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INTRODUCTION OF
CONTRACEPTIVE IMPLANTS
Prepared By: Dr.Kiak
Obstetrics & Gynecology Division
Date: 2014 - 04 - 18
Sub-dermal Contraceptive Implant
JADELLE LEVONORGESTREL
CONTENT
 Brief Introduction
 What is It
 Component/Structure
 Release Rate of Levonorgestrel
 Pre-clinical Evaluation
 Mechanism of Action
 Efficacy/Fertility
 Subjective Symptoms
 Timing of Insertion
 Implant Insertion Technique
 Comparison - New Hormonal Implants
 Monthly Stat for Implants -MGH
 Summary
Brief Introduction
 Implants are approved in more than 60 developed and
developing countries and are currently being used by
millions of women worldwide 1
. Owing to their high
contraceptive efficacy (which begins almost immediately
after insertion), low rate of complications and side-effects,
possibility of long-term use following a single intervention
and the rapid return of fertility after removal.
 Contraceptive implants are good candidates for inclusion in
the method mix offered by family planning programmes,
especially in under-resourced setting 2
.
1. Ref: Contraceptive implants come of age. Progress in Reproductive Health Research 2003; No. 61. Geneva; World
Health Organization (www.who.int/reproductive-health/hrp/progress/61/news61.htm (accessed 1 September 2008).
2. Boostra H, Duran V, Weaver K. Norplant and the boom or bust phenomenom. IPPF Medical Bulletin October
1999;33:3–4.
Countries using Implant
Burundi
Ethiopia
Ghana
Malawi
Mali
China
Indonesia
Kenya In Progress (n=20)
Under Review (n=10)
Nepal
Pakistan
Rwanda
Tanzania
Uganda
Argentina
Bangladesh
Bolivia
Brazil
Burkina Faso
Chile
Colombia
Dominican
Republic
Ecuador
Fiji
India
Mexico
Mozambique
Nigeria
Peru
Russia
South Africa
Sudan
Venezuela
Zimbabwe
REGISTERED (n=6)
Sierra Leone
Madagascar
Zambia
Levonorgestrel subdermal implants provide effective long
term contraception.
Implants are a good choice of contraceptive method in
women who desire effective contraception, but who are
unable to, or prefer not to, comply with an oral regimen or
injection.
Implants maybe used to postpone
1st pregnancy
Space pregnancy
Provide long-term contraception when desired
family size is reached
What is it?
Long-Acting & Permanent Methods
 The advantages that implants and other methods such as
the IUD offer over other contraceptive methods is that they
are not user-dependent in the way that condoms, injectables
& combined oral contraceptives (COC) are 3
.
Ref. 3.Russell J. Contraceptive failure in the United States. Contraception 2004;70:89–96.
Components
 Implants is a set of two flexible cylindrical implants
consisting of a dimethylsiloxane/ methylvinylsiloxane
copolymer core enclosed in thin-walled silicone tubing.
Each rod contains 75 mg of the progestin levonorgestrel.
The core of each rod is a mixture, half of levonorgestrel,
half of the elastomer.
The rods are sealed with polydimethylsiloxane adhesive &
sterilized.
Each rod is approximately 2.5 mm in diameter & 43 mm in
length 4
.
Ref. 4. Harold Nash, and Sandra Waldman. Jadelle ィ Levonorgestrel Rod Implants:.A
Summary of Scientific Data and Lessons Learned from Programmatic Experience Irving
Sivin,
Medical adhesive
43mm thin-walled silicon tubing
levonorgestrel & Siloxane copolyme
12.5mm
Components
Session IV A, Slide #3
Implanon Applicator
Structure
 The sole active ingredient in the rods is levonorgestrel (-)-13-
ethyl-17-hydroxy-18,19-dinor-17α-pregn-4-en-20-yn-3-one.
It has a molecular weight of 312.45 and the structural formula.
 Medical grade silicone rubber materials, including the type
used in Jadelle, have been employed in various implantable
devices for humans since 1950 4
.
