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Quality of Life after Hysteroscopic Myomectomy: A Prospective Observational Study
S148
Abstracts / Journal of Minimally Invasive Gynecology 21 (2014) S136–S190
Patients: Patients were treated with the AEGEAVapor System consisting of a Vapor Generator, Vapor Probe, and Integrity Test System. Following treatment, the alkaline hematin test and Quality of Life (QOL) questionnaires evaluated efficacy 3, 6, and 12 months. Safety was assessed postprocedure through 24 months. Intervention: 22 Patients were treated with the AEGEA Vapor System. At this time, all patients have completed the 12-month follow up visit. No device or ablation procedure related adverse events were reported. Primary effectiveness results meet the requirement of menstrual blood loss volume \80 ml by alkaline hematin at 3, 6 and 12 months posttreatment in the following percentages: 75% of patients at 3 months; 85% at 6 months, and 95% at 12 months. Secondary effectiveness results meet the requirement of reduction of menstrual blood loss volume >50% by alkaline hematin at 3, 6 and 12 months post-treatment in the following percentages: 90% of patients at 3 months; 90% at 6 months, and 100% at 12 months. All patients reported an improvement in their quality of life per questionnaire results. Measurements and Main Results: Results from this study support the safety and effectiveness of the AEGEA Vapor System to achieve endometrial ablation. 491 Endometrial Cancer Following Endometrial Ablation Tsafrir Z,1 Schiff L,1 Sangha R,1 Theoharis E,1 Mangat C,1 Siddiqui F,2 Elshiakh M,2 Eisenstein D.1 1Minimally Invasive Gynecologic Surgery, Henry Ford Hospital, Detroit, Michigan; 2Radiation Oncology, Henry Ford Hospital, Detroit, Michigan Study Objective: To evaluate clinical aspects of patients who had Endometrial cancer after Endometrial Ablation (EA). Design: Retrospective study (Canadian Task Force classification II-3). Setting: University affiliated Tertiary medical center in Southeastern Michigan. Patients: 3 patients who underwent endometrial ablation after exclusion of endometrial malignancy by biopsy, and were diagnosed later as having Endometrial cancer. Intervention: Patient who underwent endometrial ablation. Measurements and Main Results: All patients had multiple risk factors for endometrial cancer prior to EA [Table 1]. At time of EA, 2 patients were postmenopausal and additional patient was 37 years old. In all cases, endometrial cancer was excluded by endometrial sampling prior to EA. The EA method was Hysteroscopic endometrial resection. Vaginal bleeding was the first ominous symptom in all cases, and it occurred in a time range of 70-120 months post EA. Endometrial cancer was confirmed by office sampling. Surgery included total hysterectomy, bilateral salpingo-oophorectomy and LN sampling. Final pathology was Endometroid Adenocarcinoma in all 3 cases, at a stage of IA, IB and IIIC, respectively. The patient with stage IA disease did not receive adjuvant treatment, the patient with stage IB disease received pelvic radiation and the patient with stage IIIC disease received radiation +chemotherapy. Patients with stage I disease are in remission for at least 4 years, while the patient with stage III disease died 9 month from diagnoses. Table 1 Risk Factors for Endometrial Cancer
492 Quality of Life after Hysteroscopic Myomectomy: A Prospective Observational Study Uchil D,1 Vandrevala T.2 1Obstetrics and Gynaecology, Universiity Hospital Lewisham, London, United Kingdom; 2Research Design Service South East, University of Surrey, Guidlford, United Kingdom Study Objective: To assess difference in quality of life measures following hysteroscopic myomectomy in women with submucous fibroids. Design: Prospective observational study. Setting: Secondary care teaching hospital in inner London. Patients: Prememopausal women with submucosal fibroids undergoing hysteroscopic myomectomy. Intervention: Patients completed the UFS-QoL (Uterine fibroid symptoms and Quality of Life) questionnaire and an additional questionnaire on impact on daily activities and VAS scores for pain before hysteroscopic myomectomy. Women completed the same questionnaires at 3 and 6 months postoperatively. The UFS-QoL consists of 37 questions which are grouped to produce a Symptom Severity scale and a Health related quality of life (HRQL) scale which consists of 6 subscales. Measurements and Main Results: Sample size calculation suggested that 16 women needed to be recruited to demonstrate adequate power.Twenty women completed questionnaires at baseline and 3 months post surgery. Eighteen women completed questionnaires at 6 months. Prior to surgery, women had poor quality of life as evidenced by high symptom severity score and low HRQL scores. These scores were lower than those in the published literature suggesting that women with submucous fibroids are more symptomatic. In addition, there was considerable impact on daily
