Complex contraception

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1 Disclosures Complex contraception I have no relevant financial disclosures Jennifer Kerns, MD, MPH Assistant Professor, UCSF Obstetrics, Gynecology and Reproductive Sciences San Francisco General Hospital October 2015 Objectives To review resources for assessing the safety of contraceptive methods for particular women To review the evidence for selected practice recommendations for women with particular medical issues Contraceptive counseling techniques Contraception for obese women Choosing the best COC Emergency contraception Unscheduled bleeding with nexplanon Updates: Liletta, Essure Contraceptive Prevalence & Maternal Deaths Ahmed et al. Lancet

2 N o 10/14/2015 Benefits of avoiding unintended pregnancy Are you familiar with the US Medical Eligibility Criteria for Contraception? A. Yes B. No 62% 38% Y e s Frost and Lindberg Contraception 2012 Can my patient use this method? Just google this CDC Medical Eligibility Criteria (MEC) 1. CDC Medical Eligibility Criteria (CDC MEC) 2. U.S. Selected Practice Recommendations (US SPR) for Contraceptive Use, ACOG Practice Bulletin No Contraception for the Medically Challenged Patient, Rebecca Allen, Carrie Cwiak et al. 2

3 MEC Categories Birth Control Methods 1 Can use the method No restrictions 2 Can use the method Advantages generally outweigh theoretical/proven risks 3 Should not use method unless no other method is appropriate Theoretical/proven risks generally outweigh advantages 4 Should not use method Unacceptable health risk Medical Condition MEC Category Where do you find the US MEC? 3

4 Maya Approaches to counseling? Maya is a 23 yo G5P2 6 weeks post-abortion Interested in contraception. 2 NSVDs, 2 abortions BMI = 41 Information transfer Provider recommendation Allowing patient to decide Shared decision making Passive Unresponsive Information transfer Shared decision making Paternalistic Coercion LARC promotion Provider recommendation Patient makes her decision Preference-sensitive decision shared decision making SDM means the provider does not insert her/his values into the counseling Counseling influences method selection Quality of family planning care associated with use of contraception and satisfaction with method Patient-centeredness is the right thing to do Obesity and contraception Combined hormonal methods are considered safe for obese women A. True B. False 90% 10% Elwyn et al. Ann Fam Med 2014 Dehlendorf et al. Contraception 2013 Durand et al. PLoS One 2014 T r u e F a l s e 4

5 Safety of combined hormonal methods in obese women CDC Medical Eligibility Criteria: 2 Venous thromboembolism (VTE) risk increased: No evidence of synergistic effect Risk is less than that of pregnancy (29/10,000 yrs) No data on women with BMI>40 No increased risk of Acute MI or stroke Safety of other methods in obese women CDC Medical Eligibility Criteria: 1, except DMPA in obese adolescents = 2 Obesity and contraception Combined hormonal methods have similar efficacy in obese women compared to non-obese women A. True B. False T r u e 42% 58% F a l s e Obesity and oral contraceptives YES (we think) conflicting data for COCs N>52,000 RR 1.5 failure / BMI>35 N=1500 RR=1 failure (underpowered) Longer time to steady state (10 vs 5 days) May be related to dosing (incr risk with prolonged pill-free interval) Overall risk of failure still low Can consider continuous dosing Dinger et al. Obstet Gynecol 2011 McNicholas et al. Obstet Gynecol 2013 Lopez et al. Cochrane

