Modular Program Report

Transcription

1 Modular Program Report Disclaimer The following report(s) provides findings from an FDA initiated query using Sentinel. While Sentinel queries may be undertaken to assess potential medical product safety risks, they may also be initiated for various other reasons. Some examples include determining a rate or count of an identified health outcome of interest, examining medical product use, exploring the feasibility of future, more detailed analyses within Sentinel, and seeking to better understand Sentinel capabilities. Data obtained through Sentinel are intended to complement other types of evidence such as preclinical studies, clinical trials, postmarket studies, and adverse event reports, all of which are used by FDA to inform regulatory decisions regarding medical product safety. The information contained in this report is provided as part of FDA s commitment to place knowledge acquired from Sentinel in the public domain as soon as possible. Any public health actions taken by FDA regarding products involved in Sentinel queries will continue to be communicated through existing channels. FDA wants to emphasize that the fact that FDA has initiated a query involving a medical product and is reporting findings related to that query does not mean that FDA is suggesting health care practitioners should change their prescribing practices for the medical product or that patients taking the medical product should stop using it. Patients who have questions about the use of an identified medical product should contact their health care practitioners. The following report contains a description of the request, request specifications, and results from the modular program run(s). If you are using a web page screen reader and are unable to access this document, please contact the Sentinel Operations Center for assistance at info@sentinelsystem.org.

2 Request ID: cdrh_mpl1r_wp002_nsdp_v01 Overview for Request ID cdrh_mpl1r_wp002_nsdp_v01 Request Description: This report contains rates and estimates of the number of females with laparoscopic, abdominal, and vaginal hysterectomies and myomectomies with and without use of morcellators and with and without prior uterine fibroid diagnoses. Sentinel Modular Program Tool Used: Cohort Identification and Descriptive Analysis tool, version Data Source: Data from 1, 2008 up to 30, 2016 from 16 health plans contributing to the Sentinel Distributed Database (SDD) are included in this report. This request was distributed on 1, See Appendix A for a list of the latest dates of available data for each Data Partner. Study Design: This request was designed to calculate background rates. The numbers and rates of females with hysterectomies and myomectomies in the SDD were calculated overall and stratified by age group, year, and month. Events of Interest: The events of interest were laparoscopic, abdominal, or vaginal hysterectomies or myomectomies. These procedures were defined using International Classification of Diseases, 9th Revision, Clinical Modification (ICD-9-CM) procedure codes, International Classification of Diseases, 10th Revision, Clinical Modification (ICD-10-CM) procedure codes, and Current Procedural Terminology, 4th Edition (CPT-4) procedure codes (see Appendix B for a list of codes). Females with the procedures of interest, as well as morcellator use and/or a history of uterine fibroids, were also identified. Healthcare Common Procedure Coding System (HCPCS) Level II code C1782 was used to identify morcellator use. ICD-9-CM and ICD-10-CM diagnosis codes were used to identify uterine fibroid diagnoses (see Appendix C). Cohort Eligibility Criteria: The cohorts were restricted to female members only. The following age groups were analyzed: 0-49 and 50+ years. Females included in the cohorts were required to be continuously enrolled in health plans with medical coverage for at least 6 months (183 days) prior to their hysterectomy or myomectomy, during which gaps in coverage of up to 45 days were allowed. The procedures of interest could occur in any care setting. Use of morcellation was defined as a hysterectomy or myomectomy procedure that occurred on the same day as a morcellator procedure. Eight of the sixteen cohorts required patients to have had a prior diagnosis of uterine fibroids to be included. For these cohorts, history of uterine fibroids was defined as having a uterine fibroids diagnosis in any care setting within the 6 months (183 days) prior to the procedure of interest (see Appendix C for specific codes). For all cohorts, patients with a previous hysterectomy anytime in their entire available history prior to their index date were excluded (see Appendix D for specific codes). Please see Appendix E for the specifications of parameters used in the analyses for this request. Limitations: The procedures and pre-existing conditions may have been misclassified due to imperfect algorithms used to identify them. Notes: Please contact the Sentinel Operations Center Query Fulfillment Team (qf@sentinelsystem.org) for questions and to provide comments/suggestions for future enhancements to this document.

3 Glossary Table of Contents List of Terms Found in this Report and their Definitions Table 1 Summary of Hysterectomy and Myomectomy Procedures in the SDD between 1, 2008 and 30, 2016, by Type of Procedure and Prior Uterine Fibroid Diagnosis Table 2 Summary of Hysterectomy and Myomectomy Procedures in the SDD between 1, 2008 and 30, 2016, by Type of Procedure, Prior Uterine Fibroid Diagnosis, and Age Group Table 3 Summary of Hysterectomy and Myomectomy Procedures in the SDD between 1, 2008 and 30, 2016, by Type of Procedure, Prior Uterine Fibroid Diagnosis, and Year Table 4 Summary of Hysterectomy and Myomectomy Procedures in the SDD between 1, 2008 and 30, 2016, by Type of Procedure, Prior Uterine Fibroid Diagnosis, and Month Table 5 Summary of Hysterectomy and Myomectomy Procedures in the SDD between 1, 2008 and 30, 2016, by Figures 1-2 Graphs of Rates of Hysterectomy and Myomectomy Procedures in the SDD between 1, 2008 and 30, 2016 by Type of Procedure and Prior Uterine Fibroid Diagnosis Appendix A Latest Date of Available Data for Each Data Partner up to Request End Date ( 30, 2016) Appendix B Appendix C Appendix D Appendix E List of Procedure Codes Used to Define Hysterectomies, Myomectomies, and Morcellation List of Diagnosis Codes Used to Define Uterine Fibroids List of Procedure Codes Used to Define the Hysterectomy Exclusion Specifications Defining Parameters Used in this Request

