Hormonal IUDs

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Intrauterine Device (IUD) with progestogen , sold under the trademark Mirena , among others, is an intrauterine device that releases the levonorgestrel hormone. It is used for birth control, heavy menstrual periods, and to prevent excessive formation of uterine lining in those who use estrogen replacement therapy. This is one of the most effective forms of birth control with a one-year failure rate of about 0.2%. It is placed in the uterus and lasts for three to five years. After the transfer of fertility returns quickly.

Side effects include irregular periods, benign ovarian cysts, pelvic pain, and depression. Uterine perforation can rarely occur. Use is not recommended during pregnancy but is safe with breastfeeding. IUDs with progestogens are a type of long-term reversible birth control. This works by making the mucus in the opening to the thick cervix, stopping the buildup of the lining of the uterus, and sometimes preventing ovulation.

IUDs with levonorgestrel were first approved for medical use in 1990 in Finland and in the United States in 2000. This is a List of Essential Medicines of the World Health Organization, the most effective and safe drugs needed in the health system. Wholesale costs in developing countries are around US $ 122.46 each. In the United Kingdom, they weighed on the NHS for around Â£ 88 pounds. In the United States it costs about US $ 844.00. More than 120 countries have approved this device and are used by more than 10 million women.

Video Hormonal IUDs

Medical use

In addition to birth control, hormonal IUDs are used for prevention and treatment:

heavy menstruation
Endometriosis and chronic pelvic pain
Adenomyosis and dysmenorrhea
Anemia
In some cases, the use of hormonal IUDs may prevent the need for hysterectomy.

Advantages

Considered one of the most effective forms of reversible birth control
Can be used during breastfeeding (see also breastfeeding mothers)
No preparation before sex is required, although routine device string checks by patients and doctors are advised to ensure correct placement remains intact
90% of users who wish to get pregnant do so within 24 months of deletion.
May have a brighter period (some women stop full menstruation, see also amenorrhea)
Valid for up to three to five years (depending on IUD)

Deficiency

Irregular periods and spots between periods often occur after insertion
Mild to moderate pain experienced during the insertion procedure, including cramps or back pain
Potential side effects and other risks

Effectiveness

After insertion, Mirena was officially sold effectively for up to five years, although several studies have shown that it remains effective for seven years. It is approved for use up to 7 years in Europe. Skyla is effective for 3 years.

Hormonal IUDs are long-acting reversible contraceptives, and are considered to be one of the most effective forms of birth control. The first-year failure rate for hormonal IUD was 0.2% and the five-year failure rate was 0.7%. This figure is proportional to tubal sterilization, but unlike sterilization, the effects of a hormonal IUD are reversible.

Hormonal IUDs are considered to be more effective than other common forms of contraception, such as birth control pills, because they require little action by the user after insertion. The effectiveness of other forms of birth control is reduced (reduced) by the user itself. If a contraceptive drug regimen is not followed correctly, this method becomes less effective. IUDs do not require daily, weekly or monthly regimens, so their typical failure rate of use is therefore equal to their failure rate of perfect use.

In women with bicornuate uterus and in need of contraception, two IUDs are generally applied (one in each horn) for lack of evidence of efficacy with only one IUD. Less evidence on the use of progestogen IUD for menorrhagia in uterine binding, but case reports show a good effect with a single IUD for this purpose.

Breastfeeding

Progestogen contraceptives such as IUDs are not believed to affect breast milk supply or infant growth. However, a study in the Mirena application for FDA approval found a lower continuation of breastfeeding at 75 days in hormonal IUD users (44%) than copper IUD users (79%).

When using Mirena, about 0.1% of the levonorgestrel dose of the mother can be transferred through the milk to the treated baby. A six-year study of breast-fed infants whose mothers used levonorgestrel birth control methods found only infants had an increased risk of respiratory infections and eye infections, despite lower risk of neurologic conditions, compared with babies whose mothers used copper IUDs. No long-term study was conducted to assess the long-term effects of levonorgestrel infants in breast milk.

There are conflicting recommendations about the use of Mirena while breastfeeding. The US FDA does not recommend any hormonal methods, including Mirena, as the first choice of contraception for nursing mothers. The World Health Organization recommends to fight postpartum insertion immediately, citing increased rates of expulsion. It also reports concerns about potential effects on the development of the baby's liver and brain within the first six weeks of postpartum. However, he recommends offering Mirena as a contraceptive option starting from six weeks postpartum even for lactating women. Planned Parenthood offers Mirena as a contraceptive option for lactating women starting from four weeks postpartum.

