For subdermal use.
Levonorgestrel (Levoplant) is a contraceptive method for three years of use. Once the implants are inserted they may be removed at the request of the user at any time.
Method of Administration: Instructions for insertion and removal of the implants: One Levonorgestrel (Levoplant) pouch contains two sterile rods. Only health care providers trained in both insertion and removal should perform these procedures. Aseptic technique must be followed during implant insertion and removal to prevent infection. Contaminated waste must be properly disposed of and instruments and other items should be decontaminated, thoroughly cleaned, and sterilized by autoclaving or dry heat, or high-level disinfected.
Preparation for implant insertion: The following sterile instruments and supplies are needed for insertion of implants: sterile dry surgical drape; a sterile tray for the equipment; a bowl for the antiseptic soaked cotton balls; sterile pair of surgical gloves (free of talc); a 3-5 mL syringe and a 5-5.5 cm long needle (22-gauge); filter needle (if local anesthetic is supplied in glass ampule); a scalpel with blade; tweezers; a skin closure or adhesive bandage or gauze with surgical tape; gauze and compresses and set of two rods in sterile pouch.
The following non-sterile supplies are recommended for insertion of implants: examining table for the patient to lie on; soap for washing the arm; ballpoint pen or marker; antiseptic solution for the skin and 2 mL local anesthetic.
Getting ready for insertion procedure: Explain the procedure to the client and encourage questions.
Determine that required sterile or high-level disinfected instruments and implants are present.
Wash hands thoroughly and dry them.
Check to be sure that the client has thoroughly washed and rinsed her entire arm.
Position the woman's arm and place a clean, dry cloth under her arm.
Mark position on arm for insertion of rods 6 cm to 8 cm from the elbow fold (this should form a "V" pattern).
Put on a sterile pair of hand gloves.
Pre-insertion tasks: Set up sterile field and place implant rods and trocar on it.
Prep insertion site with antiseptic solution.
Place a sterile or high-level disinfected drape over the arm.
Inject 2 mL of local anesthetic applied just under the skin, raising a wheal at the insertion point and advancing up to 5 cm along the first insertion track, injecting 1 mL of local anesthetic along the track as needle is withdrawn. Without completely removing the needle, reorient to the second insertion track, advance up to 5 cm, and again inject 1 mL of local anesthetic along track as needle is withdrawn. Let the arm rest for approximately 5 minutes and check for anesthetic effect before making skin incision.
Step by step implant insertion instructions: Step 1: Make a small incision with a scalpel in the skin on the inside of the upper arm. Alternatively, use the trocar to puncture the skin. Insert the tip of the trocar beneath the skin at a shallow angle. Gently advance the trocar superficially under the skin with the bevel facing up while tenting the skin. Tenting of the skin enables the implant to be placed under the skin and not deeper into the arm.
The rod should be placed parallel to the skin. Take great care not to insert trocar into the arm muscle. Note: The trocar has two marks on it. The mark closest to the hub indicates how far the trocar should be introduced under the skin to place the implants. The mark closest to the tip indicates how much of the trocar should remain under the skin following placement of the first implant.
Step 2: When the trocar has been inserted to the mark closest to the hub, remove the obturator and load the first implant into the trocar, using thumb and forefinger.
Step 3: Using the obturator to push, gently advance the implant towards the tip of the trocar until resistance is felt. Never force the obturator.
Step 4: Holding the obturator stationary, withdraw the trocar to the mark closest to the trocar tip. The implant should be released under the skin at this point. It is important to keep the obturator stationary and to avoid pushing the implant into the tissue. Do not completely remove the trocar until both implants have been placed.
Step 5: To place the second implant, align the trocar so that the second implant will be positioned at about a 30° angle relative to the first implant. Repeat steps 3-4. The rods are placed in the shape of a V opening toward the shoulder. Leave a distance of about 5 mm between the incision and the tips of the implants. Remove the trocar and immediately dispose of it in a sharps container.
