You are about to enter a site that is for U. The system should be replaced after 6 years if continued use is desired. Use of LILETTA is contraindicated in women with the following: pregnancy; for use as post-coital contraception; congenital or acquired uterine anomaly, including fibroids, if they distort the uterine cavity and would be incompatible with correct IUS placement; known or suspected breast cancer or other hormone-sensitive cancer, now or in the past; known or suspected uterine or cervical neoplasia; acute liver disease or liver tumor; untreated acute cervicitis or vaginitis, including lower genital tract infections eg, bacterial vaginosis until infection is controlled; infected abortion in the past 3 months; unexplained uterine bleeding; a current IUS; acute pelvic inflammatory disease PID or endometritis or history of PID except with later intrauterine pregnancy ; conditions increasing susceptibility to pelvic infection; or hypersensitivity to any component of LILETTA.
Use LILETTA with caution after careful assessment in patients with coagulopathy or taking anticoagulants; migraine, focal migraine with asymmetrical visual loss or other symptoms indicating transient cerebral ischemia; exceptionally severe or frequent headache; marked increase of blood pressure; or severe arterial disease such as stroke or myocardial infarction.
If the threads are not visible or are significantly shortened, they may have broken or retracted into the cervical canal or uterus. If pregnancy should occur with LILETTA in place, remove the intrauterine system because leaving it in place may increase the risk of spontaneous abortion and preterm labor. Removal or manipulation may result in pregnancy loss. Tell women about the signs of ectopic pregnancy and associated risks, including loss of fertility.
Women with a history of ectopic pregnancy, tubal surgery, or pelvic infection carry a higher risk of ectopic pregnancy. IUSs have been associated with an increased risk of PID, most likely due to organisms being introduced into the uterus during insertion. One woman diagnosed with PID and two women diagnosed with endometritis developed the infection within a week of insertion. One endometritis case was diagnosed at 39 days after insertion. The remaining 11 cases of PID and endometritis were diagnosed more than 6 months after insertion, including one at 30 days after IUS removal.
Counsel women who receive LILETTA to notify a healthcare provider if they develop lower abdominal or pelvic pain, fever, chills, unusual or malodorous discharge, unexplained bleeding, genital lesions or sores, or dyspareunia. PID or endometritis may be asymptomatic but still result in tubal damage and its sequelae.
Inform women about the possibility of PID or endometritis and that these infections can cause tubal damage leading to ectopic pregnancy or infertility, or infrequently can necessitate hysterectomy, or cause death.
Spotting and irregular or heavy bleeding may occur during the first 3 to 6 months. Cycles may remain irregular, become infrequent, or even cease. Consider pregnancy if menstruation does not occur within 6 weeks of the onset of previous menstruation.
If a significant change in bleeding develops during prolonged use, conduct diagnostic tests to assess possible endometrial pathology. Perforation may also occur at any time during use. Perforation may reduce contraceptive efficacy. Surgery may be required. Delayed detection or removal of LILETTA in case of perforation may result in migration outside the uterine cavity, adhesions, peritonitis, intestinal perforations, intestinal obstruction, abscesses, and erosion of adjacent viscera.
The risk of perforation is higher if inserted in lactating women and may be higher if inserted in women who are postpartum or when the uterus is fixed retroverted. Delay LILETTA insertion a minimum of 4 weeks or until uterine involution is complete following a delivery or a second trimester abortion. If expulsion has occurred, a new LILETTA may be inserted within 7 days after the onset of a menstrual period after pregnancy has been ruled out.
Ovarian cysts may occur and are generally asymptomatic, but may be accompanied by pelvic or abdominal pain or dyspareunia. Evaluate persistent ovarian cysts. Teach patients to recognize and immediately report signs or symptoms of the aforementioned conditions. Pregnancy, unexplained vaginal bleeding, and a lifestyle placing the woman at risk for sexually transmitted diseases are contraindications to IUD use.
Insertion of the IUD can take place at any time during the menstrual cycle provided the woman is not pregnant. Before insertion, a bimanual examination and a sounding of the uterus are necessary to determine the uterus position and the depth of the uterine cavity.