UFS-QoL and VAS scores at baseline and 3 months post surgery Subscale
Baseline (Mean) 3 months (mean) p value
Symptom severity score Concern Activities Energy Control Self-consciousness Sexual function Total HRQL VAS score
70.78 9.0 17.5 25.71 25.25 27.92 24.34 20.15 68.4
32.66 59.75 67.32 70.71 67.50 67.08 57.50 66.16 25.2
\0.001 \0.001 \0.001 \0.001 \0.001 \0.001 \0.001 \0.001 0.004
NB: Higher the symptom severity score, the poorer the quality of life. The higher the HRQL scores, the better the quality of life UFS-QoL and VAS scores at baseline and 6 months after surgery
Risk Factor
Case 1
Case 2
Case 3
Age (years) Obesity Hypertension Diabetes Mellitus Dysfunctional Uterine Bleeding Post Menopausal Bleeding Family h/o Cancer (Uterine/Ovarian/ Breast/Colon)
66 + + + +
37 + +
62 + + + + -
h/o: history of
Comparison of demographic, historical and clinical parameters did not distinguish these 3 cases except that the patient with stage III disease had prolonged undiagnosed postmenopausal bleeding. Conclusion: EA should be utilized with caution in patients with risk factors for endometrial cancer, particularly in postmenopausal age group. Further studies are needed to establish a risk assessment model to guide application of EA for abnormal uterine bleeding.
Subscale
Baseline (Mean)
6 months (Mean)
p value
Symptom severity Concern Activities Energy Control Selfconsciousness Sexual function Total HRQL VAS score
70.78 9.0 17.5 25.71 25.25 27.92
39.58 49.71 54.41 59.03 66.18 51.96
\0.001 0.002 \0.001 \0.001 \0.001 0.006
24.34 20.15 68.4
71.32 57.66 28.1
\0.001 \0.001 \0.001
Abstracts / Journal of Minimally Invasive Gynecology 21 (2014) S136–S190 activities and high pain scores. Following surgery, there was a significant improvement in all quality of life measures at 3 months (table 1) and this did not change significantly at 6 months (table 2). There was a reduction in absenteeism due to fibroid symptoms and pain scores after surgery. There was no statistically significant difference in scores between 3 and 6 months. Conclusion: This is the first prospective study looking at quality of life measures in women undergoing hysteroscopic myomectomy. Women with submucous fibroids have significantly poorer quality of life indicators prior to surgery compared to the published literature on fibroids. Hysteroscopic myomectomy is associated with significantly improved quality of life measures at 3 and 6 months post surgery. 493 10-Year Retrospective Analysis of Unintended Pregnancies after Essure Sterilization in the Netherlands Veersema S, Hitzerd E. Obstetrics & Gynecology, St. Antonius Hospital, Nieuwegein, Utrecht, Netherlands Study Objective: Essure sterilization is becoming increasingly popular in the Netherlands. Even though Essure is a permanent method of contraception, unintended pregnancies afterwards have been reported. The aim of this study is to identify factors that contribute to the occurrence of unintended pregnancies after Essure sterilization. Design: Retrospective case-series analysis. Setting: National multicenter. Patients: Thirty-five pregnancies were reported in the Netherlands after Essure sterilization from 2002 through 2013 out of an estimated 12,000 placements. Intervention: Data regarding Essure placement procedure, confirmation tests, and pregnancy outcome were obtained and analyzed of the reported cases to identify a cause of failure. Measurements and Main Results: The main causes of failure were perforation (n=10), expulsion (n=7), and unilateral placement (n=7). Another cause was luteal pregnancy (n=2). The occurrence of most pregnancies was related to physician noncompliance (n=14). The other cases were associated with patient noncompliance (n=5) or misinterpretation of the confirmation test (n=9). Time of conception was estimated to be more than three months after placement in most cases (n=26). Conclusion: The results of this study show that the incidence of pregnancies after Essure sterilization is low. Most pregnancies were related to incorrect positioning of a device or unilateral placement, and seem therefore preventable. We want to emphasize the importance of strictly adhering to placement and follow-up protocols, as well as excluding a luteal pregnancy before placement. Unilateral placement without prior history of salpingectomy should always be considered as unsuccessful sterilization. Furthermore, interpretation of the confirmation tests should be done by trained physicians, and with caution. 