4 Glossary of Terms for Analyses Using Cohort Identification and Descriptive Analysis (CIDA) Tool* Amount Supplied - number of units (pills, tablets, vials) dispensed. Net amount per NDC per dispensing. Blackout Period - number of days at the beginning of a treatment episode that events are to be ignored. If an event occurs during the blackout period, the episode is excluded. Care Setting - type of medical encounter or facility where the exposure, event, or condition code was recorded. Possible care settings include: Inpatient Hospital Stay (IP), Non-Acute Institutional Stay (IS), Emergency Department (ED), Ambulatory Visit (AV), and Other Ambulatory Visit (OA). For laboratory results, possible care settings include: Emergency department (E), Home (H), Inpatient (I), Outpatient (O), or Unknown or Missing (U). Along with the Principal Diagnosis Indicator, forms the Care Setting/PDX parameter. Ambulatory Visit (AV) - includes visits at outpatient clinics, same-day surgeries, urgent care visits, and other same-day ambulatory hospital encounters, but excludes emergency department encounters. Emergency Department (ED) - includes ED encounters that become inpatient stays (in which case inpatient stays would be a separate encounter). Excludes urgent care visits. Inpatient Hospital Stay (IP) - includes all inpatient stays, same-day hospital discharges, hospital transfers, and acute hospital care where the discharge is after the admission date. Non-Acute Institutional Stay (IS) - includes hospice, skilled nursing facility (SNF), rehab center, nursing home, residential, overnight non-hospital dialysis and other non-hospital stays. Other Ambulatory Visit (OA) - includes other non overnight AV encounters such as hospice visits, home health visits, skilled nursing facility visits, other non-hospital visits, as well as telemedicine, telephone and consultations. Cohort Definition (drug/exposure) - indicates how the cohort will be defined: (1) 01: Cohort includes only the first valid treatment episode during the query period; (2) 02: Cohort includes all valid treatment episodes during the query period; (3) 03: Cohort includes all valid treatment episodes during Days Supplied - number of days supplied for all dispensings in qualifying treatment episodes. - number of members eligible for an incident treatment episode (defined by the drug/exposure and event washout periods) with drug and medical coverage during the query period. Enrollment Gap - number of days allowed between two consecutive enrollment periods without breaking a continuously enrolled sequence. Episodes - treatment episodes; length of episode is determined by days supplied in one dispensing or consecutive dispensings bridged by the episode Episode Gap - number of days allowed between two (or more) consecutive exposures (dispensings/procedures) to be considered the same treatment Event Deduplication - specifies how events are counted by the MP algorithm: (0) 0: Counts all occurrences of an HOI during an exposure episode; (1) 1: de-duplicates occurrences of the same HOI code and code type on the same day; (2) 2: de-duplicates occurrences of the same HOI group on the same day (e.g., de-duplicates at the group level). Exposure Episode Length - number of days after exposure initiation that is considered "exposed time." Exposure Extension Period - number of days post treatment period in which the outcomes/events are counted for a treatment episode. Extensions days are added after any episode gaps have been bridged Lookback Period - number of days wherein a member is required to have evidence of pre-existing condition (diagnosis/procedure/drug dispensing). Maximum Episode Duration - truncates exposure episodes after a requester-specified number of exposed days. Applied after any gaps are bridged and extension days added to the length of the exposure episode. Member-Years - sum of all days of enrollment with medical and drug coverage in the query period preceded by an exposure washout period all Minimum Days Supplied - specifies a minimum number of days in length of the days supplied for the episode to be considered. Minimum Episode Duration - specifies a minimum number of days in length of the episode for it to be considered. Applied after any gaps are bridged and extension days added to the length of the exposure episode. Monitoring Period - used to define time periods of interest for both sequential analysis and simple cohort characterization requests. Principal Diagnosis (PDX) - diagnosis or condition established to be chiefly responsible for admission of the patient to the hospital. 'P' = principal diagnosis, 'S' = secondary diagnosis, 'X' = unspecified diagnosis, '.' = blank. Along with the Care Setting values, forms the Caresetting/PDX parameter. Query Period - period in which the modular program looks for exposures and outcomes of interest. Treatment Episode Truncation Indicator - indicates whether the exposure episode will be truncated at the occurrence of a requester-specified code. Washout Period (drug/exposure) - number of days a user is required to have no evidence of prior exposure (drug dispensing/procedure) and continuous drug and medical coverage prior to an incident treatment episode. Washout Period (event/outcome) - number of days a user is required to have no evidence of a prior event (procedure/diagnosis) and continuous drug and medical coverage prior to an incident treatment episode. Years at Risk - number of days supplied plus any episode gaps and exposure extension periods all divided by *all terms may not be used in this report

