Mirena IUS

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Mirena IUS

• Melissa McLaney
• Medical Sales Specialist

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Why the Need for New Contraceptives

• High rate of unintended pregnancies
• 43 of all US women will have had an induced
  abortion by age 45
• 20 of women selecting sterilization at ? 30
  years of age later express regret

Henshaw SK. Fam Plann Perspect 19983024-29. Hill
is SD et al. Obstet Gynecol 199993889-895.
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Usage of Different Contraceptive Methods by Age
Groups
100
80
60
Percent
40
20
0
Gallup Survey, '98-'99.
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Characteristics of Mirena
32 mm

• High efficacy
• Long-term reversible method
• Low systemic levels of LNG
• Changes in menstrual bleeding

Steroid reservoir
32 mm
levonorgestrel20 ?g/day
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Mirena Theoretical Mechanism of Action

• Cervical mucus thickened
• Sperm motility and function inhibited
• Endometrial effects
• Ovulation inhibited (in some cycles)

Jonsson B et al. Contraception 199143447-458. Ni
lsson CG et al. Fertil Steril 19844152-55. Videl
a-Rivero L et al. Contraception 198736217-226.
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Mirena Prevents Fertilization

• Most evidence now suggests that all IUDs induce
  a foreign body reaction that is spermicidal,
  preventing fertilization
• Todays intrauterine contraceptives have other
  mechanisms of action that prevent fertilization

Alvarez F et al. Fertil Steril 198849768-773.Se
gal SJ et al. Fertil Steril 198544214-218.
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Plasma Concentrations of Levonorgestrel
Combination OCs
Mini-pill
Implant
Mirena
Nilsson CG et al. Acta Endocrinol
198093380-384. Diaz S et al. Contraception
198735551-567.
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Changes in the Endometrium
Normal Menstrual Cycle
Ovulation
Height ofendometrium
Days of cycle
Resting State with Mirena
Height ofendometrium
Days of cycle
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Pregnancy Rates for Birth Control Methods
1Used without spermicide 2Used with spermicide
3Contains spermicide Adapted from Trussell J. In
Hatcher RA et al, eds. Contraceptive
Technology Seventeenth Revised Edition. New
York Irvington Publishers, 1998.
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Mirena Return to Fertility
100
80
60
Cumulative pregnancyrate after removal ()
Mirena
40
Copper T 380A
20
0
3
6
9
12
0
Months
Andersson K et al. Contraception
199246575-584. Belhadj H et al. Contraception
198634261-267.
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Mirena Early Spotting

• Endometrial suppression effect is not immediate
• During the first month there may be more spotting
  days than clear days
• By 3 6 months, most women will experience lt 5
  7 bleeding/spotting days/month
• After the first year, 20 may experience a lack
  of menstrual bleeding
• Pre-counseling is the best treatment

Silverberg SG et al. Int J Gynecol Pathol
19865235-241.
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Mirena Ovarian Cysts

• Enlarged follicles diagnosed in 12 of subjects
  
• Mostly disappear spontaneously during 2 3
  months observation
• Surgical intervention not usually required

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Mirena Number of Bleeding Days
20 of women on Mirena will have no bleeding at
all after12 months
Nova T is not available in the US. Luukkainen T,
Toivonen J. In Sitruk R, Bardin CW, eds.
Contraception Newer Pharmacological Agents,
Devices, and Delivery Systems. New York Marcel
Dekker, 199290. Pekonen F et al. J Clin
Endocrinol Metab 199275660-664. Luukkainen T et
al. Contraception 198736169-179.
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Mirena Potential Contraindications/ Complications

• Contraindications
• Pregnancy or suspicion of pregnancy
• Active cervical or endometrial infections
• Uterine anomaly
• Prior ectopic pregnancy
• Complete list included in package labeling

• Complications
• Expulsions
• Mainly during the first 6 months after insertion
• 5-year cumulative expulsion rate is 4.9/100 women
• Uterine perforations
• Most often occur at the time of insertion
• Rare, lt 1/1000

