Trends in Mesh Use for Pelvic Organ Prolapse Repair From the Medicare Database

Accepted Manuscript Title: Trends in Mesh Use for Pelvic Organ Prolapse Repair from the Medicare Database Author: Lily C. Wang, Bashir Al Hussein Al Awamlh, Jim C. Hu, Melissa A Laudano, Wesley L. Davison, Michael L Schulster, Fujun Zhao, Bilal Chughtai, Richard K. Lee PII: DOI: Reference:

S0090-4295(15)00834-1 http://dx.doi.org/doi: 10.1016/j.urology.2015.08.022 URL 19381

To appear in:

Urology

Received date: Accepted date:

15-5-2015 25-8-2015

Please cite this article as: Lily C. Wang, Bashir Al Hussein Al Awamlh, Jim C. Hu, Melissa A Laudano, Wesley L. Davison, Michael L Schulster, Fujun Zhao, Bilal Chughtai, Richard K. Lee, Trends in Mesh Use for Pelvic Organ Prolapse Repair from the Medicare Database, Urology (2015), http://dx.doi.org/doi: 10.1016/j.urology.2015.08.022. This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.

Trends in Mesh Use for Pelvic Organ Prolapse Repair from the Medicare Database Authors: Lily C. Wang1,*, Bashir Al Hussein Al Awamlh1,*, Jim C. Hu1, Melissa A Laudano1, Wesley L. Davison1, Michael L Schulster1, Fujun Zhao2, Bilal Chughtai1, Richard K. Lee1 1) Department of Urology, Weill Medical College of Cornell University, New York, NY, USA 2) Department of Urology, Shanghai General Hospital, Shanghai Jiao Tong University, Shanghai, China * These authors contributed equally to this manuscript Runninghead: Trends in mesh-based prolapse repair

Keywords: pelvic mesh, Pelvic organ prolapse, women

Corresponding Author: Richard K. Lee Weill Cornell Medical College Department of Urology 425 East 61st Street New York, NY 10065 Office: (646)962-4811 Fax: (646)962-0140 e-mail: [email protected]

Word Count (Body): 2348 Word Count (Abstract): 219 (max 250) Word Count (Body+Abstract): 2567 (max 3000) Financial Support: none 1

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Abstract Objective: We sought to investigate recent trends in mesh use for pelvic organ prolapse (POP)-related reconstruction procedures. Methods: Using the 2001 to 2011 5% Medicare claims database, we identified POP diagnoses and related procedures. Transvaginal mesh use and sacrocolpopexy were first reported in 2005 and 2004, respectively. Results: 613,160 cases of vaginal and abdominal POP repair procedures were identified. The majority of procedures involved multiple compartments. The rate of mesh use increased dramatically from 2% of repairs in 2005 to 35% by 2008. After the FDA warning in 2008, mesh use plateaued and then decreased in 2011. Mesh was more commonly used in younger (OR 0.722, p<0.001), white (OR 0.712-0.791 for other races, p<0.001) women in the South (OR 0.741-0.848 for non-South regions, p<0.001). Starting in 2008, the rate of sacrocolpopexy procedures almost doubled yearly until 2011. Sacrocolpopexy was more common in younger patients (49% in women <70 years) and in white women (88%); the majority of sacrocolpopexies were performed in the South (60%) and laparoscopically (83-98%). Conclusions: The treatment of POP has changed over time. The use of mesh increased significantly until 2008, after which it plateaued following the FDA warning regarding mesh-related complications. Concurrently, the number of sacrocolpopexy procedures increased significantly starting in 2008 as the use of laparoscopic/robotic technique and concern regarding transvaginal mesh increased. 2

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Introduction Pelvic organ prolapse is a common condition affecting up to half of women and correlates with increasing age1. As the US population ages and the number of elderly women increases, treatment for conditions such as pelvic organ prolapse (POP) becomes more common and important in the health care system. Indeed, the demand for care of pelvic floor disorders has been projected to increase by 35% between 2010 and 2030.2 While the use of conservative management has been increasing, particularly in older women, more than 10% of females will still require some form of surgical treatment 3. Surgical options for POP have traditionally encompassed colporrhaphy and/or vaginal colpopexy or sacrocolpopexy. The introduction of transvaginal mesh kits was initially designed to facilitate transvaginal POP repair and make the surgeries easy to learn and to perform.

