Tuesday, April 15, 2014

IMPLANON in Sudan: tip of the iceberg?

My latest ATIP to CIDA/DFATD reveals that the contraceptive IMPLANON is being purchased and administered in Sudan by IPPF.

I thought I'd have a look at the risks and other issues associated with the implant.

They are all listed below. I thought I'd just point out a few of them from the Merck publication of the FDA-Approved Patient Labeling:
"It is not known if IMPLANON is as effective in very overweight women because studies did not include many overweight women."

Are overweight women in Sudan told this?
"Serious Blood Clots: IMPLANON may increase your chance of serious blood clots, especially if you have other risk factors such as smoking. It is possible to die from a problem caused by a blood clot, such as a heart attack or a stroke."

Are women in Sudan told about this, and other serious risks?
"Breast Cancer: It is not known whether IMPLANON use changes a woman’s risk for breast cancer."

They don't know the risk of breast cancer? Then why is IMPLANON being used at all?
"This is not a complete list of possible side effects." 

You mean there's more side effects? What are they?

And the document is replete with advice to call your health care provider for more information? Would that be IPPF? Does IPPF have doctors to answer these women's questions?

Finally, is the 11 page list of risks, interactions with other medications, side effects, etopic pregnancy risks, etc.--explained fully to the woman? Is she given a copy of this brochure in her own language? Can she even read it? (literacy rate in Sudan is 27%) What about informed consent?

Lots of questions. Not many answers. This is poor women's lives we are risking with Canadian money. Is that what being a Canadian is all about?

And I haven't even talked about the other drugs we are buying for the five countries (Afghanistan, Mali, Tanzania, Bangladash and Sudan).

(IMPLANON from the manufacturer MERCK)

FDA-Approved Patient Labeling
IMPLANON® (etonogestrel implant)
Subdermal Use

IMPLANON® does not protect against HIV infection (the virus that causes AIDS) or other
sexually transmitted diseases. Read this Patient Information leaflet carefully before you
decide if IMPLANON is right for you. This information does not take the place of talking with
your healthcare provider. If you have any questions about IMPLANON, ask your healthcare

IMPLANON is a hormone-releasing birth control implant for use by women to prevent pregnancy
for up to 3 years. The implant is a flexible plastic rod about the size of a matchstick that contains
a progestin hormone called etonogestrel. Your healthcare provider will insert the implant just
under the skin of the inner side of your upper arm. You can use a single IMPLANON implant for
up to 3 years. IMPLANON does not contain estrogen.

What if I need birth control for more than 3 years?
The IMPLANON implant must be removed after 3 years. Your healthcare provider can insert a
new implant under your skin after taking out the old one if you choose to continue using
IMPLANON for birth control.

What if I change my mind about birth control and want to stop using IMPLANON before 3
Your healthcare provider can remove the implant at any time. You may become pregnant as
early as the first week after removal of the implant. If you do not want to get pregnant after your
healthcare provider removes the IMPLANON implant, you should start another birth control
method right away.

How does IMPLANON work?
IMPLANON prevents pregnancy in several ways. The most important way is by stopping the
release of an egg from your ovary. IMPLANON also thickens the mucus in your cervix and this
change may keep sperm from reaching the egg. IMPLANON also changes the lining of your

How well does IMPLANON work?
When the IMPLANON implant is placed correctly, your chance of getting pregnant is very low
(less than 1 pregnancy per 100 women who use IMPLANON for 1 year). It is not known if
IMPLANON is as effective in very overweight women because studies did not include many
overweight women.

Who should not use IMPLANON?
Do not use IMPLANON if you
• Are pregnant or think you may be pregnant
• Have, or have had serious blood clots, such as blood clots in your legs (deep venous
thrombosis), lungs (pulmonary embolism), eyes (total or partial blindness), heart (heart
attack), or brain (stroke)
• Have liver disease or a liver tumor
• Have unexplained vaginal bleeding
• Have breast cancer or any other cancer that is sensitive to progestin (a female
hormone), now or in the past
• Are allergic to anything in IMPLANON

Tell your healthcare provider if you have or have had any of the conditions listed above. Your
healthcare provider can suggest a different method of birth control.

