CONTRACEPTION IUS AND INTRADERMAL IMPLANT - DAVID GLENN WEISMILLER, MD, SCM, FAAFP - EFMS ...

 
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CONTRACEPTION IUS AND INTRADERMAL IMPLANT - DAVID GLENN WEISMILLER, MD, SCM, FAAFP - EFMS ...
Contraception
IUS and Intradermal Implant
    David Glenn Weismiller, MD, ScM, FAAFP
     Department of Family and Community Medicine
   University of Nevada, Las Vegas School of Medicine
CONTRACEPTION IUS AND INTRADERMAL IMPLANT - DAVID GLENN WEISMILLER, MD, SCM, FAAFP - EFMS ...
Disclosure Statement
I have no relevant financial relationships to disclose that would in
anyway create bias in the material I am presenting.
CONTRACEPTION IUS AND INTRADERMAL IMPLANT - DAVID GLENN WEISMILLER, MD, SCM, FAAFP - EFMS ...
Learning Objectives
• Describe principles of patient selection regarding
  contraceptives
• Discuss the indications/contraindications for
  various contraceptive methods
• Appraise recommendations for use of long-
  acting reversible contraceptives

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CONTRACEPTION IUS AND INTRADERMAL IMPLANT - DAVID GLENN WEISMILLER, MD, SCM, FAAFP - EFMS ...
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CONTRACEPTION IUS AND INTRADERMAL IMPLANT - DAVID GLENN WEISMILLER, MD, SCM, FAAFP - EFMS ...
Helen tries out her new
“Not-Tonight-Honey” nightgown   5
CONTRACEPTION IUS AND INTRADERMAL IMPLANT - DAVID GLENN WEISMILLER, MD, SCM, FAAFP - EFMS ...
Why Contraception?
        Families   •   40% of US pregnancies (>2M)
        complete       are unintended
                        – In women ≥40y the
                           rate is 51%
                        – About a third of unintended
Unintended                 pregnancies occur in
pregnancies                women who consider their
                           families complete
                   •   Health Benefits
                   •   Risk(s) of Pregnancy
CONTRACEPTION IUS AND INTRADERMAL IMPLANT - DAVID GLENN WEISMILLER, MD, SCM, FAAFP - EFMS ...
Contraceptive Options
         •   Irreversible                   •   Reversible
               – Tubal ligation*                – Oral contraceptives*
                                                    • Combined pills*
               – Vasectomy
                                                    • Progestin-only pills
               – Micro insert                   – Other hormonal options
         •   Abstinence                             •   Implant
               – Reasonable, acceptable             •   Injections
                 option; particularly in            •   Vaginal ring
                 younger patients                   •   Patch
                                                – Intrauterine Devices
                                                – Intratube Device
l* Three most commonly used in US               – Barrier methods
l Pregnancy poses a greater risk than any           • Male condom*
contraceptive method
                                                – Natural Family Planning
CONTRACEPTION IUS AND INTRADERMAL IMPLANT - DAVID GLENN WEISMILLER, MD, SCM, FAAFP - EFMS ...
Principles
•   All methods can fail
•   Two methods are better than one
•   Methods used wrong fail more
•   Always need a backup plan
•   No plan offers an 85% chance of getting
    pregnant

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CONTRACEPTION IUS AND INTRADERMAL IMPLANT - DAVID GLENN WEISMILLER, MD, SCM, FAAFP - EFMS ...
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CONTRACEPTION IUS AND INTRADERMAL IMPLANT - DAVID GLENN WEISMILLER, MD, SCM, FAAFP - EFMS ...
Contraceptive Counseling
1. What are your contraceptive goals? Do you ever plan
   to get pregnant? When?
2. Are you currently having sex with ♂ partner?
3. Have you tried any contraceptive methods? If so,
   which one(s)?
4. What did you like/dislike about the method(s)?
5. Are you a good pill taker?

                                                         10
Contraceptive Counseling
6. For user-controlled methods, how often did you forget to
    use the method?
7. Are there any methods you have heard about and would
    like to try?
8. How important is spontaneity of use?
9. Is protection from STIs important considering your life
    situation?
10. Is cost an issue? Does your health insurance plan cover
    any contraceptive method?