 Silicone rubber implant have be employed in various
implantable device
 Prosthetic devices
 Heart valves
 Drainage tubes
QuickTime™ and a
decompressor
are needed to see this picture.
Ref. 4. Harold Nash, and Sandra Waldman. Jadelle ィ
Levonorgestrel Rod Implants:.A Summary of Scientific Data and
Lessons Learned from Programmatic Experience Irving Sivin,
Release Rate of Levonogestrel
 Diffusion of Levonogestrel from the rods produces a continuous
low dose of the progestin and is is delivered directly into
interstitial fluids from the subcutaneous implants
 After placement of Jadelle rods,levonorgestrel concentrations
reach a maximum level within 2-3 days after implant
 Decline rapidly over the 1st month both due to a decrease in the
rate of release & because of decreased circulating levels of sex
hormone binding globulin (SHBG), a protein that binds
levonorgestrel.
Jadelle/Day Dosage/Rate Remarks
1 month 100g/day
12 months 40g/day
24 months 30g/day -stabilizing thereafter
Pre Clinical Evaluation
Levonorgestrel implant is a totally synthetic &
Biologically active Progestin- does not contain
estrogen- a subdermal contraceptive implant
A double silicon rods preload in a sterile disposable
applicator to facilitate easy & rapid insertion
Release of Levonorgestrel sufficient to prevent
conception within 24hrs after implant
Effective role for 5 years
Mechanism Of Actions
At least 3 mechanism are active in preventing pregnancy
1. Ovulation inhibition- by suppressing of
gonadotrophins (LH&FSH) secretion
2. Thickening of the cervical mucus
-increase viscosity of the cervical
mucus that preventing passage of
sperm into the uterus
3. Decrease endometrial
thickening during the use of
implants.
Efficacy/Fertility
It is convenient, safe, and over 99% effective
Prevents against pregnancy for up to 5 years, can be
removed @ anytime
Return to fertility rapidly after removal.
Another Jadelle implant can be inserted immediately
after removal for protection against pregnancy
 It is invisible
Can be used without anything else
Subjective Symptoms
The cost is K1040-K2080 and around K200-K400
for removal
Headache
Nausea
Breast pain & Mood changes
Others include- pain, itchiness, infection and
expulsion on insertion site
This does not protect you from STDs
Timing of Insertion
Should be inserted on day 1-5 during menstrual cycle
Immediately or on week after 1st/2nd trimester
abortion
In Postpartum women
 Non BF women immediately or within 6 wks after
labor
 BF women should not use implants before 6 wks
after labor.
 However,studies have shown no significant effects on the
growth or health of infants whose nursing mothers began
using levonorgestrel implants immediately or 5-7 wks after
childbirth. There is no experience to support the use of
Jadelle earlier than six weeks after childbirth in lactating
women
Implant Insertion Technique
Session IV A, Slide #2
One-Rod Implant Insertion:
Required Equipment
• An examination table
• Sterile surgical drapes
(optional) and gloves
• Antiseptic solution
• Local anesthetic, needles,
and syringe
• Implanon applicator
• Skin closure, sterile
gauze, and compresses
QuickTime™ and a
decompressor
are needed to see this picture.
QuickTime™ and a
decompressor
are needed to see this picture.
Two rods implant Insertion
Required Equipment
Session IV A, Slide #4
Implanon Insertion: Step 1
• Have the client lie on
her back with the arm
that she doesn’t
normally use flexed at
the elbow and
externally rotated.
• Implanon should be
inserted sub-dermally
just under the skin.
QuickTime™ and a
decompressor
are needed to see this picture.
Jadelle Insertion: Step 1
Session IV A, Slide #6
Implanon Insertion: Step 3
• Mark the insertion site
with a marker.
• Make 2 marks:
– First, mark the spot where
the rod will be inserted.
– Second, mark a spot a few
centimeters proximal to the
first mark. This second
mark will later serve as a
direction guide during
insertion.
QuickTime™ and a
decompressor
are needed to see this picture.
