Be a Surgical “Multiplier” in MIGS Inspire Brilliance Through Teamwork

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Scientific Program ChairJubilee Brown, MD

Honorary ChairBarbara S. Levy, MD

PresidentMarie Fidela R. Paraiso, MD

SYLLABUSPANEL SESSION 4:

Debate: “There Will Be an Answer, Let It Be” – Expert Debate on Treatments for

Endometriosis Associated Pain

Professional Education Information

Target Audience This educational activity is developed to meet the needs of surgical gynecologists in practice and in training, as well as other healthcare professionals in the field of gynecology. Accreditation AAGL is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians. The AAGL designates this live activity for a maximum of 1.75 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity. Disclosure of Relevant Financial Relationships As a provider accredited by the Accreditation Council for Continuing Medical Education, AAGL must ensure balance, independence, and objectivity in all CME activities to promote improvements in health care and not proprietary interests of a commercial interest. The provider controls all decisions related to identification of CME needs, determination of educational objectives, selection and presentation of content, selection of all persons and organizations that will be in a position to control the content, selection of educational methods, and evaluation of the activity. Course chairs, planning committee members, presenters, authors, moderators, panel members, and others in a position to control the content of this activity are required to disclose relevant financial relationships with commercial interests related to the subject matter of this educational activity. Learners are able to assess the potential for commercial bias in information when complete disclosure, resolution of conflicts of interest, and acknowledgment of commercial support are provided prior to the activity. Informed learners are the final safeguards in assuring that a CME activity is independent from commercial support. We believe this mechanism contributes to the transparency and accountability of CME. Anti-Harassment Statement AAGL encourages its members to interact with each other for the purposes of professional development and scholarly interchange so that all members may learn, network, and enjoy the company of colleagues in a professional atmosphere. Consequently, it is the policy of the AAGL to provide an environment free from all forms of discrimination, harassment, and retaliation to its members and guests at all regional educational meetings or courses, the annual global congress (i.e. annual meeting), and AAGL-hosted social events (AAGL sponsored activities). Every individual associated with the AAGL has a duty to maintain this environment free of harassment and intimidation. AAGL encourages reporting all perceived incidents of harassment, discrimination, or retaliation. Any individual covered by this policy who believes that he or she has been subjected to such an inappropriate incident has two (2) options for reporting:

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Table of Contents Course Description ........................................................................................................................................ 1 Disclosure ...................................................................................................................................................... 2 Patient Centered Management of Endometriosis S. Pierce-Richards ......................................................................................................................................... 3 Medical Management of Endometriosis – Can It Solve the Painful Problem? M. Billow ....................................................................................................................................................... 5 Surgery the Only Answer D.B. Redwine ................................................................................................................................................. 7 Cultural and Linguistics Competency ........................................................................................................... 9

Panel Session 4: Debate: “There Will Be an Answer, Let It Be” – Expert Debate on Treatments for Endometriosis Associated Pain

Moderator: Frank F. Tu Faculty: Megan Billow, Susan Pierce-Richards, David B. Redwine

Course Description This session provides a forum to critically, holistically, and “combatively” address treatment of Endometriosis, an enigmatic condition that can significantly impact an individual’s quality of life. Its varied clinical presentation, pain symptoms, and confounding medical conditions lead to not only diagnostic challenges but also controversial treatment considerations. This session will host a lively debate regarding the optimal treatment for endometriosis. Panelists will discuss evidence-based strategies for medical management, surgical management, and interdisciplinary care coordination to support patient-centered goals. Challenging clinical scenarios will be discussed to discern best approaches to the treatments for endometriosis associated pain.

Course Objectives At the conclusion of this activity, the participant will be able to: 1) Formulate valid, specific, patient-affirming multidisciplinary treatment plans for endometriosis-associated pelvic pain.