                                                              11
Informed Consent
                     “BRAIDED”
•   Benefits
•   Risks
•   Alternatives
•   Inquiries
•   Decision to change acceptable
•   Explanation
•   Documentation
                                    12
The Current State of IUDS in the USA
•   2012
     – 10.3% of women using contraceptives (3,884,000 women)
     – Used most by women –
         • Aged 25-39
         • Married and cohabitating
         • Covered by Medicaid
         • No religious affiliation
•   Foreign-born women are three times as likely as U.S.-born women
    to have ever used an IUD.
•   Teenagers                             Guttmacher Institute Data, October 2015
     – 3%            https://www.guttmacher.org/fact-sheet/contraceptive-use-united-states
IUDs have been used in the U.S. for decades; safety controversy in the 1970s
prompted the removal of all but one IUD from the U.S. market by 1986. First
new generation IUD introduced to the U.S. market in 1988, following revised
FDA safety and manufacturing requirements.
Types of IUDs
     IUD (Copper)                    Available       Years           Use and FDA Approved                               Possible side effects
                                     Since           Effective
     Copper (Paragard)               1988            10              •    Approved only in parous                       •    Abnormal menstrual
                                                                          women, but available to all                        bleeding
                                                                          women regardless of parity                    •    Higher frequency or
                                                                     •    Can be used as Emergency                           intensity of
                                                                          Contraception when inserted                        cramps/pain
                                                                          within 5 days
     IUD (Hormonal)
     Mirena                          2001            5               Approved only in parous women,                     •    Inter-menstrual
                                                                     but available to all women                              spotting in the early
                                                                     regardless of parity                                    months
     Skyla (slightly smaller         2013            3               Approved for women regardless of                   •    Reduces menstrual
     than Mirena)                                                    parity                                                  blood loss significantly
                                                                                                                        •    Hormone-related:
     Liletta*                        2015            3               Approved for women regardless of                        headaches, nausea,
                                                                     parity                                                  breast tenderness,
     Kyleena (lower                  2016            5               Approved for women regardless of                        depression, cyst
     hormone levels than                                             parity                                                  formation.
     Mirena)
  *Actavis in conjunction with Medicines360, a non-profit women’s pharmaceutical company, developed Liletta specifically to be low cost and available to public
  health clinics enrolled in the national 340B Drug Pricing Program, which provides reduced cost pharmaceuticals to providers that serve low-income populations.
Intrauterine Contraceptives
                                            Mechanisms of Action

                                                                                                    Source:
                                                                                                    Barr Pharmaceuticals, Inc.

     Levonorgestrel-Releasing Intrauterine                                                     Copper-Releasing
      System (LNG-IUS, Mirena® and Skyla®)                                               Intrauterine Contraceptive
                                                                                              (ParaGard® T380A)
       v Inhibits fertilization
                                                                                v Inhibits fertilization
       v Thickens cervical mucous
                                                                                v Releases copper ions (Cu2+) that reduce
       v Inhibits sperm function                                                  sperm motility
       v Thins and suppresses the                                               v May disrupt the normal division of oocytes and
         endometrium                                                              the formation of fertilizable ova
      Jonsson B, et al. Contraception. 1991;43:447-458; Videla-Rivero L, et al. Contraception. 1987;36:217-226; Kulier R, et al. Cochrane Database Syst Rev.
                                                                                                                                         2006;3: CD005347.

17
Considerations for IUDs
•    IUD insertion, not IUD use, is associated with PID
     –   Cochrane
     –   Systematic Review (Grimes, Mohllajee)
     –   ACOG Practice Bulletin 2011
•    DO NOT cause future infertility
•    Nulliparas can use an IUD
     –   Uterus sounds to depth of a minimum 6 cm
•    The USMEC guidelines state that the advantages of using the IUD in
     adolescents generally outweigh the risks.
•    Risk of uterine perforation
18
Candidates for IUD Use
• Multiparous and nulliparous   • Medical Conditions – may be
  women at low risk for STI       an optimal method
• Desire long-term reversible      –   Diabetes
  contraception                    –   Thromboembolism
                                   –   AUB/dysmenorrhea
                                   –   Breastfeeding
                                   –   Breast cancer
                                   –   Liver disease

                                                                19
WHO Medical Eligibility Criteria for IUD Use in Women
                      with Certain Medical Conditions
                                                                                                                        TCu-380A                       LNG-IUS
                                                                                                                       WHO Risk                      WHO Risk
                                        Medical Conditions
                                                                                                                       Category*                     Category*

          Hypertension (controlled)                                                                                             1                            1
          Multiple cardiovascular risk factors                                                                                  1                            2
          History of DVT or pulmonary embolism                                                                                  1                            2
          Stroke                                                                                                                1                            2
          Severe valvular heart disease (complicated)                                                                           2                            2
          HIV infection                                                                                                         2                            2
          AIDS (clinically well on antiretroviral therapy)                                                                      2                            2
                                                                           AIDS = acquired immunodeficiency syndrome; DVT = deep vein thrombosis; HIV = human immunodeficiency
                                                                             virus; IUD = intrauterine device; LNG-IUS = levonorgestrel-releasing IUD; TCu-380A = copper-releasing IUD;
                                                                                                                                                      WHO = World Health Organization
                                                                             *Category 1= there are no restrictions for use of the contraceptive method; Category 2 = the benefits of
                                                                                                  using the contraceptive method generally outweigh the theoretical or proven risk

WHO. Medical Eligibility Criteria for Contraceptive Use. 3rd ed. 2004. Available at: http://www.who.int/reproductive-health/publications/mec/iuds.html.
WHO Medical Eligibility Criteria for IUD Use in Women
                   with Certain Medical Conditions (cont’d)
                                                                                                        TCu-380A                                   LNG-IUS