Jadelle Insertion: Step 2
3 Finger breath Medial Epicondyle
Session IV A, Slide #7
Implanon Insertion: Step 4
• Clean the client’s upper
arm with antiseptic
solution. Frame the
insertion area with a
drape that has an
opening (optional).
• Anesthetize the insertion
area with anesthetic
spray or by injecting 2 cc
of 1% lidocaine just under
the skin along the
planned insertion tunnel).
QuickTime™ and a
decompressor
are needed to see this picture.
QuickTime™ and a
decompressor
are needed to see this picture.
Jadelle Insertion: Step 4-5
Injection 10cc of 1% Lidocaine just under the skin
Session IV A, Slide #8
Implanon Insertion: Step 5
• Remove the needle
shield.
• Stretch the skin around
the insertion site with
thumb and index finger.
Session IV A, Slide #9
Implanon Insertion: Step 6
• Insert the tip of the
needle, at about a
20 degree angle.
QuickTime™ and a
decompressor
are needed to see this picture.
QuickTime™ and a
decompressor
are needed to see this picture.
Jadelle Insertion: Step 6
Jadelle Insertion: Step 7
QuickTime™ and a
decompressor
are needed to see this picture.
QuickTime™ and a
decompressor
are needed to see this picture.
Session IV A, Slide #10
Implanon Insertion: Step 7
• Release the skin.
• Lower the applicator
to a horizontal
position.
Session IV A, Slide #11
Implanon Insertion: Step 8
• Lift the skin with the tip
of the needle, keeping
the needle in the
subdermal connective
tissue.
• While lifting the skin,
gently insert the entire
needle. Keep the
applicator parallel to
the surface of the skin.
Jadelle Insertion: Step 8
Jadelle Insertion: Step 9
Session IV A, Slide #16
Implanon Insertion: Step 13
• Verify the presence of the implant by
palpating the site.
• Apply a sterile gauze and wrap the
arm with a pressure bandage.
• Before the client is discharged,
observe her for a few minutes for
signs of bleeding from the insertion
site.
• Fill out the user card and give it to
the client.
• Review post-insertion instructions
and other key messages.
• Dispose of the applicator and syringe
properly.
QuickTime™ anda
decompressor
areneededto seethis picture.
Jadelle Insertion: Step 10
Sino-implant (II) Jadelle Implanon
Manufacturer Shanghai Dahua
Pharmaceutical
Bayer HealthCare Schering Plough /
Organon
Formulation 150 mg
levonorgestrel
In 2 rods
150 mg
levonorgestrel
In 2 rods
68 mg etonogestrel
In 1 rod
Mean Insertion
& Removal time
Insertion: 2 min
Removal: 4.9 min
Insertion: 2 min
Removal: 4.9 min
Insertion: 1.1 min
Removal: 2.6 min
Labeled
duration of
product use
4 years 5 years 3 years
Trocars Disposable Autoclavable /
Disposable
Pre-loaded
disposable
Cost of implant
(US$)
K17.00 K55.00 K52.00
Cost per Year
(if used for
duration)
K5.20 K12.40 K17.42
New hormonal implants
Comparison of Sino-Implant, Jadelle, Implanon
Monthly Stat for Implants
 There were total of 102 implants done for the first half of April
2014, MGH 70, Ialibu 28 & MTC 14
1 2
5
10
52
0
10
20
30
40
50
60
TOTAL NUMBER
Extra-uterine
Pregnany
Purperal
Sepsis
Cearean
Section
Para >5 Para 1-4
INDICATIONS
JADELLE IMPLANTS-MGH
Remarks: Positive Response to Jadelle Implants
Summary
 Contraceptive implant system provides effective,long-
acting, reversible contraception for women.
 Two thin, flexible rods made of silicone tubing and filled
with levonorgestrel, a synthetic progestin, are inserted
just under the skin of a woman’s upper,inner arm in a
minor surgical procedure.
 Protection from pregnancy is provided within 24 hours,
when insertion is performed during the first week of a
woman’s menstrual cycle.
 The woman rapidly returns to her normal fertility when
the implants are removed.