Maps Hormonal IUDs

Contraindications

Hormonal IUD should not be used by women who:

Whether, or think they may, be pregnant
Have unexplained abnormal vaginal bleeding
Have untreated cervical or uterine cancer
Have, or possibly suffer, breast cancer
Have abnormalities in the cervix or uterus
Have had pelvic inflammatory disease in the last 3 months
Have had an STI like chlamydia or gonorrhea in the last 3 months
Have liver or tumor disease
Have allergies to levonorgestrel or any of the inactive ingredients included in the device

IUD insertion is not recommended for women who have D & amp; E (second trimester) in the last four weeks. To reduce the risk of infection, IUS insertion is not recommended for women who have had a medical abortion but have no ultrasound to ensure that an abortion is completed, or who has not had the first menstrual period after a medical abortion.

The full list of contraindications can be found in the WHO Medical Feasibility Criteria for Use of Contraception and the CDC US Medical Feasibility Criteria for Contraceptive Use .

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Side effects

Irregular menstrual patterns: irregular bleeding and spotting commonly occur in the first 3 to 6 months of use. After that time period it becomes shorter and lighter, and 20% of women stop having period after 1 year of usage. The average user reported 16 days of bleeding or spotting in the first month of use, but this was reduced to about four days at 12 months.
Cramps and Pains: many women feel discomfort or pain during and soon after insertion. Some women may experience cramps for the first 1-2 weeks after insertion.
Expulsion: Sometimes IUD can get out of the womb. This is called expulsion. About 5% of IUD users experience expulsion. If this happens a woman is not protected from pregnancy. Expulsions are more common in younger women, women who have no children, and when the IUD is inserted immediately after delivery or abortion.
Perforation: Very rarely, IUDs can be pushed through the uterine wall during insertion. The risk of perforation is largely determined by the practitioner's skill of insertion. For experienced medical practitioners, the risk of perforation is 1 per 1,000 insertions or less. With postpartum insertion, uterine perforation is more likely to occur when uterine involution is incomplete; involution is usually completed by 4-6 weeks postpartum. Special considerations apply to women who plan to breastfeed. If perforation occurs it can damage internal organs, and in some cases surgery is required to remove the IUD.
Pregnancy complications: Although the risk of pregnancy with an IUD is very small, if a person does occur, there is an increased risk of serious problems. These include ectopic pregnancy, infection, miscarriage, and early childbirth. Half of pregnancies that occur in Mirena users may be ectopic. The incidence rate of ectopic pregnancy is about 1 per 1000 users per year. Immediate removal of the IUD is recommended in case of pregnancy. No birth defect pattern was observed in 35 infants whose birth results were available at the time of FDA approval.
Infection: IUD insertion does have a small risk of pelvic inflammatory disease (PID). Infections together with gonorrhea or chlamydia at insertion increase the risk of pelvic inflammatory disease. If a PID occurs, it will most likely occur within 21 days after insertion. The device itself does not increase the risk of infection.
Ovarian cysts: Enlarged follicles (ovarian cysts) have been diagnosed in about 12% of subjects using hormonal IUDs. Most of these follicles are asymptomatic, although some may be accompanied by pelvic pain or dyspareunia. In many cases, the enlarged follicle disappears spontaneously after two to three months. Surgical intervention is usually unnecessary.
Changes in mental health include: anxiety, depressed mood, mood swings
Weight
Headaches, migraines
Nausea
Acne
Excessive hair
Lower abdominal pain or back
Libido decreases
Itching, redness or swelling of the vagina
Vaginal discharge
Breast pain, tenderness
Edema
Abdominal distension
Cervicitis
May affect glucose tolerance
May experience changes in vision or contact lens tolerance
May deplete Vitamin B1 which can affect the energy, mood, and nervous system function
"Lost coil" occurs when the thread can not be felt by the woman during routine examination and is not seen on speculum examination. A variety of simple yarn collection devices or forceps can be used to try to capture the device through the cervix. In rare cases when this does not work, an ultrasound scan can be adjusted to check the position of the coil and remove perforation through into the abdominal cavity or previous unrecognized expulsion.

Cancer

According to a 1999 evaluation of studies conducted on progestin birth control by the International Agency for Research on Cancer, there is some evidence that family planning only reduces the risk of endometrial cancer. The IARC concluded that no evidence of progestin birth control only increases the risk of cancer, although the available studies are too small to be definitely conclusive.

Progesterone is a hormone in the endometrium that opposes estrogen-driven growth. Very low levels of progesterone will cause estrogen to act more, leading to endometrial hyperplasia and adenocarcinoma. This effect can be minimized if treated with progestin, but not in most cases.

Estrogen and progesterone have antagonistic relationships. Estrogen encourages the growth of the endometrial lining, while progesterone limits it. In the case of endometrial cancer, progesterone can negatively regulate estrogen-driven growth. The tumor formed correlates with insufficient progesterone and excess estrogen. In patients with endometrial cancer using progestin released IUDs concluded mixed results.

Bone density

No evidence has been identified to indicate Mirena affects bone mineral density (BMD). Two small studies, limited to studying BMD in the forearm, did not show a decrease in BMD. One study showed that in 7 years of use, BMD was similar in the ulna midshaft and on the distal radius as non-users matched by age and BMI. In addition, BMD measurements are similar to those expected for women in the same age group as participants. The authors of the study say their results are predictable, as it has been proven that the major factor responsible for bone loss in women is hypoestrogenism, and, according to previous reports, they found the level of estradiol in Mirena users to be normal.