                              Medical Condition                                                         WHO Risk                                 WHO Risk
                                                                                                        Category*                                Category*
      Known thrombogenic mutations                                                                              1                                        2
      Migraines with aura                                                                                       1                                        2
      Epilepsy                                                                                                  1                                        1
      Diabetes                                                                                                  1                                        2
      Obesity                                                                                                   1                                        1
      Thyroid disorders                                                                                         1                                        1
      Viral hepatitis (active infection)                                                                        1                                        3
      Viral Hepatitis (carrier)                                                                                 1                                        1
                                                                                 IUD = intrauterine device; LNG-IUS = levonorgestrel-releasing IUD; TCu-380A = copper-releasing IUD;
                                                                                                                                                   WHO = World Health Organization
                                                                             * Category 1= there are no restrictions for use of the contraceptive method; Category 2 = the benefits of
                                                                             using the contraceptive method generally outweigh the theoretical or proven risk; Category 3 = the risks
                                                                                                                                     of using the method usually outweigh the benefits

WHO. Medical Eligibility Criteria for Contraceptive Use. 3rd ed. 2004. Available at: http://www.who.int/reproductive-health/publications/mec/iuds.html.
Medical Contraindications for
                           Intrauterine Contraceptive Use
•   Pregnancy
•   Immediately after puerperal sepsis or a septic abortion
•   Undiagnosed abnormal vaginal bleeding
•   Malignancy of the genital tract
•   Known anomalies or fibroids that significantly distort the uterine cavity in a
    way that is incompatible with IUD insertion
•   Current pelvic inflammatory disease
•   Current purulent cervicitis, chlamydial infection, or gonorrhea
•   Allergy to any component of an IUD or Wilson's disease (for copper-
    containing IUDs)
•   Known pelvic tuberculosis        WHO. Medical Eligibility Criteria for Contraceptive Use. 3rd ed. 2004; FFPRHC Guidance (April 2004). J Fam Plann
                                         Reprod Health Care. 2004;30:99-108; FFPRHC Guidance (January 2004). J Fam Plann Reprod Health Care.
                                                                                               2004;30:29-41; Angle MA, et al. Stud Fam Plann. 1993;24:125-131.
Patient Education and Consent
•   Failure Rate (Effectiveness)
     – ParaGard             0.6-0.8%
     – Levonorgestrel       0.2%
•   Reversibility (Median time to planned pregnancy)
     – ParaGard             3 months
     – Levonorgestrel       2-6 months
                                                                       Failure Rate
•   Pregnancy Rate                            Method         Typical use        Perfect use
     – 82% one year after device removal    Combined OCP         9%                   0.3%
     – 89% two years after device removal   Tubal Ligation      0.5%                  0.15%
                                            Male condom         18%                    2%
                                            Depo-Provera         6%                   0.3%

                                                                                              23
Levonorgestrel-Releasing Intrauterine System: Different
                               Patterns of Menstrual Bleeding*
                                 Type of                                 Copper Intrauterine                            Levonorgestrel
                                Menstrual                                      Device                                 Intrauterine System
                                Bleeding                                  Cycle 1                  Cycle 4            Cycle 1        Cycle 4

                Amenorrhea                                                   0%                       2%               0%             16%

                Infrequent bleeding                                          2%                       2%               11%            57%

                Frequent bleeding                                           19%                       0%               13%             1%

                Prolonged bleeding                                          24%                       0%               22%             3%

                Irregular bleeding                                          17%                      20%               67%            19%

                                                                   *Percentage of subjects meeting criteria for different patterns of bleeding during
                                                                                                                            a specified 90-day cycle.

                                                                                                                                                        24
Suvisaari J, Lahteenmaki P. Contraception. 1996;54:201-208; Luukkainen T, et al. Semin Reprod Med. 2001;19:355-363.
Intrauterine Contraceptives Do Not Increase the Risk of
                       Ectopic Pregnancy
•   A 2-year, 7-center, randomized trial (N=2,244) compared the levonorgestrel-
    releasing (LNg20) and the copper-releasing (Model TCu380Ag) intrauterine
    contraceptive devices (IUDs)
     – No ectopic pregnancies were found
•   A collaborative multicenter, case-controlled study compared women who had a
    history of ectopic pregnancy (n=615) with those who did not (n=3,453)
     – Women who had never used an IUD were equally likely to have had an
       ectopic pregnancy as were IUD users
     – IUD users were less likely to have had an ectopic pregnancy than were
       women who were not currently using contraceptives
                                                     Sivin I, et al. Contraception. 1987;35:245-255;
                                                        Ory HW. Obstet. Gynecol. 1981;57:137-144.