6 Obesity and other methods Ring: same efficacy Implant: same efficacy IUDs: same efficacy Patch: decreased in women >90kg Back to Maya What other obesityrelated conditions does she have? Diabetes? Only contraindicated (MEC 3, 4) for all methods if End-organ disease, or >20 yrs duration Multiple cardiovascular RFs? (age, htn, smoking, DM) Pill, patch, ring, DMPA contraindicated Room for clinical judgment re: what constitutes multiple RFs Dinger et al. Obstet Gynecol 2011 McNicholas et al. Obstet Gynecol 2013 Lopez et al. Cochrane 2010 CDC medical eligibility criteria Maya s contraceptive choice: COCs Apri, Azurette, Caziant, Cesia, Cyclessa, Desogen, Emoquette, Kariva, Mircette, Ortho-Cept, Reclipsen, Solia, Velivet, Viorele, Natazia, Gianvi, Loryna, Ocella, Syeda, Vestura, Yasmin, Yaz, Zarah, Beyaz, Safyral, Kelnor, Zovia 1/35, Zovia 1/50, Altavera, Amethia, Amethia Lo, Amethyst, Aviane, Camrese, Camrese Lo, Daysee, Enpresse, Introvale, Jolessa, Kurvelo, Lessina, Levlite, Levora, LoSeasonique, Lutera, Lybrel, Marlissa, Myzilra, Nordette, Orsythia, Portia, Quartette, Quasense, Seasonale, Seasonique, Sronyx, Triphasil, Trivora, Necon 1/50, Norinyl 1/50, Alyacen 1/35, Alyacen 7/7/7, Aranelle, Balziva, Brevicon, Briellyn, Cyclafem 1/35, Cyclafem 7/7/7, Dasetta 1/35, Dasetta 7/7/7, Estrostep Fe, Femcon Fe, Generess Fe, Gildagia, Gildess Fe, Junel /30, Junel 21 1/20, Junel Fe 1.5/30, Junel Fe 1/20, Leena, Loestrin /30, Loestrin 21 1/20, Loestrin 24 Fe, Lo Loestrin Fe, Loestrin Fe 1.5/30, Loestrin Fe 1/20, Microgestin 1/20, Microgestin 1.5/30, Microgestin Fe 1/20, Microgestin Fe 1.5/30, Modicon, Necon 0.5/35, Necon 1/35, Necon 10/11, Necon 7/7/7, Norinyl 1/35, Nortrel 0.5/35, Nortrel 1/35, Nortrel 7/7/7, Ortho-Novum 1/35, Ortho-Novum 7/7/7, Ovcon 35, Ovcon 50, Philith, Tilia Fe, Tri-Legest Fe, Tri-Norinyl, Wera, Zenchant, Zenchant Fe, Zeosa, Estarylla, Mono-Linyah, MonoNessa, Ortho Tri-Cyclen, Ortho Tri-Cyclen Lo, Ortho-Cyclen, Previfem, Sprintec, Tri-Estarylla, Tri-Linyah, Tri-Previfem, Tri-Sprintec, TriNessa, Cryselle, Elinest, Lo/Ovral-28, Low-Ogestrel, Ogestrel Progestin choice Levonorgestrel lowest risk of VTE Remember... Absolute risk remains low Balance with patient choice No clear benefit of drospirenone with PMDD, acne Non-pregnant, no COCs: 2-4 per 10,000 - yrs Levonorgestrel COCs: 5.0 per 10,000 - yrs Desogestrel COCs: 6.5 per 10,000 - yrs Drosperinone COCs: 7.8 per 10,000 - yrs Lidegaard BMJ 2009 Heinemann Contraception