In addition, talk to your healthcare provider about using IMPLANON if you:
• Have diabetes
• Have high cholesterol or triglycerides
• Have headaches
• Have gallbladder or kidney problems
• Have a history of depressed mood
• Have high blood pressure
• Have an allergy to numbing medicines (anesthetics) or medicines used to clean your
skin (antiseptics). These medicines will be used when the implant is placed into or
removed from your arm.

Interaction with Other Medicines
Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins and herbal supplements. Certain medicines may make
IMPLANON less effective, including:
• barbiturates
• bosentan
• carbamazepine
• felbamate
• griseofulvin
• oxcarbazepine
• phenytoin
• rifampin
• St. John's wort
• topiramate
• HIV medicines

Ask your healthcare provider if you are not sure if your medicine is one listed above.

If there are medicines that you have been taking for a long time, that make IMPLANON less
effective, tell your healthcare provider. Your healthcare provider may remove the IMPLANON
implant and recommend a birth control method that can be used effectively with these

When you are using IMPLANON, tell all of your healthcare providers that you have IMPLANON
in place in your arm.

How is the IMPLANON implant placed and removed?
Your healthcare provider will place and remove the IMPLANON implant in a minor surgical
procedure in his or her office. The implant is placed just under the skin on the inner side of your
upper arm.

The timing of insertion is important. Your healthcare provider may:
• Perform a pregnancy test before inserting IMPLANON
• Schedule the insertion at a specific time of your menstrual cycle (for example, within the
first days of your regular menstrual bleeding)

Immediately after the IMPLANON implant has been placed, you and your healthcare
provider should check that the implant is in your arm by feeling for it.

If you and your healthcare provider cannot feel the IMPLANON implant, use a nonhormonal
birth control method (such as condoms) until your healthcare provider
confirms that the implant is in place. You may need special tests to check that the implant is
in place or to help find the implant when it is time to take it out.

Your healthcare provider will cover the site where IMPLANON was placed with 2 bandages.
Leave the top bandage on for 24 hours. Keep the smaller bandage clean, dry, and in place for 3
to 5 days.

You will be asked to review and sign a consent form prior to inserting the IMPLANON implant.
You will also get a USER CARD to keep at home with your health records. Your healthcare
provider will fill out the USER CARD with the date the implant was inserted and the date the
implant is to be removed. Keep track of the date the implant is to be removed. Schedule an
appointment with your healthcare provider to remove the implant on or before the removal date.

Be sure to have checkups as advised by your healthcare provider.

What are the most common side effects I can expect while using IMPLANON?
Changes in Menstrual Bleeding Patterns (menstrual periods)
The most common side effect of IMPLANON is a change in your normal menstrual bleeding
pattern. In studies, about one out of ten women stopped using the implant because of an
unfavorable change in their bleeding pattern. You may experience longer or shorter bleeding
during your periods or have no bleeding at all. The time between periods may vary, and in
between periods you may also have spotting.

Talk with your healthcare provider right away if:
• You think you may be pregnant
• Your menstrual bleeding is heavy and prolonged

Besides changes in menstrual bleeding patterns, other frequent side effects that caused women
to stop using the implant include:
• Mood swings
• Weight gain
• Headache
• Acne
• Depressed mood

Other common side effects include:
• Headache
• Vaginitis (inflammation of the vagina)
• Weight gain
• Acne
• Breast pain
• Viral infections such as sore throats or flu-like symptoms
• Stomach pain
• Painful periods
• Mood swings, nervousness, or depressed mood
• Back pain
• Nausea
• Dizziness
• Pain
• Pain at the site of insertion

This is not a complete list of possible side effects. For more information, ask your healthcare
provider for advice about any side effects that concern you. You may report side effects to the
FDA at 1-800-FDA-1088.

What are the possible risks of using IMPLANON?
Problems with Insertion and Removal

The implant may not be placed in your arm at all due to a failed insertion or if the implant
has fallen out of the needle. If this happens, you may become pregnant. Immediately
after insertion, and with help from your healthcare provider, you should be able to feel
the implant under your skin. If you can’t feel the implant, tell your healthcare provider.

