Reasons for removal and continuation among Implanon users in Omdurman Maternity Hospital 2012 – 2013

Sennar University

Faculty of medicine

Obstetric & Gynecology Board

Reasons for removal and

continuation among Implanon users

in Omdurman Maternity Hospital

2012 – 2013

Prepared By:

Dr. Samir Abd Elrhman Gorashi

M.B.B.S University of Khartoum 2003

Assisted professor faculty of medicine Sennar

University

CONTENTS

Page NO

contents IList of tables IIList of figures IIIEnglish abstract IV

CHAPTER ONEIntroduction Justification Literature review Objectives

CHAPTER TWOMethodology

CHAPTER THREE

Results CHAPTER FOUR

Discussion

Conclusions RecommendationsReferences Appendix

List of tables

Table

1

Distribution of study population according to age

Table 2 Distribution of study population according to residence Table 3 Distribution of study population according to level of

education Table 4 Distribution of study population according to occupation

Table 5 Distribution of study population according to parity Table 6 Distribution of study population according to number of

children want Table 7 Distribution of study population according to source of

knowledge Table 8 Distribution of study population according to continue or

removed Implanon Table 9 Distribution of study population according to causes of

removed Implanon Table

10

Distribution of study population according to causes of

continue Implanon Table

11

Distribution of study population according to duration of

Table

12

Distribution of study population according to previous

contraception type Table

13

Distribution of study population according to menstrual

cycle patterns Table

14

Distribution of study population according to bleeding

days per 3 months Table

15

Distribution of study population according to Implanon

insertion pain Table

16


insertion cause itching Table

17


insertion local reaction Table Distribution of study population according to hand

18movement

List of figure

Figure

1

Distribution of study population according to age

Figure

2

Distribution of study population according to residence

Figure

3

Distribution of study population according to level of

education Figure

4

Distribution of study population according to occupation

Figure

5

Distribution of study population according to parity

Figure

6

Distribution of study population according to number of

children want

Figure

7

Distribution of study population according to source of

knowledge Figure

8

Distribution of study population according to continue or

removed Implanon Figure

9


removed Implanon Figure

10


continue Implanon Figure

11

Distribution of study population according to duration of

Implanon insertion Figure

12

Distribution of study population according to previous

contraception type

Figure

13

Distribution of study population according to menstrual

cycle patterns Figure

14

Distribution of study population according to bleeding

days per 3 months Figure

15


insertion pain Figure

16


insertion cause itching Figure

17


insertion local reaction Figure

18

Distribution of study population according to hand

movement

English abstract

Objective: - To assess the reasons for continuation

and removal of Implanon.

Methodology: - Descriptive cross-sectional

hospital based study among the women attended

Omdurman Maternity hospital Implanon

contraception clinic in Khartoum state, data

collected through designed questionnaire cover

the target of the objective.

Results: - The study populations involve 200 women;

most common age attended Implanon clinic between

(19 – 30) years 44.5%, majority of them residence

Urban 76%, their level of education university

graduate 48.5%, their occupation professional

49%, and their parity multipara 46%.

Family size want (4 – 6) 68.5%, and most of them

their source of knowledge from private clinic

48.5%. The women want remove of Implanon 43.5%,

their causes of removal heavy cycle 74.7%, breast

pain 37.9% and irregular cycle 34.4%.

The women want continue Implanon 56.5%, their

causes of continue Implanon safe 39.8%, had no

complication 26.5%, and delay pregnancy more than

2 years 17.7%.

Most common duration of insertion (1 – 2) years

45.5%, the previous contraceptive used before

Implanon pills 37.5%, and injectable 30%.

All of women involve in this study counsel about

Implanon before insertion.

Menstrual cycle patterns before Implanon

insertion regular 51.5%, and bleeding days per 3

months after insertion (29 – 49) days 29.5%.

Implanon insertion, tolerable pain 52%, no

itching 84% and no local reaction 78%.

Implanon restricted hand movement no restriction

of hand movement 92.5%.

Conclusion: - Implanon it is effective contraceptive

with minimal side effect, continuation and

reasons for removal differ between women, more

focus on it is used and reassurances' about it is

side effect. Private clinic play major role in

deliver massage of Implanon information in easy

way to women.

INTRODUCTION

A person quality of life depends not only on good

healthy physical well being but on variety of

other circumstances, these include: family

stability and harmony, the welfare of children

and freedom to enjoy various activities

including: leisure educational or community

pursuit. Family planning can influence nearly all

of these aspects of life ranging from those that

are strictly personal, such as individual's

health, to factors that are shared by

relationships with the others(1). The most

important problem of human being today is not

infectious diseases but population. The world

problem now is higher than at any time in its

history (2).

The progestogen contraceptive implant, Implanon,

became available in Sudan, so this new method was

rapidly embraced enthusiastically by women and

doctors. Its potential advantages over available

methods included high efficacy, the need for

minimal maintenance, absence of oestrogen and

rapid return to fertility after discontinuation.

In the two years following its introduction

around 250 doctors were trained in the use of the

implant and almost 976 implants were inserted (3).

Although Implanon is generally well tolerated,

clinical trials have indicated that a proportion

of women will discontinue use because of

unacceptable side-effects, particularly frequent

and/or prolonged irregular bleeding; with marked

variations between countries.

Discontinuation rates within the first 2 years of

use were as high as 31% in Europe, Canada, Chile

and Hungary to less than one percent of women in

South East Asia (3, 4).

