LARC Complications & Difficult Placement and Removals Patty Cason MS, FNP-BC UCLA School of Nursing Envisionsrh.com [email protected] Disclosures • Advisory Board/Consultant – Teva, Cooper Surgical, Merck, ContraMed, Evofem • Trainer/speaker – Merck, ContraMed, Medicines 360 Objectives • Identify tenaculum and sound techniques for optimizing success with placement of an IUD • Display familiarity with use of os finders for challenging IUD placement • Discuss strategies for dealing with IUD removals with missing strings • Describe counseling strategies for responding to bleeding complaints with LARC US Medical Eligibility Criteria: Categories 1 No restriction for the use of the contraceptive method for a woman with that condition Advantages of using the method generally 2 outweigh the theoretical or proven risks Theoretical or proven risks of the method usually outweigh the advantages – not usually 3 recommended unless more appropriate methods are not available or acceptable Unacceptable health risk if the contraceptive 4 method is used by a woman with that condition http://www.cdc.gov/mmwr/pdf/rr/rr5904.pdf Free and User-Friendly Download the 2016 US MEC & US SPR app • An easy to use reference that combines information from both the CDC family planning guidance. It features a streamlined interface so providers can access the guidance quickly and easily. • Available for iOS and Android operating systems Formal (Merck) training for insertion/removal required Migration of Implant N=38 cases of migration: • lung/pulmonary artery (n=9) • chest wall (n=1), • vasculature at locations other than the lung/pulmonary artery (n=14) • extravascular migrations (n=14) to other body sites (e.g., the axilla and clavicle/neck line/shoulder) (Kang, Niak et al. 2017) 1.3 Migrations per Million Placements • 7 cases reported pain, discomfort, dyspnea • 3 cases describe pulmonary fibrosis and skin reactions from migration to the vasculature, chest wall and other distant body sites • 16 cases reported surgical removal in an operating room setting (Kang, Niak et al. 2017) Clinicians are now advised to avoid placement in the biceps groove, no matter how superficial that placement might be. Place over the triceps (Rowland, Mansour et al. 2017) "pop-out" or "fingers-only" Implant Removal Technique https://www.screenr.com/MS7N Interim Results From The Nexplanon Observational Risk Assessment Study (NORA) • 7369 placements • Providers reported 208 events involving 189 patients (2.6% of the study population) • Difficulty removing the protection cap was the most common event (93 insertions) NORA 0.7% of patients reported an event at insertion • Pins/needles/numbness in the arm/hand/fingers –repeat or consecutive implant users: 10.1 per 1000 –first-time implant users: 1.2 per 1000 NORA 0.7% of patients reported an event at insertion • 271 patients reported 394 events • pins/needles/numbness (145) • severe pain (120) • altered strength (47) • other events (82) NORA- Removal • 1413 removal procedures, 16 (1.1%) involved one or more challenges: –encasement in fibrotic tissue (7) –multiple removal attempts needed (5) –Local migration (1) –deep implant (1) –other challenges (3) Simone 21 year old G0 • Using contraceptive implant for 3 years • Her regular provider attempted to remove it 2 weeks ago and was unsuccessful • On palpation, you feel the body of the implant, but the distal tip is hard to discern and the implant is somewhat fixed to the underlying tissue and is not very mobile Difficult Implant Removal: The “U” Technique Extra instrument: Modified vasectomy clamp Make incision next to implant Insert modified vasectomy clamp Gently pull implant up out of incision Use second forceps to grasp implant Tips • Can use curved and straight mosquitos if needed • Use 4x4 gauze and scalpel to cut and loosen fibrous sheath • Never make an incision if you’re not positive you can feel the implant Tips • It’s OK to do the removal from the proximal end if that’s the end that pops up to the surface • Don’t spend more than 15 minutes • Wait at least 2 weeks between removal attempts to allow swelling to completely resolve Counseling Tips Language for LARC • Rather than using the words “long acting,” use: –The most effective methods –Highly effective methods IUD or Implant “This method is good for up to 10, 5, 3 years and if you want to get pregnant before then or you would like it removed for any reason, come in, we will take it out for you and your ability to get pregnant will go back to whatever is normal for you, immediately.” Choosing Which IUD Brand Name Skyla® Kyleena® Mirena® Liletta® CuT LNG content (mg in 13.5 19.5 52 52 0 reservoir) Release rate (mcg/24 14 17.5 20 19.5 0 hrs) 5 7.4 +/-10 17, 14.8, 12.9, At end 11.3, 9.8 0 Max duration, years 3 5 5 (7) 4 (7) 10 (12+) T-frame, mm 28x30 28x30 32x32 32x32 32x36 Insertion tube 3.80 3.80 4.40 4.80 4.75 diameter String color Brown Blue Brown Blue White Silver ring Yes Yes No No No Single-rod Etonogestrel (ENG) Contraceptive Implant Nexplanon® • Most effective method • Suppression