16
– Redness, itching, swelling, flaky, dehydrated skin. Over a longer period,
the skin may become thicker and may develop cracks and keratosis.
Other symptoms may also occur, such as respiratory problems.
These might be caused by the copper released by the MelbeaGold
product. If you did not experience these symptoms before insertion,
you should definitely have yourself tested for copper allergy. If you are
allergic to copper, the product must be removed (
contraindication
).
The risk of developing a copper allergy is low since pure copper is
typically non-allergenic.
The alloy used in the MelbeaGold device consists of high purity
copper and gold.
– If you have any questions beside the above or you are uncertain about
any symptoms, please contact your gynaecologist or health care service
provider.
14. WHAT ARE THE POSSIBLE SIDE EFFECTS THAT MAY ARISE
DURING THE USE OF MELBEAGOLD?
The known side effects caused by the MelbeaGold product are the followings:
– pregnancy,
– rejection (complete or partial),
– uterine perforation (complete or partial perforation or implantation),
– breakage of the device,
– anaemia (low red blood cell count),
– pain during intercourse,
– spotting or heavy bleeding, bloodstains,
– prolonged menstrual periods,
– painful menstrual periods, including cramps,
– vaginal irritation or discharge,
– allergy.
This list of the possible side effects of the MelbeaGold product is non-
exhaustive. Please contact your gynaecologist or health care service
provider for further information.
Overview of the possible serious side effects that may be caused by the
MelbeaGold device or its use:
– Ectopic or intrauterine pregnancy
If you become pregnant during the use of the MelbeaGold device, the
chance of ectopic pregnancy is exceedingly high. This means that the
pregnancy occurs outside the womb.
Unusual vaginal bleeding or abdominal pain, especially in combination
with a missed menstrual cycle, may be symptoms of an ectopic pregnancy.
An ectopic pregnancy may cause internal bleeding, infertility, and
even death.
Intrauterine pregnancy also presents risks. As the uterus grows during
gestation, the indicator string of the MelbeaGold device is pulled into
the uterine cavity, thus allowing pathogenic microorganisms to enter
the uterus, possibly causing infection, spontaneous abortion, sepsis,
and even death.
Becoming pregnant while using copper-containing coils is a medical
emergency which often warrants surgery.
Based on our current understanding, the copper-containing coils
themselves, including MelbeaGold, do not cause harm to the foetus.
– Life-threatening infection