494 Two Minute Thermal Balloon Endometrial Ablation (Thermablate EASÔ) with and without Concomitant Hysteroscopic Fallopian Tube Micro-Inserts (EssureÔ) Placement Vilos A, Vilos G, Marks J, Oraif A, Abduljabar H, Doulaverakis C. The Fertility Clinic, LHSC, Division of REI, Department of Obstetrics and Gynecology, Schulich School of Medicine and Dentistry, Western University, London, Ontario, Canada Study Objective: To determine the feasibility, safety, and efficacy of the 2 minute Thermablate balloon endometrial ablation system, with and without concomitant hysteroscopic tubal occlusion with Essure micro-inserts, in women with abnormal uterine bleeding (AUB). Design: This is a prospective cohort trial including 66 women, (Thermablate alone, n=44, Thermablate + Essure, n=22), with AUB and/
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or requesting sterilization treated from January 2010 through December 2013 (II-2). Setting: University affiliated teaching hospital. Patients: Women presenting with AUB and/or requesting sterilization. Intervention: Pelvic examination determined the size, shape, tenderness, mobility, and position of the uterus. All women had pre-operative Pap smear, transvaginal sono(hystero)graphy to assess the uterine cavity and pelvic organs, and endometrial biopsy to determine ease of insertion, cavity length, patient tolerance, and obtain endometrial sample. All procedures were done under general anesthesia. Patients were assessed at baseline, 3, 6, 12 months and annually thereafter. Measurements and Main Results: The mean(SD) Age (years), BMI (m/kg2), Uterine Sound (cm) and Parity for Thermablate alone vs Thermablate + Essure was 43.1(5.1), 30.4(8.4), 8.9(1.0) and 2.0(1.1) vs 36.1(6.4), 29.4(8.2), 8.6(1.0) and 2.1(1.2) respectively with only age being statistically different between groups (unpaired t-test). At 1 year follow-up, the combined amenorrhea/hypomenorrhea and overall satisfaction rates where 66% and 68% for Thermablate alone vs 77% and 77% for Thermablate + Essure respectively with no statistical difference between the groups (X2). Women requiring re-intervention were considered not satisfied. In total, there were 9 re-interventions within the first year, all in the Thermablate alone group. They included 7 repeat hysteroscopic ablations, 1 subtotal hysterectomy and 1 woman requiring COC. The surgical pathology was adenomyosis in 2 women, fibroids in 1 woman and both in 1 woman. All other women had normal pathology. Conclusion: The two-minute Thermablate treatment is feasible, efficacious and safe and can be performed immediately after Essure micro-inserts placement.
495 Impact of Levonorgestrel Intrauterine Device on Endometrial Ablation Utilization for Treatment of Menorrhagia Wasson MN, Yuen HTH, Hoffman MK. Obstetrics and Gynecology, Christiana Care Health System, Newark, Delaware Study Objective: To determine changes in endometrial ablation utilization following Food and Drug Administration (FDA) approval of the levonorgestrel intrauterine device (IUD) for treatment of menorrhagia. Design: Retrospective cohort study. Setting: A large community-based academic medical center. Patients: All women who underwent endometrial ablation or levonorgestrel IUD placement for treatment of menorrhagia between January, 2009 and December, 2013 were considered for inclusion in the study. Women were excluded if the primary indication for treatment was not menorrhagia or if outpatient evaluation and treatment records were not available for review. Intervention: Levonorgestrel intrauterine device placement or second generation global endometrial ablation. Measurements and Main Results: A total of 231 women met study inclusion criteria and underwent endometrial ablation (N=183) or levonorgestrel IUD placement (N=48). The primary outcome measured was the number of patients undergoing endometrial ablation or levonorgestrel IUD placement prior to and following FDA approval of the levonorgestrel IUD for treatment of menorrhagia on October 1, 2009. Prior to FDA approval, 36 patients with menorrhagia were treated with endometrial ablation (80.00%) and 9 patients were treated with the levonorgestrel IUD (20.00%). Following FDA approval, 147 patients were treated with endometrial ablation (79.03%) and 39 patients were treated with the levonorgestrel IUD (20.97%) (p=0.886). Secondary outcomes measured included patient age, body mass index (BMI), and ethnicity. All secondary outcomes were not noted to have a statistically significant difference in patients treated prior to or following FDA approval of the levonorgestrel IUD for treatment of menorrhagia.
