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 1/14
Intro: Getting to know the non-reloadable Skyla inserter 2/14
Intro: Getting to know the non-reloadable Skyla inserter 3/14
Intro: Timing of Insertion 4/14
Intro: Timing of Insertion 5/14
Intro: Timing of Insertion 6/14
Intro: Timing of Insertion 7/14
Intro: Timing of Insertion 8/14
Intro: Timing of Insertion 9/14
Intro: Timing of Insertion 10/14
Intro: Tools for Insertion 11/14
Intro: Preparation for Insertion 12/14
Intro: Preparation for Insertion 13/14
Intro: Getting to know the non-reloadable Skyla inserter 14/14
Step 1: Opening of 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: Release Skyla and withdraw the inserter 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 rate declines progressively to approximately 6 mcg/day after 1 year and to 5 mcg/day after 3 years. The average in vivo release rate of LNG is approximately 8 mcg/day over the first year of use and 6 mcg/day over the 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 can be physically distinguished from other intrauterine systems (IUSs) by the combination of the visibility of the silver ring on ultrasound and the brown color of the removal threads.

    Skyla is supplied in a sterile package within an inserter that enables single-handed loading. Do not open the package 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.

  • Insertion Instructions

    1. Obtain a complete medical and social history 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.
    2. 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.
    3. Check expiration date of Skyla prior to initiating insertion.
    4. Skyla should be inserted by a trained healthcare provider. Healthcare providers should become thoroughly familiar with the insertion instructions before attempting insertion of Skyla.
    5. Insertion may be associated with some pain and/or bleeding or vasovagal reactions (for example, syncope, bradycardia) or with seizure, especially in patients with a predisposition to these conditions. Consider administering analgesics prior to insertion.
  • Starting Skyla in women not currently using
    hormonal or intrauterine contraception

    1. Skyla can be inserted any time the provider can be reasonably certain the woman is not pregnant. Consider the possibility of ovulation and conception prior to initiation of this product
    2. If Skyla is inserted during the first seven days of the menstrual cycle or immediately after a first trimester abortion, back up contraception is not needed.
    3. If Skyla is not inserted during the first seven days of the menstrual cycle, a barrier method of contraception should be used or the patient should abstain from vaginal intercourse for seven days to prevent pregnancy.
  • Switching to Skyla from an oral, transdermal or vaginal hormonal contraceptive

    1. Skyla may be inserted at any time, including during the hormone-free interval of the previous method.
    2. If inserted during active use of the previous method, continue that method for 7 days after Skyla insertion or until the end of the current treatment cycle.
    3. If the woman was using continuous hormonal contraception, discontinue that method seven days after Skyla insertion.
  • Switching to Skyla from an injectable progestin contraceptive

    1. Skyla may be inserted at any time; a back-up method of contraception (such as condoms or spermicide) should also be used for 7 days if Skyla is inserted more than 3 months (13 weeks) after the last injection.
  • Switching to Skyla from a contraceptive implant or another IUS

    1. Insert Skyla on the same day the implant or IUS is removed.
    2. Skyla may be inserted at any time during the menstrual cycle.
  • Inserting Skyla after abortion or miscarriage: First Trimester

    1. Skyla may be inserted immediately after a first-trimester abortion or miscarriage.
  • Inserting Skyla after abortion or miscarriage:
    Second Trimester

    1. Do not insert Skyla until a minimum of 6 weeks after second trimester abortion or miscarriage, or until the uterus is fully involuted. If involution is delayed, wait until involution is complete before insertion
    2. If the woman has not yet had a period, consider the possibility of ovulation and conception occurring prior to insertion of Skyla. Skyla can be inserted any time the provider can be reasonably certain the woman is not pregnant.
    3. If Skyla is not inserted during the first 7 days of the menstrual cycle, a back-up method of contraception should be used or the patient should abstain from vaginal intercourse for 7 days to prevent pregnancy.
  • Inserting Skyla after Childbirth

