Long Acting Reversible Contraceptions Presenation

LARC:
What Is It and
Why Is It Important for Teens?
Jan Shepherd, MD, FACOG
Learning Objectives
• Define LARC and discuss why it can be
important in preventing unintended pregnancy
• Discuss the increasing role of intrauterine
contraception in family planning for all age
groups
• Describe the contraceptive implant and discuss
potential benefits and side effects of the method
• Describe the concept of a Reproductive Life Plan
and how it can be used in counseling teens
Disclosure
• I am on the Speakers Bureau for
– Bayer (IUCs)
– Merck (Implant)
– Teva (IUD)
U.S. Pregnancies:
Unintended vs. Intended
Intended 51%
Unintended 49%
Unintended births 29%
Elective abortions 20%
Guttmacher Institute; January 2012.
Teenage pregnancy is more common in the
USA than in most other industrialized
countries
Russian Federation
United States
Bulgaria
Hungary
England and Wales
Births
Canada
Abortions
Sweden
France
Miscarriages
Spain
Netherlands
Japan
0
10
20
30
40
50
60
70
80
90
100 110 120
Pregnancies per 1,000 women aged 15-19
Our Teen Birth Rate is Declining
Change from
1991-2011
Change from
2010-2011
Colorado
United States
-50%
-49%
-13%
-8%
And Colorado went from #23 to #29 in latest statistics
CDC
But We Still Have Work To Do
Total Teen Births 2011
Total
Colorado
United States
67
3,974
15-17
1,383
95,538
18-19
3,351
234,234
Under 15
Race/Ethnicity
Colorado
United States
Non-Hispanic White
37%
39%
Non-Hispanic Black
7%
24%
Native American
2%
2%
Asian or Pacific Islander
1%
2%
Hispanic
53%
33%
Colorado Statistics
• 41% of high school students (36% of
females) have had sexual intercourse
• 4% (2% of females) had first intercourse
before age 13
• 13% (11% of females) have had intercourse
with 4 or more partners
• 7% (8% of females) did not use any
contraception with last intercourse
CDC
Contraceptive Use and
Unintended Pregnancy
•
•
52% of unintended pregnancies
attributable to sexually active women
using no method
48% of unintended pregnancies —
women using some form of birth control
Mosher WD, Jones J. Vital and Health Statistics 2010.
First Year Contraceptive Failure:
Perfect Use vs Typical Use
Perfect Use
Typical Use
30
25
20
15
10
5
0
Hatcher RA. Contraceptive Technology.
Typical Use
• Women forget to take pills
• Injectable users miss a shot
• Couples don’t use a condom every time they
have sex
• Methods are used incorrectly
• Women do not expect to have sex
• Users’ supplies run out
* All especially common in teens
Current Trends in Contraception
• Emphasizing greater success
 Duration of action   Ease of
adherence   Efficacy in typical use
LARC: Long Acting Reversible
Contraception
Intrauterine contraception
Subcutaneous implant
• Improved Counseling
– Reproductive Life Plan
LongActing
Reversible
Contraception
= “Forgettable
Contraception”
WHO Method Comparison
Intrauterine Contraception
(IUC)
Levonorgestrel Intrauterine Systems
Copper T 380A
Debunking Myths
About Intrauterine Contraception
•
•
•
•
IUCs are abortifacients
IUCs cause pelvic inflammatory disease (PID)
IUCs cause infertility
IUCs cannot be used in nulliparous women
IUC: Mechanism of Action
• Mechanism of Action - Spermicidal
– Foreign body reaction
• Copper T 380A
– Heavy metal toxic to sperm
• Levonorgestrel IUC
– Progestin thickens cervical mucous
• Prevents egg & sperm getting together
– Not an abortifacient
History of IUC
Dalkon Shield
• Increased rate of PID, septic
abortion, infertility
• Infections related to woven thread
• Off the market for over 30 years
• Modern IUCs are not your
grandmother’s IUD
Dalkon
Shield
IUCs Do Not Cause PID
5-Year Cumulative Rates of Discontinuation for PID
A. Randomized trial comparing
Mirena to CuT 380A
5
Mirena
B. Randomized trial comparing
Mirena to Nova T
5
CuT 380A
4
3
2
Percent
Percent
4
Nova T*
P < .05
3
2
1
1
0
0
*Nova T is not available in the US.
Sivin I et al. Contraception 1990;42:361-378.
Mirena
Andersson K et al. Contraception 1994;49:56-72.
IUCs Do Not Cause PID
• Therefore do not cause infertility
– Tubal infertility not linked to IUC use1
– PID risk with cervicitis same with & without IUC2
• Therefore can be used by women who have
not had children, including adolescents
1. Hubacher D. NEJM 2001;345:561-7. 2. Grimes D. Lancet 2000;356:1013-9.
Fertility After Discontinuation of
Contraceptive
•100
•80
•IUD
•60
•OC
Pregnancies
•40
(%)
•Diaphragm
•Other methods
•20
•0
•0
•12
•18
•24
•30
Months After Discontinuation
Vessey MP, et al. Br Med J. 1983;286:106.
