Insertion Instructions for Skyla®
Click through the pages below to review the step-by-step insertion instructions for Skyla®
Intro: Getting to know the non-reloadable Skyla inserter 1/7
Intro: Getting to know the non-reloadable Skyla inserter 2/7
Intro: Getting to know the non-reloadable Skyla inserter 3/7
Intro: Getting to know the non-reloadable Skyla inserter 4/7
Intro: Getting to know the non-reloadable Skyla inserter 5/7
Intro: Getting to know the non-reloadable Skyla inserter 6/7
Intro: Getting to know the non-reloadable Skyla inserter 7/7
Step 1: Opening the package 1/1
Step 2: Load Skyla into the insertion tube 1/1
Step 3: Setting the flange 1/1
Step 4: Skyla is now ready to be inserted 1/1
Step 5: Open the arms 1/1
Step 6: Advance to fundal position 1/1
Step 7: Release Skyla and withdraw the inserter 1/3
Step 7: Cutting the thread 2/3
Step 7: Patient follow-up 3/3
Removal of Skyla1/3
Removal of Skyla2/3
Removal of Skyla3/3
Welcome to the Skyla insertion instructions.
The instructions are designed to help you understand how to properly insert Skyla.
Because the Skyla inserter is different from other IUS/IUD inserters you may be used to—and since it cannot be reloaded—it's important to understand its defining features and learn proper insertion technique prior to using Skyla.
This is a supplement to the Full Prescribing Information, which you can find on the top right corner of the website. You can also view the insertion video using the left-hand side navigation.
Skyla contains 13.5 mg of levonorgestrel (LNG) released in vivo at a rate of approximately 14 mcg/day after 24 days. This decreases progressively to 5 mcg/day after 3 years. The average in vivo release rate of LNG is approximately 6 mcg/day over a period of 3 years. Skyla must be removed by the end of the third year and can be replaced at the time of removal with a new Skyla if continued contraceptive protection is desired.
Skyla is supplied within an inserter in a sterile package that must not be opened until required for insertion. Do not use if the seal of the sterile package is broken or appears compromised. Use strict aseptic techniques throughout the insertion procedure.
- A complete medical and social history should be obtained to determine conditions that might influence the selection of a levonorgestrel-releasing intrauterine system (LNG IUS) for contraception. If indicated, perform a physical examination, and appropriate tests for any forms of genital or other sexually transmitted infections.
- Follow the insertion instructions exactly as described to ensure proper placement and avoid premature release of Skyla from the inserter. Once released, Skyla cannot be reloaded.
- Skyla should be inserted by a trained healthcare provider. Healthcare providers should become thoroughly familiar with the insertion instructions before attempting insertion of Skyla.
- Insertion may be associated with some pain and/or bleeding or vasovagal reactions (for example, syncope, bradycardia) or seizure in an epileptic patient, especially in patients with a predisposition to these conditions. Consider administering analgesics prior to insertion.
Timing of Insertion
- Insert Skyla into the uterine cavity during the first 7 days of the menstrual cycle or immediately after a first trimester abortion. Back-up contraception is not needed when Skyla is inserted as directed.
- Postpone postpartum insertion and insertions following second trimester abortions a minimum of 6 weeks or until the uterus is fully involuted. If involution is delayed, wait until involution is complete before insertion.
Tools for Insertion
- Sterile uterine sound
- Sterile tenaculum
- Antiseptic solution, applicator
Preparation for Insertion
- Exclude pregnancy and confirm that there are no other contraindications to the use of Skyla.
- Ensure that the patient understands the contents of the Patient Information Booklet and obtain the signed patient informed consent located on the last page of the Patient Information Booklet.
- Check expiration date of Skyla prior to initiating insertion.
- Sterile gloves
- Skyla with inserter in sealed package
- Instruments and anesthesia for paracervical block, if anticipated
- Consider having an unopened backup Skyla available
- Sterile, sharp curved scissors
Preparation for Insertion (cont.)
- With the patient comfortably in lithotomy position, do a bimanual exam to establish the size, shape and position of the uterus.
- Gently insert a speculum to visualize the cervix.
- Thoroughly cleanse the cervix and vagina with a suitable antiseptic solution.
- Prepare to sound the uterine cavity. Grasp the upper lip of the cervix with a tenaculum forceps and gently apply traction to stabilize and align the cervical canal with the uterine cavity. Perform a paracervical block, if needed. If the uterus is retroverted, it may be more appropriate to grasp the
lower lip of the cervix. The tenaculum should remain in position and gentle traction on the cervix should be maintained throughout the insertion procedure.
- Gently insert a uterine sound to check the patency of the cervix, measure the depth of the uterine cavity, confirm cavity direction, and detect the presence of any uterine anomaly. If you encounter difficulty or cervical stenosis, use dilatation, and not force, to overcome resistance. If cervical dilatation is required, consider using a paracervical block.
