116,426 (42.6%) women underwent concurrent incontinence surgery whereas 156,849 (57.4%) underwent surgery for prolapse without concurrent incontinence surgery. Given that incontinence was a strong predictor of mesh use (OR 9.95; 95% CI 9.70–10.21), women with and without incontinence were analyzed separately. Table 1 displays the characteristics of both groups.
Among women with incontinence, year of surgery was the strongest predictor of mesh use. Mesh use increased from 16.8% in 2000 to a peak of 55.8% in the third quarter of 2005, and declined to 43.6% in 2010 (Fig. 1A). In a multivariable model, predictors of surgical mesh use in women with incontinence included age older than 50 years, apical and anterior compartment defects, surgery at an intermediate-volume hospital, surgery by an intermediate or high-volume surgeon, and surgery performed by a urologist (P<.05 for all) (Table 2). In contrast, nonwhite women and those who underwent a hysterectomy at the time of surgery were less likely to receive mesh (P<.05). For women with incontinence, mesh use peaked for all compartments in 2004 and 2005, followed by a decline in mesh use to 39.1%–49.1% for all procedures (Fig. 1B). In women with incontinence, peak mesh use increased with increasing surgeon volume as calculated from our database and declined to 40.7%–46.4% in 2010 (Fig. 1C). Urologists performed 14.8% of combined prolapse and incontinence procedures with mesh in 2000, 63.6% in 2005, and 44.3% in 2010 (Fig. 1D). Similarly, gynecologists performed 10.5% of combined prolapse and incontinence procedures with mesh in 2000, 55.0% in 2005, and 43.3% in 2010 (P<.05).
Among women undergoing prolapse surgery without incontinence, mesh use increased from 3.3% in 2000, peaked in the fourth quarter of 2006 at 13.5%, and then declined slightly to 12.8% by the first quarter of 2010 (Fig. 2A). Women older than age 50 years and those with apical and anterior compartment defects were more likely to receive surgical mesh than younger women and those with posterior and multiple compartment defects (P<.05 for all) (Table 1). Black women were 27% (OR 0.73; 95% CI 0.66–0.82) less likely to receive mesh than white women, whereas Medicare beneficiaries were 10% more likely (OR 1.10; 95% CI 1.03–1.17) to undergo a mesh-augmented repair than those with commercial insurance. Intermediate-volume (OR 1.53; 95% CI 1.44–1.62) and high-volume (OR 2.74; 95% CI 2.58–2.92) surgeons were more likely to use mesh than low-volume surgeons. Compared with women who underwent operation by gynecologists, those treated by urologists were more than three times more likely to undergo a mesh-augmented prolapse repair (OR 3.36; 95% CI 3.09–3.66).
When analyzed by year, mesh use for prolapse increased consistently over time for women who underwent apical and anterior compartment repair without a concurrent incontinence procedure (Fig. 2B). In contrast, for women with posterior prolapse, mesh use increased from 0.7% in 2000 to a peak of 8.7% in 2005, and then decreased to 7.0% in 2010. Mesh for multiple compartment repair followed similar trends. Mesh use by high-volume surgeons was greatest in 2006 (23.7%), and then declined to 18.9% in 2010 (Fig. 2C). In contrast, intermediate-volume surgeons used mesh in 8.4% of cases in 2006, and in 7.9% of cases in 2010; similarly, low-volume surgeons used mesh in 14.9% of cases, in 2009 and they used mesh in 13.8% of cases in 2010. Mesh use by urologists was higher than use by gynecologists throughout the study period (Fig. 2D). Mesh use by urologists peaked at 36.8% in 2005, whereas mesh use by gynecologists peaked at 12.8% in 2008. In 2010, mesh was used for prolapse repair in women without incontinence in 29.2% of the procedures performed by urologists compared with 11.2% of those performed by gynecologists. Use of mesh in white women increased from 3.6% in 2000 to 15.1% in 2006, and remained stable at 14.0% in 2010. Mesh use in black women increased from 4.7% in 2000 to 10.6% in 2007, and 9.8% in 2010 (Fig. 3).
Our findings suggest the use of surgical mesh for POP repair has increased substantially over the past decade. The increase in mesh use is most pronounced in women with both prolapse and incontinence, but was also noted for those without incontinence. Although patient race influences mesh use, physician factors play a significant role in the decision to perform a mesh-augmented repair.
Mesh use for prolapse repair highlights many of the challenges of introducing novel surgical devices and procedures into clinical practice.6,22 A recent Cochrane review examining prolapse treatment noted that mesh-augmented anterior compartment repair was associated with a lower rate of anatomic failure than standard repair.8 However, despite decreased anatomic failure rates, there does not appear to be a difference in subjective outcomes, quality of life, de novo dyspareunia, or reoperation rates between mesh and nonmesh repairs.4,23 Even with the limitations of current data, mesh-augmented prolapse repair has become widespread.
