15
of video footage, the gynaecologist must ensure that the device, which
is considered infectious hazardous waste after removal, is placed in a
marked container, and disposed of as required.
– After the removal or spontaneous expulsion of the product, check the
MelbeaGold device to verify that neither of its arms remained in the
uterine cavity, the wire is not damaged or fractured, and the device as
a whole is undamaged.
If the MelbeaGold device was damaged (
became broken
) in the uterus,
its position has to be established using hysteroscopy, ultrasound, or
X-ray imaging; surgical intervention might be necessary.
– Call your gynaecologist or health care service provider if the heavier
bleeding typical after the insertion becomes more severe or prolonged
or the spotting bleeding continues.
– Visit your doctor if you or your partner experience pain during intercourse.
Neither you nor your partner is supposed to feel the MelbeaGold product
during intercourse.
The MelbeaGold product is inserted into the uterine cavity, not the vagina.
It is possible for your partner to feel the double ends of the indicator
string during intercourse.
– Please inform your gynaecologist or health care service provider of any
side effects that bother you as well as of any persistent side effects. Ask
your doctor about side effects.
You or your doctor may report side effects to the manufacturer directly
or using the dedicated medical device vigilance system.
In such cases, the device should be retained by your gynaecologist or
healthcare service provider in the manner required in the case of infectious
materials or at least take photographs or record video footage in order
to facilitate a successful investigation by the manufacturer and/or the
certification body or the competent authorities.
Experiencing a known side effect does not mean that the product is faulty.
– Immediately notify your gynaecologist or healthcare service provider if
you are experiencing any of the following symptoms:
– lower abdominal or pelvic pain, odourless discharge, unusual
vaginal discharge, unexplained or heavy or prolonged bleeding,
fever, body chills, the appearance of genital lesions or genital sores,
pain during intercourse, typically shortly after the insertion of the
MelbeaGold device.
These might also be the symptoms of pelvic inflammatory disease (PID),
endometritis, or resultant sepsis.
PID, endometritis, and sepsis require immediate treatment since untreated
PID or endometriosis may have severe consequences (
e.g. infertility,
damage to the fallopian tubes, hysterectomy
) and may cause death;
sepsis may also cause death.
– Immediately notify your gynaecologist or healthcare service provider if
you are experiencing any of the following symptoms:
Excessive pain or vaginal bleeding during the insertion of the MelbeaGold
device, pain or bleeding that becomes more severe after insertion, or if
you cannot find the indicator string.
These might be the symptoms of uterine perforation.
– Metal allergy (
e.g. caused by copper
) most commonly manifests in the
form of dermal symptoms.
Visit your gynaecologist or healthcare service provider if you are
experiencing any of the following symptoms:
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