Proceed with insertion only after completing the above steps and ascertaining that the patient is appropriate for Skyla. Ensure use of aseptic technique throughout the entire procedure.
Step 1 - Opening the package
- Open the package. The contents of the package are sterile.
- Using sterile gloves, lift the handle of the sterile inserter and remove from the package.
Step 2 - Load Skyla into the insertion tube
- Push the slider forward as far as possible in the direction of the arrow thereby moving the insertion tube over the Skyla T-body to load Skyla into the insertion tube. The tips of the arms will meet to form a rounded end that extends slightly beyond the insertion tube.
- Maintain forward pressure with your thumb or forefinger on the slider. DO NOT move the slider downward at this time as this may prematurely release the threads of Skyla. Once the slider is moved below the mark, Skyla cannot be reloaded.
Step 3 - Setting the flange
- Holding the slider in this forward position, set the upper edge of the flange to correspond to the uterine depth (in centimeters) measured during sounding.
Step 4 - Skyla is now ready to be inserted
- Continue holding the slider in this forward position. Advance the inserter through the cervix until the flange is approximately 1.5-2 cm from the cervix and then pause.
- Do not force the inserter. If necessary, dilate the cervical canal.
Step 5 - Open the arms
- While holding the inserter steady, move the slider down to the mark to release the arms of Skyla. Wait 10 seconds for the horizontal arms to open completely.
Step 6 - Advance to fundal position
- Advance the inserter gently towards the fundus of the uterus until the flange touches the cervix. If you encounter fundal resistance do not continue to advance. Skyla is now in the fundal position. Fundal positioning of Skyla is important to prevent expulsion.
Step 7 - Release Skyla and withdraw the inserter
- Holding the entire inserter firmly in place, release Skyla by moving the slider all the way down.
- Continue to hold the slider all the way down while you slowly and gently withdraw the inserter from the uterus.
Important information to consider during or after insertion
- Using a sharp, curved scissor, cut the threads perpendicular, leaving about 3 cm visible outside of the cervix (cutting threads at an angle may leave sharp ends). Do not apply tension or pull on the threads when cutting to prevent displacing Skyla.
Skyla insertion is now complete. Prescribe analgesics, if indicated. Keep a copy of the Consent Form with lot number for your records.
- If you suspect that Skyla is not in the correct position, check placement (for example, using transvaginal ultrasound). Remove Skyla if it is not positioned completely within the uterus. Do not insert a removed Skyla.
- If there is clinical concern, exceptional pain, or bleeding during or after insertion, appropriate steps should be taken immediately to exclude perforation, such as physical examination and ultrasound.
- Patients should be reexamined and evaluated 4 to 6 weeks after insertion and once a year thereafter, or more frequently if clinically indicated.
Timing of Removal
- Skyla should not remain in the uterus after 3 years.
- If pregnancy is not desired, the removal should be carried out during the first 7 days of the menstrual cycle, provided the woman is still experiencing regular menses. If removal will occur at other times during the cycle, consider starting a new contraceptive method a week prior to removal. If removal occurs at other times during the cycle and the woman has had intercourse in the week prior to removal, she is at risk of pregnancy.
Tools for Removal
- Sterile forceps
- Remove Skyla by applying gentle traction on the threads with forceps.
- If the threads are not visible, determine location of Skyla by ultrasound.
- If Skyla is found to be in the uterine cavity on ultrasound exam, it may be removed using a narrow forceps, such as an alligator forceps. This may require dilation of the cervical canal. After removal of Skyla, the system should be examined to ensure that it is intact.
- Removal may be associated with some pain and/or bleeding or vasovagal reactions (for example syncope), or with seizure in an epileptic patient, especially in patients with a predisposition to these symptoms.
Continuation of Contraception After Removal
- If pregnancy is not desired and if a woman wishes to continue using Skyla, a new system can be inserted immediately after removal any time during the cycle.
- If a patient with regular cycles wants to start a different birth control method, time removal and initiation of new method to ensure continuous contraception. Either remove Skyla during the first 7 days of the menstrual cycle and start the new method or start the new method at least 7 days prior to removing Skyla if removal is to occur at other times during the cycle.
- If a patient with irregular cycles or amenorrhea wants to start a different birth control method, start the new method at least 7 days before removal.
INDICATION FOR SKYLA
Skyla® (levonorgestrel-releasing intrauterine system) 13.5 mg is indicated for the prevention of pregnancy for up to 3 years. Skyla should be replaced after 3 years if continued use is desired.