Counseling women on expected bleeding patterns

has been shown to improve continuation rates for

injectable and implantable progestogen

contraceptives (5, 6). Acceptability of bleeding

pattern changes or other side effects is probably

only ever truly evidenced in continuation rates

in the real life setting. Several audits (7, 8)

have examined data from UK clinics and found

lower continuation rates than in clinical trials,

although the rates were sufficiently high to

support the use of implants as a cost effective

method of contraception (8).

An Australian study suggested that about one

third of users had the implant removed within 12

months of insertion (9).

To date there is only limited published data on

the patterns of use and continuation rates of

Implanon users in Sudan. This paper determines

continuation rates and rationale for

discontinuation among Sudanese women attending

two Family Planning clinics for removal over a

six month period.

JUSTIFICATIONS

With increasing realization that development

refers not only to economic growth, but also

fundamental & human development which is coming

into focus. It is not only women's health is a

strong determinant of their contribution towards

national development, but also their social

studies; literacy level, income generating

capacity and right to determine their own

fertility plan equally important roles in the

social development of countries.

Sudan is faced with an increasing number of

populations.

Moreover, there is no spacing between

deliveries. The fertility rate is estimated at

4.6 children per woman. On average for every 15

percentage points increase in contraceptive use

in the community there is a reduction of the one

birth per woman. This suggests that countries

with high total fertility rates tend to have low

contraceptive use and vice versa. Maternal

mortality rate is estimated in Sudan to be 1107

according to last SHHS. This is one of the

highest rate of maternal mortality world wide.

Use of contraception could be one of the means by

which maternal mortality & morbidity decreased.

Few studies have been performed in Sudan

addressing knowledge of women towards

contraceptive use especially with regard to

Implanon. It is hoped that this study will make a

contribution.

LITERATURE REVIEW

IMPLANON (etonogestrel implant) 68 mg For

Subdermal Use Only(10).

DESCRIPTION IMPLANON

(etonogestrel implant) is an off-white, non-

biodegradable, etonogestrel-containing single

sterile rod implant for subdermal use. The

implant is 4 cm in length with a diameter of 2

mm. Each IMPLANON rod consists of an ethylene

vinylacetate (EVA) copolymer core, containing 68

mg of the synthetic progestin etonogestrel (ENG),

surrounded by an EVA copolymer skin. The release

rate is 60–70 µg/day in week 5–6 and decreases to

approximately 35–45 µg/day at the end of the

first year, to approximately 30–40 µg/day at the

end of the second year, and then to approximately

25–30 µg/day at the end of the third year.

IMPLANON is a progestin-only contraceptive and

does not contain estrogen. IMPLANON does not

contain latex and is not radio-opaque(10).

CLINICAL PHARMACOLOGY

Pharmacodynamics

The contraceptive effect of IMPLANON is achieved

by several mechanisms that include suppression of

ovulation, increased viscosity of the cervical

mucus, and alterations in the endometrium (11).

Pharmacokinetics

Absorption After subdermal insertion of IMPLANON,

ENG is released into the circulation and is

approximately 100% bioavailable. The mean peak

serum concentrations in 3 pharmacokinetic studies

ranged between 781 and 894 pg/mL and were reached

within the first few weeks after insertion. The

mean serum ENG concentration decreases gradually

over time declining to 192 – 261 pg/mL at 12

months (n=41), 154 – 194 pg/mL at 24 months

(n=35), and 156 – 177 pg/mL at 36 months (n=17)

(11).

Distribution

The apparent volume of distribution averages

about 201 L. ENG is approximately 32% bound to

sex hormone binding globulin (SHBG) and 66% bound

to albumin in blood.

Metabolism

In vitro data shows that ENG is metabolized in

liver microsomes by the cytochrome P450 3A4

isoenzyme. The biological activity of ENG

metabolites is unknown (12).

Excretion

The elimination half-life of ENG is

approximately 25 hours. Excretion of ENG and its

metabolites, either as free steroid or as

conjugates, is mainly in urine and to a lesser

extent in feces. After removal of IMPLANON, ENG

concentrations decreased below sensitivity of the

assay by one week (12).

Special Populations

Overweight Women

The effectiveness of IMPLANON in overweight women

has not been defined because women who weighed

more than 130% of their ideal body weight were

not studied. However, serum concentrations of ENG

are inversely related to body weight and decrease

with time after insertion. It is therefore

possible that with time IMPLANON may be less

effective in overweight women, especially in the

presence of other factors that decrease

etonogestrel concentrations such as concomitant

use of hepatic enzyme inducers(12).

Race

No formal studies were conducted to evaluate the

effect of race on the pharmacokinetics of

IMPLANON.

Hepatic Insufficiency


effect of hepatic disease on the pharmacokinetics

of IMPLANON. However, ENG is metabolized by the

liver, and therefore use in patients with active

liver disease is contraindicated (13).

Renal Insufficiency


effect of renal disease on the pharmacokinetics

of IMPLANON (13).

INDICATIONS AND USAGE

IMPLANON (etonogestrel implant) is indicated for

women for the prevention of pregnancy. IMPLANON

is a long-acting (up to 3 years), reversible,

contraceptive method. IMPLANON must be removed by

the end of the third year and may be replaced by

a new IMPLANON at the time of removal, if

continued contraceptive protection is desired. In

clinical trials involving 923 subjects and 1,854

women-years of IMPLANON use, the total exposure

in 28-day cycles by year was

Year 1: 10,867 cycles



Among women aged 18–35 years of age at entry, six

pregnancies during 20,648 cycles of use were

reported. Two pregnancies occurred in each of

Years 1, 2 and 3. Each conception was likely to

have occurred shortly before or within two weeks

after IMPLANON removal. With these six

pregnancies, the cumulative Pearl Index was 0.38

pregnancies per 100 women-years of use. The

efficacy of IMPLANON does not depend on patient

self-administration. IMPLANON may be less

effective in women who are overweight or who are

taking medications that induce liver enzymes (14).