Post-insertion tasks: Remove drape and wipe the client's skin with alcohol.
Bring edges of incision together and close it using surgical tape, then cover it with tape on a sterile gauze (2x2) or an adhesive bandage.
Instruct client regarding wound care: Keep the area around the insertion site dry and clean for at least 48 hours.
Leave the gauze pressure bandage in place for 48 hours and the surgical tape or adhesive bandage in place until the incision heals (normally 3-5 days).
Apply pressure dressing snugly.
Discuss with the client what to do if she experiences any problems following insertion or side effects from the implant.
Advise client that she can have the rods removed at any time if she desires.
Make a return visit appointment, if necessary.
Observe the client for at least 15-20 minutes before discharging.
Timing of insertion: Implants may be inserted at any time during the menstrual cycle when it is reasonably certain that the client is not pregnant or at risk of being pregnant.
Note on backup methods of contraception: Extra "backup" contraceptive precautions should be advised in many circumstances, as outlined as follows. These should be described to the patient as including barrier methods (e.g. condoms) and refraining from sex altogether. The patient should be advised that the "rhythm" or "temperature" methods are not adequate for backup. (Changes in body temperature and cervical mucus that normally take place during the menstrual cycle may not occur during the use of Levonorgestrel (Levoplant) implants.)
No contraceptive use: If the woman has been using no contraception, advise her to use a backup method or refrain from sexual intercourse for 7 days after insertion.
If insertion is done within 7 days of the start of the woman's usual monthly bleeding, there is no need for a backup method. If insertion is done more than 7 days after the start of the woman's usual monthly bleeding, a backup method should be used for the first 7 days following insertion.
If the woman is switching from an IUD, she can have implants inserted immediately.
Switching from a hormonal method: If the woman has been using a hormonal method consistently and correctly, or if it is otherwise reasonably certain that she is not pregnant, the implant may be inserted immediately. There is no need to wait for the next monthly bleeding. No backup method is needed.
If switching from injectables, the woman can have the implant inserted on the date when the repeat injection would have been given. There is no need for a backup method.
Switching from copper or Levonorgestrel IUD: If the woman is currently in her first 7 days of monthly bleeding, insert the implant now and remove the IUD. There is no need for a backup method.
If the implant is desired 7 days or more after the end of her last monthly bleeding and she has had intercourse since the last monthly bleeding, it may be inserted at once. The IUD should be left in place until after her next monthly bleeding.
If the implant is desired 7 days or more after the end of her last monthly bleeding, and she has not had intercourse since the last monthly bleeding, the IUD can stay in place and be removed during her next monthly bleeding, or the IUD can be removed and she can use a backup method for the next 7 days.
Breastfeeding: If the woman's monthly bleeding has not returned, she can have implants inserted any time between giving birth and 6 months, with no need for a backup method.
If the woman's monthly bleeding has returned, she can have implants inserted as advised for women having menstrual cycles.
No monthly bleeding (not related to childbirth or breastfeeding): She can have implants inserted any time it is reasonably certain she is not pregnant. She will need a backup method for the first 7 days after insertion.
After miscarriage or abortion: Immediately: If implants are inserted within 7 days after first- or second-trimester miscarriage or abortion, there is no need for a backup method.
If it is more than 7 days after first or second trimester miscarriage or abortion: she can have implants inserted any time it is reasonably certain she is not pregnant. She will need a backup method for the first 7 days after insertion.
After taking emergency contraceptive pills (ECPs): Implants can be inserted within 7 days after the start of her next monthly bleeding, or any other time it is reasonably certain she is not pregnant. Give her a backup method, or oral contraceptives to start the day after she finishes taking the ECPs, to use until the implants are inserted.
Implant Removal: Levonorgestrel (Levoplant) should be removed after 3 years of use.
The implants can be removed, for personal or medical reasons, at the request of the client at any time. The implants should be removed by the end of the third year. Removal of implants can be done at any time in the menstrual cycle.