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Hormonal composition and release

Hormonal IUD is a small piece of 'T' shaped plastic, which contains levonorgestrel, a type of progestin. The device cylinder is coated with a membrane that regulates drug release. Mirena releases the drug at an initial rate of 20 micrograms per day. This decreases to a rate of 14 micrograms per day after 5 years, which is still within the range of clinical effectiveness. Skyla releases 14 micrograms per day and decreases to 5 micrograms per day after 3 years. Bayer markets Skyla as a Jaydess in the UK. Jaydess released 6 micrograms per day and lasted for 3 years. For comparison, oral contraceptives may contain 150 micrograms of levonorgestrel. Hormonal IUD releases levonorgestrel directly into the uterus, since its effect is largely paracrine rather than systemic. Most drugs remain in the uterus, and only a small amount is absorbed throughout the body. The level of levonorgestrel blood in Mirena users is half that found in Norplant users and one-tenths found in levonorgestrel pill users alone.

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Insertion and deletion

Hormonal IUDs are included in procedures similar to nonhormonal copper IUDs, and can only be inserted by a qualified medical practitioner. Before insertion, a pelvic exam is performed to examine the shape and position of the uterus. It is recommended that patients be tested for gonorrhea and chlamydia prior to insertion, as current STIs may increase the risk of pelvic infection. However, if a person has previously been examined and there is no evidence of infection in the insertion of an IUD examination should not be delayed.

During insertion, the vagina is opened with the speculum, the same tool used when the pap smear. The grasping instrument is used to stabilize the cervix, the length of the uterus measured for proper insertion, and the IUD is placed using a narrow tube through the cervical opening to the uterus. The short monofilament plastic/nylon yarn dangles from the cervix into the vagina. The strap allows doctors and patients to check to make sure the IUD is still installed and allows easy removal of the device. Mild to moderate cramps can occur during the procedure, which usually takes five minutes or less. Insertion can be done immediately after delivery and post-abortion if no infection occurs. Misoprostol is not effective in reducing pain in IUD insertion.

The removal of the device should also be performed by qualified medical practitioners. Once removed, the fertility will return to previous levels relatively quickly. One study found that most participants returned to fertility within three months.

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Action mechanism

Levonorgestrel is a progestogen, a progesterone receptor agonist. The main mechanism of action of a hormonal IUD is to prevent conception. The levonorgestrel intrauterine system has several contraceptive effects:

The inside of the womb becomes fatal to the sperm
Cervical cervix thickens
Ovulation is not blocked
They can also thin the endometrial lining and potentially disrupt implantation but this is not a normal function.

Numerous studies have shown that IUDs primarily prevent conception, not implantation. In one trial involving tubal flushing, a fertilized egg was found in half of women who did not use contraception, but no fertilized eggs were found in women using IUDs. IUDs also reduce the risk of ectopic pregnancy, which further indicates that the IUD prevents conception.

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History

Hormonal IUDs were developed in the 1970s after the development of copper IUDs in the 1960s and 1970s. Dr Antonio Scommenga, who works at Michael Reese Hospital in Chicago, found that giving progesterone in the womb may have contraceptive benefits. With knowledge of Scommegna's work, a Finnish physician, Jouni Valtteri Tapani Luukkainen, created a T-shaped IUD that produced progesterone, marketed as a Progestasert System in 1976. The IUD has a short 1 year life span and never reaches wide popularity.. After the relative lack of success, Dr. Luukkainen replaces progesterone with levonorgestrel hormone to be released over a 5-year period, creating what is now Mirena.

The Mirena IUD was studied for safety and efficacy in two clinical trials in Finland and Sweden involving 1,169 women all aged between 18 and 35 years old at the start of the experiment. The trials included mainly Caucasian women who were previously pregnant without a history of ectopic pregnancy or pelvic inflammatory disease in the previous year. Over 70% of previous participants used IUDs.

In 2013 Skyla, an effective low dose levonorgestrel IUD of up to 3 years, has been approved by the FDA. Skyla has a different bleeding pattern than Mirena, with only 6% of women in clinical trials being amenorrheic (compared to about 20% with Mirena). In 2015, Liletta is approved by the FDA. Liletta has the same size and characteristics of levonorgestrel release as Mirena, and FDA approved for 3 years of use after research in which 6 women of 1,751 were conceived while using Liletta.

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Controversy

In 2009, Bayer, maker of Mirena, issued the FDA's Letter of Caution by the US Food and Drug Administration for exaggerating its efficacy, minimizing the risks of use, and making "false or misleading presentations" about the device. From 2000 to 2013, the federal agency received more than 70,072 complaints about device and related adverse effects. As of April 2014, more than 1,200 lawsuits have been filed in the United States.

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References