CONTRAINDICATIONS

IMPLANON (etonogestrel implant) should not be

used in women who have (14)

Known or suspected pregnancy

Current or past history of thrombosis or

thromboembolic disorders

Hepatic tumors (benign or malignant), active

liver disease

Undiagnosed abnormal genital bleeding

Known or suspected carcinoma of the breast

or personal history of breast cancer

Hypersensitivity to any of the components of

IMPLANON

WARNINGS

A. WARNINGS BASED ON EXPERIENCE WITH IMPLANON AND

OTHER PROGESTIN-ONLY CONTRACEPTIVES

1. Complications of Insertion and Removal

IMPLANON should be inserted subdermally so that

it is palpable after insertion. Failure to insert

IMPLANON properly may go unnoticed unless the

implant is palpated immediately after insertion.

Deep insertions may lead to difficult or

impossible removals. Failure to remove IMPLANON

may result in infertility, ectopic pregnancy, or

inability to stop a drug-related adverse event.

Undetected failure to insert IMPLANON may lead to

an unintended pregnancy (15).

In clinical trials, 1.0% of patients had

complications at implant insertion and 1.7% had

complications at implant removal. Complications

expected of a minor surgical procedure, such as

pain, paresthesias, bleeding, hematoma, scarring

or infection, have been reported. Occasionally in

post-marketing use, implant insertions have

failed because the implant fell out of the needle

or remained in the needle during insertion.

Implant removals may be difficult because the

implant is deep, not palpable, encased in fibrous

tissue, or has migrated. Implants have broken

during difficult removals. Deep insertions may

result in the need for a surgical procedure in an

operating room in order to remove IMPLANON. Any

of the possible complications of surgery may

occur. When IMPLANON is inserted too deeply

(intramuscular or in the fascia) this may cause

neural or vascular damage. Too deep insertions

have been associated with paraesthesia (due to

neural damage) and migration of the implant (due

to intramuscular or fascial insertion), and in

rare cases with intravascular insertion. In post-

marketing use there have been cases of failure to

localize and remove the implant, probably due to

deep insertion (15). There has been one case of an

intravascular insertion reported post-marketing

which led to inability to remove the implant. If

infection develops at the insertion site, start

suitable treatment. If infection persists, remove

IMPLANON. Incomplete insertions or infections may

lead to expulsion (16).

2. Ectopic Pregnancies

Be alert to the possibility of an ectopic

pregnancy among patients using IMPLANON who

become pregnant or complain of lower abdominal

pain. Although ectopic pregnancies should be

uncommon among patients using IMPLANON, a

pregnancy that occurs in a patient using IMPLANON

may be more likely to be ectopic than a pregnancy

occurring in a patient using no contraception (16).

3. Bleeding Irregularities

Patients who use IMPLANON are likely to have

changes in their vaginal bleeding patterns, which

are often unpredictable. These may include

changes in bleeding frequency or duration, or

amenorrhea. Patients should be counseled

regarding unpredictable bleeding irregularities

so that they know what to expect. Abnormal

bleeding should be evaluated as needed to exclude

pathologic conditions or pregnancy. In clinical

trials, bleeding changes were the single most

common reason for stopping treatment with

IMPLANON (11.1%, or 105 of 942 patients using

IMPLANON). Most patients stopped treatment with

IMPLANON because of irregular bleeding (10.8%),

but some stopped because of amenorrhea (0.3%). In

these studies, patients using IMPLANON had an

average of 17.7 days of bleeding or spotting

every 90 days (based on 3315 intervals of 90 days

recorded by 780 patients) (17).

4. Interaction with Anti-Epileptic and Other

Drugs

IMPLANON is not recommended for women who

chronically take drugs that are potent hepatic

enzyme inducers because etonogestrel levels may

be substantially reduced in these women (17).

5. Ovarian Cysts

If follicular development occurs, atresia of the

follicle is sometimes delayed, and the follicle

may continue to grow beyond the size it would

attain in a normal cycle. Generally, these

enlarged follicles disappear spontaneously.

Rarely, they can require surgery (18).

6. Thrombosis

There have been postmarketing reports of serious

thromboembolic events, including cases of

pulmonary emboli (some fatal) and strokes, in

patients using IMPLANON. IMPLANON should be

removed in the event of a thrombosis. Consider

removal of IMPLANON in case of long-term

immobilization due to surgery or illness. Women

with a history of thromboembolic disorders should

be made aware of the possibility of a recurrence

(18).

B. WARNINGS BASED ON EXPERIENCE WITH COMBINATION

(PROGESTIN PLUS ESTROGEN) ORAL CONTRACEPTIVES

1. Thromboembolic Disorders and Other Vascular

Problems Thromboembolism: Epidemiological

investigations have associated the use of

combination hormonal contraceptives with an

increased incidence of venous thromboembolism

(VTE, deep venous thrombosis, retinal vein

thrombosis, and pulmonary embolism). The use of

combination hormonal contraceptives is associated

with increased risks of several serious

conditions including myocardial infarction,

thromboembolism and stroke, although the risk of

serious morbidity or mortality is very small in

healthy women without underlying risk factors.

The risk increases significantly in the presence

of other underlying risk factors such as

hypertension, hyperlipidemias, obesity, and

diabetes (19).

2. Cigarette Smoking Cigarette smoking increases

the risk of serious cardiovascular side effects

from the use of combination hormonal

contraceptives. This risk increases with age and

with heavy smoking (15 or more cigarettes per

day) and is quite marked in women over 35 years

old who smoke. While this is believed to be an

estrogen-related effect, it is not known whether

a similar risk exists with progestin-only

methods. However, patients should be advised not

to smoke (20).