5 Table 1: Summary of Hysterectomy and Myomectomy Procedures in the Sentinel Distributed Database (SDD) between 1, 2008 and 30, 2016, by Type of Procedure and Prior Uterine Fibroid Diagnosis Procedure Number of Females with Procedure (Females Only) Member- Years Number of Females with Procedure/ 1K Abdominal Hysterectomy 349,573 85,538, ,833, Abdominal Hysterectomy with Prior Uterine Fibroid Diagnosis 240,691 3,455,618 2,132, Abdominal or Vaginal Myomectomy 119,362 85,538, ,547, Abdominal or Vaginal Myomectomy with Prior Uterine Fibroid Diagnosis 88,432 3,455,618 2,072, Laparoscopic Hysterectomy 585,222 85,538, ,833, Laparoscopic Hysterectomy with Prior Uterine Fibroid Diagnosis 368,708 3,455,618 2,132, Laparoscopic Hysterectomy with Morcellation 15,354 85,538, ,833, Laparoscopic Hysterectomy with Morcellation and Prior Uterine Fibroid Diagnosis 10,936 3,455,618 2,132, Laparoscopic Myomectomy 43,213 85,538, ,748, Laparoscopic Myomectomy with Prior Uterine Fibroid Diagnosis 38,277 3,455,618 2,107, Laparoscopic Myomectomy with Morcellation 2,711 85,538, ,827, Laparoscopic Myomectomy with Morcellation and Prior Uterine Fibroid Diagnosis 2,620 3,455,618 2,130, Morcellation with any Procedure 18,457 85,538, ,827, Morcellation with any Procedure and Prior Uterine Fibroid Diagnosis 13,765 3,455,618 2,130, Vaginal Hysterectomy 179,531 85,538, ,833, Vaginal Hysterectomy with Prior Uterine Fibroid Diagnosis 85,170 3,455,618 2,132,

6 Table 2: Summary of Hysterectomy and Myomectomy Procedures in the Sentinel Distributed Database (SDD) between 1, 2008 and 30, 2016, by Type of Procedure, Prior Uterine Fibroid Diagnosis, and Age Group Procedure Age Group (Years) Number of Females with Procedure (Females Only) Member- Years Number of Females with Procedure/ 1K Abdominal Hysterectomy Abdominal Hysterectomy with Prior Uterine Fibroid Diagnosis Abdominal or Vaginal Myomectomy Abdominal or Vaginal Myomectomy with Prior Uterine Fibroid Diagnosis Laparoscopic Hysterectomy Laparoscopic Hysterectomy with Prior Uterine Fibroid Diagnosis Laparoscopic Hysterectomy with Morcellation Laparoscopic Hysterectomy with Morcellation and Prior Uterine Fibroid Diagnosis Laparoscopic Myomectomy Laparoscopic Myomectomy with Prior Uterine Fibroid Diagnosis Laparoscopic Myomectomy with Morcellation Laparoscopic Myomectomy with Morcellation and Prior Uterine Fibroid Diagnosis Morcellation with any Procedure Morcellation with any Procedure and Prior Uterine Fibroid Diagnosis Vaginal Hysterectomy Vaginal Hysterectomy with Prior Uterine Fibroid Diagnosis ,981 62,598, ,619, ,592 27,236,221 89,213, ,591 2,272,217 1,337, ,100 1,345, , ,578 62,598, ,406, ,784 27,229,212 89,141, ,186 2,272,217 1,284, ,246 1,343, , ,555 62,598, ,619, ,667 27,236,221 89,213, ,726 2,272,217 1,337, ,982 1,345, , ,983 62,598, ,619, ,371 27,236,221 89,213, ,846 2,272,217 1,337, ,090 1,345, , ,981 62,598, ,545, ,232 27,234,725 89,202, ,214 2,272,217 1,315, ,063 1,344, , ,558 62,598, ,615, ,236,142 89,212, ,488 2,272,217 1,335, ,344, , ,762 62,598, ,614, ,695 27,236,109 89,212, ,485 2,272,217 1,335, ,280 1,344, , ,768 62,598, ,619, ,763 27,236,221 89,213, ,021 2,272,217 1,337, ,149 1,345, ,

7 Table 3: Summary of Hysterectomy and Myomectomy Procedures in the Sentinel Distributed Database (SDD) between 1, 2008 and 30, 2016, by Type of Procedure, Prior Uterine Fibroid Diagnosis, and Year Procedure Year (Females Only) Member- Years Abdominal Hysterectomy Abdominal Hysterectomy with Prior Uterine Fibroid Diagnosis Abdominal or Vaginal Myomectomy Abdominal or Vaginal Myomectomy with Prior Uterine Fibroid Diagnosis ,875 34,905,274 22,059, ,819 36,670,129 29,652, ,765 36,064,930 29,256, ,413 36,160,918 29,552, ,759 37,399,562 30,348, ,349 37,784,673 31,103, ,998 38,366,116 30,930, ,092 38,365,815 31,119, ,503 30,254,437 13,809, , , , , , , , , , , , , , , , , , , , , , , , , , , , ,769 34,905,274 22,054, ,914 36,658,411 29,633, ,039 36,040,842 29,227, ,281 36,127,836 29,515, ,797 37,359,695 30,307, ,050 37,742,253 31,060, ,262 38,321,823 30,886, ,804 38,319,632 31,073, ,446 30,211,921 13,788, , , , , , , , , , , , , , , , , , , , , , , , , , , ,