Preparation for implant removal: The following items are needed for removal: examining table for the woman to lie on; soap for washing the arm; ballpoint pen or marker; sterile dry surgical drape; a bowl for the antiseptic solution; pair of sterile surgical gloves; antiseptic solution for the skin; 2 mL local anesthetic; a sterile tray for the equipment; a sterile 3-5 mL syringe and a 2.5-4 cm long needle (22-gauge); scalpel with #11 blade; 1 curved and 1 straight Crile or Kelly forceps; 1 tissue forceps (optional) and a skin closure or adhesive bandage or sterile gauze with surgical tape.
Removal procedure: Getting ready for removal procedure: Determine that required sterile or high-level disinfected instruments are present.
Check that the client has thoroughly washed and rinsed her arm.
Explain the procedure to the client and encourage questions.
Position the woman's arm and place a clean, dry cloth under her arm.
Palpate the rods to determine point of removal.
Mark position on arm where the tip of the rods is palpated.
Pre-removal tasks: Wash hands thoroughly and dry clean them.
Put on a sterile pair of hand gloves.
Arrange instruments and supplies.
Prep removal site with antiseptic solution twice.
Place a sterile or high-level disinfected drape over the arm.
Inject 1 mL of local anesthetic applied at the incision site and under the end of the rods.
Check for anesthetic effect before making skin incision.
Step by Step implant removal instructions: Step 1: Before starting the removal, the implants must be located by palpation with ungloved fingers and the position of each rod marked. To help view the proximal tip near the insertion incision (bottom of the V), push down on the distal end of the implant. After cleaning the skin with an antiseptic, a small amount of local anesthetic is infiltrated under the implant ends. Anesthetic injected over the implants may obscure their position and make removal more difficult.
Step 2: A small skin incision of 2-4 mm is made close to the ends of the implants (below the bottom of the V). Do not make a large incision.
Step 3: Push each implant gently with fingers towards the incision. When the tip is visible in the incision, grasp it with the straight Crile/Kelly forceps and gently pull out the rod without twisting or pulling on the rod, as this may lead to rod breakage.
If the tip of the implant does not become visible in the incision, gently insert the curved Crile/Kelly forceps into the incision, trying to grasp the implant. Flip the forceps over with the other hand and with the scalpel, carefully dissect the tissue around the implant to expose it and then grasp the implant with the straight Crile/Kelly forceps. The implant can then be removed, being careful to avoid a twisting or pulling motion.
If the implant is encapsulated, grasp and stabilize the exposed rod with the curved Crile/Kelly forceps. Use the scalpel to very gently make a small incision into the tissue sheath to expose the tip of the rod. Use the tip of the scalpel to gently separate the encapsulated tissue from the rod, moving distally, keeping light but steady traction on the rod until the rod is completely freed from the tissue.
After the procedure is completed, close the incision and bandage it as after insertion.
The arm should be kept dry for 24-28 hours.
Note: Mosquito forceps can be used if Crile/Kelly forceps are not available; however, use of Crile/Kelly forceps has been shown to minimize damage to the implants during removal.
The implants should be removed very gently. This will take more time than the insertion. The implants may be nicked, cut or broken during removal. If removal proves difficult or both implants cannot be removed, the patient should be asked to return for a second visit after the removal area has healed. A non-hormonal method of contraception should be used until both implants have been completely removed. If the patient wishes to continue using the method, a new set of Levonorgestrel (Levoplant) may be inserted through the same incision, either in the same or in the opposite direction. Loss of contraceptive effect occurs practically immediately after removal, and another contraceptive method should be applied unless pregnancy is desired. Following removal, pregnancy may occur at any time.
Levonorgestrel (Levoplant) is different from other contraceptive methods. It must be inserted and removed by a health care provider familiar with the minor surgical procedure.
Before inserting the implants, the health care provider will: ask about the medical history, perform a physical examination, and make sure that the patient is not pregnant.
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