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Melbea MelbeaGold - Absolute Contraindications

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7
you are looking for a contraceptive method that you do not need to
re-apply every day,
you are willing to use a contraceptive method that involves the insertion
of a device into the uterine cavity in spite of the risks,
you are looking for a contraceptive method that does not contain
hormones,
your current health conditions do not preclude the use of such a product
(see the contraindications under Sections 6.2 and 6.3).
There are health conditions in the case of which the use of copper-containing
coils is contraindicated. Either because it would not be safe or because there
is currently insufficient information about how safe it would be.
In the case of the presence or suspected presence of certain medical
conditions, the use of a copper-containing IUD, such as MelbeaGold, is
contraindicated (see
absolute contraindications
).
In the case of the presence of certain other conditions, your gynaecologist
or health care service provider may decide, having consulted you whether
MelbeaGold can be used and the insertion implemented, after which you
may agree to the insertion of the device at your own responsibility in spite
of the heightened risks (see
relative contraindications
).
6.2. Absolute contraindications
The MelbeaGold product must not be inserted in the following cases:
» Confirmed or suspected pregnancy,
» Your medical history includes ectopic pregnancy,
» Malignant disease or tumour in the reproductive organs, malignant
gestational trophoblastic disease (
cancerous diseases or lesions of
the reproductive system
),
» Congenital or acquired deformities of the uterus any uterine condition
that affects the shape of the uterine cavity,
such as a large fibroid tumour,
retroverted uterus
,
» Abnormal (acyclic) uterine bleeding or bleeding of unknown origin in
the vagina,
» An infection of the uterus, the reproductive organs, or the pelvic organs
in the past 12 months (cervicitis, vaginitis,
especially bacterial vaginosis,
recurrent herpes infection or hepatitis B infection
),
» Pelvic tuberculosis or untreated acute pelvic inflammatory disease (PID),
» Inflammatory genital diseases,
including genital diseases of autoimmune
or unknown origin and multifactorial genital diseases
(
e.g. the long-
term use of a copper-containing IUD may be a risk factor in the case of
endometriosis, especially in the presence of adhesions
),
» Copper allergy, hypersensitivity to any component or material of the
product (
e.g. metal contaminants in the alloy such as nickel, or polyethene
plastic
), anaphylaxis (
a severe generalised potentially life-threatening
immunological hypersensitivity reaction of the body to a foreign material
)
or epileptic seizures (
a disorder of the nervous system that manifests
as a series of convulsive or nonconvulsive seizures
),
» Maternal sepsis (sometimes called
blood poisoning
) or abortion in the
last (
past
) three months.
» Sexually transmitted infections (
abbreviated as
STIs),
» An IUD or IUS inserted earlier which has not yet been removed from the
uterus of the patient.
Other conditions, in the presence of which the risks generally exceed the
advantages of using a copper-containing IUD, such as the MelbeaGold
device:

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