Expulsion may occur with both types of IUDs. For many years, the intrauterine device IUD has been a contraceptiv choice for women. In , the IUD was used by It was associated with a significant incidence of pelvic inflammatory disease PID because its multifilament threads were believed to be prone to transmitting bacteria into the uterus and fallopian tubes.
Both IUDs have monofilament threads that minimize the risk for bacteria transmission. The copper-releasing IUD Figure 1 is a T-shaped polyethylene device with mm 2 of exposed surface area of copper on its arms and stem. The released copper ions interfere with sperm mobility and incite a foreign-body reaction that results in a spermicidal environment. A 3-mm plastic ball is located at the base of the IUD, through which the monofilament thread passes.
Once inserted, the IUD can remain in place for up to 10 years. Copper-releasing intrauterine device ParaGard and inserter. The hormone-releasing IUD Figure 2 is a radiopaque T-shaped device with 52 mg of levonorgestrel on its arms and stem.
The progestin is released at a rate of 20 mcg a day. Levonorgestrel is thought to thicken cervical mucus, creating a barrier to sperm penetration through the cervix, and it may stop ovulation and thin the uterus lining. Once inserted, the IUD can remain in place for up to five years. Hormone-releasing intrauterine device Mirena and inserter.
Reprinted with permission from Berlex, Inc. Data are conflicting on which mechanism primarily is responsible for efficacy of IUDs. The results of a recent review indicated that pre- and post-fertilization mechanisms of action play a role in both IUDs. The contraceptive effects of the IUD are reversible after removal.
The results of a recent study suggest that long-term IUD use i. IUDs are for parous women who are in a stable, mutually monogamous relationship, with no history of PID. Although not contraindicated in this group, nulliparous women tend to have higher expulsion and failure rates, and also offer more challenging insertion because they have a smaller uterine cavity.
A history of PID suggests a risk for reinfection, although a remote history does not totally preclude choosing an IUD. A World Health Organization scientific working group concluded that women who have been pregnant after an occurrence of PID and are not currently at risk for infection can be candidates for IUDs.
The hormone-releasing IUD may benefit women with anemia, menorrhagia, or dysmenorrhea. Both IUDs are classified as pregnancy category X. Contraindications are summarized in Table 1. History of pelvic inflammatory disease unless subsequent intrauterine pregnancy occurred.
Information from references 4 , 5 , 7 , 10 , and IUDs may be inserted anytime during the menstrual cycle. Documentation of a negative pregnancy test is prudent. Insertion may be performed during menstruation to provide additional reassurance that the woman is not pregnant.
If insertion is planned during the luteal phase, another nonhormonal contraceptive should be used until after the next menses. A pregnancy test can be done, but the patient should be made aware that a pregnancy test at this time cannot always rule out early pregnancy. The American College of Obstetricians and Gynecologists recommends a pelvic examination before insertion to screen for Chlamydia and gonorrhea.
Routine prophylactic antibiotic administration is not necessary. Doxycycline Vibramycin or erythromycin may be used for prophylaxis. According to the American Heart Association, antibiotic prophylaxis in patients at risk for endocarditis is not necessary before IUD insertion or removal. The physician should discuss with the patient the risks and benefits of the IUD and, if necessary, other forms of contraception.
Informed consent may be obtained after these steps are completed. Administration of a nonsteroidal anti-inflammatory drug e. The physician should instruct the patient about how to locate the IUD threads.
It is necessary for the woman to locate the threads to verify the position of the IUD after each menstruation. The proper equipment Table 2 should be assembled before the procedure. Then, a bimanual examination with nonsterile gloves should be performed to determine the position of the uterus.
Cotton balls moistened with antiseptic solution or povidone-iodine Betadine swabs. The arms of the IUD are to be folded into the insertion tube far enough to retain them. This can be done before the start of the procedure, working through the sterile package Figure 3. The arms of the copper-releasing intrauterine device are folded into the insertion tube.
Sterile technique, including sterile gloves, is necessary during the procedure to minimize the risk of contamination or infection. The cervix and adjacent vaginal fornices should be cleansed liberally with an antiseptic solution. Chlorhexidine gluconate Hibiclens may be used if the patient is allergic to iodine. The physician should stabilize the cervix during the insertion of the IUD with a tenaculum.