Although we noted that black women were less likely than white women to receive mesh, our findings suggest that surgeon characteristics have the strongest influence on surgical mesh use for prolapse. Previous work has demonstrated that surgeon volume and specialty play important roles in the allocation of care and outcomes.24 Although a number of reports have suggested that women who have undergone hysterectomy have superior outcomes when the procedure is performed by high-volume surgeons, less data are available describing outcomes after pelvic reconstructive surgery.25,26 In an analysis of 1,356 women who underwent a sling procedure for urinary incontinence, Anger et al27 noted that high-volume surgeons were more likely to perform concomitant prolapse surgery, thus decreasing the need for future prolapse repair.
The performance of incontinence procedures affected trends in mesh use. Trends in mesh use for women who underwent concurrent incontinence procedures (Figs. 1 and 3A) were different from those who did not (Figs. 2 and 3B). Peak mesh use for combined procedures occurred between the years 2005 and 2006, with a decline in the subsequent years. This compared with trends in mesh use for prolapse repairs alone, which are best described as a gradual increase from 2000 to 2010. This observation is likely explained by trends in incontinence procedures during the study period.28
In our cohort, high-volume surgeons and urologists were most likely to use surgical mesh for prolapse repair. The explanation for this difference in mesh use is likely multifactorial and attributable to differences in training, referral patterns, and provider experience. Additionally, previous work suggests that urologists are more likely to be early adopters of novel surgical techniques.29,30 It is notable that in the wake of the controversy regarding surgical mesh, professional societies recommend these procedures should be performed by experienced surgeons.7 Although these recommendations may be prudent, objective data indicating that this will reduce mesh-related complications are largely lacking.
Strengths of our analysis include large sample size and inclusion of billing records for surgical mesh. We recognize a number of methodologic limitations. A number of previous studies have used this database to evaluate drugs and devices; however, it remains possible that a small number of women were misclassified.18,19 We decided a priori to analyze all mesh products in aggregate because a large number of mesh products are commercially available, many of which have similar compositions. The currently available ICD-9-CM classification system for prolapse procedures cannot account for differences in defect severity and type. Using administrative data, it is impossible to perform complete risk adjustment. Although we adjusted for comorbidity, undoubtedly unmeasured factors such as previous surgery and defect severity significantly affected treatment choices. The de-identified nature of this dataset does not allow for review of individual records to determine whether study protocols were in place during the study period that provided implants free of charge, eliminating them from the billing record. Finally, administrative studies lack the ability to capture individual preferences that likely influence treatment planning.
Arguably the most interesting finding of our analysis was the fact that surgical mesh use decreased only slightly after concerns were raised by the FDA notification in 2008. Since 2008 the use of surgical mesh by high-volume surgeons decreased, unlike use by low-volume and intermediate-volume physicians. We hypothesize these differences may reflect increased experience with mesh-related complications in individual practices; however, the exact cause of the changes in practice remain unknown.
The approval process of the FDA for devices has become the subject of increased public scrutiny. Not only does the process allow for the approval of many devices and technologies in the absence of efficacy data, but also there have been a number of approved devices for which safety concerns have arisen.31–33 Recent attention has focused on a metal-on-metal hip replacement system approved in 2005 through the 510(k) process. Subsequently, it was found that the revision rate at 6 years was 49%. Before recall in 2010, the product had been implanted in nearly 100,000 patients.31 Given the concerns surrounding the safety and efficacy of devices, the Institute of Medicine released a report in 2011 recommending that the FDA eliminate the 510(k) clearance process.31,32 These recommendations support a process in which safety and efficacy are monitored before approval as well as during the postapproval period of use. Other groups also have called for a more evidence-based approach to the integration of surgical innovations into practice.31,34 Further initiatives such as heightened postmarketing surveillance may be needed to ensure appropriate use of mesh for women undergoing prolapse repair.35,36
The use of surgical mesh for pelvic reconstruction has increased substantially over the past decade, and this increase was most pronounced in the years before the publication of safety advisories. Additional measures should promote the evidence-based use of surgical mesh for pelvic reconstruction.
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International Classification of Diseases, 9th Revision, Clinical Modification Procedure Codes Used for Patient Selection From the Health Care Quality and Resource Utilization Database, 2000–2010
© 2012 by The American College of Obstetricians and Gynecologists. Published by Wolters Kluwer Health, Inc. All rights reserved.