8 Table 3: Summary of Hysterectomy and Myomectomy Procedures in the Sentinel Distributed Database (SDD) between 1, 2008 and 30, 2016, by Type of Procedure, Prior Uterine Fibroid Diagnosis, and Year Procedure Year (Females Only) Member- Years Laparoscopic Hysterectomy Laparoscopic Hysterectomy with Prior Uterine Fibroid Diagnosis Laparoscopic Hysterectomy with Morcellation Laparoscopic Hysterectomy with Morcellation and Prior Uterine Fibroid Diagnosis ,249 34,905,274 22,059, ,358 36,670,129 29,652, ,955 36,064,930 29,256, ,372 36,160,918 29,552, ,022 37,399,562 30,348, ,716 37,784,673 31,103, ,708 38,366,116 30,930, ,464 38,365,815 31,119, ,378 30,254,437 13,809, , , , , , , , , , , , , , , , , , , , , , , , , , , , ,905,274 22,059, ,670,129 29,652, ,797 36,064,930 29,256, ,998 36,160,918 29,552, ,014 37,399,562 30,348, ,138 37,784,673 31,103, ,897 38,366,116 30,930, ,365,815 31,119, ,254,437 13,809, , , , , , , , , , , , , , , , , , , , , , , ,

9 Table 3: Summary of Hysterectomy and Myomectomy Procedures in the Sentinel Distributed Database (SDD) between 1, 2008 and 30, 2016, by Type of Procedure, Prior Uterine Fibroid Diagnosis, and Year Procedure Year (Females Only) Member- Years Laparoscopic Myomectomy Laparoscopic Myomectomy with Prior Uterine Fibroid Diagnosis Laparoscopic Myomectomy with Morcellation Laparoscopic Myomectomy with Morcellation and Prior Uterine Fibroid Diagnosis ,732 34,905,274 22,058, ,378 36,667,924 29,649, ,099 36,060,002 29,249, ,567 36,153,290 29,543, ,153 37,389,417 30,336, ,462 37,772,022 31,089, ,352 38,351,165 30,915, ,114 38,349,572 31,103, ,356 30,238,556 13,801, , , , , , , , , , , , , , , , , , , , , , , , , , , , ,905,274 22,059, ,670,038 29,652, ,064,724 29,256, ,160,570 29,551, ,399,031 30,347, ,783,911 31,102, ,365,062 30,929, ,364,665 31,118, ,253,417 13,809, , , , , , , , , , , , , , , , , , ,

10 Table 3: Summary of Hysterectomy and Myomectomy Procedures in the Sentinel Distributed Database (SDD) between 1, 2008 and 30, 2016, by Type of Procedure, Prior Uterine Fibroid Diagnosis, and Year Procedure Year (Females Only) Member- Years Morcellation with any Procedure Morcellation with any Procedure and Prior Uterine Fibroid Diagnosis Vaginal Hysterectomy Vaginal Hysterectomy with Prior Uterine Fibroid Diagnosis ,905,274 22,059, ,194 36,670,013 29,652, ,102 36,064,659 29,255, ,472 36,160,494 29,551, ,578 37,398,934 30,347, ,800 37,783,794 31,102, ,364 38,364,899 30,929, ,364,451 31,118, ,253,219 13,809, , , , , , , , , , , , , , , , , , , , , , , , ,656 34,905,274 22,059, ,817 36,670,129 29,652, ,985 36,064,930 29,256, ,092 36,160,918 29,552, ,673 37,399,562 30,348, ,704 37,784,673 31,103, ,666 38,366,116 30,930, ,466 38,365,815 31,119, ,472 30,254,437 13,809, , , , , , , , , , , , , , , , , , , , , , , , , , , ,

11 Table 4: Summary of Hysterectomy and Myomectomy Procedures in the Sentinel Distributed Database (SDD) between 1, 2008 and 30, 2016, by Type of Procedure, Prior Uterine Fibroid Diagnosis, and Month Year Month with Procedure (Females Only) Abdominal Hysterectomy Member- Years with Procedure/ 1K Eligible Members 2,479 13,960,254 1,166, ,190 13,804,212 1,091, ,159 13,863,652 1,171, ,335 13,883,318 1,135, ,150 13,853,964 1,171, ,501 13,782,254 1,128, ,722 30,434,368 2,528, ,038 30,796,654 2,572, ,116 30,277,833 2,477, ,306 30,671,066 2,562, ,794 30,287,870 2,479, ,085 31,035,461 2,572, ,715 29,113,211 2,422, ,209 28,678,034 2,189, ,792 28,799,797 2,432, ,449 28,829,735 2,359, ,121 28,804,250 2,435, ,392 28,674,037 2,347, ,428 31,131,504 2,616, ,738 31,347,075 2,622, ,680 30,792,991 2,521, ,729 30,997,050 2,597, ,954 30,639,496 2,509, ,612 31,185,977 2,597, ,934 28,804,273 2,402, ,829 28,414,333 2,170, ,361 28,494,293 2,407, ,819 28,473,961 2,331, ,807 28,407,539 2,403, ,576 28,261,994 2,313, ,318 30,589,067 2,572, ,182 30,787,721 2,576, ,895 30,290,958 2,480, ,915 30,537,745 2,558, ,354 30,199,179 2,473, ,775 30,864,746 2,565, ,508 28,956,925 2,413, ,228 28,590,437 2,185, ,701 28,751,885 2,429, ,364 28,787,664 2,356, ,397 28,762,519 2,432, ,040 28,670,998 2,347, ,662 30,861,763 2,596, ,860 31,072,443 2,600, ,372 30,602,267 2,505, ,509 30,878,933 2,586, ,749 30,560,428 2,502, ,023 31,219,200 2,595,

