Medical Informations

 

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OPTIMA IUD TCu 380A

About the product

OPTIMA is an intrauterine contraceptive with copper widely tested in the United States and other countries. It is the most advanced IUD of copper and has been approved for clinical use worldwide.

OPTIMA is suitable for women who want a reversible, long-term contraceptive method.

OPTIMA is a contraceptive with copper and is inserted into female uterus to prevent pregnancy. The product body is made in flexible polyethylene in format of a T. Its central rod is rolled with copper wire and each arm of the T carries a copper cylinder. Two polyethylene wires with 2 to 3 length are positioned outside the cervical canal to indicate device’s presence and to facilitate its removal.

How it works

The contraceptive effect is obtained by continuous release of copper into the uterine cavity. Copper interferes with the number and transport of spermatozoa, making it difficult for the egg to move through the woman’s fallopian tube, preventing fertilization (egg-sperm meeting). OPTIMA does not impair ovulation and does not cause miscarriage.

 

Effectiveness

The pregnancy rate in women who use the IUD uninterruptedly for one year is less than 1%. This means that out of every 100 women who use the IUD for a period of one year, less than one will become pregnant.

Table 1. Effectiveness of contraceptive methods when used correctly and consistently (per 100 women / year).

MethodCorrect and ongoing useOrdinary
None8585
Oral Contraceptives
– Low dose medicine0,10,1
– Mini-pills during lactation0,50,5
OPTIMA IUD TCu 380A 0,60,6
Condom33
Diaphragm with cream or spermicidal jelly66
Only spermicides (foam, creams, jellies, and vaginal suppositories) 66
Routine abstinence (all methods) 1 – 91 – 9
Injection (shot) for 3 months 0,30,3
Monthly injections0,10,1
LAM (six months) 0,50,5
Female condom 55
Female sterilization 0,50,5
Male Sterilization 0,10,1

Source: Adapted from The Essentials of Contraceptive Technology, Johns Hopkins

Population Information Program, 1998

* Newton, J.R. J. Obstet. Gynaecol, 1994.

Rates of ongoing use

IUD users continue to use the method for much longer than users of other reversible contraceptive methods. The one-year continuation rate is approximately 86 per 100 users.

The frequency of closures per pregnancy and infection is very low. Other causes for discontinuation of the IUD are personal reasons, such as the desire for pregnancy.

Absence of contraceptive effect after removal of IUD

After discontinuation of OPTIMA its contraceptive effect ceases. When removed, the woman can become pregnant as quickly as a woman who has not used the IUD.

What your gynecologist should know about you

Before you have inserted the OPTIMA IUD TCU 380A it is your responsibility to fully inform your gynecologist the past medical history of yours. Tell your doctor if you have, if you have had or suspect to have a coronary, metabolic, or uterine dysfunction.

Situations that may occur

If you are an OPTIMA IUD TCU 380A user you must immediately notify your gynecologist if any of the following situations happen:

  • Failure of menstruation.
  • Abnormal or unexplained vaginal bleeding or discharge.
  • Menstrual delay followed by sparse and irregular flow.
  • Pain in the pelvis, lower abdomen, cramps or unexplained fever.
  • Presence of a sign or symptom of sexually transmitted diseases (STDs).
  • Wounds, genital lesions or fever with vaginal discharge.
  • Severe or prolonged menstrual bleeding.
  • Do not notice the presence of IUD wires.
  • Feeling pain during intercourse.

Insertion and removal

Before insertion of the IUD, the gynecologist will perform a pelvic exam to determine the size, shape, and position of the uterus.

The cervix and vagina will be cleaned with an antiseptic solution.

The doctor will take less than 5 minutes to place the OPTIMA IUD TCu 380A.

If you want to remove OPTIMA consult your gynecologist.

The contraceptive effect of OPTIMA ceases as soon as it is removed.

How to do self-examination

To make sure OPTIMA is in the correct position you can do the self-examination. Do the following:

  • Wash the hands.
  • Crouch or sit on the toilet.
  • Insert the index or middle finger deep into the vagina and locate your cervix; it can be felt like the tip of your nose.
  • Feel the OPTIMA If you can touch the wires, OPTIMA is probably in the right place. You should not pull the wires as you may move OPTIMA.
  • If you cannot touch the wires, or touch the IUD itself, it is probably because it has shifted from the uterine fundus. Look for the gynecologist doctor for a new exam.

Follow-up visits to gynecologist

It is recommended to return to the doctor after three months of insertion of the IUD.

OPTIMA has long life. The gynecologist will advise the date for the replacement or removal of the device.

OPTIMA allows the regular use of showers and plugs.