Course Outline

11:00 Welcome, Introductions, and Course Overview F. Tu11:05 Patient Centered Management of Endometriosis S. Pierce-

Richards11:25 Medical Management of Endometriosis – Can It Solve the Painful

Problem? M. Billow

11:45 Surgery the Only Answer D.B. Redwine12:05 The Down and Dirty Clinical Realities: EAPP Management in the Real

World All Faculty

12:25 Questions & Answers All Faculty12:45 Adjourn

Page 1

PLANNER DISCLOSURE The following members of AAGL have been involved in the educational planning of this workshop (listed in alphabetical order by last name). Art Arellano, Professional Education Director, AAGL* Linda D. Bradley, Medical Director, AAGL* Erin T. Carey Consultant: MedIQ Mark W. Dassel Contracted Research: Myovant Sciences Erica Dun* Adi Katz* Linda Michels, Executive Director, AAGL* Erinn M. Myers Speakers Bureau: Laborie Medical Technologies, Teleflex Medical Other: Unrestricted educational grant to support NC FPMRS Fellow Cadaver Lab: Boston Scientific Corp. Inc. Amy Park* Grace Phan, Professional Education Specialist, AAGL* Harold Y. Wu* Linda C. Yang Other: Ownership Interest: KLAAS LLC Frank F. Tu Consultant: AbbVie, Uroshape Speakers Bureau: AbbVie

SCIENTIFIC PROGRAM COMMITTEE Linda D. Bradley, Medical Director, AAGL* Jubilee Brown* Nichole Mahnert* Shanti Indira Mohling* Fariba Mohtashami Consultant: Hologic Marie Fidela R. Paraiso* Shailesh P. Puntambekar* Matthew T. Siedhoff Consultant: Applied Medical, Caldera Medical, CooperSurgical, Olympus Amanda C. Yunker Consultant: Olympus Linda Michels, Executive Director, AAGL*

FACULTY DISCLOSURE The following have agreed to provide verbal disclosure of their relationships prior to their presentations. They have also agreed to support their presentations and clinical recommendations with the “best available evidence” from medical literature (in alphabetical order by last name). Megan Billow Consultant: AbbVie Susan Pierce-Richards* David B. Redwine* Frank F. Tu Consultant: AbbVie, Uroshape Speakers Bureau: AbbVie

Content Reviewer has nothing to disclose.

Asterisk (*) denotes no financial relationships to disclose.

Page 2

Patient-Centered Management of Endometriosis

Susan Pierce-Richards, DNP, ARNP, FNP-BC, ANP-BC, RN-BCCAPT, US Public Health Service

Nurse Practitioner/Clinical Informaticist/Senior Health Insurance Specialist

Disclosure

● I have no financial relationships to disclose

● Disclaimer: The views presented herein do not represent the views of the Federal Government

Objectives

● Describe the impact of endometriosis on patients and the health care system1-3

● Recognize biases and limitations in the literature that impact the application of evidence in an evidence-informed, person-centered approach to care

● Identify areas of your practice where you can better engage with and empower patients

Brokengirl… the secret shame of pelvic pain

UrgencyFrequencyObstipation

DysmenorrheaDyscheziaMenorrhagiaFixed uterusDyspareunia

Pelvic fullness“Hemorrhagic” cystsInfertilityFlank painHematochezia

Bleeding x 3 years

Stopped seeking care

Hyst for bleeding –dx endometriosis

Excision + appy/LAR

NauseaSBO sxMelena

Teens… 30s…. 40s…20s…

Symptom onset: Early teensFamily hx of endo: M, MGM

Time to dx: 30+ yearTime on hormones pre dx: 19+ years

What is person-centered care?

The ideal4

● Dignity, compassion, respect ● Coordinated care● Personalized care● Collaborative and empowering Invalidation

Psychologization

Castration

Hopelessness

The reality5-11

Dx & Tx delay

Repeated ablation surgery

What evidence do we need to support PCC?