                                                                                                25
Intrauterine Contraceptives
                Noncontraceptive      Benefits
• Intrauterine contraceptives decrease the risk for endometrial
  cancer
• The levonorgestrel-releasing intrauterine system (LNG-IUS)
  can be used as a first-line option to treat menorrhagia
   – May be used in the presence of fibroids, unless they significantly distort or enlarge the
     uterine cavity
   – Produces a 97% decrease in menstrual blood loss
   – In a retrospective study, 80% of women who were prescribed the LNG-IUS for
     menorrhagia chose not to undergo a hysterectomy, as opposed to 9% of women who
     received normal care for the condition

                                            Hubacher D, Grimes DA. Obstet Gynecol Survey. 2002;57:120-128; Castellsague X, et al.
                                                                                                  Int J Cancer. 1993;54:911-916.
Some other recommendations…
• IUD may be offered to women with a history of ectopic pregnancy
• Levonorgestrel system may be an acceptable alternative to
  hysterectomy in women with AUB-O
• FDA recommends that IUDs be removed from pregnant women when
  possible without an invasive procedure
• Remove in menopausal woman
• Counseling should include information about risk factors for STIs and
  PID
                              -ACOG Practice Bulletin No. 59, IUD Obstet Gynecol 2005;105:223-232
                                              - Rauramo I.et al. Obstet Gynecol 2004; 104:1314-21.

                                                                                       27
Intrauterine Contraceptives
               Management of Cramping and Bleeding
•   If a patient has severe or prolonged cramping:
     – Examine for partial IUD expulsion, uterine perforation, or pelvic inflammatory disease
       and treat if necessary
     – Remove the IUD if the severe cramping      is unrelated to menses or is
       unacceptable to the patient
     – If symptoms are mild, they can be treated with nonsteroidal anti-
       inflammatory drugs (NSAIDs)
•   Heavy bleeding for more than 3 months:
     – Examine the patient for infection, fibroids, or signs of anemia and treat if necessary
     – Prescribe NSAIDs
     – Remove the device if there is a medical contraindication or if the bleeding is
       unacceptable to the patient

                                                                                                28
Intrauterine Contraceptives
                            Management of Infections
•   Symptoms
     – Fever, chills, unusual vaginal discharge
     – Severe bleeding or abdominal cramping occurring 3 to 5 days after insertion
     – Pain during intercourse
•   If a sexually transmitted infection (STI) is diagnosed:
     – Treat the infection
     – Counsel the patient about how to prevent transmission of the STI
     – Removal of intrauterine contraceptive (IUD) is not necessary
•   If pelvic inflammatory disease is diagnosed:
     – Treat the infection
     – Remove the IUD only if symptoms fail to improve within 72 hours of after treatment
       begins                 Penney G, et al. J Fam Plann Reprod Health Care. 2004;30:29-41; WHO. Selected Practice
                                         Recommendations for Contraceptive Use. 2002; Grimes D. Lancet. 2000;356:1013-1019.

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Intrauterine Contraceptives
Management of Perforation during Insertion
• If uterine perforation occurs at the time of
  insertion:
   –   Remove the device
   –   Provide alternative contraception
   –   Monitor for excessive bleeding
   –   Follow up as appropriate
   –   Insert another device after next menses if desired
       by patient
Intrauterine Contraceptives
         Management of Missing Strings
• May be the result of partial or complete expulsion of
  the device or perforation of the uterus
   – Rule out pregnancy
   – Probe for strings in cervical canal
   – Obtain ultrasound or x-ray, as needed
   – Remove promptly if found outside the uterine cavity, and
     advise patient she is no longer protected
   – Prescribe back-up contraceptive method, if necessary

                                Speroff L, Darney PD. A clinical guide for contraception. 3rd ed. 2001;
                                            Ben-Rafael Z, Bider D. Obstet Gynecol. 1996;87:785–786.       31
Intrauterine Contraceptives ions
• Partial or unnoticed expulsion may present as irregular bleeding and/or
  pregnancy
• Risk of expulsion related to:
   –   Healthcare provider’s skill at fundal placement
   –   Age and parity of woman
   –   Time since insertion
   –   Timing of insertion (e.g., expulsion risk is greater following a second-trimester
       abortion than a first-trimester abortion)

                  WHO. In: Medical Eligibility Criteria for Contraceptive Use. 3rd ed. Available at: http://www.who.int/reproductive-
                                                                                                  health/publications/mec/iuds.html.

                                                                                                                                32
Billing and Coding
  Contraception        Code     Cost of     Billing amount      Other Billing        Billing Charge with
                                Device             for          Requirements              Insertion or
                                            Contraceptive                            Administration Fee
Mirena               J7298     $468.71     $708.00           Bill w/ IUD insertion   $1,076.00
                                                             58300/$368.00
Skylar               J7301
Paragard T380-A      J7300     $392.00     $431.00           Bill w/ IUD insertion   $799.00
                                                             58300/$368.00
         ICD-10-CM Diagnostic Codes:
         Z30.430             Encounter for contraceptive management; insertion of
         intrauterine contraceptive device
         V30.43(_)           Intrauterine contraceptive device; checking (1), reinsertion (3), or
                             removal of intrauterine device(2)
         Z31.01              Screening pregnancy test (+)
         Z32.02              Screening pregnancy test (-)