3. Elevated Blood Pressure

An increase in blood pressure has been reported

in women taking combination hormonal

contraceptives and this increase is more likely

with continued use and with those users who are

older. Studies have shown that the incidence of

hypertension increases with increasing

concentrations of progestins. Women with a

history of hypertension-related diseases or renal

disease should be discouraged from using hormonal

contraceptives. If women with hypertension elect

to use hormonal contraceptives, they should be

monitored closely. lf sustained hypertension

develops during the use of hormonal

contraceptives, or if a significant increase in

blood pressure does not respond adequately to

antihypertensive therapy, hormonal contraceptives

should be discontinued. For most women, elevated

blood pressure will return to normal after

stopping hormonal contraceptives, and there is no

difference in the occurrence of hypertension

between ever- and never-users (20).

4. Carcinoma of the Breast and Reproductive

Organs

Women with breast cancer should not use hormonal

contraceptives because breast cancer may be

hormonally sensitive. The risk of having breast

cancer diagnosed may be slightly increased among

current and recent users of combination oral

contraceptives. However, after combination oral

contraceptive discontinuation this excess risk

appears to decrease over time and within 10 years

after cessation the increased risk disappears.

Some studies report an increased risk with

duration of use while other studies do not, and

no consistent relationships have been found with

dose or type of steroid. Some studies have found

a small increase in risk for women who first used

combination oral contraceptives before age 20.

Most studies show a similar pattern of risk with

combination oral contraceptive use regardless of

a woman's reproductive history or her family

breast cancer history. In addition, breast

cancers diagnosed in current or ever oral

contraceptive users may be less clinically

advanced than in never-users. Some studies

suggest that oral contraceptive use has been

associated with an increase in the risk of

cervical intraepithelial neoplasia in some

populations of women. However, there continues to

be controversy about the extent to which such

findings may be due to differences in sexual

behavior and other factors. In spite of many

studies on the relationship between combination

oral contraceptive use and breast and cervical

cancers, a cause-and-effect relationship has not

been established (21).

5. Hepatic Neoplasia

Benign hepatic adenomas have been associated

with the use of combination oral contraceptives,

although the incidence of benign tumors is rare

in the United States. Indirect calculations have

estimated the attributable risk to be in the

range of 3.3 cases/100,000 for users, a risk that

increases after four or more years of use..

Rupture of benign hepatic adenomas may cause

death through intra-abdominal hemorrhage. Studies

from Britain have shown an increased risk of

developing hepatocellular carcinoma in long-term

(>8 years) oral contraceptive users. However,

these cancers are extremely rare in the U.S. and

the attributable risk (the excess incidence) of

liver cancers in oral contraceptive users

approaches less than one per million users (22).

6. Gallbladder Disease

Earlier studies have reported an increased

lifetime relative risk of gallbladder surgery in

users of combination oral contraceptives and

estrogens. More recent studies, however, have

shown that the relative risk of developing

gallbladder disease among combination oral

contraceptive users may be minimal. The recent

findings of minimal risk may be related to the

use of combination oral contraceptive

formulations containing lower doses of estrogens

and progestins (23).

PRECAUTIONS

1. General

Women should be informed that this product does

not protect against infection from HIV (the virus

that causes AIDS) or other sexually transmitted

diseases. IMPORTANT: Pregnancy must be excluded

before inserting IMPLANON (etonogestrel implant)

(24).

2. Physical Examination and Follow-up

A complete medical evaluation, including history

and physical examination and relevant laboratory

tests, should be performed prior to IMPLANON

insertion or reinsertion. It is good medical

practice for patients using IMPLANON to have

regular physical examinations. In case of

undiagnosed, persistent, or recurrent abnormal

vaginal bleeding, appropriate measures should be

conducted to rule out malignancy. Women with a

family history of breast cancer or who have

breast nodules should be monitored with

particular care (25).

3. Information for the Patient

Provide your patient with a copy of the Patient

Labeling and ensure that she understands the

information in the Patient Labeling before

insertion and removal. A USER CARD and consent

form are included in the packaging, Have the

patient complete a consent form and retain it in

your records. The USER CARD should be filled out

and given to the patient after IMPLANON insertion

so that she will have a record of the location of

IMPLANON and when IMPLANON should be removed (26).

4. Weight Gain

In clinical studies, mean weight gain in

IMPLANON users was 2.8 pounds after one year and

3.7 pounds after two years. How much of the

weight gain was related to IMPLANON is unknown.

In studies, 2.3% of IMPLANON users reported

weight gain as the reason for having IMPLANON

removed (26).

5. Carbohydrate and Lipid Metabolic Effects

IMPLANON may induce mild insulin resistance and

small changes in glucose concentrations of

unknown clinical significance. Women with

diabetes or impaired glucose tolerance should be

carefully observed while using IMPLANON. Women

who are being treated for hyperlipidemias should

be followed closely if they elect to use hormonal

contraceptives. Some progestins may elevate LDL

levels and may render the control of

hyperlipidemias more difficult (27).

6. Liver Function

If jaundice develops in any patient using

IMPLANON, remove IMPLANON. The hormone in

IMPLANON may be poorly metabolized in patients

with impaired liver function (27).

7. Depression

Women with a history of depression should be

carefully observed. Consideration should be given

to removing IMPLANON in patients who become

significantly depressed (27).

8. Contact Lenses

Contact lens wearers who develop visual changes

or changes in lens tolerance should be assessed

by an ophthalmologist (28).