12 Table 4: Summary of Hysterectomy and Myomectomy Procedures in the Sentinel Distributed Database (SDD) between 1, 2008 and 30, 2016, by Type of Procedure, Prior Uterine Fibroid Diagnosis, and Month Year Month with Procedure (Females Only) Member- Years with Procedure/ 1K Eligible Members 3,124 29,216,369 2,437, ,115 28,875,759 2,285, ,123 28,943,659 2,445, ,846 29,005,160 2,375, ,043 28,976,001 2,451, ,230 28,935,634 2,370, ,335 32,016,630 2,698, ,151 32,272,285 2,697, ,785 31,811,012 2,604, ,316 32,071,988 2,687, ,355 31,740,743 2,600, ,336 32,334,310 2,694, ,684 30,577,233 2,541, ,554 30,231,023 2,310, ,563 30,564,564 2,581, ,757 30,556,470 2,502, ,778 30,532,537 2,583, ,848 30,386,947 2,489, ,122 32,349,582 2,723, ,884 32,499,453 2,722, ,650 32,015,248 2,621, ,049 32,251,575 2,704, ,950 31,924,566 2,615, ,510 32,543,326 2,706, ,468 30,236,754 2,522, ,307 29,894,034 2,284, ,446 30,039,432 2,539, ,608 30,057,994 2,460, ,665 30,002,571 2,538, ,044 30,011,130 2,457, ,190 32,569,607 2,739, ,691 32,691,417 2,712, ,810 31,959,207 2,617, ,100 32,448,762 2,710, ,944 32,089,052 2,629, ,725 32,626,211 2,717, ,444 30,416,072 2,537, ,376 30,076,785 2,278, ,747 30,205,985 2,551, ,607 30,255,047 2,476, ,471 30,245,188 2,558, ,061 30,258,812 2,478, ,993 32,540,378 2,738, ,709 32,838,844 2,739, ,713 32,351,209 2,649, ,754 32,639,742 2,734, ,835 32,287,887 2,645, ,382 32,782,635 2,732, ,081 28,343,725 2,340, ,131 27,687,976 2,192, ,330 27,888,693 2,348, ,117 27,854,481 2,281, ,215 27,874,516 2,358, ,629 27,905,861 2,286,

13 Table 4: Summary of Hysterectomy and Myomectomy Procedures in the Sentinel Distributed Database (SDD) between 1, 2008 and 30, 2016, by Type of Procedure, Prior Uterine Fibroid Diagnosis, and Month Year Month with Procedure (Females Only) Abdominal Hysterectomy with Prior Uterine Fibroid Diagnosis Member- Years with Procedure/ 1K Eligible Members 1, ,757 9, , ,334 8, , ,104 9, , ,249 8, , ,504 9, , ,011 8, , ,094 22, , ,181 22, , ,321 21, , ,246 22, , ,218 22, , ,994 23, , ,921 21, , ,531 19, , ,254 21, , ,094 20, , ,478 21, , ,385 20, , ,304 23, , ,848 23, , ,481 22, , ,708 23, , ,118 23, , ,197 23, , ,800 21, , ,736 19, , ,719 21, , ,932 20, , ,893 20, , ,266 20, , ,259 22, , ,630 22, , ,270 22, , ,059 22, , ,785 22, , ,612 23, , ,778 21, , ,941 19, , ,723 21, , ,044 20, , ,360 21, , ,653 20, , ,929 22, , ,151 22, , ,629 22, , ,238 22, , ,162 22, , ,641 23,

14 Table 4: Summary of Hysterectomy and Myomectomy Procedures in the Sentinel Distributed Database (SDD) between 1, 2008 and 30, 2016, by Type of Procedure, Prior Uterine Fibroid Diagnosis, and Month Year Month with Procedure (Females Only) Member- Years with Procedure/ 1K Eligible Members 2, ,800 21, , ,385 20, , ,361 21, , ,801 20, , ,802 21, , ,088 20, , ,420 23, , ,288 23, , ,907 22, , ,750 22, , ,172 22, , ,932 22, , ,893 21, , ,774 19, , ,752 21, , ,512 20, , ,035 21, , ,713 20, , ,100 22, , ,967 22, , ,255 22, , ,085 23, , ,688 22, , ,673 23, , ,141 21, , ,293 19, , ,633 21, , ,069 20, , ,364 20, , ,715 20, , ,067 22, , ,000 22, , ,179 22, , ,252 22, , ,604 22, , ,239 23, , ,995 21, , ,209 18, , ,207 21, , ,855 20, , ,456 20, , ,124 20, , ,260 22, , ,255 23, , ,234 22, , ,048 23, , ,594 22, , ,778 23, , ,706 20, , ,870 18, , ,930 20, , ,212 19, , ,590 20, , ,074 19,

15 Table 4: Summary of Hysterectomy and Myomectomy Procedures in the Sentinel Distributed Database (SDD) between 1, 2008 and 30, 2016, by Type of Procedure, Prior Uterine Fibroid Diagnosis, and Month Year Month with Procedure (Females Only) Abdominal or Vaginal Myomectomy Member- Years with Procedure/ 1K Eligible Members ,960,254 1,166, ,803,559 1,091, ,862,412 1,171, ,881,478 1,135, ,851,556 1,171, ,779,283 1,128, ,888 30,430,844 2,528, ,697 30,791,507 2,571, ,702 30,271,270 2,477, ,875 30,663,072 2,561, ,591 30,278,323 2,479, ,926 31,024,627 2,571, ,605 29,101,579 2,421, ,542 28,665,183 2,188, ,628 28,785,741 2,431, ,632 28,814,482 2,357, ,590 28,787,741 2,433, ,689 28,656,359 2,346, ,785 31,112,736 2,615, ,691 31,327,035 2,621, ,645 30,771,863 2,519, ,678 30,974,859 2,595, ,597 30,616,136 2,507, ,832 31,161,470 2,595, ,375 28,780,553 2,400, ,271 28,389,792 2,168, ,517 28,468,954 2,405, ,520 28,447,706 2,328, ,369 28,380,327 2,400, ,517 28,234,024 2,311, ,636 30,560,353 2,570, ,580 30,758,066 2,573, ,484 30,260,451 2,477, ,525 30,506,402 2,555, ,596 30,166,900 2,471, ,649 30,831,371 2,562, ,328 28,924,591 2,410, ,285 28,557,490 2,182, ,510 28,718,199 2,426, ,485 28,753,106 2,353, ,363 28,727,113 2,429, ,517 28,634,879 2,344, ,431 30,824,897 2,593, ,518 31,034,784 2,597, ,498 30,563,902 2,502, ,423 30,839,720 2,583, ,465 30,520,532 2,499, ,458 31,178,426 2,591,