of ovulation • Thickens cervical mucous Moderate progestin dose not associated with a hypo-estrogenic state (Darney, Patel et al. 2009) LNG IUDs • Highly effective • Cervical mucus thickened • Sperm motility and function inhibited • Alterations in ovulation (Jonsson, Landgren et al. 1991; Lewis, Taylor et al. 2010; Natavio, Taylor et al. 2013; Ortiz, Croxatto 2007; Rivera, Yacobson et al. 1999; Stanford, Mikolajczyk 2002; Videla-Rivero et al. 1987) Best Question “Do you have a sense of what is important to you in your birth control method?” (Dehlendorf, Henderson et al. 2016) Questions to Ask after Giving Information • How would that be for you? • Knowing that how would it be for you…? • Has it ever happened before? • How did you manage it? • Do you have a sense of how you would manage it? Progestin Side Effects • 1-3% of women discontinue use due to complaints of: –weight gain, acne, hair loss, headache, moodiness, depression, emotional lability • Even less likely: vaginal dryness, breast pain, abdominal pain, nausea, decreased sex drive LNG 52 IUD Side Effects • Weight gain comparable to users of CU T • Acne rarely reported • Uncommon: headaches, nausea, breast tenderness, mood changes, and ovarian cyst formation (Ilse, Greenberg et al. 2008; Modesto, de Nazare Silva dos Santos et al. 2015; Vickery, Madden et al. 2013) BLEEDING COMPLAINTS Cases • Wanda is a 36 y.o. G3P3 who had a LNG IUD placed 2 months ago. She complains of irregular bleeding and is wondering when it will stop. • Skye is 21 y.o. G0 who has had an etonogestrel implant for 8 months. She has had spotting every day for a month and is tired of it. She wants her implant removed. Unscheduled Bleeding with Progestin-Only Contraceptives • Etiology poorly understood • Depends on dose/route of progestin • Initially due to rapid endometrial thinning caused by progestin • Sustained exposure may lead to endometrial instability and atrophy leading to fragile endometrium that bleeds easily (Zigler, McNicholas 2017) Implant Menstrual Effects • Most women have minimal, scant bleeding or no bleeding • Bleeding pattern is unpredictable • 1 in 4-5 women have frequent or prolonged bleeding • Pattern tends to get better with time • 20% discontinuation rate – half of discontinuation is for bleeding (Alie, Akin et al. 2016; McNicholas, Maddipati et al. 2015; McNicholas, Swor et al. 2017) LNG 52 IUDs: Menstrual Effects • Initially some women have frequent spotting and irregular bleeding • Usually resolves after 3-6 months • Menses become increasingly light • Amenorrhea 20-80% (Bachmann, Korner 2009; Backman, Huhtala et al. 2002; Gemzell-Danielsson, Schellschmidt et al. 2012; Hidalgo, bahamondes et al. 2002; Mansour, 2012) Levonorgestrel 52 IUDs: Ovulatory Effects • 93% of the cycles were ovulatory but just 58% of these 'ovulatory' cycles showed normal follicular growth and rupture. • Ovulation 63% of amenorrheic group; 58% in regularly menstruating group (Barbosa, Olsson et al. 1995; Nilsson, Lahteenmaki et al. 1984) It Just Gets Better and Better… Decreased bleeding with placement of subsequent LNG IUD (Heikinheimo, Inki et al. 2014) Levonorgestrel 19.5 and 13.5 IUDs: Menstrual Effects • Less data about bleeding profile • Initially some women have frequent spotting and irregular bleeding • Usually have light, regular menses--become increasingly light • Less amenorrhea than LNG 52 (Gemzell-Danielsson, Schellschmidt et al. 2012; Nelson, Apter et al. 2013) Copper IUC Menstrual Effects • Longer/heavier menses/dysmenorrhea o Gets better with time o NSAIDs prophylactically WITH FOOD . Pre-emptive use for 1st 3 cycles . Start before onset of menses for anti-prostaglandin effect Naproxen sodium 220mg x2 BID (max 1100mg/day) Ibuprofen 600-800mg TID (max 2400mg/day) (Godfrey, Folger et al. 2013; Grimes, Hubacher et al. 2006; Hubacher, Chen et al. 2009) Addressing Unscheduled Bleeding • Anticipatory guidance • Ask what concerns her • Normal side effect, not dangerous, doesn’t indicate reduced effectiveness • Any concomitant medications that may reduce effectiveness of progestin Work up of unscheduled bleeding Work up in context of other symptoms (pain, vaginal discharge, postcoital bleeding) Consider: • Pregnancy test • Speculum and bimanual exam • Cervical cancer screening • GC/CT • Pelvic ultrasound • EMB Estrogen for Unscheduled Bleeding with Implant • Estrogen to build/support/ repair endometrium • Options –Monophasic combined OCP –Vaginal Ring –Estradiol 2 mg PO –Conjugated Equine Estrogen 1.25 mg PO (Zigler, McNicholas 2017) NSAIDs for Unscheduled Bleeding • Inhibit prostaglandin synthesis which is increased in the endometrium of women with abnormal bleeding –Most effective when bleeding is “heavier” • Options –Naproxen sodium 220 mg PO BID –Ibuprofen 800mg PO TID –Mefanamic acid 500 mg PO TID (Zigler, McNicholas 2017) Treatment for Bleeding with LNG IUD in the First 90 days • Naproxen sodium may work-- particularly if bleeding is heavy • Progesterone Only Pill • Transdermal E2 and tranexamic acid likely not to work (Madden, Proehl et al.