 Sub-dermal implantable contraceptives are highly
effective, easy to use and carry a low risk of side-effects.
These features make them a good option for women in
under-resourced settings.
You cannot have maternal health without reproductive health. And
reproductive health includes contraception and family planning and
access to legal, safe abortion.
Hillary Clinton quotes

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Implants.ppt3

  • 1. INTRODUCTION OF CONTRACEPTIVE IMPLANTS Prepared By: Dr.Kiak Obstetrics & Gynecology Division Date: 2014 - 04 - 18 Sub-dermal Contraceptive Implant JADELLE LEVONORGESTREL
  • 2. CONTENT  Brief Introduction  What is It  Component/Structure  Release Rate of Levonorgestrel  Pre-clinical Evaluation  Mechanism of Action  Efficacy/Fertility  Subjective Symptoms  Timing of Insertion  Implant Insertion Technique  Comparison - New Hormonal Implants  Monthly Stat for Implants -MGH  Summary
  • 3. Brief Introduction  Implants are approved in more than 60 developed and developing countries and are currently being used by millions of women worldwide 1 . Owing to their high contraceptive efficacy (which begins almost immediately after insertion), low rate of complications and side-effects, possibility of long-term use following a single intervention and the rapid return of fertility after removal.  Contraceptive implants are good candidates for inclusion in the method mix offered by family planning programmes, especially in under-resourced setting 2 . 1. Ref: Contraceptive implants come of age. Progress in Reproductive Health Research 2003; No. 61. Geneva; World Health Organization (www.who.int/reproductive-health/hrp/progress/61/news61.htm (accessed 1 September 2008). 2. Boostra H, Duran V, Weaver K. Norplant and the boom or bust phenomenom. IPPF Medical Bulletin October 1999;33:3–4.
  • 4. Countries using Implant Burundi Ethiopia Ghana Malawi Mali China Indonesia Kenya In Progress (n=20) Under Review (n=10) Nepal Pakistan Rwanda Tanzania Uganda Argentina Bangladesh Bolivia Brazil Burkina Faso Chile Colombia Dominican Republic Ecuador Fiji India Mexico Mozambique Nigeria Peru Russia South Africa Sudan Venezuela Zimbabwe REGISTERED (n=6) Sierra Leone Madagascar Zambia
  • 5. Levonorgestrel subdermal implants provide effective long term contraception. Implants are a good choice of contraceptive method in women who desire effective contraception, but who are unable to, or prefer not to, comply with an oral regimen or injection. Implants maybe used to postpone 1st pregnancy Space pregnancy Provide long-term contraception when desired family size is reached What is it?
  • 6. Long-Acting & Permanent Methods  The advantages that implants and other methods such as the IUD offer over other contraceptive methods is that they are not user-dependent in the way that condoms, injectables & combined oral contraceptives (COC) are 3 . Ref. 3.Russell J. Contraceptive failure in the United States. Contraception 2004;70:89–96.