Removal of the implant may be very difficult or impossible because the implant is not
where it should be. Special procedures, including surgery in the hospital, may be needed
to remove the implant. If the implant is not removed, then the effects of IMPLANON will
continue for a longer period of time.

Other problems related to insertion and removal are:
• Pain, irritation, swelling, or bruising at the insertion site
• Scarring, including a thick scar called a keloid around the insertion site
• Infection
• Scar tissue may form around the implant making it difficult to remove
• The implant may come out by itself. You may become pregnant if the implant
comes out by itself. Use a back up birth control method and call your healthcare
provider right away if the implant comes out.
• The need for surgery in the hospital to remove the implant
• Injury to nerves or blood vessels in your arm
• The implant breaks making removal difficult

Ectopic Pregnancy
If you become pregnant while using IMPLANON, you have a slightly higher chance that
the pregnancy will be ectopic (occurring outside the womb) than do women who do not
use birth control. Unusual vaginal bleeding or lower stomach (abdominal) pain may be a
sign of ectopic pregnancy. Ectopic pregnancy is a medical emergency that often requires
surgery. Ectopic pregnancies can cause serious internal bleeding, infertility, and even
death. Call your healthcare provider right away if you think you are pregnant or have
unexplained lower stomach (abdominal) pain.

Ovarian Cysts
Cysts may develop on the ovaries and usually go away without treatment but sometimes
surgery is needed to remove them.

Breast Cancer
It is not known whether IMPLANON use changes a woman’s risk for breast cancer. If you
have breast cancer now, or have had it in the past, do not use IMPLANON because
some breast cancers are sensitive to hormones.

Serious Blood Clots
IMPLANON may increase your chance of serious blood clots, especially if you have
other risk factors such as smoking. It is possible to die from a problem caused by a blood
clot, such as a heart attack or a stroke.

Some examples of serious blood clots are blood clots in the:
• Legs (deep vein thrombosis)
• Lung (pulmonary embolism)
• Brain (stroke)
• Heart (heart attack)
• Eyes (total or partial blindness)

The risk of serious blood clots is increased in women who smoke. If you smoke and want
to use IMPLANON, you should quit. Your healthcare provider may be able to help.
Tell your healthcare provider at least 4 weeks before if you are going to have surgery or
will need to be on bed rest. You have an increased chance of getting blood clots during
surgery or bed rest.

Other Risks
A few women who use birth control that contains hormones may get:
• High blood pressure
• Gallbladder problems
• Rare cancerous or noncancerous liver tumors

Broken or Bent Implant
If the implant breaks or bends while in your arm, how the implant works should not be
affected. If you have questions contact your healthcare provider.

When should I call my healthcare provider?
Call your healthcare provider right away if you have:
• Pain in your lower leg that does not go away
• Severe chest pain or heaviness in the chest
• Sudden shortness of breath, sharp chest pain, or coughing blood
• Symptoms of a severe allergic reaction, such as swollen face, tongue or pharynx;
trouble swallowing; or hives and trouble breathing
• Sudden severe headache unlike your usual headaches
• Weakness or numbness in your arm, leg, or trouble speaking
• Sudden partial or complete blindness
• Yellowing of your skin or whites of your eyes, especially with fever, tiredness, loss of
appetite, dark colored urine, or light colored bowel movements
• Severe pain, swelling, or tenderness in the lower stomach (abdomen)
• Lump in your breast
• Problems sleeping, lack of energy, tiredness, or you feel very sad
• Heavy menstrual bleeding

What if I become pregnant while using IMPLANON?
You should see your healthcare provider right away if you think that you may be pregnant. It is
important to remove the implant and make sure that the pregnancy is not ectopic (occurring
outside the womb). Based on experience with other hormonal contraceptives, IMPLANON is not
likely to cause birth defects.

Can I use IMPLANON when I am breastfeeding?
If you are breastfeeding your child, you may use IMPLANON if 4 weeks have passed since you
had your baby. A small amount of the hormone contained in IMPLANON passes into your
breast milk. The health of breast-fed children whose mothers were using the implant has been
studied up to 3 years of age in a small number of children. No effects on the growth and
development of the children were seen. If you are breastfeeding and want to use IMPLANON,
talk with your healthcare provider for more information.

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