9. Drug Interactions

Changes in Contraceptive Effectiveness Associated

with Co-Administration of Other Drugs (28)

a. Anti-Infective Agents and Anticonvulsants

IMPLANON is not recommended for women who require

chronic use of drugs that are potent inducers of

hepatic enzymes because IMPLANON is likely to be

less effective for these women. Contraceptive

effectiveness may be reduced when hormonal

contraceptives are co- administered with some

antibiotics, antifungals, anticonvulsants, and

other drugs that increase the metabolism of

contraceptive steroids. This could result in an

unintended pregnancy or breakthrough bleeding.

Examples include barbiturates, griseofulvin,

rifampin, phenylbutazone, phenytoin,

carbamazepine, felbamate, oxcarbazepine,

topiramate, and modafinil. Patients should use an

additional nonhormonal contraceptive method when

taking medications that may decrease the efficacy

of hormonal contraceptives (29).

b. Anti-HIV Protease Inhibitors

Several of the anti-HIV protease inhibitors have

been studied with co-administration of

combination oral contraceptives; significant

changes (increase and decrease) in the mean area

under the curve (AUC) of the estrogen and

progestin have been noted in some cases. The

efficacy and safety of combination oral

contraceptive products may be affected with co-

administration of anti-HIV protease inhibitors;

it is unknown whether this applies to IMPLANON.

Healthcare providers should refer to the labeling

of the individual anti-HIV protease inhibitors

for further drug-drug interaction information (30).

c. Herbal Products

Herbal products containing St. John's Wort

(Hypericum perforatum) may induce hepatic enzymes

and p-glycoprotein transporter and may reduce the

effectiveness of contraceptive steroids (31).

Increase in Plasma Hormone Levels Associated with

Co-Administered Drugs Inhibitors of hepatic

enzymes such as itraconazole or ketoconazole may

increase plasma hormone levels (31).

10. Interactions with Laboratory Tests

Certain endocrine tests may be affected by

IMPLANON use (32):

a. Sex hormone-binding globulin concentrations

may be decreased for the first six months after

IMPLANON insertion followed by a gradual

recovery.

b. Thyroxine concentrations may initially be

slightly decreased followed by gradual recovery

to baseline.

11. Carcinogenesis, Mutagenesis, Impairment of

Fertility

In a 24-month carcinogenicity study in rats with

subdermal implants releasing 10 and 20 µg

etonogestrel (ENG) per day (equal to

approximately 1.8–3.6 times the systemic steady

state exposure of women using IMPLANON), no drug-

related carcinogenic potential was observed. ENG

was not genotoxic in the in vitro Ames/Salmonella

reverse mutation assay, the chromosomal

aberration assay in Chinese hamster ovary cells

or in the in vivo mouse micronucleus test.

Fertility returned after withdrawal from

treatment (33).

12. Pregnancy

IMPLANON is not indicated for use during

pregnancy.

Teratology studies have been performed in rats

and rabbits, respectively using oral

administration up to 390 and 790 times the human

IMPLANON dose (based upon body surface) and

revealed no evidence of fetal harm due to ENG

exposure. Studies have revealed no increased risk

of birth defects in women who have used

combination oral contraceptives before pregnancy

or during early pregnancy. There is no evidence

that the risk associated with IMPLANON is

different from that of combination oral

contraceptives. IMPLANON should be removed if

maintaining a pregnancy (33).

13. Nursing Mothers

Based on limited data, IMPLANON may be used

during lactation after the 4th postpartum week.

Use of IMPLANON before the 4th postpartum week

has not been studied. Small amounts of ENG are

excreted in breast milk. During the first months

after IMPLANON insertion, when maternal blood

levels of ENG are highest, about 100 ng of ENG

may be ingested by the child per day based on an

average daily milk ingestion of 658 mL. Based on

daily milk ingestion of 150 mL/kg, the mean daily

infant ENG dose one month after insertion of

IMPLANON™ is about 2.2% of the weight-adjusted

maternal daily dose, or about 0.2% of the

estimated absolute maternal daily dose. The

health of breast-fed infants whose mothers began

using IMPLANON during the 4th to 8th week

postpartum (n=38) was evaluated in a comparative

study with infants of mothers using a non-

hormonal IUD (n=33). They were breast-fed for a

mean duration of 14 months and followed up to 36

months of age. No significant effects and no

differences between the groups were observed on

the physical and psychomotor development of these

infants. No differences between groups in the

production or quality of breast milk were

detected (34).

14. Return to Ovulation

In clinical trials, pregnancies occurred as early

as during the first week after removal of

IMPLANON. Therefore, a patient should re-start

contraception immediately after removal of

IMPLANON if she still needs to prevent pregnancy

(34).

15. Fluid Retention

Steroid contraceptives may cause some degree of

fluid retention. They should be prescribed with

caution, and only with careful monitoring, in

patients with conditions which might be

aggravated by fluid retention. It is unknown if

IMPLANON causes fluid retention (35).

16. Pediatric Use

Safety and efficacy of IMPLANON have been

established in women of reproductive age. Safety

and efficacy are expected to be the same for post

pubertal adolescents. However, no clinical

studies have been conducted in women less than 18

years of age. Use of this product before menarche

is not indicated (35).

17. Geriatric Use

This product has not been studied in women over

65 years of age and is not indicated in this

population.

DOSAGE AND ADMINISTRATION

All healthcare providers performing insertions

and/or removals of IMPLANON (etonogestrel

implant) must receive instruction and training

and where appropriate, supervision prior to

inserting or removing IMPLANON. To minimize the

risk of neural or vascular damage, IMPLANON

should be inserted at the inner side of the non-

dominant upper arm about 8–10 cm (3–4 inches)

above the medial epicondyle of the humerus.