IMPORTANT SAFETY INFORMATION ABOUT SKYLA
Who is not appropriate for Skyla
Skyla is contraindicated in women with: known or suspected pregnancy and cannot be used for post-coital contraception; congenital or acquired uterine anomaly, including fibroids if they distort the uterine cavity; known or suspected breast cancer or other progestin-sensitive cancer, now or in the past; known or suspected uterine or cervical neoplasia; liver disease, including tumors; untreated acute cervicitis or vaginitis, including lower genital tract infections (eg, bacterial vaginosis) until infection is controlled; postpartum endometritis or infected abortion in the past 3 months; unexplained uterine bleeding; current IUD; acute pelvic inflammatory disease (PID) or history of PID (except with later intrauterine pregnancy); conditions increasing susceptibility to pelvic infection; or hypersensitivity to any component of Skyla.
Clinical considerations for use and removal of Skyla
Use Skyla 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 headache; marked increase of blood pressure; or severe arterial disease such as stroke or myocardial infarction. Consider removing Skyla if these or the following arise during use: uterine or cervical malignancy or jaundice. If the threads are not visible or are significantly shortened they may have broken or retracted into the cervical canal or uterus. If Skyla is displaced (e.g., expelled or perforated the uterus), remove it. Skyla can be safely scanned with MRI only under specific conditions.
Pregnancy related risks with Skyla
If pregnancy should occur with Skyla in place, remove Skyla because leaving it in place may increase the risk of spontaneous abortion and preterm labor. Removal or manipulation may result in pregnancy loss. Evaluate women for ectopic pregnancy because the likelihood of a pregnancy being ectopic is increased with Skyla. Also consider the possibility of ectopic pregnancy in the case of lower abdominal pain, especially in association with missed menses or if an amenorrheic woman starts bleeding. 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.
Educate her about PID
Skyla is contraindicated in the presence of known or suspected PID or in women with a history of PID, unless there has been a subsequent intrauterine pregnancy. IUDs have been associated with an increased risk of PID, most likely due to organisms being introduced into the uterus during insertion. Inform women about the possibility of PID and that PID can cause tubal damage leading to ectopic pregnancy or infertility, or infrequently can necessitate hysterectomy, or cause death. PID is often associated with sexually transmitted infections (STIs); Skyla does not protect against STIs, including HIV. PID may be asymptomatic but still result in tubal damage and its sequelae.
In Skyla clinical trials, PID occurred more frequently within the first year and most often within the first month after insertion.
Expect changes in bleeding patterns
Spotting and irregular or heavy bleeding may occur during the first 3 to 6 months. Periods may become shorter and/or lighter thereafter. 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.
Because irregular bleeding/spotting is common during the first months of Skyla use, exclude endometrial pathology (polyps or cancer) prior to the insertion of Skyla in women with persistent or uncharacteristic bleeding. If a significant change in bleeding develops during prolonged use, take appropriate diagnostic measures to rule out endometrial pathology.
Be aware of other serious complications and most common adverse reactions
Some serious complications with IUDs like Skyla are sepsis, perforation and expulsion. Severe infection, or sepsis, including Group A streptococcal sepsis (GAS) have been reported following insertion of a LNG-releasing IUS. Aseptic technique during insertion of Skyla is essential in order to minimize serious infections, such as GAS.
Perforation (total or partial, including penetration/embedment of Skyla in the uterine wall or cervix) may occur, most often during insertion, although the perforation may not be detected until sometime later. Perforation may reduce contraceptive efficacy. If perforation occurs, locate and remove Skyla. Surgery may be required. Delayed detection or removal of Skyla 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 may be increased if inserted when the uterus is not completely involuted or fixed retroverted. A postmarketing safety study over a 1-year observational period reported that lactation at the time of insertion of an IUS/IUD was associated with an increased risk of perforation. In this study, for users of another LNG-releasing IUS, the incidence of uterine perforation was reported as 6.3 per 1,000 insertions for lactating women, compared to 1.0 per 1,000 insertions for non-lactating women.
Partial or complete expulsion of Skyla may occur resulting in the loss of contraceptive protection. Delay insertion a minimum of six weeks or until uterine involution is complete following a delivery or a second trimester abortion. Remove a partially expelled Skyla. If expulsion has occurred, Skyla may be replaced 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 pain or dyspareunia. Evaluate persistent enlarged ovarian cysts.
The most common adverse reactions (≥5%) were vulvovaginitis (20.2%), abdominal/pelvic pain (18.9%), acne/seborrhea (15.0%), ovarian cyst (13.2%), headache (12.4%), dysmenorrhea (8.6%), breast pain/discomfort (8.6%), increased bleeding (7.8%), and nausea (5.5%).
Teach patients to recognize and immediately report signs or symptoms of the aforementioned conditions. Evaluate patients 4 to 6 weeks after insertion and then yearly or more often if clinically indicated.
For important information about Skyla, please see the Full Prescribing Information.