● Is our evidence base patient-centered?12-14

● Are meta-analyses of RCTs the best evidence?12-19

● Do we really engage in shared decision making?12, 14, 20

● Do we appreciate the power imbalances?8,9,12

● What happens outside of the exam room?12

● What about the people we don’t see?12

Understand limitations and biases … appraise carefully

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What can I do differently to meet patients needs?

Dimensions of patient centered endometriosis care20:● Respect for patient’s values, preferences, and needs6,7,8,11,14,20

● Information, communication, and education6,7,20

● Continuity and transition7,20,21

● Access to care20

● Technical skills18,20

“’Evidence-based, patient-focused’ ideology”14

“‘Evidence-informed, person-centered’ health and social care”14

Summary

“I will remember that there is an art to medicine as well as a science, and that the warmth, sympathy, and understanding may outweigh the surgeon’s knife or the chemists drug.”22 Dr. Louis Lasagna

Your words, silence, and actions are powerful

Choose them wisely

Ask, listen, hear, validate, ACT

References1. Nnoaham, K. E., Hummelshoj, L., Webster, P., D’Hooghe, T., de Cicco Nardone, F., de Cicco

Nardone, C., … Zondervan, K. T. (2011). Impact of endometriosis on quality of life and work productivity: a multicenter study across ten countries. Fertility and Sterility, 96(2), 366-373.e8. https://doi.org/10.1016/j.fertnstert.2011.05.090

2. D’Hooghe, T., Dirksen, C. D., Dunselman, G. A. J., de Graaff, A., & Simoens, S. (2012). The costs of endometriosis: it’s the economy, stupid. Fertility and Sterility, 98(3), S218–S219. https://doi.org/10.1016/j.fertnstert.2012.07.791

3. Howard, F. (2016). Causes of chronic pelvic pain in women (R. L. Barbieri & K. Eckler, Eds.). Retrieved February 6, 2016, from Up To Date website: http://www.uptodate.com/contents/chronic-pelvic-pain-in-women-beyond-the-basics

4. The Heatlh Foundation. (2016). Person-centred care made simple. Retrieved from https://www.health.org.uk/sites/default/files/PersonCentredCareMadeSimple_0.pdf

5. Gjesdal, K., Dysvik, E., & Furnes, B. (2018). Living with chronic pain: Patients’ experiences with healthcare services in Norway. Nurs Open, 5(4), 517–526. https://doi.org/10.1002/nop2.160

6. Grundstrom, H., Alehagen, S., Kjolhede, P., & Bertero, C. (2018). The double-edged experience of healthcare encounters among women with endometriosis: A qualitative study. Journal of Clinical Nursing, 27(1–2), 205–211. https://doi.org/10.1111/jocn.13872

7. Kundu, S., Wildgrube, J., Schippert, C., Hillemanns, P., & Brandes, I. (2015). Supporting and inhibiting factors when coping with endometriosis from the patients’ perspective. Geburtshilfe Und Frauenheilkunde, 75(5), 462–469. https://doi.org/10.1055/s-0035-1546052

8. Samulowitz, A., Gremyr, I., Eriksson, E., & Hensing, G. (2018). “Brave Men” and “Emotional Women”: A theory-guided literature review on gender bias in health care and gendered norms towards patients with chronic pain. Pain Res Manag, 2018, 6358624. https://doi.org/10.1155/2018/6358624

9. Werner, A., & Malterud, K. (2003). It is hard work behaving as a credible patient: encounters between women with chronic pain and their doctors. Soc Sci Med, 57(8), 1409–1419.