                                                                                                     33
Patient Education and Consent
                                                                 Adverse
                             Advantages
                                                          effects/disadvantages
IUD                Long term, no patient               Rare uterine perforation; risk
                   compliance required; rapid          of infection with insertion
                   return of fertility after removal
Paragard T380-A    FDA approved for up to10            Irregular/heavy bleeding and
                   years; (shown to be effective       dysmenorrhea
                   for up to 12 years)
Mirena (LNG-IUs)   Decreased bleeding and              Irregular bleeding initially,
                   dysmenorrhea;                       followed by amenorrhea
                   FDA approved for up to 5            (reported in about 20% of
                   years; (shown to be effective       users after 1 year of use);
                   for up to 7 years)                  ovarian cysts

                                                                                        34
So how does choice impact lactation?
nLAM               n   IUD             n   Progestin-only    nCombined pill
nAbstinence/              n  Copper           nPills         nPatch

                       Sterilization          nInjectables
Periodic           n                                         nRing

Abstinence/                            nImplants             nInjectable

NFP Methods                            nLevonorgestrel

nBarrier Methods                       IUD

No known impact    Little to no        Some reports of       Expected to
on lactation       known impact        negative impact on    have negative
                   on lactation        lactation             impact on
                                                             lactation
Techniques for Insertion
• Copper T-380A
• Levonorgestrel (Mirena, Skylar)
• AHA Guidelines for Prophylaxis for Endocarditis

                                                    36
Insertion of an Intrauterine
                               Contraceptive Device
 •      Use the proper insertion technique for
        each device to decrease the risk of
        uterine perforation and expulsion
 •      Use a sterile technique to reduce the
        risk of infection
          – Antibiotic prophylaxis does not
             prevent infection at time of device
             insertion

Johnson BA. Am Fam Physician. 2005;71:95-102
Oloto EJ, et al. Br J Fam Plann. 1997;22:177–180;
Hubacher D, et al. Am J Obstet Gynecol. 2006 Nov;195(5):1272-1277.

                                                                     37
When to Insert an Intrauterine Contraceptive?
• Any time during menstrual cycle
• Any other time during a woman’s cycle if:
   o She used appropriate contraception
   o She was not sexually active, or
   o Her pregnancy test was negative
• Any time after a pregnancy, a spontaneous abortion, a
  miscarriage, or an induced abortion if a woman has not
  engaged in unprotected intercourse
                WHO. Medical Eligibility Criteria for Contraceptive Use. 3rd ed. 2004; FFPRHC Guidance (April 2004). J Fam Plann Reprod
                     Health Care. 2004;30:99-108; FFPRHC Guidance (January 2004). J Fam Plann Reprod Health Care. 2004;30:29-41.
Use of misoprostol before insertion?
• A 2007 study suggested that the use of misoprostol (Cytotec)
  before IUD insertion allowed for easier insertion.
• However, more recent studies show no benefit and increased
  side effects with misoprostol.
• The American College of Obstetricians and Gynecologists
  makes no recommendation regarding the use of misoprostol
  before IUD insertion.
          •    Edelman AB, Schaefer E, Olson A, et al. Effects of prophylactic misoprostol administration prior to intrauterine device insertion in
                                                                                        nulliparous women. Contraception. 2011;84(3):234-239.
      •       Espey E, Singh RH, Leeman L, Ogburn T, Fowler K, Greene H. Misoprostol for intrauterine device insertion in nulliparous women: a
                                               randomized controlled trial [published ahead of print November 8, 2013]. Am J Obstet Gynecol.
                                                                        http://www.sciencedirect.com/science/article/pii/ S0002937813020176

                                                                                                                                             39
Guidelines for IUDs
Organization      Recommendation
ACOG 2007         Asymptomatic women may use an IUD within 3 months of treated pelvic
                  infection or septic abortion.
ACOG 2007         All adolescents should be screened for GC and chlamydia prior to
                  insertion.
Cochrane 2007     No benefit from doxycycline or azithromycin prior to insertion.

CDC 2010          Evidence is insufficient to recommend the removal of IUDs in
                  women diagnosed with acute PID. However, caution should be
                  exercised if the IUD remains in place, and close clinical follow-up is
                  mandatory. The rate of treatment failure and recurrent PID in women
                  continuing to use an IUD is unknown, and no data have been
                  collected regarding treatment outcomes by type of IUD (eg, copper
                  or levonorgestrel).

40
Key Recommendations for Practice
Clinical Recommendation                                                                              Evidence Rating
Nulliparous women and adolescents can be offered an IUD, although the 20-mcg per 24
hours levonorgestrel-releasing IUD (Mirena) is not approved by the U.S. Food and Drug                       C
Administration for use in nulliparous women
Women who are at high risk of STIs but have no active signs or symptoms of genital tract STI
should be tested for STIs at the time of IUD insertion. Insertion of the IUD may occur on the
same day as STI testing, without waiting for test results. If results are subsequently found to be
                                                                                                            C
positive, treatment can be administered at that time and the IUD left in place.
For women with a known STI that causes cervical infection, it is recommended that IUD
insertion be delayed for at least three months after resolution of the infection.
                                                                                                            C
Prophylactic antibiotics should not routinely be administered before IUD insertion. Antibiotic
prophylaxis does not have a major effect on reducing the risk of pelvic infection, and does not             B
alter the need for IUD removal in the months after insertion.
Misoprostol (Cytotec) should not be administered before IUD insertion. Although an
earlier study showed easier insertion with misoprostol, subsequent studies showed no                        B
benefit and increased side effects.
If a woman with an IUD becomes pregnant, the IUD should be removed.                                         C