16 Table 4: Summary of Hysterectomy and Myomectomy Procedures in the Sentinel Distributed Database (SDD) between 1, 2008 and 30, 2016, by Type of Procedure, Prior Uterine Fibroid Diagnosis, and Month Year Month with Procedure (Females Only) Member- Years with Procedure/ 1K Eligible Members 1,095 29,177,477 2,433, ,047 28,836,487 2,282, ,020 28,904,111 2,442, ,965,289 2,372, ,042 28,935,771 2,447, ,045 28,895,051 2,366, ,138 31,975,686 2,695, ,110 32,230,881 2,693, ,769,277 2,601, ,111 32,029,927 2,683, ,111 31,698,278 2,596, ,151 32,291,192 2,690, ,536,192 2,538, ,189,756 2,307, ,522,956 2,578, ,012 30,514,526 2,498, ,058 30,490,170 2,579, ,344,222 2,485, ,101 32,306,446 2,719, ,011 32,455,825 2,718, ,971,434 2,618, ,037 32,207,359 2,701, ,009 31,879,994 2,611, ,155 32,498,161 2,702, ,194,445 2,518, ,851,560 2,281, ,996,618 2,535, ,014,871 2,457, ,959,159 2,534, ,967,308 2,454, ,057 32,525,026 2,735, ,646,469 2,708, ,914,383 2,613, ,403,463 2,707, ,043,481 2,625, ,083 32,580,195 2,713, ,372,006 2,533, ,032,563 2,274, ,161,713 2,547, ,210,447 2,472, ,200,254 2,554, ,213,555 2,474, ,494,237 2,734, ,792,253 2,735, ,304,492 2,646, ,592,752 2,730, ,240,832 2,641, ,735,274 2,728, ,301,754 2,337, ,646,322 2,189, ,846,830 2,345, ,812,676 2,278, ,832,590 2,355, ,863,856 2,283,

17 Table 4: Summary of Hysterectomy and Myomectomy Procedures in the Sentinel Distributed Database (SDD) between 1, 2008 and 30, 2016, by Type of Procedure, Prior Uterine Fibroid Diagnosis, and Month Year Month with Procedure (Females Only) Member- Years Abdominal or Vaginal Myomectomy with Prior Uterine Fibroid Diagnosis with Procedure/ 1K Eligible Members ,757 9, ,926 8, ,335 9, ,088 8, ,983 8, ,149 8, , ,861 21, , ,080 22, , ,540 21, , ,809 22, , ,069 21, , ,240 22, , ,829 20, , ,333 18, , ,873 20, , ,504 20, , ,753 20, , ,519 20, , ,342 23, , ,619 23, , ,081 22, , ,184 23, , ,434 22, , ,305 22, ,335 20, ,332 18, , ,269 20, , ,438 19, ,350 20, , ,715 19, , ,746 22, , ,896 22, ,365 21, , ,145 22, , ,739 21, , ,338 22, ,918 20, ,136 18, , ,819 20, ,013 19, ,236 20, , ,498 19, ,784 21, , ,833 22, ,177 21, ,678 22, , ,480 21, , ,753 22,

18 Table 4: Summary of Hysterectomy and Myomectomy Procedures in the Sentinel Distributed Database (SDD) between 1, 2008 and 30, 2016, by Type of Procedure, Prior Uterine Fibroid Diagnosis, and Month Year Month with Procedure (Females Only) Member- Years with Procedure/ 1K Eligible Members ,555 20, ,204 19, ,185 20, ,699 19, ,796 20, ,169 19, ,686 22, ,435 22, ,046 21, ,823 22, ,168 21, ,699 22, ,043 20, ,950 18, ,932 20, ,710 19, ,099 20, ,752 19, ,122 21, ,791 22, ,092 21, ,784 22, ,342 21, ,222 22, ,185 20, ,494 18, ,740 20, ,084 19, ,358 20, ,684 19, ,985 22, ,765 22, ,948 21, ,882 22, ,296 21, ,790 22, ,936 20, ,273 18, ,187 20, ,737 19, ,327 20, ,966 19, ,020 22, ,861 22, ,785 21, ,580 22, ,143 22, ,244 22, ,208 19, ,547 18, ,457 19, ,773 19, ,225 19, ,737 19,

