INTRAUTERINE DEVICE (IUD)

• 1.Hormonal with progesterone
• 2.Non-Hormonal

An Intrauterine device is basically a highly safe and effective form of long-acting reversible contraception (LARC). An intrauterine device (IUD), also referred to as an intrauterine contraceptive (IUC) is a T-shaped, small and flexible device that is inserted into the uterus through the vagina. This device can provide pregnancy prevention for 3-10 years depending on the type.

Skyla is a hormonal intrauterine device classified as a long-acting reversible contraceptive method; LARC (long acting reversible contraception)

Skyla was introduced in 2013. It is a low-dose type of hormonal levonorgestrel intrauterine device containing progestin which has been approved by the U. S. Food and Drug Administration (FDA). It is a small and safe device with 99% effectiveness. This updated form of an intrauterine device also delivers lower doses of hormones compared with other hormonal intrauterine devices, lasting up to 3 years. Thus, it has been indicated for prevention of pregnancy for up to 3 years. If even after 3 years continual usage is desired, replacement of the system is essential.

SKYLA IUD 

The small size and flexibility of Skyla IUD makes it a better option for most women including those who have not given birth and are not planning to, for example, the newly married as well as college students.

Skyla is basically made up of a polyethylene T-shaped frame that has a loop at one end of the vertical stem and two horizontal arms at the other end. The vertical stem harbours a hormone reservoir consisting of a whitish or pale yellow cylinder, made of a mixture of levonorgestrel (LNG) and silicone. It contains a total of 13.5 mg LNG. A semi-opaque silicone membrane encloses the reservoir and is composed of polydimethylsiloxane and colloidal silica. Also a pure silver ring is present at the top of the vertical stem close to the horizontal arms. The polyethylene of the T-body is compounded with barium sulfate, which makes it radiopaque. Thus both the silver ring as well as the T-body can be visualised on ultrasound examinations. There is a removal thread that is attached to a loop at the end of the vertical stem of the T-body which facilitates easy removal. The Skyla IUD releases levonorgestrel (LNG) at the rate of 14 mcg/day after 24 days which further declines to 5 mcg/day after 3 years thus requiring must its removal or replacement after 3 year.

What is an IUD and how common is it used as a method of contraception (birth-control)?

Advantages

The foremost advantage of Skyla intrauterine device includes a provision of 99% effectiveness at pregnancy prevention; one can become pregnant almost immediately once the device is removed.

• Excellent alternative to birth control pills for women who cannot take estrogen, for example women having history of blood clots or some types of migraines
• Highly effective
• Safe method
• No estrogen released thus reducing the risk of endometrial cancer
• Long term protection that can be effortlessly reversed
• Rapid reversibility
• Cost effective
• Convenient
• Easy placement and removal
• Decreased ectopic i.e. tubal pregnancy
• Decreased bleeding and cramps
• Can be placed at the end of a pregnancy as in cases of termination, miscarriage, or delivery
• High user satisfaction

Apart from these advantages, researchers are also studying the use of Skyla IUD in treatment of heavy vaginal bleeding, for instance, making the monthly periods a little lighter or in case of fibroid tumors or bleeding disorders.

Usage Directions

It is deemed necessary that the insertion of device be done by a trained healthcare provider using strict aseptic technique throughout the insertion procedure. The placement is very simple.

Skyla is supplied within an inserter in a sterile package that must not be opened until required for insertion. Intially a speculum is inserted by the clinician and the cervix is cleaned with a disinfectant. Skyla is inserted through a long, thin tube after measurement of the size of uterus. Skyla must be inserted into the uterine cavity during the first seven days of the menstrual cycle or immediately after a first trimester abortion. No back up contraception is necessary on insertion of Skyla. There might be a little pan or bleeding after insertion of the device. In some cases vasovagal responses such as syncope, bradycardia or even seizure in an epileptic patient, especially in patients with a predisposition to these symptoms can occur. Thus prior administration of analgesics is considered in some cases. Regular examination and evaluation 4 to 6 weeks after insertion and then yearly is indicated.

Removal

After 3 years Skyla should not remain in the uterus. If the woman is still experiencing regular menses and pregnancy is not desired, the device should be removed during menstruation. The process of removal is easy and quick wherein usually the clinician just pulls it out by the strings.