10. Young, K., Fisher, J., & Kirkman, M. (2015). Women’s experiences of endometriosis: a systematic review and synthesis of qualitative research. The Journal of Family Planning and Reproductive Health Care, 41(3), 225–234. https://doi.org/10.1136/jfprhc-2013-100853

11. Young, K., Fisher, J., & Kirkman, M. (2017). Clinicians’ perceptions of women’s experiences of endometriosis and of psychosocial care for endometriosis. The Australian & New Zealand Journal of Obstetrics & Gynaecology, 57(1), 87–92. https://doi.org/10.1111/ajo.12571

12. Greenhalgh, T., Snow, R., Ryan, S., Rees, S., & Salisbury, H. (2015). Six “biases” against patients and carers in evidence-based medicine. BMC Med, 13, 200. https://doi.org/10.1186/s12916-015-0437-x

13. Dhillon, M. S. (2019). Evidence-based medicine: Hype or reality? Indian Journal of Orthopaedics, Vol. 53, pp. 221–223. https://doi.org/10.4103/ortho.IJOrtho_54_19

14. Miles, A. (2018). Evidence-based medicine - 2018. Quo Vadis? J Eval Clin Pract, 24(1), 3–6. https://doi.org/10.1111/jep.12924

15. Guo, S. W., & Groothuis, P. G. (2018). Is it time for a paradigm shift in drug research and development in endometriosis/adenomyosis? Human Reproduction Update, 24(5), 577–598. https://doi.org/10.1093/humupd/dmy020

16. Horwitz, R. I., Charlson, M. E., & Singer, B. H. (2018). Medicine based evidence and personalized care of patients. Eur J Clin Invest, 48(7), e12945. https://doi.org/10.1111/eci.12945

17. Horwitz, R. I., & Singer, B. H. (2017). Why evidence-based medicine failed in patient care and medicine-based evidence will succeed. J Clin Epidemiol, 84, 14–17. https://doi.org/10.1016/j.jclinepi.2017.02.003

18. Koninckx, P. R., Ussia, A., Keckstein, J., Adamyan, L. V, Zupi, E., Wattiez, A., & Gomel, V. (2018, March). Evidence-based medicine: Pandora’s box of medical and surgical treatment of endometriosis. Journal of Minimally Invasive Gynecology, Vol. 25, pp. 360–365. https://doi.org/10.1016/j.jmig.2017.11.012

19. Koninckx, P. R., Ussia, A., Zupi, E., & Gomel, V. (2017, July). Evidence-based medicine in endometriosis surgery: Double-blind randomized controlled trial versus the consensus opinion of experts. Journal of Minimally Invasive Gynecology, Vol. 24, pp. 692–694. https://doi.org/10.1016/j.jmig.2017.04.019

20. Geukens, E. I., Apers, S., Meuleman, C., D’Hooghe, T. M., & Dancet, E. A. F. (2018). Patient-centeredness and endometriosis: Definition, measurement, and current status. Best Practice & Research. Clinical Obstetrics & Gynaecology, 50, 11–17. https://doi.org/10.1016/j.bpobgyn.2018.01.009

21. Goddu, A., O’Conor, K. J., Lanzkron, S., Saheed, M. O., Saha, S., Peek, M. E., … Beach, M. C. (2018). Do words matter? Stigmatizing language and the transmission of B=bias in the medical record. Journal of General Internal Medicine, 33(5), 685–691. https://doi.org/10.1007/s11606-017-4289-2

22. Physicians oaths. (n.d.). Retrieved from http://www.aapsonline.org/ethics/oaths.htm

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Medical Management of Endometriosis:Can it solve the painful problem?

Megan Billow, DO

Director, Division of Minimally Invasive Gynecologic Surgery

Assistant Professor

University Hospitals Cleveland Medical Center

Case Western Reserve University

Disclosure

Consultant: Abbvie

2

Objective

• Discuss the medical management of endometriosis.

3

Principles

• Reduce symptoms

• Improve quality of life

• Increase interval time between surgical intervention

– Prevent disease recurrence

• Post-operative hormonal suppression

– Without, recurrence 21.5% at 2 years, 40-50% at 5 years

Factors to consider:

Patient age

Patient preference

Treatment goals- pain, fertility

Extent of disease – presence of DIE?