Abstracts / Journal of Minimally Invasive Gynecology 21 (2014) S136–S190
Patients: Patients were treated with the AEGEAVapor System consisting of a Vapor Generator, Vapor Probe, and Integrity Test System. Following treatment, the alkaline hematin test and Quality of Life (QOL) questionnaires evaluated efficacy 3, 6, and 12 months. Safety was assessed postprocedure through 24 months. Intervention: 22 Patients were treated with the AEGEA Vapor System. At this time, all patients have completed the 12-month follow up visit. No device or ablation procedure related adverse events were reported. Primary effectiveness results meet the requirement of menstrual blood loss volume \80 ml by alkaline hematin at 3, 6 and 12 months posttreatment in the following percentages: 75% of patients at 3 months; 85% at 6 months, and 95% at 12 months. Secondary effectiveness results meet the requirement of reduction of menstrual blood loss volume >50% by alkaline hematin at 3, 6 and 12 months post-treatment in the following percentages: 90% of patients at 3 months; 90% at 6 months, and 100% at 12 months. All patients reported an improvement in their quality of life per questionnaire results. Measurements and Main Results: Results from this study support the safety and effectiveness of the AEGEA Vapor System to achieve endometrial ablation. 491 Endometrial Cancer Following Endometrial Ablation Tsafrir Z,1 Schiff L,1 Sangha R,1 Theoharis E,1 Mangat C,1 Siddiqui F,2 Elshiakh M,2 Eisenstein D.1 1Minimally Invasive Gynecologic Surgery, Henry Ford Hospital, Detroit, Michigan; 2Radiation Oncology, Henry Ford Hospital, Detroit, Michigan Study Objective: To evaluate clinical aspects of patients who had Endometrial cancer after Endometrial Ablation (EA). Design: Retrospective study (Canadian Task Force classification II-3). Setting: University affiliated Tertiary medical center in Southeastern Michigan. Patients: 3 patients who underwent endometrial ablation after exclusion of endometrial malignancy by biopsy, and were diagnosed later as having Endometrial cancer. Intervention: Patient who underwent endometrial ablation. Measurements and Main Results: All patients had multiple risk factors for endometrial cancer prior to EA [Table 1]. At time of EA, 2 patients were postmenopausal and additional patient was 37 years old. In all cases, endometrial cancer was excluded by endometrial sampling prior to EA. The EA method was Hysteroscopic endometrial resection. Vaginal bleeding was the first ominous symptom in all cases, and it occurred in a time range of 70-120 months post EA. Endometrial cancer was confirmed by office sampling. Surgery included total hysterectomy, bilateral salpingo-oophorectomy and LN sampling. Final pathology was Endometroid Adenocarcinoma in all 3 cases, at a stage of IA, IB and IIIC, respectively. The patient with stage IA disease did not receive adjuvant treatment, the patient with stage IB disease received pelvic radiation and the patient with stage IIIC disease received radiation +chemotherapy. Patients with stage I disease are in remission for at least 4 years, while the patient with stage III disease died 9 month from diagnoses. Table 1 Risk Factors for Endometrial Cancer
492 Quality of Life after Hysteroscopic Myomectomy: A Prospective Observational Study Uchil D,1 Vandrevala T.2 1Obstetrics and Gynaecology, Universiity Hospital Lewisham, London, United Kingdom; 2Research Design Service South East, University of Surrey, Guidlford, United Kingdom Study Objective: To assess difference in quality of life measures following hysteroscopic myomectomy in women with submucous fibroids. Design: Prospective observational study. Setting: Secondary care teaching hospital in inner London. Patients: Prememopausal women with submucosal fibroids undergoing hysteroscopic myomectomy. Intervention: Patients completed the UFS-QoL (Uterine fibroid symptoms and Quality of Life) questionnaire and an additional questionnaire on impact on daily activities and VAS scores for pain before hysteroscopic myomectomy. Women completed the same questionnaires at 3 and 6 months postoperatively. The UFS-QoL consists of 37 questions which are grouped to produce a Symptom Severity scale and a Health related quality of life (HRQL) scale which consists of 6 subscales. Measurements and Main Results: Sample size calculation suggested that 16 women needed to be recruited to demonstrate adequate power.Twenty women completed questionnaires at baseline and 3 months post surgery. Eighteen women completed questionnaires at 6 months. Prior to surgery, women had poor quality of life as evidenced by high symptom severity score and low HRQL scores. These scores were lower than those in the published literature suggesting that women with submucous fibroids are more symptomatic. In addition, there was considerable impact on daily