                                                                                                                       41
Intradermal Implant
              Hormonal (Progestin-only) Method

• Single-rod implant (4 cm in length and 2 mm in diameter)
  made of ethylene vinyl acetate and contains 68 mg of
  etonogestrel
• Duration of use: 3 years
• 2012 – 1.3% (492,000 women) of contraceptive users*

     *https://www.guttmacher.org/fact-sheet/contraceptive-use-united-states
Implantable Hormonal Devices

•   Single rod, subdermal implantation.
•   68 mg of etonogestrel – period of up to three years        Merck
     – Heavier women may need a new implant every two years
•   Since 1998 – > 3.5 million women (30 countries)
•   Side Effects: Irregular bleeding
     – HA, acne, dysmenorrhea, emotional lability
     – NO significant side effect on BMD or lipid metabolism
Contraceptive Implant
                                     Mechanisms of Action
         • Suppresses ovulation
               – Occurs within 1 day of insertion
               – Ovulation in
Common Myths About Contraceptive
          Implants Among Clinicians
• Insertion and removal is time-consuming and difficult to learn –
  Not true!
   – Time to insert is 1.1 minutes
   – Time to remove is 2.6 minutes
• Implants are associated with a higher risk of ectopic pregnancy –
  Not true!
   – No pregnancies were reported during 5,629 woman-years of use

   – The baseline ectopic pregnancy rate in the United States is 1.97%
                  Mascarenhas L. Eur J Contracept Reprod Health Care. 2000;5 Suppl 2:29-34; Glasier A. Contraception.
              2002;65:29-37; Centers for Disease Control and Prevention. MMWR Morb Mortal Wkly Rep. 1995;44:46-48.

                                                                                                                 45
Contraceptive Implant:
 A 2-year study investigated the efficacy and tolerability of IMPLANONTM (N=330)

• Reasons for discontinuing participation in the study:
   – Irregular bleeding: 13%
        •   Bleeding patterns were studied for reference periods of 90 days. The average number of bleeding or
            spotting days was 17.7 every 90 days.
        •   Bleeding patterns that occur with IMPLANON are unpredictable and may include changes in frequency or
            duration. Amenorrhea also occurs among some women. Change in the frequency or duration of bleeding is
            the most common reason women discontinue IMPLANON treatment.

   – Other adverse events: 23%
        •   Emotional lability: 14.2%
        •   Headache: 12.7%
        •   Weight gain: 12.1%
        •   Dysmenorrhea: 9.7%
        •   Depression: 7.3%
                                                        The IMPLANON US Study Group. Contraception. 2005;71:319-326.
Contraceptive Implant
                                                                         Funk S, et al. Contraception. 2005;71:319-326.
                                                                    Noncontraceptive Benefits
                                         Changes in Acne (n=315)                  Changes in Dysmenorrhea
                                                                                          (n=315)
Percentage change from baseline

                                  70%                                  50%
                                  60%
                                                                       40%
                                  50%
                                  40%                                  30%
                                  30%
                                                                       20%
                                  20%
                                                                       10%
                                  10%
                                  0%                                    0%
                                    Decrease      No     Increase                              No
                                                Change                       Decrease                    Increase
                                                                                             Change

                                                                                                                    47
Contraceptive Implantht Change
• In clinical trials, the mean cumulative weight gain was:
   – End of first year: +2.8 lbs.
   – End of second year: +3.7 lbs.
   – Weight gain was the reason given for discontinuation of participation
     by 2.3% of subjects
• In one study, 12.7% of participants reported weight gain as
  an adverse event
   – The majority of these adverse events were found to be related to the
     study medication
                                    The IMPLANON US Study Group. Contraception. 2005;71:319-326.

                                                                                            48
Contraceptive Implant
•    Effect
    An         on Bone
       open, prospective,    Mineral
                          comparative      Density
                                      two-year study of a
    single-rod implant (n=44) vs. a nonhormonal intrauterine
    device (n=29) found:
    – Essentially similar changes in bone mineral density from baseline
    – No relationship between 17β-estradiol concentrations and
      changes in bone mineral density

                                          Beerthuizen R, et al. Hum Reprod. 2000;15:118-122.

                                                                                        49
Contraceptive Implant
•
                  Administration                     IMPLANON™ [physician insert]. 2006

    If no hormonal contraceptive has been used in past month:
    – Insert within 5 days of initiation of menses
• If switching from combination contraceptives, insert within
  7 days of last active tablet, or during the ring-free or patch-
  free period
• If switching from a progestin-only method:
    – Any day if using the progestin-only pill
    – Same day as intrauterine device or implant removal
    – On due date for next contraceptive injection

                                                                                   50
Contraceptive Implant
                          Quick Start*

• If using Quick Start to insert the implant:
   – It may be inserted any time during the menstrual cycle
   – Determine risk for pregnancy
      • Perform pregnancy test, if indicated
      • Provide emergency contraception, if indicated
      • Recommend nonhormonal contraception for 7 days
        *This method deviates from the manufacturers recommendations for timing of insertion and
                                                         is considered a non-FDA approved use.