4

• Does not increase fecundity

• Does not resolve endometriomas

• Does not resolve DIE

Pathophysiology of Pain

5

• Estrogen dependent sloughing of implants

• Implants secrete E2 and PGE2

• Chronic inflammatory reaction

6Falcone and Flyckt. Clinical management of endometriosis. Obst and Gyn. 2018

Page 5

• ACOG and ASRM: empiric medical therapy prior to definitive surgical diagnosis

• COCPs: cyclic vs continuous

– Muzii et al. AJOG 2016. Systematic review and metaanalysis– continuous is more effective in improving dysmenorrhea

• Progestin monotherapy:

– Casper et all. Fert Steril 2017. POP may be more effective than COCPs– Levonorgestrel IUS decreases endometriosis related pain – Crosignani et al. Hum Reprod 2006. DMPA as effective as GnRH agonist

• GnRH agonist: higher cost, side effects

– Brown et al. Cochrane review, 41 studies• GnRH agonist superior to placebo• GnRH agonist as effective as COCPs and progestin methods

• GnRH antagonist

– Significant improvement in dysmenorrhea– Less hypoestrogenic side effects

7 8

Algorithm

9

• Clinical suspicion of endometriosis

– Empiric therapy for 3 months (cocps, Progestin only method, GnRH agonist or antagonist)

– Assess for improvement in pain – switch to another method?

• Surgical intervention – patient goals

– Conservative – post operative suppression (duration?)

– Hysterectomy with ovarian conservation – post-operative suppression? Duration?

– Hysterectomy + BSO – suppression?

References

• Falcone et al. Clinical Management of Endometriosis. Obstetrics and Gynecology. 2018.

• Management of endometriosis. Practice Bulletin No 1 ACOG 2010.

• Guo et al. Recurrence of endometriosis and its control. Hum Reprod Update. 2009.

• Practice Committee of the American Society for Reproductive Medicine. Treatment of pelvic pain associated with endometriosis: a committee opinion. Fertil Steril 2014; 101: 927-35

• Harada et al. Low dose oral contraceptive pill for dysmenorrhea associated with endometriosis: a placebo-controlled, double-blind, randomized trial. Fertil Steril 2008; 90:1583-8.

• Muzii et al. Continuous versus cyclic oral contraceptives after laparoscopic excision of ovarian endometriomas: a systematic review and metaanalysis. Am J Obstet Gyn 2016;214:203-11.

• Casper et al. Progestin only pills may be a better first-line treatment for endometriosis than combined estrogen-progestin contraceptive pills. Fertil Steril. 2017; 107:533-6.

• Vercellini et al. Norethindrone acetate or dienogest for the treatment of symptomatic endometriosis: a before and after study. Fertil Steril 2016.

• Crosignani et al. Subcutaneous depot medroxyprogesterone acetate vs. leuprolide acetate in the treatment of endometriosis-associated pain. Hum Reprod 2006.

• Brown et al. Gonadotropin-releasing hormone analogues for pain associated with endometriosis. The Cochrane Database of Systematic Reviews 2010. Issue 12.

• Vercellini et al. A gonadotropin-releasing hormone agonist versus a low-dose oral contraceptive for pelvic pain associated with endometriosis. Fertil Steril 1993.

• Alkatout et al. Combined surgical and hormone therapy for endometriosis is the most effective treatment: prospective, randomized, controlled trial. JMIG 2013.

• Shakiba et al. Surgical treatment of endometriosis: a 7 year follow-up on the requirement for further surgery. Obst Gyn 2008.

• Abrao et al. Deep endometriosis infiltrating the recto-sigmoid: clinical factors to consider before management. Hum Reprod. 2015.

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Surgery the Only Answer

David B. Redwine, M.D.Retired general ob/gyn

I have no financial disclosure$

ObjectiveApply a critical review of Lupron and Orilissa to surgical practiceApply a critical review of Lupron and Orilissa to surgical practice

Lupron:Klein vs AbbottUnited States District Court, Las Vegas Case 2:08-CV-00681

Orilissa:Taylor HS et al. Treatment of endometriosis-associated pain with elagolix, an oral GnRHantagonist. NEJM 2017;3777;28-40.