    1. Do not insert Skyla until a minimum of 6 weeks after delivery, or until the uterus is fully involuted. If involution is delayed, wait until involution is complete before insertion.
    2. If the woman has not yet had a period, consider the possibility of ovulation and conception occurring prior to insertion of Skyla. Skyla can be inserted any time the provider can be reasonably certain the woman is not pregnant.
    3. If Skyla is not inserted during the first 7 days of the menstrual cycle, a back-up method of contraception should be used or the patient should abstain from vaginal intercourse for 7 days to prevent pregnancy.
    4. There is an increased risk of perforation in lactating women.
  • Tools for Insertion

    Preparation
    1. Gloves
    2. Speculum
    3. Sterile Uterine Sound
    4. Sterile Tenaculum
    5. Antiseptic solution, applicator
    Prodecure
    1. Sterile gloves
    2. Skyla with inserter in sealed
      package
    3. Instruments and anesthesia
      for paracervical block, if
      anticipated
    4. Consider having an
      unopened backup Skyla
      available
    5. Sterile, sharp curved scissors
  • Preparation for Insertion

    1. Exclude pregnancy and confirm that there are no other contraindications to the use of Skyla
    2. 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
  • Preparation for Insertion (cont.)
    1. With the patient comfortably in lithotomy position, do a bimanual exam to establish the size, shape and position of the uterus.
    2. Gently insert a speculum to visualize the cervix.
    3. Thoroughly cleanse the cervix and vagina with a suitable antiseptic solution.
    4. 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.
    5. 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.

    1. 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.
  • Insertion Procedure

    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 of the package

    1. Open the package. The contents of the package are sterile.
    2. Using sterile gloves, lift the handle of the sterile inserter and remove from the sterile package.
  • Step 2 - Load Skyla into the insertion tube

    1. 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.
    2. 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 re-loaded.

  • Step 3 - Setting the flange

    1. 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

    1. 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.
    2. Do not force the inserter. If necessary, dilate the cervical canal.
  • Step 5 - Open the arms

    1. 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

    1. 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

    1. Holding the entire inserter firmly in place, release Skyla by moving the slider all the way down.
    1. Continue to hold the slider all the way down while you slowly and gently withdraw the inserter from the uterus.
    1. 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.
    2. Skyla insertion is now complete. Prescribe analgesics, if indicated. Keep a copy of the Consent Form with lot number for your records.

    Important information to consider during or after insertion
    1. 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 reinsert a removed Skyla.
    2. If there is clinical concern, exceptional pain, or bleeding during or after insertion, take appropriate steps (such as physical examination and ultrasound) immediately to exclude perforation.
  • Patient Follow-up

    1. Reexamine and evaluate patients 4 to 6 weeks after insertion and once a year thereafter, or more frequently if clinically indicated.
  • Timing of Removal

    1. Skyla should not remain in the uterus after 3 years.
    2. If pregnancy is not desired, the removal should be carried out during the first 7 days of the menstrual cycle, provided the woman is experiencing regular menses. If removal will occur at other times during the cycle or the woman does not experience regular menses, she is at risk of pregnancy: start a new contraceptive method a week prior to removal for these women.

    Tools for Removal

    Preparation
    1. Gloves
    2. Speculum
    Procedure
    1. Sterile forceps
  • Removal Procedure
    1. Remove Skyla by applying gentle traction on the threads with forceps.
    2. If the threads are not visible, determine location of Skyla by ultrasound.
    3. 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, examine the system to ensure that it is intact.
    4. Removal may be associated with some pain and/or bleeding or vasovagal reactions (for example, syncope, bradycardia) or seizure, especially in patients with a predisposition to these conditions.
  • Continuation of Contraception after Removal

    1. 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.
    2. If a patient with regular cycles wants to start a different contraceptive method, time removal and initiation of the 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.
    3. If a patient with irregular cycles or amenorrhea wants to start a different contraceptive method, start the new method at least 7 days before removal.

INDICATION FOR SKYLA

Skyla® (levonorgestrel-releasing intrauterine system) 13.5mg is indicated for the prevention of pregnancy for up to 3 years. Replace the system 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. Promptly examine users with complaints of lower abdominal pain or pelvic pain, odorous discharge, unexplained bleeding, fever, genital lesions or sores. 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 streptococcoal 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, a new Skyla can be inserted any time the provider can be reasonably certain the woman is not pregnant.

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.

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