In October 2008, however, the FDA issued a notification denoting a

concerning rate of complications associated with the use of transvaginal mesh in POP repair. Interestingly, a study by Reynolds et al. then reported that the rate of mesh use continued to increase in the immediate period following the FDA notification4. In July 2011, the FDA issued an update to the previous notification, again emphasizing the complications associated with use of transvaginal mesh in POP repair.

3

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In this study, we sought to examine recent trends in POP repair, particularly with regards to the types of surgeries performed and the use of mesh over time. The impact of the FDA warnings on surgical trends and patterns was noted. Material and Methods After Institutional Review Board approval, Medicare claims data from the years 2001 until 2011 were obtained from the Centers for Medicare and Medicaid Services. The Public Use files include multiple datasets consisting of physician and hospital inpatient and outpatient medical claims. The data represent a 5% random sample of national beneficiaries. Patients with a urologic diagnosis of POP were identified on the basis of International Classification of Diseases, 9th Edition (ICD-9) codes (Appendix 1). Patients who underwent treatment of POP were identified on the basis ICD-9 Clinical Modification (ICD-9-CM) and Current Procedure Terminology (CPT-4) codes. Surgical procedures were classified by compartment (anterior, posterior, and apical). Patients with simultaneous multi-compartment repair were classified under “multiple” compartment repair (Appendix 2). Patients undergoing sacrocolpopexy were counted as receiving an apical compartment repair and were excluded from the transvaginal mesh analysis. Transvaginal mesh analysis included patients identified in 2005 and onwards, as the CPT-4 code was first developed in 2005 (Appendix 3). Of note, due to a coding limitation, the use of synthetic mesh could not be differentiated from the use of organic graft material allowing for overestimation of synthetic mesh use. In addition, the outpatient database may contain “observation stay” patients which may lead to an overestimation of outpatient procedures but this effect is likely small. 4

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To obtain national estimates, counts were multiplied by a constant weight of 20. 5 Patients were categorized according to year of treatment, age, race and geographical location.6 Statistical tests were two-sided and were performed using SPSS v22 (IBM Corp., Armonk, NY, USA) and SAS v9.3 (SAS institute Inc., Cary, NC, USA) Results A total of 613,160 cases of transvaginal and abdominal prolapse repair cases were identified between 2001 and 2011.

22% of surgeries addressed the anterior

compartment only, 10% posterior compartment only, 11% apical compartment only, while 57% involved multiple compartment repair (See Table 1). Multiple compartment repair represented the majority of cases (53 to 60%) in each of the years between 2001 and 2011, followed by anterior compartment-only repair (20 to 25%).

This trend

persisted over various age groups, geographical locations, and races. From 2001 to 2011, the rate of posterior repair declined, while the rate of apical repair increased. Isolated posterior repair was more common in younger women, while apical repair was more common in older women. Anterior and posterior repairs were more likely to occur in the outpatient setting, while apical and multiple compartment repairs were more likely to occur in the inpatient setting. Transvaginal mesh use in POP repair was first reported in 2005 with 1160 cases, comprising 2% of non-sacrocolpopexy repairs. The use of mesh increased significantly, increasing 16.5 times to 19,160 (35%) cases in 2008 (Table 2). Corresponding with the FDA notice regarding mesh-associated complications, the growth in transvaginal mesh use slowed after 2008, peaking at 21,140 (38.5%) in 2010 and then decreasing in 2011 5