UFS-QoL and VAS scores at baseline and 3 months post surgery Subscale
Baseline (Mean) 3 months (mean) p value
Symptom severity score Concern Activities Energy Control Self-consciousness Sexual function Total HRQL VAS score
70.78 9.0 17.5 25.71 25.25 27.92 24.34 20.15 68.4
32.66 59.75 67.32 70.71 67.50 67.08 57.50 66.16 25.2
\0.001 \0.001 \0.001 \0.001 \0.001 \0.001 \0.001 \0.001 0.004
NB: Higher the symptom severity score, the poorer the quality of life. The higher the HRQL scores, the better the quality of life UFS-QoL and VAS scores at baseline and 6 months after surgery
Risk Factor
Case 1
Case 2
Case 3
Age (years) Obesity Hypertension Diabetes Mellitus Dysfunctional Uterine Bleeding Post Menopausal Bleeding Family h/o Cancer (Uterine/Ovarian/ Breast/Colon)
66 + + + +
37 + +
62 + + + + -
h/o: history of
Comparison of demographic, historical and clinical parameters did not distinguish these 3 cases except that the patient with stage III disease had prolonged undiagnosed postmenopausal bleeding. Conclusion: EA should be utilized with caution in patients with risk factors for endometrial cancer, particularly in postmenopausal age group. Further studies are needed to establish a risk assessment model to guide application of EA for abnormal uterine bleeding.
Subscale
Baseline (Mean)
6 months (Mean)
p value
Symptom severity Concern Activities Energy Control Selfconsciousness Sexual function Total HRQL VAS score
70.78 9.0 17.5 25.71 25.25 27.92
39.58 49.71 54.41 59.03 66.18 51.96
\0.001 0.002 \0.001 \0.001 \0.001 0.006
24.34 20.15 68.4
71.32 57.66 28.1
\0.001 \0.001 \0.001
Abstracts / Journal of Minimally Invasive Gynecology 21 (2014) S136–S190 activities and high pain scores. Following surgery, there was a significant improvement in all quality of life measures at 3 months (table 1) and this did not change significantly at 6 months (table 2). There was a reduction in absenteeism due to fibroid symptoms and pain scores after surgery. There was no statistically significant difference in scores between 3 and 6 months. Conclusion: This is the first prospective study looking at quality of life measures in women undergoing hysteroscopic myomectomy. Women with submucous fibroids have significantly poorer quality of life indicators prior to surgery compared to the published literature on fibroids. Hysteroscopic myomectomy is associated with significantly improved quality of life measures at 3 and 6 months post surgery. 493 10-Year Retrospective Analysis of Unintended Pregnancies after Essure Sterilization in the Netherlands Veersema S, Hitzerd E. Obstetrics & Gynecology, St. Antonius Hospital, Nieuwegein, Utrecht, Netherlands Study Objective: Essure sterilization is becoming increasingly popular in the Netherlands. Even though Essure is a permanent method of contraception, unintended pregnancies afterwards have been reported. The aim of this study is to identify factors that contribute to the occurrence of unintended pregnancies after Essure sterilization. Design: Retrospective case-series analysis. Setting: National multicenter. Patients: Thirty-five pregnancies were reported in the Netherlands after Essure sterilization from 2002 through 2013 out of an estimated 12,000 placements. Intervention: Data regarding Essure placement procedure, confirmation tests, and pregnancy outcome were obtained and analyzed of the reported cases to identify a cause of failure. Measurements and Main Results: The main causes of failure were perforation (n=10), expulsion (n=7), and unilateral placement (n=7). Another cause was luteal pregnancy (n=2). The occurrence of most pregnancies was related to physician noncompliance (n=14). The other cases were associated with patient noncompliance (n=5) or misinterpretation of the confirmation test (n=9). Time of conception was estimated to be more than three months after placement in most cases (n=26). Conclusion: The results of this study show that the incidence of pregnancies after Essure sterilization is low. Most pregnancies were related to incorrect positioning of a device or unilateral placement, and seem therefore preventable. We want to emphasize the importance of strictly adhering to placement and follow-up protocols, as well as excluding a luteal pregnancy before placement. Unilateral placement without prior history of salpingectomy should always be considered as unsuccessful sterilization. Furthermore, interpretation of the confirmation tests should be done by trained physicians, and with caution. 