Local anesthesia, such as 5 percent lidocaine gel Xylocaine placed in the cervical canal, or a paracervical block may be used to minimize discomfort. A sterile uterine sound should be used to determine the depth of the uterine cavity. Contact with the vagina or speculum blades should be avoided. The uterine sound has a bulbous tip to help prevent perforation. An alternative to the uterine sound is an endometrial aspirator such as those used for endometrial biopsy sampling.
An IUD should not be inserted if the depth of the uterus is less than 6 cm. The physician should use sterile gloves to remove the IUD from the sterile package. The blue flange should be aligned with the IUD arms and set at the distance the uterus was sounded. The white inserter rod should then be placed into the insertion tube at the end opposite the arms of the IUD and approximated against the ball at the base of the IUD.
The physician should then insert the IUD into the uterus until the flange is against the cervical os. The tube should be advanced slowly to ensure a correct positioning of the IUD Figure 5. The physician should remove the insertion rod by holding the insertion tube in place Figure 6 and then remove the insertion tube and the tenaculum.
Finally, the threads emerging from the cervical os should be cut to a length of 3 cm. The arms of the copper-releasing intrauterine device are released. The insertion tube is advanced for placement of the copper-releasing intrauterine device. The insertion rod of the copper-releasing intrauterine device is withdrawn. As with the copper-releasing IUD, the proper equipment Table 2 for insertion of the hormone-releasing IUD should be assembled before the procedure.
Then, a bimanual examination with nonsterile gloves should be done to determine the position of the uterus. Sterile technique with sterile gloves is necessary during the procedure itself to minimize the risk of contamination or infection. The cervix and adjacent vaginal mucosa should be cleansed liberally with an antiseptic solution.
Chlorhexidine gluconate may be used if the patient is allergic to iodine. Local anesthesia, such as 5 percent lidocaine gel placed in the cervical canal, or a paracervical block may be used to minimize discomfort. A sterile uterine sound or an endometrial aspirator should be used to determine the depth of the uterine cavity. The physician should open the sterile IUD package, put on sterile gloves, pick up the inserter containing the IUD, and carefully release the threads from behind the slider, allowing them to hang freely.
The slider should be positioned at the top of the handle nearest the IUD. While looking at the insertion tube, the physician should check that the arms of the device are horizontal. If not, they must be aligned using sterile technique Figure 7. The physician should pull on both threads to draw the IUD into the insertion tube so that the knobs at the end of the arms cover the open end of the inserter Figure 8.
The threads should be fixed tightly in the cleft at the end of the handle Figure 9 , and the flange should be set to the depth measured by the sound Figure The arms of the hormone-releasing intrauterine device are aligned to a horizontal position when removing the device from the package.
The hormone-releasing intrauterine device is drawn into the insertion tube. Threads are fixed tightly in the cleft. The flange is adjusted to sound depth. The physician should insert the IUD by holding the slider firmly at the top of the handle and gently placing the inserter into the cervical canal.
The insertion tube should be advanced into the uterus until the flange is situated at a distance of about 1. While holding the inserter steady, the physician should release the arms of the IUD by pulling the slider back until the top of the slider reaches the raised horizontal line on the handle Figure The inserter should be pushed gently into the uterine cavity until the flange touches the cervix. The slider is pulled back to reach the mark.
The IUD should now be positioned at the top of the fundus. The physician then releases the IUD by pulling the slider all the way down while holding the inserter firmly in position. The threads will be released automatically Figure The inserter should be removed from the uterus. Finally, the threads emerging from the cervical os should be cut to a length of 2 to 3 cm. The inserter is withdrawn while the intrauterine device is released.
Following insertion of either device, a follow-up appointment should be planned after the next menses to address any concerns or adverse effects, ensure the absence of infection, and check the presence of the strings. The most common adverse effects of IUDs are cramping, abnormal uterine bleeding, and expulsion Table 3. First-year failure rates are reported to be between 1 and 2 percent. Information from references 4 , 5 , 7 , 11 , and If the IUD threads are ever not present, a pregnancy test should be performed.
When the results are negative, a cytobrush can be inserted gently into the cervical canal to locate the threads. If this method is unsuccessful, radiography or ultrasonography may be used to locate the IUD. Uterine perforation, which is more likely to occur during insertion of the device, ranges from 0. When the results of the pregnancy test are positive, an ectopic implantation must be ruled out.
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