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to 16,640 procedures (35.2%). In patients undergoing transvaginal POP repair, mesh was used more commonly in younger women (OR=0.72 in women >85 years vs. women aged 65-69) and in white women (OR 0.71-0.79 for other races, all p<0.001, Table 2). Mesh was also used more often in the South than in other regions of the US (OR=0.74-0.85 for other regions compared with the South, p<0.001). When mesh use was compared by compartment, apical and multiple compartment surgeries utilized mesh more often than anterior or posterior-only surgeries. Mesh was also more likely used in outpatient compared to inpatient procedures (OR=1.44, p<0.001). Similar to mesh use in POP procedures, the rate of sacrocolpopexy procedures increased steadily over the past decade. The annual volume of sacrocolopexy was fairly low from 2004 to 2007, averaging 100 to 180 cases yearly, representing 0.1-0.2% of total POP procedures (See Table 3). Corresponding with the FDA notification in 2008, however, the rate of sacrocolpopexies then nearly doubled yearly until a rate of 1720 cases in 2011, representing 1.8% of total POP procedures. Sacrocolpopexy was far more common in younger patients; of those patients undergoing sacrocokpopexy, 1960 (49%) were

69 years and younger. The vast majority (n=3560, 88%) of

sacrocolpopexy procedures were performed in white women, with a predominance (60%) of cases being performed in the South. The majority of sacrocolpopexies were performed laparoscopically, with only 20 to 40 (2 to 20%) performed in open fashion yearly (See Table 4). Of note, robotic assistance in laparoscopic cases was not coded in the Medicare database and its rate of utilization could therefore not be ascertained. Discussion 6

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The surgical treatment of POP has been changing over time, with significant influence from two FDA notifications influencing the use of transvaginal mesh. After mesh kits were initially introduced, the use of transvaginal mesh for POP repairs increased dramatically with provider adoption of technology that allowed POP repairs to be performed easily, quickly, and in the ambulatory setting. However, with the advent of reports on mesh-related complications such as vaginal erosion and the two subsequent FDA notifications as well as transvaginal mesh-related litigation, mesh use then plateaued and subsequently declined. Concomitantly, the rate of laparoscopic sacrocolpopexy increased as an alternative to transvaginal mesh repair. Similar to findings from Khan et al.,7 this study found that the stratification of POP repair by compartment has remained relatively constant over time, with multiple compartment repair performed in the inpatient setting representing the majority of surgeries. Mesh was more likely to be used in apical or multiple compartment repairs, likely reflecting the complexity or severity of POP in these patients. Interestingly, while the majority of transvaginal procedures using mesh (65.7%) were performed in the inpatient setting, mesh was more likely to be used in the outpatient setting (OR 1.44, p<0.001). It is unclear what accounts for this difference, but the use of transvaginal mesh kits may have played a role in allowing providers to offer more complex procedures in the outpatient setting. Mesh use however did not come without cost. The FDA notification of 2008 warned of mesh-related complications, vaginal erosions, infections, pain, urinary problems and recurrent symptoms. Several prior studies have examined the effect of the FDA 7

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notification on mesh use in POP surgery. Reynolds et al., for example, first studied the near-term effect of the FDA notification on mesh use in POP surgery using Medicare claims data, finding no difference in transvaginal mesh use up to the third quarter of 2009.4 Similarly, Elterman et al. examined case logs from the American Board of Urology (ABU) for 2003 to 2013, reporting that the use of transvaginal mesh in POP surgery increased rapidly initially and then remained constant between 2008 and 2013. 8 Jonsson Funk et al. also examined vaginal mesh use in commercial and Medicare claims databases between 2005 and 2010 and found that the use of transvaginal mesh increased during this period, encompassing 75% of all vaginal POP reconstructive procedures.9 In contrast to these prior studies, ours is the first to note a decline in mesh utilization contemporaneous with the FDA warnings. While we noted an increase in mesh use from 2005 to 2008 similar to other studies, a plateau in utilization was noted subsequent to the 2008 FDA notification. In fact, we also noted a subsequent decrease in the rate of mesh use in 2011 when the FDA issued an update to their original 2008 notification. Of note, the percentage of transvaginal mesh-based POP procedures, e.g. 35% in 2008 and up to 39% in 2010, was far lower compared to the studies of Elterman et al. (up to 60%) and Jonsson Funk et al. (75%), likely reflecting a decreased use of mesh in elderly woman who comprise the majority of relevant patients in the Medicare database. Indeed, this was confirmed by the significantly lower odds of mesh use in older women compared to younger women in our study (OR=0.72, p<0.001).