7 Maya s contraceptive choice: COCs Levonorgestrel-containing COCs Apri, Azurette, Caziant, Cesia, Cyclessa, Desogen, Emoquette, Kariva, Mircette, Ortho-Cept, Reclipsen, Solia, Velivet, Viorele, Natazia, Gianvi, Loryna, Ocella, Syeda, Vestura, Yasmin, Yaz, Zarah, Beyaz, Safyral, Kelnor, Zovia 1/35, Zovia 1/50, Altavera, Amethia, Amethia Lo, Amethyst, Aviane, Camrese, Camrese Lo, Daysee, Enpresse, Introvale, Jolessa, Kurvelo, Lessina, Levlite, Levora, LoSeasonique, Lutera, Lybrel, Marlissa, Myzilra, Nordette, Orsythia, Portia, Quartette, Quasense, Seasonale, Seasonique, Sronyx, Triphasil, Trivora, Necon 1/50, Norinyl 1/50, Alyacen 1/35, Alyacen 7/7/7, Aranelle, Balziva, Brevicon, Briellyn, Cyclafem 1/35, Cyclafem 7/7/7, Dasetta 1/35, Dasetta 7/7/7, Estrostep Fe, Femcon Fe, Generess Fe, Gildagia, Gildess Fe, Junel /30, Junel 21 1/20, Junel Fe 1.5/30, Junel Fe 1/20, Leena, Loestrin /30, Loestrin 21 1/20, Loestrin 24 Fe, Lo Loestrin Fe, Loestrin Fe 1.5/30, Loestrin Fe 1/20, Microgestin 1/20, Microgestin 1.5/30, Microgestin Fe 1/20, Microgestin Fe 1.5/30, Modicon, Necon 0.5/35, Necon 1/35, Necon 10/11, Necon 7/7/7, Norinyl 1/35, Nortrel 0.5/35, Nortrel 1/35, Nortrel 7/7/7, Ortho- Novum 1/35, Ortho-Novum 7/7/7, Ovcon 35, Ovcon 50, Philith, Tilia Fe, Tri-Legest Fe, Tri-Norinyl, Wera, Zenchant, Zenchant Fe, Zeosa, Estarylla, Mono-Linyah, MonoNessa, Ortho Tri-Cyclen, Ortho Tri-Cyclen Lo, Ortho-Cyclen, Previfem, Sprintec, Tri-Estarylla, Tri-Linyah, Tri- Previfem, Tri-Sprintec, TriNessa, Cryselle, Elinest, Lo/Ovral-28, Low- Ogestrel, Ogestrel Ethinyl estradiol dose Nearly all modern-day OCs are low-dose 30mcg EE higher continuation (vs. 20mcg EE) Monophasic Option to shorten or eliminate placebo week VanViet Cochrane 2006 LaGuardia Contraception, 2003 Freeman Womens Health 2001 van Vloten Cutis months later Maya returns asking for emergency contraception because she missed pills Choose the answer that lists the EC methods in order of most effective to least effective a. Ulipristal (Ella) levonorgestrel (Plan B) Copper IUD b. Copper IUD ulipristal levonorgestrel c. Levonorgestrel Copper IUD ulipristal Oral Emergency Contraception LNG: 120 mg x 1, up to 5 days Ulipristal Acetate: Selective progesterone receptor modulator Mechanism: Delayed follicular rupture Will not harm existing pregnancy Dosing: 30mg, FDA-approved up to 5 days 1. Brache 2010 Hum Reprod 7

8 Misinformation about LARC Levonorgestrel less effective for obese women Emergency contraception Percent of women pregnant after taking LNG pills Glasier A et al. Contraception Summarizing Maya s visit Used shared decision making for contraceptive counseling Reviewed evidence of safety/ efficacy of contraception in obese women Used evidence to choose the best COC Considered obesity in EC recommendation Gave her resources BEDSIDER! Etonogestrel implant and unscheduled bleeding Discontinuation common, largely because of unscheduled bleeding Nearly 80% of women report some unscheduled bleeding with ETG implant 8

9 Etonogestrel implant and unscheduled bleeding First 3 months predicts future (but not perfectly) Those w/ favorable bleeding are likely to continue to have favorable bleeding Those w/ unfavorable bleeding have a 50% chance of improving Management: Expectant NSAIDs ( mg TID, 5-10 days) COCs (cyclic) Estrogen (oral conjugated, estradiol, transdermal) Tamoxifen, mifepristone, doxycycline Liletta Low-cost Mirena FDA-approved for 3 years effective 5-7, just like Mirena No increase in pricing until 2017 Title X clinics - $50 Rebate from company if patient pays full price Essure update Pre-marketing studies 2 non-blinded, non-randomized studies w/ no comparator group Analysis was not intention to treat, and 15% had failed attempts at placement Only 85% followed up at 1 yr for effectiveness (and 25% at 2 yrs) 71% followed out to 5 yrs: no pregnancies reported Post-marketing studies Stopped early, no follow up, all results redacted on FDA website Reports to MAUDE database 5093 reports made: incomplete procedures, chronic pain, device migration, tubal perforation, bleeding, pregnancies ~ 5.7% annual risk of pregnancy estimated Dhruva et al. NEJM 2015 Conclusions Contraception is integral to public health Counseling should be patient-centered Resources are at your fingertips to help you decide which methods are safe for your patient! Including the UCSF family planning pager (415)