IMPLANON should be inserted subdermally just

under the skin to avoid the large blood vessels

and nerves that lie deeper in the subcutaneous

tissues in the sulcus between the triceps and

biceps muscles (36).

OBJECTIVES

General Objective:

To assess the reasons for continuation and

removal of Implanon.

Specific Objectives:

1- To assess the reasons' of discontinuation

and removal of Implanon

2-To assess reasons for continuation of

Implanon.

3-To assess the side effects of Implanon

METHODOLOGY

(1) Study design:

This is a case control hospital based study.

(2) Study Area : Maternity Hospital

antenatal clinic

(3) Study Period: From August 2012 to January

2013.

(4) Study Population:

(a) Sudanese women attending in the Antenatal

clinic at Maternity Hospital for removal of

Implanon (case).

(b) Sudanese women who were inserted the Implanon

in maternity hospital antennal clinic and

continue to use it (control) .

(5)Sample size.

Sample size will be calculated with the help

of the formula:

N=z²(pq)

d²

Where:

N=sample size

Z=Coefficient level at 1.96 (95%).

P= Prevalence.

q= (p-1)

d= error 5%

Sample size is estimated to be( 200) Sudanese

women for each case and control.

(6) Data collections:

Data will be collected by a questionnaire this

will include close-ended questions covering the

following areas: Personal and demographic

information's. Baseline menstrual pattern, most

recent contraceptive use, duration of Implanon

insertion, subsequent clinical consultations,

reported side-effects,discontinuation and

rationale for removal and continuation of

implanon.

(7) Exclusion Criteria:-

Refusal of Sudanese women to participate in the

study.

(8) Data analysis:-

Data will be analyzed using SPSS Computer Program

(9) Ethical approval:-

Written consent should be optional from the

manager of Maternaty Hospital. Women will be

informed that their participation is voluntary.

RESULTS

The interviews conducted from 1st of August 2012

to 1st of January 2013. The participants were the

women attended Omdurman Maternity hospital

Implanon contraception clinic.

All women in this study counsel about Implanon

before insertion.

Table 1: shows the age of the study population,

<18 years 6(3%), (19 – 30) years 89(44.5%), (31 –

40) years 87(43.5%), and >40 years 18(9%).

Table 2: shows the residence of the study

population, rural 48(24%), and urban 152(76%).

Table 3: shows the level of education of the

study population, illiterate 6(3%), Khalwa 2(1%),

primary school 16(8%), secondary school 54(27%),

university graduate 97(48.5%), and postgraduate

25(12.5%).

Table 4: shows the occupation of the study

population, housewife 63(31.5%), professional

98(49%), businesswoman 21(10.5%), small scale

businesswoman 11(5.5%), skilled laborer 5(2.5%),

and unskilled laborer 2(1%).

Table 5: shows the parity of study population,

Primparous 31(15.5%), multiparae 92(46%), and

grand multiparae 77(38.5%).

Table 6: shows number of children want, (1 – 3)

29(14.5%), (4 – 6) 137(68.5%), (7 – 9) 20(10%),

and (>9) 14(7%).

Table 7: shows source of knowledge of study

population, mass media 10(5%), friends 53(26.5%),

family planning centers 40(20%), and private

clinic 97(48.5%).

Table 8: shows the study population wants to

continue in Implanon 113(56.5%) and who want

removal of Implanon 87(43.5%).

Table 9: shows the study population causes of

removal of Implanon, irregular cycle 30(34.4%),

headache 15(17.2%), breast pain 33(37.9%), heavy

cycle 65(74.7%), and insertion site reaction

13(14.9%).

Table 10: shows the study population wants to

continue Implanon causes, safe 45(39.8%), no

complication 30(26.6%), delay pregnancy more than

2 years 20(17.7%), and had medical problem

18(15.9%)

Table 11: shows Implanon insertion duration, 6<

months 21(10.5%), 6 – 12 months 50(25%), 1 – 2

years 91(45.5%) and >2 years 38(19%).

Table 12: shows previous contraception used,

pills 75(37.5%), IUCD 42(21%), natural method

23(11.5%), and Injectable 60(30%).

Table 13: shows menstrual cycle patterns before

Implanon insertion, regular 103(51.5%), irregular

30(15%), and normal 67(33.5%).

Table 14: shows bleeding days per 3 month,

amenorrhea 11(5.5%), (1 – 14) days 50(25%), ( 15

– 28 ) days 42(21%), ( 29 – 49) days 59(29.5%),

and > 50 days 38(19%).

Table 15: shows Implanon insertion pain, painful

52(26%), tolerable pain 104(52%), and not painful

44(22%).

Table 16: shows Implanon insertion cause itching

32(16%), and not cause itching 168(84%).

Table 17: shows Implanon insertion site causes

local reaction, yes 44(22%), and no local

reaction 156(78%).

Table 18: shows Implanon insertion restricted

hand movement, 4(2%), limited restriction

11(5.5%), and not restricted 185(92.5%)

Table 1: Distribution of study population for

study of reasons for removal and continuation

among Implanon users, according to age in OMH

2012/2013.

Age in years Frequency Percent

<18 06 03.0%

19 – 30 89 44.5%

31 – 40 87 43.5%

>40 18 09.0%

Total 200 100%



among Implanon users, according to residence in

OMH 2012/2013.

Residence Frequency Percent

Rural 048 24%

Urban 152 76%

Total 200 100%



among Implanon users, according to level of

education in OMH 2012/2013.