                                                                                             51
Complications Insertion
• Discomfort at insertion site
• Bleeding
• Infection

                                     52
Patient Education and Consent
•   Cost                                 $524.34
     – per month over 3 years            ($ 14.57)
•   Failure Rate                  0.05%
•   Very convenient
•   Adverse effects/Disadvantages
     – Irregular bleeding ( as with other progestin-based methods
     – Removal issues                                                             Failure Rate
                                              Method                Typical use                  Perfect use
                                           Combined OCP                 9%                          0.3%
                                            Tubal Ligation             0.5%                         0.5%
                                            Male condom                18%                           2%
                                            Depo-Provera                6%                          0.3%

                                                                                                               53
Risks to Lactation
• May decrease milk supply if initiated before milk supply is
  well established
• Anecdotal reports of immediate negative impact even
  when initiated after lactation is well established
• Progestin IUD typically has MINIMAL impact
   – Potential to have the same impact as other progestin-only
     methods

                                                                 54
So how does choice impact lactation?
 nLAM               n   IUD                n   Progestin-only         nCombined pill
 nAbstinence/                 n   Copper           nPills             nPatch

 Periodic           n   Sterilization              nInjectables       nRing
 Abstinence/NFP                            nImplant                   nInjectable
 Methods                                   nLevonorgestrel IUD
 nBarrier Methods

 No known impact    Little to no known     Some reports of negative   Expected to have
 on lactation       impact on lactation    impact on lactation        negative impact on
                                                                      lactation
Coding and Billing
Contraception   Code      Cost of    Billing amount for        Other Billing      Billing Charge with
                          Device       Contraceptive          Requirements             Insertion or
                                                                                  Administration Fee
Nexplanon       J7307   $566.93     $914.00               Bill w/ Insertion     $1,215.00
                                                          Capsule
                                                          11981/$301.00
Depo            J1055   $23.17 per $85.50 per dose;       Bill w/               $128.50 per dose;
Injection               dose;      $342.00 per year       administration        $514.00 per year
(DMPA)* q               $92.68 per                        90772/$43.00
12 weeks                year
 ICD-10-CM Diagnostic Codes:
 Z30.49 Nexplanon, unspecified birth control
 Z31.01 Screening pregnancy test (+)
 Z31.02 Screening pregnancy test (-)                                           * DMPA for comparison

  56
So what might we say about
            hormonal contraception…
• Given the high level of anecdotal reports of the association of
  hormonal contraception (including progestin-only) with milk supply
  – discourage where there is
   – A young infant: < six weeks for progestin-only, < 6 months for combined
   – Existing low milk supply or history of lactation failure
   – History of breast surgery
   – Multiple birth
   – Preterm birth
   – Compromised health of mother and/or baby

                                                                               57
1 – No restriction

WHO Medical Eligibility Criteria                                                           2 – Generally use
                                                                              3 – Not usually recommended
                                                                                         4 – Not to be used

Duration of BF   Progestin-   Progestin-    Progestin-   Combined     Combined       Low dose
method           only pills   only depots   only         injectable   patch or       combined
                                            implants/    contracep-   ring
                                            IUD          tives
< 6 weeks PP
                      3           3              3           4            4                4

> 6 w to < 6 m
PP (primarily
                      1           1              1           3            3                3
breastfeed)

> 6 m PP
                      1           1              1           2            2                2
ACOG
Breastfeeding: Maternal and Infant Aspects Committee Opinion
 •   All family planning choices are available to the postpartum lactating
     woman.
 •   Choice and clinical ramifications merit additional counseling.
 •   Support women in choosing breastfeeding
     – Accurate information
     – Problems arise
 •   Early discussion of contraception and follow-up
     – Options to be explained in detail
               – Nonhormonal methods
               – Hormonal Methods
               – Lactational Amenorrhea Method

                                                                             59
Progestin vs. Combined OCP and Lactation
      Espey et al. Obstet Gynecol 2012;119(1):5-13
Objective: Estimate the effect of progestin-only
compared with combined hormonal contraceptive pills on
rates of breastfeeding continuation in postpartum women
Results: No difference in breastfeeding continuation
rates, contraceptive continuation, and infant growth
parameters at 8 weeks
Conclusion: Choice of combined hormonal or progestin-
only contraceptive pills administered 2 weeks postpartum
did not adversely affect breastfeeding continuation.
                                                           60
Contraceptive Implant
                           Summary
•   One option available in the United States
•   Easy and quick to insert and remove
•   Efficacy equivalent to sterilization
•   Safe and rapidly reversible
•   Irregular bleeding patterns may be a problem for some patients
•   Majority of reproductive-age women are candidates, including
    adolescents
•   Appropriate option for those preferring a long-term progestin-only
    method and do not want injections or an intrauterine device