8

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Similar to Elterman et al. and Jonsson Funk et al., we found that the total rate of sacrocolpopexies increased from 2008 to 2011. This increase in sacrocolpopexy coincided with the plateau and subsequent decline in transvaginal mesh-augmented repairs over the same period of time and may reflect a shift from the use of transvaginal mesh to the use of transabdominal mesh. Since the first FDA notification, tens of thousands of lawsuits have been filed against the makers of transvaginal mesh and the providers who implanted them. Settlements in the multi-million dollar range have been awarded and the learned intermediary doctrine has been employed by mesh manufacturer to shift liability to medical professionals who use mesh. 10 In fact, advertisements seeking potential plaintiffs for anti-mesh litigation are pervasive in television ads, subway postings, and even Facebook pages. These lawsuits were likely fueled by and given legitimacy by the FDA notifications. The fear of litigation, in addition to the FDA notifications, likely dissuaded surgeons from offering transvaginal repairs with mesh while the barrage of negative publicity likely also deterred patients from consenting to transvaginal mesh. The use of transabdominal mesh offers an attractive alternative to transvaginal mesh but a recent study from Nygaard et al. warns against the durability of sacrocolpopexy repairs.11 While some practitioners continued to employ transvaginal mesh in POP surgeries, the decline in mesh use and the corresponding rise in sacrocolpopexies likely reflect both a surgeon response to increased litigation risk associated with mesh use as well as increased patient awareness regarding the potential complications of transvaginal mesh. It is interesting to note that use of sacrocolpopexy was not evenly distributed among different races or geographical regions of the US. Eighty-eight percent of all 9

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sacrocolpopexies were performed in white women, raising the question of whether differences existed in racial access to care. Geographic variation was also noted. While the South comprised 39% of all POP repairs nationally, it accounted for an even greater 59% of all sacrocolpopexy surgeries. This difference cannot be explained solely by a difference in adoption of new technology such as the da Vinci robotic system, as the rates of robotic-assisted laparoscopic prostatectomy and pyeloplasty were lower in the South compared to other parts of the US over the same time period.12,13 While an increased rate of POP surgery has also been reported in the South by other groups,9,14 the preponderance of sacrocolpopexy use in the region significantly outpaces the overall rate of POP surgery. Other potential explanations include surgeon or patient preference, but clearly this represents an area warranting further investigation. In addition, just as advertisements against transvaginal mesh may have influenced its use in POP repair, advertising for robotic surgeries may have also driven the rise in robotassisted laparoscopic sacrocolpopexies. The study possesses several strengths. It captures both inpatient and outpatient data from 2005 to 2011, allowing us to examine the use of transvaginal mesh in POP repairs at several different timepoints, including 1) when it was first coded in 2005, 2) the response to the initial FDA notification in 2008, and 3) the response to the subsequent FDA update in 2011. It leverages a population-based database including women of varying age groups, races, and geographical locations. A major limitation of this study however is the omission of younger women who are not included in the Medicare database. In addition, we were unable to assess clinical factors, such as the severity of prolapse, indication for surgery, or body mass index which may have played a role in 10