Level of education Frequenc

y

Percent

Illiterate 06 03%

Khalwa 02 01%

Primary school 16 08%

Secondary school 54 27%

University graduate 97 48.5%

Post graduate 25 12.5%

Total 200 100%



among Implanon users, according to occupation in

OMH 2012/2013.

Occupation Frequenc

y

Percent

Housewife 63 31.5%

Professional 98 49.0%

business woman 21 10.5%

Small scale business woman 11 05.5%

Skilled laborer 05 02.5%

Unskilled laborer 02 01.0%

Total 200 100%



among Implanon users, according to parity in OMH

2012/2013.

Parity Frequency Percent

Primparous 31 15.5%

Multipara 92 46.0%

Grandmultipara 77 38.5%

Total 200 100%



among Implanon users, according to number of

children women want in OMH 2012/2013.

No of children Frequency Percent

1 – 3 029 14.5%

4 – 6 137 68.5%

7 – 9 020 10.0%

>9 014 07.0%

Total 200 100



among Implanon users, according to source of

knowledge in OMH 2012/2013.

Source of knowledge Frequenc

y

Percent

Mass media 10 05.0%

Friends 53 26.5%

Family planning centers 40 20.0%

Private clinic 97 48.5%

Total 200 100%



among Implanon users, according to continue or

remove Implanon in OMH 2012/2013.

Remove Implanon Frequency Percent

Yes 087 43.5%

No 113 56.5%

Total 200 100%



among Implanon users, according to cause of

removed Implanon in OMH 2012/2013.

Cause of removed

Implanon

Frequency

(n=87)

Percent

Irregular cycles 30 34.4%

Headache 15 17.2%

Breast pain 33 37.9%

Heavy cycle 65 74.7%

Insertion site reaction 13 14.9%



among Implanon users, according to causes of

continue Implanon in OMH 2012/2013.

Causes of continue Implanon Frequency

n=113

Percen

t

Safe 45 39.8%

No complication 30 26.6%

Delay pregnancy more than 2

years

20 17.7%

Had medical problem 18 15.9%

Total 113 100%



among Implanon users, according to duration of

insertion in OMH 2012/2013.

Duration of insertion Frequency Percent

6< months 21 10.5%

6 – 12 months 50 25.0%

1 – 2 years 91 45.5%

> 2 years 38 19.0%

Total 200 100%



among Implanon users, according to previous

contraception type in OMH 2012/2013.

Previous contraceptive type Frequenc

y

Percent

Pills 75 37.5%

IUCD 42 21.0%

Natural methods 23 11.5%

Injectable 60 30.0%

Total 200 100%



among Implanon users, according to menstrual

cycle patterns in OMH 2012/2013.

Menstrual cycle

patterns

Frequency Percent

Regular 103 51.5%

Irregular 030 15.0%

Normal 067 33.5%

Total 200 100%



among Implanon users, according to bleeding days

per 3 months in OMH 2012/2013.

Bleeding days per 3 months Frequency Percent

Amenorrhea 11 05.5%

1 – 14 days 50 25.0%

15 – 28 days 42 21.0%

29 – 49 days 59 29.5%

> 50 days 38 19.0%

Total 200 100%



among Implanon users, according to Implanon

insertion pain in OMH 2012/2013.

Implanon insertion pain Frequency Percent

Painful 052 26%

Tolerable pain 104 52%

Not painful 044 22%

Total 200 100%




insertion cause itching in OMH 2012/2013.

Implanon insertion cause

itching

Frequency Percent

Yes 032 16%

No 168 84%

Total 200 100%




insertion local reaction in OMH 2012/2013.

Local reaction Frequency Percent

Yes 044 22%

No 156 78%

Total 200 100%



among Implanon users, according to hand movement

in OMH 2012/2013.

Hand movement Frequency Percent

Restricted 004 02.0%

Limited

restriction

011 05.5%

Not restricted 185 92.5%

Total 200 100%

Figure 1:

Age

3%

44.50% 43.50%

9%

0%5%10%15%20%25%30%35%40%45%50%

<18 19 - 30 31 - 40 >40

Figure 2:

Residence

24%

76%

Rural Urban

Figure 3:

Level of education

3%

1%

8%

27%

48.50%

12.50%

0% 10% 20% 30% 40% 50% 60%

Illiterate

Khalwa

Prim ary school

Secondary school

university graduate

postgraduate

Figure 4:

Occupation

31.50%

49%10.50%

55%

1%2.50%Housewife

Professional

Business wom an

Sm all scale businesswom anSkilled laborer

Unskilled laborer

Figure 5:

Parity

15.50%

38.50%

46%

0.00%5.00%10.00%15.00%20.00%25.00%30.00%35.00%40.00%45.00%50.00%

Prim parous m ultipara grand m ultipara

Figure 6:

14.50%

68.50%

10%

7%

0.00% 10.00% 20.00% 30.00% 40.00% 50.00% 60.00% 70.00%

(1 - 3)

(4 - 6)

(7 - 9)

(>9)

Num ber of childern w ant

Figure 7:

Source of know ledge

26.50%

20%

48.50%

5%M ass m edia

Friends

Fam ily planning centers

Private clinic

Figure 8:

Renoval of Im planon43.50% 56.50%

0.00%

10.00%

20.00%

30.00%

40.00%

50.00%

60.00%

Yes No

Figure 9:

Causes of Im planon rem oval 14.90%

74.70%

37.90%

17.20%

34.40%

Irregular cycleHeadacheBreast pain Heavy cycle Insertion site reaction

Figure 10:

Causes of used Im planon

39.80%

26.50%

17.70%

15.90%Safe & easy

No com plication

Delay pregnancy m orethan 2 yearsHad m edical problem

Figure 11:

Duration of insertion

10.50%

25%

45.50%

19%

0.00%5.00%10.00%15.00%20.00%25.00%30.00%35.00%40.00%45.00%50.00%

(6< m onths) (6 - 12) m onths (1 - 2) Years (>2 years)

Figure 12:

Contraceptive used before

30%

11.50%

21%

37.50% PillsIUCDNatural m ethod Injectable

Figure 13:

51.50%

15%

33.50%

0.00% 10.00% 20.00% 30.00% 40.00% 50.00% 60.00%

Regular

Irregular

Norm al

M enstrual cycle patterns

Figure 14:

Bleeding days per 3 m onth5.50%

25.00%

21%

29.50%

19%

Am enorrhea(1 - 14) days(15 - 28) days(29 - 49) days(>50 days

Figure 15:

Im planon insertion pain

26%

52%

22%

0%

10%

20%

30%

40%

50%

60%

Painful Tolerable pain not painful

Figure 16:

Im planon insertion cause itching

16%

84%

YesNo

Figure 17:

Im planon insertion local reaction

22%

78%

YesNo

Figure 18:

2% 5.50%

92.50%

0%

20%

40%

60%

80%

100%

Restricted Lim ited restriction Not restricted

Im planon restrict hand m ovem ent

DISCUSION

This study examined continuation rates of the

contraceptive implant Implanon and reasons for

early discontinuation. As expected, lower

continuation rates for the method were seen than

those in clinical trials where overall > 80% were

still using the implant at two years (37). Strict

inclusion criteria in clinical trials tend to

bias towards a willingness to continue with

regular follow up visits, free supplies and

health services serving as positive reinforcement

to continuation. Implanon continuation rates in

this study of 56.5% and discontinuation rate

43.5% this result consistent with findings from

a review of evidence from real use settings in

the UK and Europe which concluded that 20-25% and

up to 44% of women will discontinue within one

year and two years respectively (38). Continuation

rates at three years are more difficult to

determine as implant users are generally advised

to have routine implant removal before the three

year expiry date (38). A detailed cost analysis of

all contraceptive methods and concluded that

despite their high initial purchase price

implants are more cost effective than the

combined oral contraceptive pill, even after one

year of use (38). In Sudan, the government funds

the majority of cost of an implant via the

Pharmaceutical Benefits Scheme. The cost to women

of the implant purchase is low and the same as,

or less than, four months oral contraceptive pill

supply; however there is no published cost

analysis in the Sudan setting of other

contraceptive methods. Bleeding pattern

dissatisfaction was the commonest reason for

premature discontinuation which is consistent

with clinical trials and other audits (39, 40).

There were 74.7% reported heavy cycles bleeding

as the main reason for premature removal, there

was difference in recorded reasons for premature

removal like breast pain 37.9% and irregular

cycle 34.4%. Reasons for continuation in this

study, safe 39.8% and had no complication 26.6%.

Insertion duration was found 1 – 2 years 45.5%,

this result comparable to study done by Harvey,

Caroline and Seib 46.9% (41). The analysis

suggested, women who have regular baseline

menstrual cycles before Implanon insertion 51.5%

this result comparable to study done by Harvey,

Caroline and Seib in which regular cycle 56% (41).

Most common used contraception prior to Implanon

insertion in this study pills 37.5% this result

in contrast to Harvey, Caroline and Seib study

46% used IUCD (41).

Variations in initial counselling provided by the

individual service providers, altered bleeding

patterns, and reassure the women, so this will

appear in bleeding days per 3 month 29 – 49 day

for cycle 29.5%, previous studies have found that

improvements in continuation rates for long term

methods may be associated with both provider

characteristics (42, 43) and counselling strategies

being tailored to a woman’s personal context (44).

Despite the limitations associated with the data

collection method, this audit provided an

opportunity for Family Planning Centre to review

current clinical practices and the information

provided to patients when considering Implanon as

a contraceptive choice; specifically on expected

continuation rates and common reasons for

premature removal in the Sudan setting.

Overall, this study found that Implanon has

continuation rates in Sudan very similar to

settings in Europe and the United Kingdom. These

continuation rates are higher than those for

injectable and oral hormonal methods, which

combined with its low failure rate and minimal

maintenance makes it a viable and cost effective

method to be offered to women.

However, a proportion of women continue to have

the implant removed, most often due to altered

bleeding patterns. This supports the need for

pre-insertion counselling to specifically

emphasis the potential changes in bleeding

patterns that may be expected from this form of

contraception.

Previous studies have found that improvements in

continuation rates for long term methods may be

associated with both provider characteristics (42,

43) and counselling strategies being tailored to a

woman’s personal context (44).

This study and all other studies conclude

Implanon insertion not limited hand movement and

had no local reaction or itching at site of

insertion (44).

Private clinic play major role in deliver massage

about Implanon and proper counselling.

A proportion of women continue to have the

implant removed, most often due to altered

bleeding patterns. This supports the need for

pre-insertion counselling to specifically

emphasise the potential changes in bleeding

patterns that may be expected from this form of

contraception.

CONCLUSIONS

In this study found the source of knowledge

about Implanon from private clinic.

- Implanon it is effective contraceptive with

minimal side effect, continuation and reasons

for removal differ between women, more focus

on it is used and reassurances' about it is

side effect.

RECOMMONDATIONS

Implanon it is effective contraceptive with

minimal side effect, and cost effective

method of contraception.

Pre insertion counselling very important in

reduced side effect like bleeding pattern per

cycle.

Private clinic play major role in delivered

massage to women about Implanon as

contraception.

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