Andersson K et al. Contraception 19944956-72.
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Mirena Side Effects
Andersson K et al. Contraception 19944956-72.
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Myths and Misconceptions
Women are not interested in intrauterine
contraception (IUC)
Worldwide, 12 of married women of reproductive
age use IUC
Before the Dalkon Shield controversy, 9.5 of
married US women using contraception used IUC
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Myths and Misconceptions
If I provide intrauterine contraception I will
be subject to litigation
Since 1988 there has been only 1 lawsuit against
the manufacturer of the Copper T 380A, and the
decision was for the defense
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Myths and Misconceptions
IUDs cause PID and sterility
While PID has been one of the biggest concerns,
it is now known that IUDs do not cause PID it
is contracting an STD like chlamydia that does
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Offering Mirena as an Option

• gt 15 years experience in Europe
• gt 6 years experience in the US
• gt 2000 Mirenas inserted daily in the US
• gt 2 million users worldwide
• Overall failure rate 0.14/100 woman-years
• Gross cumulative 5-year failure rate 0.71/100
  women
• Rapid return to fertility

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Explaining Mirena to Your Patients

• Why Mirena as an option?
• When? Whom?
• Describing Mirena
• How does it work?
• Insertion procedure
• Side effects
• Return to fertility

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Patient Selection

• First-line for almost all women who desire
  effective long-term contraception, especially
• Postpartum women
• Women dissatisfied with current contraception
• Women considering tubal ligation
• Any woman desiring contraception for greater than
  a year

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Considering Tubal Ligation
1995 data
Surgical Sterilization in the United States
Prevalence and Characteristics, 1965-95. Centers
for Disease Control.
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Mirena vs Sterilization Advantages
Frantzen C et al. Frauenarzt 200142.
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Safety

• Signs of complications
• Perforation
• Expulsion
• Ectopic pregnancy

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Follow-up

• Timing of follow-up visit
• Check the positioning
• Reinforce counseling

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Mirena Insertion

• Different insertion technique than other
  intrauterine contraception
• New, one-handed insertion
• Requires hands-on training
• Efficacy and continuation depend on skillful
  insertion

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Prior to Insertion

• Consent
• Exam
• Preparation of the cervix
• Tenaculum
• Sound uterus

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Insertion (1) Opening the Package

• Open the sterile package
• Release the threads
• Make sure the slider is in the furthest position
  away from you
• Check that the arms of the system are horizontal

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Insertion (2) The Inserter
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Insertion (3) Preparation

• Pull on both sides to draw the Mirena system into
  the insertion tube
• The knobs at the end of the arms now close the
  open end of the inserter
• Fix the threads tightly in the cleft at the near
  end of the inserter shaft

Slider top position
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Insertion (4) Setting the Flange

• Set the upper edge of the flange at the uterine
  sound measure

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Insertion (5) Insertion

• Hold the blue slider with your forefinger or
  thumb firmly in the top position
• Move the inserter carefully through the cervical
  canal into the uterus until the flange is about
  1.5 2.0 cm from the cervix to give sufficient
  space for the arms to open

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Insertion (6) Releasing the Arms

• While holding the inserter steady, release the
  arms of Mirena by pulling the slider back until
  it reaches the mark (raised horizontal line)

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Insertion (7) Fundal Positioning

• Advance the inserter gently toward the fundus
  until the flange touches the cervix
• Mirena should now be in the fundal position

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Insertion (8) Release of Mirena

• Hold the inserter firmly in position and release
  Mirena by pulling down the slider all the way to
  the bottom position
• The threads willrelease from the cleft
  automatically

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Insertion (9) Cut the Threads

• Remove the inserter carefully from the uterus
• Cut the threads to leave about 4-6 cm visible
  outside the cervix

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Insertion
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Mirena IUD

• Melissa McLaney