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the type of surgery performed. Due to coding limitations, we were unable to distinguish between the use of synthetic mesh and organic graft material leading to potential overestimation of synthetic mesh use. However, this overestimation is likely small 4 and would only contribute to underestimation of the decline in synthetic mesh use. We were also unfortunately not able to distinguish between laparoscopic and robot-assisted laparoscopic procedures due to the lack of a separate robotic billing code. However, given that robot-assisted laparoscopic sacrocolpopexy was first described in 2004, 15,16 it is likely that the increase in minimally-invasive sacrocoplpexies also reflects increased use of the robotic technique. Finally, this study is limited to claims data which may not fully reflect clinical practice patterns. The use of transvaginal mesh reflects the classic attempt to leverage new technologies to enhance surgical repair. However, its use serves as warning that all new technologies must eventually pass the scrutiny of not only rigorous preclinical testing but more importantly clinical experience. Conclusions The treatment of POP has changed over time. The use of mesh increased dramatically until 2008 when it plateaued after the FDA notification regarding mesh-related complications. The use of mesh then declined after the FDA update in 2011. Concurrently, the number of sacrocolpopexy procedures increased significantly starting in 2008 as the use of laparoscopic/robotic technique and concern regarding transvaginal mesh increased.

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Conflict of interest The authors declared that there is no conflict of interest.

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References 1. 2.

3. 4.

5. 6. 7.

8.

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Machin SE, Mukhopadhyay S. Pelvic organ prolapse: review of the aetiology, presentation, diagnosis and management. Menopause international. Dec 2011;17(4):132-136. Kirby AC, Luber KM, Menefee SA. An update on the current and future demand for care of pelvic floor disorders in the United States. American journal of obstetrics and gynecology. Dec 2013;209(6):584 e581-585. Hagen S, Stark D. Conservative prevention and management of pelvic organ prolapse in women. The Cochrane database of systematic reviews. 2011(12):CD003882. Reynolds WS, Gold KP, Ni S, Kaufman MR, Dmochowski RR, Penson DF. Immediate effects of the initial FDA notification on the use of surgical mesh for pelvic organ prolapse surgery in medicare beneficiaries. Neurourology and urodynamics. Apr 2013;32(4):330-335. Litwin MS, Saigal CS, Yano EM, et al. Urologic diseases in America Project: analytical methods and principal findings. The Journal of urology. Mar 2005;173(3):933-937. US Census Bureau. Census Regions and Divisions of the United States 1984. Khan AA, Eilber KS, Clemens JQ, Wu N, Pashos CL, Anger JT. Trends in management of pelvic organ prolapse among female Medicare beneficiaries. American journal of obstetrics and gynecology. Oct 19 2014. 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. The Journal of urology. Apr 2014;191(4):1022-1027. Jonsson Funk M, Edenfield AL, Pate V, Visco AG, Weidner AC, Wu JM. Trends in use of surgical mesh for pelvic organ prolapse. American journal of obstetrics and gynecology. Jan 2013;208(1):79 e71-77. Mucowski SJ, Jurnalov C, Phelps JY. Use of vaginal mesh in the face of recent FDA warnings and litigation. American journal of obstetrics and gynecology. Aug 2010;203(2):103 e101-104. Nygaard I, Brubaker L, Zyczynski HM, et al. Long-term outcomes following abdominal sacrocolpopexy for pelvic organ prolapse. Jama. May 15 2013;309(19):2016-2024. Kim SP, Boorjian SA, Shah ND, et al. Disparities in access to hospitals with robotic surgery for patients with prostate cancer undergoing radical prostatectomy. The Journal of urology. Feb 2013;189(2):514-520. Monn MF, Bahler CD, Schneider EB, Sundaram CP. Emerging trends in robotic pyeloplasty for the management of ureteropelvic junction obstruction in adults. The Journal of urology. Apr 2013;189(4):1352-1357. Brown JS, Waetjen LE, Subak LL, Thom DH, Van den Eeden S, Vittinghoff E. Pelvic organ prolapse surgery in the United States, 1997. American journal of obstetrics and gynecology. Apr 2002;186(4):712-716. Elliott DS, Frank I, Dimarco DS, Chow GK. Gynecologic use of robotically assisted laparoscopy: Sacrocolpopexy for the treatment of high-grade vaginal vault prolapse. American journal of surgery. Oct 2004;188(4A Suppl):52S-56S. Di Marco DS, Chow GK, Gettman MT, Elliott DS. Robotic-assisted laparoscopic sacrocolpopexy for treatment of vaginal vault prolapse. Urology. Feb 2004;63(2):373-376.