In-house studies:

M84-042 M92-878 M86-031 M86-039 M90-471 M91-601 M92-878

Lupron x 6 months for pain relief

Abbott interference in medical educationLupron: BMD loss, adverse events higher than reported

M84-042: Lupron SC x 7 d then nasal spray x 6 monthsBy one year after stopping Lupron:

average estradiol 98.5 pg/mL (baseline: 121.8)75% of patients had not returned to baseline E212% had menopausal estradiol

Lupron effects on estradiol

Biberolglu/Behrman pain scaleDysmenorrheaDyspareuniaNon-menstrual pelvic painPelvic tendernessPelvic nodularity

Age 18 - 35

M92-878: Lupron + NET x 52 weeks . Post-Rx E2 below baseline in >50%

M92-878: > 33% of patients stopped Rx before 1 year

M91-601: 40% used narcotics during Rx

M90-471: pain returned to baseline in majority by 6 months after Rx

M86-039: no change in analgesic usage during Rx

M86-031: 50% of patients required narcotics during Rx59% still had dyspareunia at end of 6 mo Rx75% still had pain at end of 6 months Rx

Of 22 authors, 8 (36%) were employees or ex-employees of AbbVie with stock or stock options; an increase from Lupron era (0% – 33% of authors)The first draft of the manuscript was written by an AbbVie employee.

Of 22 authors, 8 (36%) were employees or ex-employees of AbbVie with stock or stock options; an increase from Lupron era (0% – 33% of authors)The first draft of the manuscript was written by an AbbVie employee.

July 2017

Biberoglu/Behrman 5 factors pain scale collectedBiberoglu/Behrman 5 factors pain scale collected

BUT: 2 main endpoints: dysmenorrhea, NMPPDyspareunia responded only at higher doseData on tenderness and nodularity collected but not reported.

BUT: 2 main endpoints: dysmenorrhea, NMPPDyspareunia responded only at higher doseData on tenderness and nodularity collected but not reported.

150 mg/d or 200 mg bid x 6 months150 mg/d or 200 mg bid x 6 months

Age: 18 – 49 (was 18 – 35 for Lupron studies)Age: 18 – 49 (was 18 – 35 for Lupron studies)

‘Safety’: report if estradiol level < 10 pg/mL‘Safety’: report if estradiol level < 10 pg/mL

OrilissaOrilissa

Corrected for dropouts, placebo effectCorrected for dropouts, placebo effect

No decrease in pain meds = response if Global Impression of Change improvedNo decrease in pain meds = response if Global Impression of Change improved

Most patients will not respond to Orilissa. Not a cure, like all hormonal medical Rx.Most patients will not respond to Orilissa. Not a cure, like all hormonal medical Rx.

OrilissaOrilissa

Informed consentInformed consent

Elagolix is not indicated for:Tenderness on pelvic examPelvic nodularity (deep endometriosis)Severe or deep endometriosisOvarian endometriomas > 3cmGI, GU endometriosisDiaphragmatic endometriosis

Elagolix is not indicated for:Tenderness on pelvic examPelvic nodularity (deep endometriosis)Severe or deep endometriosisOvarian endometriomas > 3cmGI, GU endometriosisDiaphragmatic endometriosis

1960’s BCP1970’s danazol1980’s progesterone1990’s Lupron2000’s Mirena2018 OrilissaWhat’s wrong with this picture?

1960’s BCP1970’s danazol1980’s progesterone1990’s Lupron2000’s Mirena2018 OrilissaWhat’s wrong with this picture?