494 Two Minute Thermal Balloon Endometrial Ablation (Thermablate EASÔ) with and without Concomitant Hysteroscopic Fallopian Tube Micro-Inserts (EssureÔ) Placement Vilos A, Vilos G, Marks J, Oraif A, Abduljabar H, Doulaverakis C. The Fertility Clinic, LHSC, Division of REI, Department of Obstetrics and Gynecology, Schulich School of Medicine and Dentistry, Western University, London, Ontario, Canada Study Objective: To determine the feasibility, safety, and efficacy of the 2 minute Thermablate balloon endometrial ablation system, with and without concomitant hysteroscopic tubal occlusion with Essure micro-inserts, in women with abnormal uterine bleeding (AUB). Design: This is a prospective cohort trial including 66 women, (Thermablate alone, n=44, Thermablate + Essure, n=22), with AUB and/
S149
or requesting sterilization treated from January 2010 through December 2013 (II-2). Setting: University affiliated teaching hospital. Patients: Women presenting with AUB and/or requesting sterilization. Intervention: Pelvic examination determined the size, shape, tenderness, mobility, and position of the uterus. All women had pre-operative Pap smear, transvaginal sono(hystero)graphy to assess the uterine cavity and pelvic organs, and endometrial biopsy to determine ease of insertion, cavity length, patient tolerance, and obtain endometrial sample. All procedures were done under general anesthesia. Patients were assessed at baseline, 3, 6, 12 months and annually thereafter. Measurements and Main Results: The mean(SD) Age (years), BMI (m/kg2), Uterine Sound (cm) and Parity for Thermablate alone vs Thermablate + Essure was 43.1(5.1), 30.4(8.4), 8.9(1.0) and 2.0(1.1) vs 36.1(6.4), 29.4(8.2), 8.6(1.0) and 2.1(1.2) respectively with only age being statistically different between groups (unpaired t-test). At 1 year follow-up, the combined amenorrhea/hypomenorrhea and overall satisfaction rates where 66% and 68% for Thermablate alone vs 77% and 77% for Thermablate + Essure respectively with no statistical difference between the groups (X2). Women requiring re-intervention were considered not satisfied. In total, there were 9 re-interventions within the first year, all in the Thermablate alone group. They included 7 repeat hysteroscopic ablations, 1 subtotal hysterectomy and 1 woman requiring COC. The surgical pathology was adenomyosis in 2 women, fibroids in 1 woman and both in 1 woman. All other women had normal pathology. Conclusion: The two-minute Thermablate treatment is feasible, efficacious and safe and can be performed immediately after Essure micro-inserts placement.
495 Impact of Levonorgestrel Intrauterine Device on Endometrial Ablation Utilization for Treatment of Menorrhagia Wasson MN, Yuen HTH, Hoffman MK. Obstetrics and Gynecology, Christiana Care Health System, Newark, Delaware Study Objective: To determine changes in endometrial ablation utilization following Food and Drug Administration (FDA) approval of the levonorgestrel intrauterine device (IUD) for treatment of menorrhagia. Design: Retrospective cohort study. Setting: A large community-based academic medical center. Patients: All women who underwent endometrial ablation or levonorgestrel IUD placement for treatment of menorrhagia between January, 2009 and December, 2013 were considered for inclusion in the study. Women were excluded if the primary indication for treatment was not menorrhagia or if outpatient evaluation and treatment records were not available for review. Intervention: Levonorgestrel intrauterine device placement or second generation global endometrial ablation. Measurements and Main Results: A total of 231 women met study inclusion criteria and underwent endometrial ablation (N=183) or levonorgestrel IUD placement (N=48). The primary outcome measured was the number of patients undergoing endometrial ablation or levonorgestrel IUD placement prior to and following FDA approval of the levonorgestrel IUD for treatment of menorrhagia on October 1, 2009. Prior to FDA approval, 36 patients with menorrhagia were treated with endometrial ablation (80.00%) and 9 patients were treated with the levonorgestrel IUD (20.00%). Following FDA approval, 147 patients were treated with endometrial ablation (79.03%) and 39 patients were treated with the levonorgestrel IUD (20.97%) (p=0.886). Secondary outcomes measured included patient age, body mass index (BMI), and ethnicity. All secondary outcomes were not noted to have a statistically significant difference in patients treated prior to or following FDA approval of the levonorgestrel IUD for treatment of menorrhagia.