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Appendices: Appendix 1: POP ICD-9 diagnostic codes ICD-9 code Details 618.00

Unspecified prolapse of vaginal walls without mention of uterine prolapse

618.01

cystocele without mention of uterine prolapse, midline

618.02

cystocele without mention of uterine prolapse, lateral

618.03

urethrocele without mention of uterine prolapse

618.04

rectocele without mention of uterine prolapse

618.05

perineocele without mention of uterine prolapse

618.09

other prolapse of vaginal walls without mention of uterine prolapse

618.1

uterine prolapse without mention of vaginal wall prolapse

618.2

Uterovaginal prolapse, incomeplete

618.3

Uterovaginal prolapse, complete

618.4

Uterovaginal prolapse, unspecified

618.5

prolapse of vaginal vault after hysterectomy

618.6

vaginal enterocele, congenital or acquired

618.7

genital prolapse, old laceration of muscles of pelvic floor

618.81

incompetence or weakening of pubocervical tissue

618.82

incompetence or weakening of rectovaginal tissue

618.83

pelvic muscle wasting

618.84

cervical stump prolapse

618.89

Other specified genital prolapse

618.9

Unspecified genital prolapse

14

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Appendix 2: Coding for surgical repair of POP Code

Details

Anterior compartment 57240 Anterior colporrhaphy, repair of cystocele with or without repair of urethrocele 57285

Paravaginal defect repair (including repair of cystocele, if performed) – vaginal approach 57284 Paravaginal defect repair (including repair of cystocele, if performed) open abdominal approach 57423 Paravaginal defect repair (including repair of cystocele, if performed) – laparoscopic approach 57289 Pereyra procedure, including anterior colporrhaphy 70.51 Repair of Cystocele 70.54 repair of cystocele with graft or prosthesis Apical compartment 57268 Repair of enterocele, vaginal approach (separate procedure) 57270 Repair of enterocele, abd approach (separate procedure) 57282 Colpopexy, vaginal; extra-peritoneal approach (sacrospinous, illococcygeus) 57283 Colpopexy, vaginal; intra-peritoneal approach (uterosacral, levator myorrhaphy) 70.77 Vaginal suspension and fixation 70.78 Vaginal suspension and fixation with graft or prosthesis 70.92 Other operations on cul-de-sac 70.93 Other operations on cul-de-sac with graft 70.8 Obliteration of vaginal vault 57280 Sacrocolpopexy – abdominal approach 57425 Sacrocolpopexy – laparoscopic Posterior compartment 57250 Posterior colporrhaphy, repair of rectocele with or without perineorrhaphy 70.52 Repair of rectocele 70.55 repair of rectocele with graft or prosthesis Multiple compartment Repair 57265 Combined anteroposterior colporrhaphy, with enterocele repair 57260 Combined anteroposterior colporrhaphy 70.53 Repair of cystocele and rectocele with graft or prosthesis(anterior and posterior colporrhaphy) 70.50 Repair of cystocele and rectocele (anterior and posterior colporrhaphy) 15

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70.64 70.62

Vaginal reconstruction with graft or prosthesis Vaginal reconstruction

16

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Appendix 3: Coding for use of transvaginal mesh Code

Detail

57267

Insertion of mesh or other prosthesis for repair of pelvic floor defect

70.54

Repair of cystocele with graft or prosthesis

70.78

Vaginal suspension and fixation with graft or prosthesis

70.53

Repair of cystocele and rectocele with graft or prosthesis

70.55

Repair of rectocele with graft or prosthesis

70.94

Insertion Of Biological Graft

70.95

Insertion Of Synthetic Graft Or Prosthesis

70.93

Other operations on cul-de-sac with graft

70.64

Vaginal reconstruction with graft or prosthesis

Table 1 - Demographic and Clinical Data on Female Medicare Beneficiaries Undergoing POP Surgery 2001–2011