•36
•42
Copper T 380A (Paragard®)
•
•
•
•
On US market since 1988
High efficacy
(failure rate .5-.8% per year)
Approved for 10 years use
Changes in menstrual
bleeding
–
–
Can increase flow and
cramping
Controlled by NSAIDS
Cu T 380A
September 2005 Labeling Changes
• Contraindications
– Removed “depressed immune
conditions, including HIV”
• Recommended patient profile
– Removed multiparity
– Removed mutual monogamy
CuT380A and Menstrual Problems
• Counsel that first few periods likely to be
heavier and may have increased cramping
• NSAIDS (e.g. ibuprofen) around the clock
on the first day and continued for 3-5 days
– Decreases bleeding by up to 50%1
• Symptoms usually improve after first few
cycles2
1. Contraception 2013;87:549-66. 2. Contraception 2009;79:356-62.
Levonorgestrel IUS (Mirena®)
32 mm
32 mm
Steroid
reservoir
levonorgestrel
20-10 g/day
• High efficacy
(failure rate .2% per year)
• Approved for 5 years use
• Low systemic levels of
hormone
• Changes in menstrual
bleeding
– Irregular bleeding at first,
then decreased flow or no
periods (20%)
LNG IUS - Noncontraceptive Benefits
• FDA-approved for treatment of heavy
menstrual bleeding
–Better than medical therapy*
• Decreases menstrual cramps (off-label)
–Even in medical conditions
* N Engl J Med 2013;368:128-37.
New Levonorgestrel IUS (Skyla®)
• High efficacy
(failure rate .4%/year)
• Effective for 3 years
• Smaller, thin inserter,
lower hormone dose
• Approved for nullips
• Changes in menstrual
bleeding
Levonorgestrel
14-5 μg/day
– Irregular bleeding at
first, then short, light
periods
Risks of Intrauterine Contraception
•
•
•
•
Expulsion - 3.2-5%
Perforation - 1,000-2,000
Infection/PID - related to insertion
If pregnancy occurs, ectopic possible
– 1 of 2 with Mirena and Skyla
– 1 of 16 with Paragard
Discussion for patients
http://bedsider.org/features/287
ACOG Statements
• On IUDs: “IUDs offer safe, effective, longterm contraception and should be
considered for all women…”
• On Adolescents: “Providers should strongly
encourage young women who are
appropriate candidates to use this method.”
– “IUDs are safe to use among adolescents.”
– “IUDs do not increase an adolescent’s risk of
infertility.” *
*Committee Opinion #539 October 2012.
Which IUC?
• LNG IUS
– Woman with heavy flow or cramps
– Anyone who desires  bleeding/amenorrhea
• Cu T 380A
– Woman who prefers regular predictable cycles
– Wants/Needs to avoid hormones
– Prefers longer duration (10 years)
• Low-dose LNG IUS
– Lighter, less painful periods
– Lower systemic hormone exposure
The Subdermal Implant
(Implanon®  Nexplanon®)
Norplant®
Implanon®
Single-Rod Implant
Rate-controlling membrane (0.06 mm)
2 mm
Core
40 mm
Core:
Membrane:
40% Ethylene vinyl acetate (EVA)
60% Etonogestrel (68 mg)
100% EVA
Nexplanon®
Advantages
•
•
•
3 years of most effective contraception
Pelvic exam not required
Progestin-only method, can use
– When estrogen contraindicated
– If estrogenic side effects with another method
• Improves acne and menstrual cramps
• Insertion and removal easier than previous
implants
Estradiol Levels During Treatment
Mean estradiol (pmol/L)
1500
1250
Implant
n = 44
Copper IUD
n = 29
1000
750
500
250
0
Baseline
Month 12
Month 24
Last
measurement
 Does not affect bone density like Depo Provera does
Beerthuizen R, et al. Hum Reprod. 2000;15:118-122
Discontinuation Rates
due to Adverse Events
Bleeding irregularities
Weight gain
Emotional lability
Headache
Acne
Depression
11.0%
2.3%
2.3%
1.6%
1.3%
1.0%
(104/942)
(22/942)
(22/942)
(15/942)
(12/942)
(9/942)
1.7% of Women Experienced Problems at Removal
IMPLANON™ [package insert]. Roseland, NJ:
Organon USA Inc; 2006.
Bleeding Patterns
• Bleeding is usually irregular
– Can be light or heavy, short or prolonged
– Skipped periods most common
• Pattern can vary throughout the duration of use
• Total amount of bleeding/spotting days usually
similar to or slightly less than a normal
menstruating woman
– Key difference is the irregularity and
unpredictability of the bleeding
Managing BTB with Nexplanon
• COUNSELING
• *Oral contraceptives,
if not contraindicated
• Provera or Aygestin for 21 days x 3 mos
• Progestin-only pills x 3 months
• Estrogen x 10 days
• NSAIDs (e.g. ibuprofen) x 5-10 days
Contraception 2008;78:106-112. Contraception 2011;83:203-2010.
