4.2.1 How to use Implanon
Pregnancy should be excluded before insertion of Implanon.Prior to inserting Implanon it is strongly recommended to carefully read the instructions for insertion and removal of the implant in section 4.2.2 How to insert Implanon and section 4.2.4 How to remove Implanon. Implanon is a long-acting contraceptive. One implant is inserted subdermally. The user should be informed that she can request the removal of Implanon at any time but the implant should not be left in place more than three years. Clinicians may consider earlier replacement of the implant in heavier women (see section 4.4.1). Only a physician who is familiar with the removal technique should perform, on request or at the end of the 3 years of use, the removal of Implanon. After the removal of the implant, immediate insertion of another implant will result in continued contraceptive protection.To ensure uncomplicated removal it is necessary that Implanon is inserted correctly, directly under the skin. The risk of complications is small if the provided instructions are followed. Some cases have been reported in which the implant was not inserted on the correct day, or was not properly inserted or not inserted at all. Incidentally, this has resulted in an unintended pregnancy. The occurrence of such incidents can be minimized when the instructions for insertion (section 4.2.2 How to insert Implanon and 4.2.3 When to insert Implanon) are strictly followed. The presence of the implant should be verified by palpation directly after insertion. In case the implant cannot be palpated or when the presence of the implant is doubtful, other methods must be applied to confirm its presence (see section 4.2.2 How to insert Implanon). Until the presence of Implanon has been verified a contraceptive barrier method must be used.It is strongly recommended that physicians, prior to practicing the insertion of Implanon, participate in training sessions by the company supplying Implanon. Physicians who have little experience with subdermal insertion are advised to acquire the correct technique under supervision of a more experienced colleague. Additional information and more detailed instructions concerning the insertion and removal of Implanon will be sent on request free of charge (Organon Laboratories Ltd, Telephone +44 (0)1223 432700).The Implanon package contains a USER CARD intended for the user, and an adhesive label intended for the physician's user record. Amongst others, the USER CARD records the batch number of the provided implant and helps to note the date of insertion, the arm of insertion, the name of the doctor and / or the hospital, and the intended day of removal. The adhesive label records the batch number and date of insertion.
4.2.2 How to insert Implanon
• Insertion of Implanon should be performed under aseptic conditions, and only by a physician who is familiar with the procedure.
• Insertion of Implanon is performed with the specially designed applicator. The use of this applicator differs substantially from that of a classical syringe. A drawing of a dismantled applicator and its individual components (e.g. cannula, obturator and needle with double-angled bevel) is shown in this leaflet to clarify their specific functions.
• The procedure used for insertion of Implanon is opposite to giving an injection
. When inserting Implanon the obturator
must remain fixed while the cannula
(needle) is retracted from the arm. For normal injections the plunger
is pushed and the body
of the syringe remains fixed.
• Allow the subject to lie on her back with her non-dominant arm (the arm which the woman does not use for writing) turned outwards and bent at the elbow.
• To minimize the risk of neural or vascular damage, Implanon should be inserted at the inner side of the non-dominant upper arm about 8-10 cm above the medial epicondyle of the humerus.
•Implanon should be inserted subdermally, i.e. just under the skin (subcutaneously).
•When Implanon is inserted too deeply (intramuscular or in the fascia) this may cause neural or vascular damage.Too deep insertions have been associated with paraesthesia (due to neural damage) and migration of the implant (due to intramuscular or fascial insertion), and in rare cases with intravascular insertion. Moreover, when the implant is inserted too deeply, it may not be palpable and the localization and/or removal can be difficult later on.
• Mark the insertion site.
• Clean the insertion site with a disinfectant.
• Anaesthetize with an anaesthetic spray, or with 2 ml of lidocaine (1%) applied just under the skin along the 'insertion canal'.
• Remove the sterile disposable applicator carrying Implanon from its blister.
• While keeping the shield on the needle, visually verify the presence of the implant, seen as a white body inside the needle-tip. If the implant is not seen, tap the top of the needle shield against a firm surface to bring the implant into the needle tip. Following visual confirmation, the implant should be lowered back into the needle by tapping it back into the needle tip. The needle shield can now be removed.
• Please note that the implant can fall out of the needle prior to insertion. Therefore, always hold the applicator in the upward position (i.e. with the needle pointed upwards) until the time of insertion. This is to prevent the implant from dropping out. Keep the needle and the implant sterile. If contamination occurs, a new package with a new sterile applicator must be used.
• Stretch the skin around the insertion site with thumb and index finger (Figure 1).
• Insert first only the tip of the needle, slightly angled (~ 20°) (Figure 2).
• Release the skin.
• Lower the applicator to a horizontal position (Figure 3).
• While lifting the skin, gently insert the needle to its full length. Do not exert force. The needle should be inserted parallel to the skin to ensure that Implanon is inserted superficially just under the skin (Figure 4)
• Keep the applicator parallel to the surface of the skin.