  • 7. Components  Implants is a set of two flexible cylindrical implants consisting of a dimethylsiloxane/ methylvinylsiloxane copolymer core enclosed in thin-walled silicone tubing. Each rod contains 75 mg of the progestin levonorgestrel. The core of each rod is a mixture, half of levonorgestrel, half of the elastomer. The rods are sealed with polydimethylsiloxane adhesive & sterilized. Each rod is approximately 2.5 mm in diameter & 43 mm in length 4 . Ref. 4. Harold Nash, and Sandra Waldman. Jadelle ィ Levonorgestrel Rod Implants:.A Summary of Scientific Data and Lessons Learned from Programmatic Experience Irving Sivin,
  • 8. Medical adhesive 43mm thin-walled silicon tubing levonorgestrel & Siloxane copolyme 12.5mm Components Session IV A, Slide #3 Implanon Applicator
  • 9. Structure  The sole active ingredient in the rods is levonorgestrel (-)-13- ethyl-17-hydroxy-18,19-dinor-17α-pregn-4-en-20-yn-3-one. It has a molecular weight of 312.45 and the structural formula.  Medical grade silicone rubber materials, including the type used in Jadelle, have been employed in various implantable devices for humans since 1950 4 .  Silicone rubber implant have be employed in various implantable device  Prosthetic devices  Heart valves  Drainage tubes QuickTime™ and a decompressor are needed to see this picture. Ref. 4. Harold Nash, and Sandra Waldman. Jadelle ィ Levonorgestrel Rod Implants:.A Summary of Scientific Data and Lessons Learned from Programmatic Experience Irving Sivin,
  • 10. Release Rate of Levonogestrel  Diffusion of Levonogestrel from the rods produces a continuous low dose of the progestin and is is delivered directly into interstitial fluids from the subcutaneous implants  After placement of Jadelle rods,levonorgestrel concentrations reach a maximum level within 2-3 days after implant  Decline rapidly over the 1st month both due to a decrease in the rate of release & because of decreased circulating levels of sex hormone binding globulin (SHBG), a protein that binds levonorgestrel. Jadelle/Day Dosage/Rate Remarks 1 month 100g/day 12 months 40g/day 24 months 30g/day -stabilizing thereafter
  • 11. Pre Clinical Evaluation Levonorgestrel implant is a totally synthetic & Biologically active Progestin- does not contain estrogen- a subdermal contraceptive implant A double silicon rods preload in a sterile disposable applicator to facilitate easy & rapid insertion Release of Levonorgestrel sufficient to prevent conception within 24hrs after implant Effective role for 5 years
  • 12. Mechanism Of Actions At least 3 mechanism are active in preventing pregnancy 1. Ovulation inhibition- by suppressing of gonadotrophins (LH&FSH) secretion 2. Thickening of the cervical mucus -increase viscosity of the cervical mucus that preventing passage of sperm into the uterus 3. Decrease endometrial thickening during the use of implants.
  • 13. Efficacy/Fertility It is convenient, safe, and over 99% effective Prevents against pregnancy for up to 5 years, can be removed @ anytime Return to fertility rapidly after removal. Another Jadelle implant can be inserted immediately after removal for protection against pregnancy  It is invisible Can be used without anything else
  • 14. Subjective Symptoms The cost is K1040-K2080 and around K200-K400 for removal Headache Nausea Breast pain & Mood changes Others include- pain, itchiness, infection and expulsion on insertion site This does not protect you from STDs
  • 15. Timing of Insertion Should be inserted on day 1-5 during menstrual cycle Immediately or on week after 1st/2nd trimester abortion In Postpartum women  Non BF women immediately or within 6 wks after labor  BF women should not use implants before 6 wks after labor.  However,studies have shown no significant effects on the growth or health of infants whose nursing mothers began using levonorgestrel implants immediately or 5-7 wks after childbirth. There is no experience to support the use of Jadelle earlier than six weeks after childbirth in lactating women
  • 16. Implant Insertion Technique Session IV A, Slide #2 One-Rod Implant Insertion: Required Equipment • An examination table • Sterile surgical drapes (optional) and gloves • Antiseptic solution • Local anesthetic, needles, and syringe • Implanon applicator • Skin closure, sterile gauze, and compresses QuickTime™ and a decompressor are needed to see this picture. QuickTime™ and a decompressor are needed to see this picture. Two rods implant Insertion Required Equipment