“ It is simply no longer possible to believe much of the clinical research that is published,. . . Marcia Angell, former Editor-in-chief NEJM“ It is simply no longer possible to believe much of the clinical research that is published,. . . Marcia Angell, former Editor-in-chief NEJM

All hormonal. All with fanfareAll hormonal. All with fanfare

Page 7

Genetic basis of the embryonic origin of endometriosis

Sapkota Y, et al. Nat Commun2017;8:15539 PMC5458088

Genome-Wide Association Study of SNPs

GREB1

WNT4

FN1

KDR

ID47p15.2

CDKN28-AS1

FSH BVEZT

Embryonic development, HOXA 4AngiogenesisCell proliferationGene silencerTumor suppressionEstrogen response

Also: attractiveness gene, Y chromosome; others no doubt

Genetic load at conception Mesoderm forms:

coelom and its lininguterus, tubes, ovaries, endometrium, GI and GU muscularis, kidneyprostatemuscleslymph nodesbone marrow

Mesoderm forms:

coelom and its lininguterus, tubes, ovaries, endometrium, GI and GU muscularis, kidneyprostatemuscleslymph nodesbone marrow

PATTERNS: Anti-mesentericAnti-mesosalpingeal

Machairiotis et al.

Hidden seeding in:

Colon

Ovary

Lymph nodes

Russell, 1899

From: Redwine, Hopton editorial re: Badescu, Roman, et al. JMIG 2018

Badescu, Roman et al. JMIG 2018;25:522-7.

Gastrulation

Epiblast cells are converted to mesoderm through primitive groove.

In other words: everywhere endometriosis has been described

SOMATICMESODERM(LIMBS, SKELETAL MUSCLES)

SPLANCHNICMESODERM (INTERNAL ORGANS)

Genetic hierarchyHUMAN GENOME

MULLERIOSIS gene ensemble(HOXA8-13, WNT, GREB1, FN1,KDR,ID4,CDK,FSHb,VEZT,Y,LEFTY,attractive, others)

Endometriosis fibroids adenomyosis endosalpingiosis structural defects

Results in abnormal differentiation and migration of mesoderm during gastrulation

cervical stenosisuterine duplicationsrenal agenesisperitoneal pocketsetc

Everything else

anatomic location morphology activity symptom severity

GENETICALLY DETERMINED TRAITS FOR EACH TISSUE TYPE

severe

none

Leading to patterned tracts

Any Mullerian tissue can be involved in Mulleriosis

Fimbria on peritoneumRedwine DB. Mulleriosis: The single best-fit theory of origin of endometriosis. J Reprod Med 1988;33:915-20.

“Recurrence is not frequent and cure by conservative surgery is usual” Joe Meigs, 1953

Published cure rates following excision: 50 – 100%. Video length 9:30.

“The diseases which medicines cannot cure, excision cures; . . .“ Hippocrates, 450 BCE

The father of deep endometriosis

“The diseases which medicines cannot cure, excision cures; . . .“ Hippocrates, 450 BCE

The father of deep endometriosis

THE ENDNilufer R et al. Large-scale genome-wide association meta-analysis of endometriosis reveals13 novel loci and genetically-associated comorbidity with other pain conditions. doi: http://dx.doi.org/10.1101/406967

Sapkota Y et al. Meta-analysis identifies five novel loci associated with endometriosis highlighting key genes involved in hormone metabolism. doi 10.1038/ncomms15539

Redwine DB. Mulleriosis: the single best fit model of origin of endometriosis. J Reprod Med 1988;33:915-920.

Redwine DB. Googling Endometriosis: The lost centuries. August 2012. Createspace Publishing, Amazon.

Klein vs Abbott, United States District Court Case 2:08-CV-00681

Redwine DB. Leuprolide, the ‘d’ is silent. https://drive.google.com/file/d/0B8niPVY6iWUqcTFVUjV1UkRNSjg/view?usp=sharing

Taylor HS et al. Treatment of endometriosis-associated pain with elagolix, an oral GnRH antagonist. NEJM 2017;3777;28-40.

Badescu A et al. Patterns of bowel invisible microscopic endometriosis reveal the goal of surgery: Removal of visual lesions only. JMIG 2018;25:522-7.

Russell WW. Aberrant portions of the Mullerian duct found in the ovary. Johns Hopkins Hosp Bull 1899;10:8 -.