19 Table 4: Summary of Hysterectomy and Myomectomy Procedures in the Sentinel Distributed Database (SDD) between 1, 2008 and 30, 2016, by Type of Procedure, Prior Uterine Fibroid Diagnosis, and Month Year Month with Procedure (Females Only) Laparoscopic Hysterectomy Member- Years with Procedure/ 1K Eligible Members 1,534 13,960,254 1,166, ,334 13,804,212 1,091, ,363 13,863,652 1,171, ,504 13,883,318 1,135, ,391 13,853,964 1,171, ,678 13,782,254 1,128, ,200 30,434,368 2,528, ,710 30,796,654 2,572, ,795 30,277,833 2,477, ,118 30,671,066 2,562, ,145 30,287,870 2,479, ,477 31,035,461 2,572, ,900 29,113,211 2,422, ,653 28,678,034 2,189, ,289 28,799,797 2,432, ,186 28,829,735 2,359, ,006 28,804,250 2,435, ,931 28,674,037 2,347, ,232 31,131,504 2,616, ,785 31,347,075 2,622, ,888 30,792,991 2,521, ,778 30,997,050 2,597, ,122 30,639,496 2,509, ,588 31,185,977 2,597, ,356 28,804,273 2,402, ,268 28,414,333 2,170, ,123 28,494,293 2,407, ,709 28,473,961 2,331, ,661 28,407,539 2,403, ,709 28,261,994 2,313, ,631 30,589,067 2,572, ,546 30,787,721 2,576, ,340 30,290,958 2,480, ,515 30,537,745 2,558, ,506 30,199,179 2,473, ,591 30,864,746 2,565, ,111 28,956,925 2,413, ,891 28,590,437 2,185, ,768 28,751,885 2,429, ,061 28,787,664 2,356, ,546 28,762,519 2,432, ,425 28,670,998 2,347, ,103 30,861,763 2,596, ,485 31,072,443 2,600, ,936 30,602,267 2,505, ,248 30,878,933 2,586, ,340 30,560,428 2,502, ,458 31,219,200 2,595,

20 Table 4: Summary of Hysterectomy and Myomectomy Procedures in the Sentinel Distributed Database (SDD) between 1, 2008 and 30, 2016, by Type of Procedure, Prior Uterine Fibroid Diagnosis, and Month Year Month with Procedure (Females Only) Member- Years with Procedure/ 1K Eligible Members 5,839 29,216,369 2,437, ,947 28,875,759 2,285, ,321 28,943,659 2,445, ,783 29,005,160 2,375, ,357 28,976,001 2,451, ,584 28,935,634 2,370, ,010 32,016,630 2,698, ,113 32,272,285 2,697, ,092 31,811,012 2,604, ,405 32,071,988 2,687, ,908 31,740,743 2,600, ,663 32,334,310 2,694, ,378 30,577,233 2,541, ,880 30,231,023 2,310, ,098 30,564,564 2,581, ,429 30,556,470 2,502, ,630 30,532,537 2,583, ,810 30,386,947 2,489, ,303 32,349,582 2,723, ,050 32,499,453 2,722, ,634 32,015,248 2,621, ,744 32,251,575 2,704, ,797 31,924,566 2,615, ,963 32,543,326 2,706, ,352 30,236,754 2,522, ,553 29,894,034 2,284, ,135 30,039,432 2,539, ,167 30,057,994 2,460, ,071 30,002,571 2,538, ,396 30,011,130 2,457, ,979 32,569,607 2,739, ,035 32,691,417 2,712, ,362 31,959,207 2,617, ,834 32,448,762 2,710, ,761 32,089,052 2,629, ,063 32,626,211 2,717, ,384 30,416,072 2,537, ,315 30,076,785 2,278, ,905 30,205,985 2,551, ,824 30,255,047 2,476, ,616 30,245,188 2,558, ,931 30,258,812 2,478, ,805 32,540,378 2,738, ,179 32,838,844 2,739, ,387 32,351,209 2,649, ,731 32,639,742 2,734, ,212 32,287,887 2,645, ,175 32,782,635 2,732, ,012 28,343,725 2,340, ,321 27,687,976 2,192, ,982 27,888,693 2,348, ,420 27,854,481 2,281, ,869 27,874,516 2,358, ,774 27,905,861 2,286,

21 Table 4: Summary of Hysterectomy and Myomectomy Procedures in the Sentinel Distributed Database (SDD) between 1, 2008 and 30, 2016, by Type of Procedure, Prior Uterine Fibroid Diagnosis, and Month Year Month with Procedure (Females Only) Laparoscopic Hysterectomy with Prior Uterine Fibroid Diagnosis Member- Years with Procedure/ 1K Eligible Members ,757 9, ,334 8, ,104 9, ,249 8, ,504 9, , ,011 8, , ,094 22, , ,181 22, , ,321 21, , ,246 22, , ,218 22, , ,994 23, , ,921 21, , ,531 19, , ,254 21, , ,094 20, , ,478 21, , ,385 20, , ,304 23, , ,848 23, , ,481 22, , ,708 23, , ,118 23, , ,197 23, , ,800 21, , ,736 19, , ,719 21, , ,932 20, , ,893 20, , ,266 20, , ,259 22, , ,630 22, , ,270 22, , ,059 22, , ,785 22, , ,612 23, , ,778 21, , ,941 19, , ,723 21, , ,044 20, , ,360 21, , ,653 20, , ,929 22, , ,151 22, , ,629 22, , ,238 22, , ,162 22, , ,641 23,