Effectiveness

The basic mechanism of action of Skyla IUD is the continuous release of LNG. This continuous release of levonorgestrel is likely to enhance the contraceptive effectiveness of Skyla along with other mechanisms such as thickening of cervical mucus preventing passage of sperm into the uterus, inhibition of sperm capacitation or survival and alteration of the endometrium.

Unintended pregnancy remains a major issue in the United States. Many of the pregnancies are the result of using contraception incorrectly or inconsistently. The failure rate for Skyla IUD was 0.4% at year 1and 0.9% cumulative over 3 years making Skyla IUD one of the most effective methods of birth control. It is also one of the safest methods.

Precautions

• Remove Skyla if pregnancy occurs with Skyla in place. There is increased risk of ectopic pregnancy including loss of fertility, pregnancy loss, septic abortion (including septicemia, shock and death), and premature labor and delivery
• Strict aseptic technique is essential during insertion as Group A streptococcal infection has been reported
• Before using Skyla, the risks of pelvic inflammatory disease should be considered
• Bleeding patterns become altered, may remain irregular and amenorrhea may ensue.
• Evaluation of persistent enlarged ovari an follicles is necessary

Indications

Indications of Skyla intrauterine device include majority of women of reproductive age, as they can use it safely and effectively. Efficacy is expected to be the unchanged for post-pubertal females under the age of 18 as for users 18 years and older.

• Women who have not had children
• Unmarried women including adolescents and women over 40 years old
• Women who have just had an abortion or miscarriage
• Women doing physical jobs
• Women who have had an ectopic pregnancy
• Women who have had pelvic inflammatory disease, anemia, infected with HIV and are on antiretroviral therapy and doing well

Contra-Indications

Skyla intrauterine device is contraindicated in women with following medical disorders.

• Pregnancy: Skyla intrauterine device is contraindicated for use when pregnancy is suspected or during pregnancy. Before insertion of the Skyla intrauterine device it is necessary to exclude pregnancy through pregnancy test and other appropriate confirmatory tests. It cannot be used for post-coital contraception.
• Vaginal bleeding or incomplete abortion: Skyla intrauterine device is contraindicated absolutely in patients with undiagnosed vaginal bleeding or incomplete abortion.
• Use in females before menarche
• Significant hepatic disease (jaundice and hepatocellular cancers)
• Cervical cancer, uterine cancer, vaginal bleeding, breast cancer, menstrual irregularity and ovarian cyst.
• Women with an acquired or congenital anomaly, such as fibroids if the lead to distortion of the uterine cavity.
• Diabetes mellitus, before the end of six weeks following an obstetric delivery
• Cervicitis, endometritis, vaginitis,
• Leukemia
• Sexually transmitted infections: Skyla intrauterine device use is also contraindicated in patients with an active untreated sexually transmitted infections such as acute cervicitis or vaginitis, known gonococcal or chlamydial infection, lower genital tract infections and genital actinomycosis until the infections are controlled.
• Bradycardia
• Obesity
• Skyla levonorgestrel intrauterine device is to be cautiously used considering patients with active thromboembolic disease or history or thromboembolic disease or thrombophlebitis.A previous intrauterine device that has not been removed.

Complications

Serious complications associated with Skyla intrauterine device use are rare, but in some cases, there are possible risks that can occur. The signs of complications that should be reported to the doctor immediately include:

Perforation is one of the complications that can occur when Skyla intrauterine device is pushed through the uterine wall during the procedure of insertion. It may also move to the other parts of the pelvic area and damage internal organs; this will require surgical intervention to remove the device.

Infections such as pelvic inflammatory disease can occur after the insertion of Skyla intrauterine device. Pelvic infection can also occur when bacteria gets into the uterus during insertion of the intrauterine device.

Expulsion is another complication where the Skyla intrauterine device slips out of the uterus. This occurs in about 3% of women and mostly during the first two months of insertion or even during the monthly period. Use of a back-up birth control method such as condoms and spermicide is deemed necessary if expulsion is suspected. Also, it must be confirmed as early as possible.

Ovarian cysts About 14% of women using Skyla are likely to develop a cyst on the ovary. These cysts usually are asymptomatic, disappear on their own in a month or two, but can cause pelvic pain and at times require surgery. Even sexual intercourse can become painful. Ovarian cysts which are persistent should be evaluated.

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