Redwine DB, Hopton EN. Bowel invisible microscopic endometriosis: Leave it alone. JMIG 2018;25:352-355. (editorial accompanying Badescu et al article above.)

Machairiotis N et al. Extrapelvic endometriois: a rare entity or an under diagnosed condition? Diagnostic Pathology. 2013;8:194. doi: 10.1186/1746-1596-8-194.

Cochrane reviews for pain: medroxyprogesterone better than placebo but no better than low dose BCP or Lupron; Lupron better than gestrinone. doi: 10.1002/14651858.CD002122.pub2.

Gestrinone no better than danazol, worse than Lupron for dysmenorrhea but better than Lupron for dyspareunia. doi: 10.1002/14651858.CD009881.pub2.

Combined oral contraceptives better than placebo for dysmenorrhea but low quality evidence. BCP equal to goserelindoi: 10.1002/14651858.CD001019.pub3.

TAP/Abbott in-house studies and the resulting journal publications:M84-042 Tummon et al. Fertil Steril 1089.390.M86-031 Dlugi AM et al. Fertil Steril 1990;54:419.M86-039 Wheeler JM et al. Am J Obstet Gynecol 1992;167:1367-71/1993;169:26-33.M92-878 Hornstein MD et al. Obstet Gynecol 1998;91:16-24

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CULTURAL AND LINGUISTIC COMPETENCY

Governor Arnold Schwarzenegger signed into law AB 1195 (eff. 7/1/06) requiring local CME providers, such as

the AAGL, to assist in enhancing the cultural and linguistic competency of California’s physicians

(researchers and doctors without patient contact are exempt). This mandate follows the federal Civil Rights Act of 1964, Executive Order 13166 (2000) and the Dymally-Alatorre Bilingual Services Act (1973), all of which

recognize, as confirmed by the US Census Bureau, that substantial numbers of patients possess limited English proficiency (LEP).

California Business & Professions Code §2190.1(c)(3) requires a review and explanation of the laws

identified above so as to fulfill AAGL’s obligations pursuant to California law. Additional guidance is providedby the Institute for Medical Quality at http://www.imq.org

Title VI of the Civil Rights Act of 1964 prohibits recipients of federal financial assistance from

discriminating against or otherwise excluding individuals on the basis of race, color, or national origin in any of their activities. In 1974, the US Supreme Court recognized LEP individuals as potential victims of national

origin discrimination. In all situations, federal agencies are required to assess the number or proportion of LEP individuals in the eligible service population, the frequency with which they come into contact with the

program, the importance of the services, and the resources available to the recipient, including the mix of oral

and written language services. Additional details may be found in the Department of Justice Policy Guidance Document: Enforcement of Title VI of the Civil Rights Act of 1964 http://www.usdoj.gov/crt/cor/pubs.htm.

Executive Order 13166,”Improving Access to Services for Persons with Limited English

Proficiency”, signed by the President on August 11, 2000 http://www.usdoj.gov/crt/cor/13166.htm was the genesis of the Guidance Document mentioned above. The Executive Order requires all federal agencies,

including those which provide federal financial assistance, to examine the services they provide, identify any

need for services to LEP individuals, and develop and implement a system to provide those services so LEP persons can have meaningful access.

Dymally-Alatorre Bilingual Services Act (California Government Code §7290 et seq.) requires every

California state agency which either provides information to, or has contact with, the public to provide bilingual

interpreters as well as translated materials explaining those services whenever the local agency serves LEP members of a group whose numbers exceed 5% of the general population.

~

If you add staff to assist with LEP patients, confirm their translation skills, not just their language skills.

A 2007 Northern California study from Sutter Health confirmed that being bilingual does not guarantee competence as a medical interpreter. http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=2078538.

US Population

Language Spoken at Home

English

Spanish

AsianOther

Indo-Euro

California

Language Spoken at Home

Spanish

English

OtherAsian

Indo-Euro

19.7% of the US Population speaks a language other than English at home In California, this number is 42.5%

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