  • 17. Session IV A, Slide #4 Implanon Insertion: Step 1 • Have the client lie on her back with the arm that she doesn’t normally use flexed at the elbow and externally rotated. • Implanon should be inserted sub-dermally just under the skin. QuickTime™ and a decompressor are needed to see this picture. Jadelle Insertion: Step 1
  • 18. Session IV A, Slide #6 Implanon Insertion: Step 3 • Mark the insertion site with a marker. • Make 2 marks: – First, mark the spot where the rod will be inserted. – Second, mark a spot a few centimeters proximal to the first mark. This second mark will later serve as a direction guide during insertion. QuickTime™ and a decompressor are needed to see this picture. Jadelle Insertion: Step 2 3 Finger breath Medial Epicondyle
  • 19. Session IV A, Slide #7 Implanon Insertion: Step 4 • Clean the client’s upper arm with antiseptic solution. Frame the insertion area with a drape that has an opening (optional). • Anesthetize the insertion area with anesthetic spray or by injecting 2 cc of 1% lidocaine just under the skin along the planned insertion tunnel). QuickTime™ and a decompressor are needed to see this picture. QuickTime™ and a decompressor are needed to see this picture. Jadelle Insertion: Step 4-5 Injection 10cc of 1% Lidocaine just under the skin
  • 20. Session IV A, Slide #8 Implanon Insertion: Step 5 • Remove the needle shield. • Stretch the skin around the insertion site with thumb and index finger. Session IV A, Slide #9 Implanon Insertion: Step 6 • Insert the tip of the needle, at about a 20 degree angle. QuickTime™ and a decompressor are needed to see this picture. QuickTime™ and a decompressor are needed to see this picture. Jadelle Insertion: Step 6 Jadelle Insertion: Step 7
  • 21. QuickTime™ and a decompressor are needed to see this picture. QuickTime™ and a decompressor are needed to see this picture. Session IV A, Slide #10 Implanon Insertion: Step 7 • Release the skin. • Lower the applicator to a horizontal position. Session IV A, Slide #11 Implanon Insertion: Step 8 • Lift the skin with the tip of the needle, keeping the needle in the subdermal connective tissue. • While lifting the skin, gently insert the entire needle. Keep the applicator parallel to the surface of the skin. Jadelle Insertion: Step 8 Jadelle Insertion: Step 9
  • 22. Session IV A, Slide #16 Implanon Insertion: Step 13 • Verify the presence of the implant by palpating the site. • Apply a sterile gauze and wrap the arm with a pressure bandage. • Before the client is discharged, observe her for a few minutes for signs of bleeding from the insertion site. • Fill out the user card and give it to the client. • Review post-insertion instructions and other key messages. • Dispose of the applicator and syringe properly. QuickTime™ anda decompressor areneededto seethis picture. Jadelle Insertion: Step 10
  • 23. Sino-implant (II) Jadelle Implanon Manufacturer Shanghai Dahua Pharmaceutical Bayer HealthCare Schering Plough / Organon Formulation 150 mg levonorgestrel In 2 rods 150 mg levonorgestrel In 2 rods 68 mg etonogestrel In 1 rod Mean Insertion & Removal time Insertion: 2 min Removal: 4.9 min Insertion: 2 min Removal: 4.9 min Insertion: 1.1 min Removal: 2.6 min Labeled duration of product use 4 years 5 years 3 years Trocars Disposable Autoclavable / Disposable Pre-loaded disposable Cost of implant (US$) K17.00 K55.00 K52.00 Cost per Year (if used for duration) K5.20 K12.40 K17.42 New hormonal implants Comparison of Sino-Implant, Jadelle, Implanon
  • 24. Monthly Stat for Implants  There were total of 102 implants done for the first half of April 2014, MGH 70, Ialibu 28 & MTC 14 1 2 5 10 52 0 10 20 30 40 50 60 TOTAL NUMBER Extra-uterine Pregnany Purperal Sepsis Cearean Section Para >5 Para 1-4 INDICATIONS JADELLE IMPLANTS-MGH Remarks: Positive Response to Jadelle Implants
  • 25. Summary  Contraceptive implant system provides effective,long- acting, reversible contraception for women.  Two thin, flexible rods made of silicone tubing and filled with levonorgestrel, a synthetic progestin, are inserted just under the skin of a woman’s upper,inner arm in a minor surgical procedure.  Protection from pregnancy is provided within 24 hours, when insertion is performed during the first week of a woman’s menstrual cycle.  The woman rapidly returns to her normal fertility when the implants are removed.  Sub-dermal implantable contraceptives are highly effective, easy to use and carry a low risk of side-effects. These features make them a good option for women in under-resourced settings.
  • 26. You cannot have maternal health without reproductive health. And reproductive health includes contraception and family planning and access to legal, safe abortion. Hillary Clinton quotes