22 Table 4: Summary of Hysterectomy and Myomectomy Procedures in the Sentinel Distributed Database (SDD) between 1, 2008 and 30, 2016, by Type of Procedure, Prior Uterine Fibroid Diagnosis, and Month Year Month with Procedure (Females Only) Member- Years with Procedure/ 1K Eligible Members 3, ,800 21, , ,385 20, , ,361 21, , ,801 20, , ,802 21, , ,088 20, , ,420 23, , ,288 23, , ,907 22, , ,750 22, , ,172 22, , ,932 22, , ,893 21, , ,774 19, , ,752 21, , ,512 20, , ,035 21, , ,713 20, , ,100 22, , ,967 22, , ,255 22, , ,085 23, , ,688 22, , ,673 23, , ,141 21, , ,293 19, , ,633 21, , ,069 20, , ,364 20, , ,715 20, , ,067 22, , ,000 22, , ,179 22, , ,252 22, , ,604 22, , ,239 23, , ,995 21, , ,209 18, , ,207 21, , ,855 20, , ,456 20, , ,124 20, , ,260 22, , ,255 23, , ,234 22, , ,048 23, , ,594 22, , ,778 23, , ,706 20, , ,870 18, , ,930 20, , ,212 19, , ,590 20, , ,074 19,

23 Table 4: Summary of Hysterectomy and Myomectomy Procedures in the Sentinel Distributed Database (SDD) between 1, 2008 and 30, 2016, by Type of Procedure, Prior Uterine Fibroid Diagnosis, and Month Year Month with Procedure (Females Only) Laparoscopic Hysterectomy with Morcellation Member- Years with Procedure/ 1K Eligible Members 48 13,960,254 1,166, ,804,212 1,091, ,863,652 1,171, ,883,318 1,135, ,853,964 1,171, ,782,254 1,128, ,434,368 2,528, ,796,654 2,572, ,277,833 2,477, ,671,066 2,562, ,287,870 2,479, ,035,461 2,572, ,113,211 2,422, ,678,034 2,189, ,799,797 2,432, ,829,735 2,359, ,804,250 2,435, ,674,037 2,347, ,131,504 2,616, ,347,075 2,622, ,792,991 2,521, ,997,050 2,597, ,639,496 2,509, ,185,977 2,597, ,804,273 2,402, ,414,333 2,170, ,494,293 2,407, ,473,961 2,331, ,407,539 2,403, ,261,994 2,313, ,589,067 2,572, ,787,721 2,576, ,290,958 2,480, ,537,745 2,558, ,199,179 2,473, ,864,746 2,565, ,956,925 2,413, ,590,437 2,185, ,751,885 2,429, ,787,664 2,356, ,762,519 2,432, ,670,998 2,347, ,861,763 2,596, ,072,443 2,600, ,602,267 2,505, ,878,933 2,586, ,560,428 2,502, ,219,200 2,595,

24 Table 4: Summary of Hysterectomy and Myomectomy Procedures in the Sentinel Distributed Database (SDD) between 1, 2008 and 30, 2016, by Type of Procedure, Prior Uterine Fibroid Diagnosis, and Month Year Month with Procedure (Females Only) Member- Years with Procedure/ 1K Eligible Members ,216,369 2,437, ,875,759 2,285, ,943,659 2,445, ,005,160 2,375, ,976,001 2,451, ,935,634 2,370, ,016,630 2,698, ,272,285 2,697, ,811,012 2,604, ,071,988 2,687, ,740,743 2,600, ,334,310 2,694, ,577,233 2,541, ,231,023 2,310, ,564,564 2,581, ,556,470 2,502, ,532,537 2,583, ,386,947 2,489, ,349,582 2,723, ,499,453 2,722, ,015,248 2,621, ,251,575 2,704, ,924,566 2,615, ,543,326 2,706, ,236,754 2,522, ,894,034 2,284, ,039,432 2,539, ,057,994 2,460, ,002,571 2,538, ,011,130 2,457, ,569,607 2,739, ,691,417 2,712, ,959,207 2,617, ,448,762 2,710, ,089,052 2,629, ,626,211 2,717, ,416,072 2,537, ,076,785 2,278, ,205,985 2,551, ,255,047 2,476, ,245,188 2,558, ,258,812 2,478, ,540,378 2,738, ,838,844 2,739, ,351,209 2,649, ,639,742 2,734, ,287,887 2,645, ,782,635 2,732, ,343,725 2,340, ,687,976 2,192, ,888,693 2,348, ,854,481 2,281, ,874,516 2,358, ,905,861 2,286,

25 Table 4: Summary of Hysterectomy and Myomectomy Procedures in the Sentinel Distributed Database (SDD) between 1, 2008 and 30, 2016, by Type of Procedure, Prior Uterine Fibroid Diagnosis, and Month Year Month with Procedure (Females Only) Member- Years Laparoscopic Hysterectomy with Morcellation and Prior Uterine Fibroid Diagnosis with Procedure/ 1K Eligible Members ,757 9, ,334 8, ,104 9, ,249 8, ,504 9, ,011 8, ,094 22, ,181 22, ,321 21, ,246 22, ,218 22, ,994 23, ,921 21, ,531 19, ,254 21, ,094 20, ,478 21, ,385 20, ,304 23, ,848 23, ,481 22, ,708 23, ,118 23, ,197 23, ,800 21, ,736 19, ,719 21, ,932 20, ,893 20, ,266 20, ,259 22, ,630 22, ,270 22, ,059 22, ,785 22, ,612 23, ,778 21, ,941 19, ,723 21, ,044 20, ,360 21, ,653 20, ,929 22, ,151 22, ,629 22, ,238 22, ,162 22, ,641 23,