Managing Hormonal Side Effects
with Implant (or LNG- IUS)
• Acknowledge client’s concerns
• Agree to remove it if she desires
• Point out very low incidence of these side
effects, then: “Is there anything else in your
life that could be causing this headache,
moodiness, etc.”
• Remind client that if related to the method,
side effects usually decrease over time
Role of LARC: CHOICE Project
Method Chosen
•
•
•
•
•
LNG IUS – 45%
Copper IUD - 10%
Implant – 13%
Depo Provera – 8%
OCPs – 23%
Obstet Gynecol 2011;117:1105-13.
Continuation: CHOICE Project
2 year2
1 year1
•
•
•
•
•
LNG IUS – 88%
Copper IUD – 85%
Implant - 83%
Depo Provera – 57%
OCPs – 55%
• LARC – 87%
• Non-LARC – 57%
•
•
•
•
•
LNG IUS – 79%
Copper IUD – 77%
Implant - 68%
Depo Provera – 38%
OCPs – 43%
• LARC – 77%
• Non-LARC – 41%
1. Obstet Gynecol 2011;117:1105-13. 2. Obstet Gynecol 2013;122:1083-91.
Efficacy of LARC: CHOICE Project
• 22X more effective than pill, patch or ring
(0.27 vs. 4.27 pregnancies per 100 women)
• Double this effect in teens
• Rate of teenage birth in the CHOICE cohort
6.3/1000 vs. 34.3/1000 nationally
• Rate of abortion less than half the regional
and national average
1. N Engl J Med 2012;366;1998-2007. 2. Obstet Gynecol 2012;120:11291-7.
Depo Provera
The almost-LARC
Depo Provera (DMPA)
Positives
• Highly Effective
(.22 pregnancy rate)
• Easy to use
• Anonymous
• Can use when
estrogen
contraindicated
• No drug interactions
Negatives
• Amenorrhea
• Prolonged pituitary
suppression
– Median time to pregnancy
is 9–10 months
– Up to 18 months is WNL
•
•
•
•
Weight gain
Vaginal dryness
Adverse effect on lipids
↓ Bone density
Recovery of Bone Density in
Adolescents
3
2.5
2
1.5
1
DMPA
Control
0.5
0
-0.5
-1
-1.5
Hip during
Spine
during
Hip After Spine After
J Adolesc Health 2006;39:296-301.
ACOG Statement
“Concerns regarding the effect of DMPA
on bone mineral density should neither
prevent practitioners from prescribing
DMPA nor limit its use to 2 consecutive
years.”
Committee Opinion #415 September 2008.
Improved Contraceptive Counseling

Reproductive Life Plan
• Being intentional about preparing for and
starting pregnancies
• Making conscious decisions about
– When to have children
– How many to have
– Ensuring the healthiest pregnancies and families
CDC
Reproductive Life Plan =
True “Family Planning”
• Encouraging clients to think about
contraception
– In terms of
• Planning for when they do want children
• Protecting themselves until that time
– Not just for this year or this relationship
Reproductive Life Plan
• Clinicians help clients make a
Reproductive Life Plan by asking:
– Do you hope to have children? More children?
– How many?
– When?
Every woman, every year
Reproductive Life Plan
• Avoiding unintended pregnancy
– More effective use of contraception
– First-line option for many
LARC: Long Acting Reversible
Contraception
– Fertility-preserving behavior
• Planning for desired pregnancies
– Preconception care
Case
• A 16-year-old, newly sexually
active, presents to the clinic
for her first appointment, requesting
contraception.
• Do you plan to have children? Yes
• How many? Two or three
• When? Not until I finish high school and
college
Reproductive Life Plan
• Avoiding unintended pregnancy
– Effective use of contraception
– First-line option
LARC: Long Acting Reversible
Contraception
• Intrauterine contraception
• Subcutaneous implant
• Protection against STIs!
More Ways to
Encourage Use of LARC
• You are >22 times more likely to become
pregnant with OCPs, patch, or ring than
with a LARC method!
• Ask about feasibility of daily pill taking  “How
often do you want to have to think about your
birth control?”
• Get It and Forget it
• Anticipate and dispel misconceptions
Counseling About Safety
• LARC methods are very safe
• All avoid the blood clot risks of estrogencontaining methods
• All reduce the risk of ectopic pregnancy and
certain cancers
• IUC is the #1 method of birth control in the
world and its use is on the rise in the US
LARC
• Methods requiring attention > q 3 years
• Independent from
– Intercourse
– User motivation and adherence
• Do not require frequent visits for resupply
• Highest effectiveness, continuation rates,
and user satisfaction proven in teens
• Excellent safety record
*Always need condoms to prevent STIs