                                                                         61
Strategies to Reduce Barriers and Increase Use of
                Implants and IUDS
• Encourage implants and IUDS for all appropriate
  candidates – including nulliparous women and
  adolescents
• Adopt same-day insertion protocols
  – Screening for chlamydia, gonorrhea, and cervical dysplasia SHOULD
    NOT be required before implant or IUD insertion, but may be obtained on
    the day of insertion, if indicated

   ACOG Committee Opinion No. 450. Increasing use of Contraceptive Implants and Intrauterine Devices to Reduce Unintended
                                                                       Pregnancy. Obstet Gynecol. 2009;114(6):1434-1438
Progestin-Only Methods More Appropriate
            Than Combined
                         ACOG 2006
 • Smoking or obesity AND over age 35 [SOR B, A; respectively]
 • Hypertension with vascular disease or > age 35 [SOR B]
 • Lupus with vascular disease, nephritis [SOR A]
 • Migraine with focal aura [SOR B]
 • Current or personal history of VTE associated with pregnancy
   or estrogen unless on anticoagulation [SOR A]
 • Coronary artery/cerebrovascular disease [SOR C]
Management of Unscheduled Bleeding in Women
                  Using Contraception
Contraceptive                       Preferred Treatment
DMPA                                •    Expectant management
                                    •    7-14 days oral estrogen (1.25 mg conjugated estrogen or 2
                                         mg micronized estradiol
                                    •    Transdermal patch (0.1 mg estradiol/24 h)
                                    •    10-20 days of low-dose combined OCP
Etonogestrel implant                •    Expectant management
                                    •    Low-dose combined OCP for 10-20 days (not studied)
                                    •    NSAID for 5-7 days
Progestin pills                     •    Take at same time each day and minimize missed doses.

Levonorgestrel IUD                  •    NSAID for 5-7 days (eg, ibuprofen 400 mg, naproxen 250 mg,
                                         or mefanamic acid 500 mg TID)
          Edelman A and Kaneshiro B. Management of unscheduled bleeding in women using contraception. www.uptodate.com, 2017.
Contraception and Adolescents
• Adolescents are capable of understanding
  complex messages that include support for
  abstinence, but also provide appropriate
  information about sexual activity and
  contraception
• It’s a conversation…at any age

                                              65
Cavazos-Rehg PA, et. al. Age of sexual debut among US adolescents. doi:10.1016/j.contraception.2009.02.014

                              Age of Sexual Debut

Kaplan–Meier curves: probability of surviving free of sexual debut, according to race and
gender.
Abstinence
• Convey to adolescents that this is expected, be realistic
• Abstinence teaching programs have some success
• Encouragement to practice abstinence can be a powerful
  tool to enhance empowerment for self care
• Advantages: no STDs, no cost, no pregnancy
• Disadvantages: difficult to maintain
Sexual Abstinence
• Educational programs that teach BOTH abstinence and
  contraception
   – Delay onset of sexual activity and reduce number of sexual
     partners
      • Ancheta et al. J Pediatr Adolesc Gynecol 2005;18.
• “Pledge” to remain abstinent: 50% honor pledge 12
  months later
   – STIs same whether pledgers or non-pledgers
      • Rosenbaum et al. Am J Public Health. 2006;96
Best Practice Recommendations
•   Clinicians should consider a tiered approach to contraceptive counseling, whereby the most
    effective and appropriate options are presented before less effective options.
•   Requiring prerequisite preventive services, such as cervical cytology; breast examination; or
    evaluation for sexually transmitted infections, diabetes mellitus, dyslipidemia, liver disease,
    or thrombophilia, can introduce unnecessary barriers to contraceptive care.
•   Family planning services should be offered to adolescents with assurances of confidentiality,
    in the context of relevant law.
•   Intrauterine devices and contraceptive implants are safe and effective for postmenarchal
    adolescents and adults.
•   The most common side effect of a progesterone only contaceptive (regardless of the the
    vehicle) is irregular bleeding,
•   Evidence is insufficient to recommend the removal of IUDs in women diagnosed with acute
    PID.
Thank You

70
References
1. ACOG Practice Bulletin 121. Long-Acting Reversible Contraception: Implants and Intrauterine
   Devices. Obstet Gynecol 2011;118:184-195. (Reaffirmed 2015)
2. ACOG Practice Bulletin 152. Emergency Contraception. Obstet Gynecol 2015;126:e1-11.
3. Smoley BA, Robinson CM. Natural Family Planning. Am Fam Physician. 2012;86(10):924-928.
4. Hardeman J and Weiss BD. Intrauterine Devices: An Update. Am Fam Physician
   2014;89(6):445-450.
5. Centers for Disease Control and Prevention. U.S. Medical eligibility criteria for contraceptive
   use, 2010. MMWR Recomm Rep. 2010;59(RR-4):1-86.
6. Klein DA, Arnold JJ and Reese ES. Provision of Contraception: Key Recommendations from
   the CDC. Am Fam Physician. 2015;91(9):625-633.
7. US Medical Eligibility Criteria (USMEC) for Contraceptive Use, 2016.
   https://www.cdc.gov/reproductivehealth/contraception/usmec.htm

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