Compartments Total (%)

Anterior

Posterior

Apical

Multiple

137000 (22.3%)

59640 (9.7%)

64880 (10.6%)

351640 (57.3%)

P value

Year 2001

11780 (20.3%)

6440 (11.1%)

4600 (7.9%)

35140 (60.6%)

2002

11900 (20.8%)

6420 (11.2%)

5320 (9.3%)

33480 (58.6%)

2003

12740 (21.8%)

6280 (10.8%)

5360 (9.2%)

33960 (58.2%)

<0.0001

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2004

12620 (22.2%)

5640 (9.9%)

5360 (9.4%)

33180 (58.4%)

2005

11900 (20.7%)

5880 (10.2%)

6000 (10.4%)

33680 (58.6%)

2006

12980 (22.9%)

5520 (9.7%)

5320 (9.4%)

32980 (58.1%)

2007

12760 (23.4%)

5220 (9.6%)

5720 (10.5%)

30720 (56.4%)

2008

12800 (23.2%)

4160 (7.5%)

6120 (11.1%)

32060 (58.1%)

2009

13660 (24.9%)

4520 (8.2%)

6160 (11.2%)

30540 (55.6%)

2010

12880 (23.1%)

5060 (9.1%)

7440 (13.3%)

30380 (54.5%)

2011

10980 (22.6%)

4500 (9.3%)

7480 (15.4%)

25520 (52.6%)

<65

13280 (25.6%)

9120 (17.6%)

4220 (8.1%)

25300 (48.7%)

65-69

41640 (22.8%)

17760 (9.7%)

15840 (8.7%)

107340 (58.8%)

70-74

35600 (21.8%)

14620 (9.0%)

16140 (9.9%)

96700 (59.3%)

75-79

27840 (22.2%)

10640 (8.5%)

13600 (10.9%)

73120 (58.4%)

80-84

13080 (21.2%)

5300 (8.6%)

9400 (15.3%)

33840 (54.9%)

>85

4200 (18.6%)

1920 (8.5%)

4940 (21.9%)

11500 (51.0%)

N/A

1360 280 (4.5%) (21.9%)

740 (11.9%)

3840 (61.7%)

Age

<0.0001 18

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Race White

115080 (22.1%)

52080 (10.0%)

54300 (10.4%)

299800 (57.5%)

Black

4760 (25.6%)

1340 (7.2%)

2820 (15.2%)

9640 (51.9%)

Other

17160 (23.4%)

6220 (8.5%)

7760 (10.6%)

42200 (57.5%)

South

51640 (21.7%)

24280 (10.2%)

26300 (11.1%)

135540 (57.0%)

Northeast

17600 (23.0%)

6940 (9.1%)

8840 (11.5%)

43180 (56.4%)

Midwest

33580 (22.8%)

13960 (9.5%)

15080 (10.3%)

84400 (57.4%)

West

21540 (21.9%)

10460 (10.6%)

9220 (9.4%)

57080 (58.1%)

others

12640 (23.6%)

4000 (7.5%)

5440 (10.2%)

31440 (58.7%)

Inpatient

90420 (18.2%)

42300 (8.5%)

56240 (11.4%)

306500 (61.9%)

Outpatient

46580 (39.6%)

17340 (14.7%)

8640 (7.3%)

45140 (38.4%)

<0.0001

Geography

<0.0001

Setting

<0.0001

Table 2 – Transvaginal mesh use in POP Surgery in Female Medicare Beneficiaries 2005–2011 19

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Mesh

No Mesh

OR of Mesh (Confidence Interval)

P value

Year 2005

1160 (2.0%)

56220 (98.0%)

Reference

2006

2240 (3.9%)

54540 (96.1%)

2.07 (1.47-2.90)

2007

5680 (10.5%)

48560 (89.5%)

5.83 (4.30-7.92)

2008

19160 (34.9%)

35760 (65.1%)

32.51 (22.8-46.3)

2009

19960 (36.7%)

34420 (63.3%)

28.28 (21.2-37.8)

2010

21140 (38.5%)

33840 (61.5%)

30.17 (22.6-40.3)

2011

16640 (35.2%)

30620 (64.8%)

25.68 (19.2-34.4)

6940 (20.3%)

27200 (79.7%)

65-69

26500 (23.0%)

88500 (77.0%)

Reference

70-74

23220 (23.5%)

75780 (76.5%)

1.01 (0.92-1.11)

75-79

16200 (22.0%)

57420 (78.0%)

0.94 (0.85-1.05)

80-84

8040 (21.5%)

29380 (78.5%)

0.93 (0.81-1.06)

>85

2700 (18.6%)

11840 (81.4%)

0.72 (0.59-0.89)

N/A

2380 (38.3%)

3840 (61.7%)

White

64640 (21.1%)

241020 (78.9%)

Reference

Black

2200 (19.1%)

9300 (80.9%)

0.71 (0.55-0.93)

Other

19140 (30.5%)

43640 (69.5%)

0.79 (0.64-0.99)

<0.001

33080 (23.4%)

108240 (76.6%)

Reference

<0.001

<0.001

Age <65

<0.001

Race

Geography South

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8800 (19.7%)

35820 (80.3%)

0.79 (0.69-0.90)

Midwest

15280 (18.1%)

69360 (81.9%)

0.74 (0.66-0.83)

West

11860 (20.1%)

47060 (79.9%)

0.85 (0.75-0.96)

Others

16960 (33.6%)

33480 (66.4%)

0.82 (0.61-1.12)

Anterior

18700 (21.3%)

69260 (78.7%)

Reference

Posterior

4840 (13.9%)

30020 (86.1%)

0.66 (0.55-0.79)

Apical

10600 (25.7%)

30640 (74.3%)

1.41 (1.22-1.51)

Multiple

51840 (24.0%)

164040 (76.0%)

1.37 (1.24-1.51)

Inpatient

56440 (11.4%)

439020 (88.6%)

Reference

Outpatient

29560 (25.1%)

88140 (74.9%)

1.44 (1.31-1.57)

Northeast

Compartment

<0.001

Setting

<0.001

Table 3 – Sacrocolpopexy Surgery in Female Medicare Beneficiaries 2001–2011

% of Total Total P value Procedures Procedures

Sacrocolpopexy Year 2001

0

0.00%

57960

2002

0

0.00%

57120

2003

0

0.00%

58340

2004

140

0.10%

56800 <0.001

21

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2005

120

0.10%

57460

2006

100

0.10%

56800

2007

180

0.20%

54420

2008

340

0.30%

55160

2009

680

0.60%

54880

2010

780

0.70%

55740

2011

1720

1.80%

48480

360

0.30%

51920

65-69

1600

0.40%

182580

70-74

1140

0.40%

163060

75-79

560

0.20%

125200

80-84

280

0.20%

61620

>85

100

0.20%

22560

N/A

0

0.00%

White

3560

0.30%

521260

Black

120

0.30%

18560

Other

360

0.20%

73340 <0.001

2380

0.50%

237760

0.30%

76560

Age <65

6220 <0.001

Race

Geography South

Northeast Midwest

460 480

0.20%

147020 <0.001 22

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West

480

0.20%

98300

Others

240

0.20%

53520

Table 4 – Trends in open versus laparoscopic/robotic sacrocolpopexy in female Medicare beneficiaries 2004–2011

Sacrocolpopexy Technique Open

Laparoscopic / Robotic

Total Cases

Year 2004

20 (4.3%)

120 (85.7%)

140

2005

20 (16.7%)

100 (83.3%)

120

2006

20 (20.0%)

80 (80.0%)

100

2007

20 (11.1%)

160 (88.9%)

180

2008

20 (5.9%)

320 (94.1%)

340

2009

40 (5.9%)

640 (94.1%)

680

2010

40 (5.1%)

740 (94.9%)

780

2011

40 (2.3%)

1680 (97.7%)

1720

23

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