•When the implant is placed too deeply paresthesia and migration of the implant may occur. Moreover, removal can be difficult later on.
• Break the seal of the applicator (Figure 5).
• Turn the obturator 90° (Figure 6).
• Fix the obturator with one hand parallel to the arm and with the other hand slowly retract the canula (needle) out of the arm (Figure 7).
•Never push against the obturator.
• Check the needle for the absence of the implant. After retraction of the canula, the grooved tip of the obturator should be visible (Figure 8).
•Always verify the presence of the implant by palpation and also have the woman palpate it herself.
• In case the implant can not be palpated or when the presence of the implant is doubtful, other methods must be applied to confirm its presence. Suitable methods to locate the implant are first of all ultrasound (USS) and secondly magnetic resonance imaging (MRI). Prior to the application of USS or MRI for the localization of Implanon it is recommended to consult Organon for instructions. In case these imaging methods fail, it is advised to verify the presence of the implant by measuring the etonogestrel level in a blood sample of the subject. In this case Organon will also provide the appropriate procedure.
•Until the presence of Implanon has been confirmed a contraceptive barrier method must be used.
• Apply sterile gauze with a pressure bandage to prevent bruising.
• Fill out the User Card and hand it over to the subject to facilitate removal of the implant later on.
• The applicator is for single use only and must be adequately disposed of, in accordance with local regulations for the handling of biohazardous waste.
4.2.3 When to insert Implanon
No preceding hormonal contraceptive useImplanon should be inserted between Day 1-5, but at the latest on Day 5 of the woman's natural cycle (Day 1 is the first day of her menstrual bleeding).
Changing from a combined hormonal contraceptive (combined oral contraceptive (COC), vaginal ring, or transdermal patch)Implanon should be inserted preferably on the day after the last active tablet (the last tablet containing the active substances) of her previous COC or on the day of removal of the vaginal ring or transdermal patch, but at the latest on the day following the usual tablet-free, ring-free, patch-free or placebo tablet interval of her previous combined hormonal contraceptive. All contraceptive methods (transdermal patch, vaginal ring) may not be marketed in all EU countries.
Changing from a progestagen-only-method (minipill, injectable, a different implant, or from a progestagen-releasing intrauterine system [IUS])Implanon may be inserted any day when the woman is switching from a minipill, from another implant or an IUS on the day of its removal, from an injectable when the next injection would be due.
Following first-trimester abortionImplanon should be inserted immediately.
Following childbirth or a second-trimester abortionFor breastfeeding women see section 4.6 'Pregnancy and lactation'Implanon should be inserted on day 21-28 after delivery or second-trimester abortion. When the implant is inserted later, the woman should be advised to additionally use a barrier method on the first 7 days after the insertion. However, if intercourse has already occurred, pregnancy should be excluded or the woman's first natural period should be awaited before the actual insertion of the implant.
4.2.4 How to remove Implanon
• Removal of Implanon should only be performed by a physician who is familiar with the removal technique.
• The precise location of the implant is indicated on the USER CARD
• Locate the implant by palpation and mark the distal end (Figure a).
• A non-palpable implant should always first be localized by either ultrasound (USS) or magnetic resonance imaging (MRI) before removal is attempted and subsequently be removed under the guidance of USS. In case of doubt, the presence of Implanon can be verified by etonogestrel determination. Please contact Organon for further guidance. Exploratory surgery without knowledge of the exact localisation of the implant is strictly discouraged. Removal of deeply inserted implants should be conducted with caution in order to prevent damage to deeper neural or vascular structures in the arm and be performed by healthcare providers familiar with the anatomy of the arm.
• Wash the area and apply a disinfectant.
• Anaesthetize the arm with 0.5-1 ml lidocaine (1%) at the site of incision, which is just below the distal end of the implant. Note: Apply the anaesthetic under
the implant. Application above
the implant makes the skin swell, which may cause difficulties in locating the implant (Figure b).
• Push down the proximal tip to fix the implant; a bulge may appear indicating the distal end of the implant. Starting at the distal tip of the implant, make a longitudinal incision of 2 mm towards the elbow (Figure c)
• Gently push the implant towards the incision until the tip is visible. Grasp the implant with forceps (preferably 'mosquito' forceps) and remove it (Figure d).
• If the tip of the implant is not visible, there might be formation of fibrotic tissue around the implant. The fibrotic tissue can be split by continuing to cut towards the distal tip, until the tip is clearly visible. Remove the implant with a forceps (Figures e and f).
• If the tip of the implant is not visible, gently insert a forceps into the incision and grasp the implant (Figures g and h). With a second forceps carefully dissect the tissue around the implant. The implant can then be removed (Figure i).
• Close the incision with a butterfly closure.
• Apply sterile gauze with a pressure bandage to prevent bruising.
• There have been occasional reports of displacement of the implant (see also section 4.4.1 'Warnings'); usually this involves minor movement relative to the original position. This may complicate localisation of the implant by palpation, USS and/or MRI, and removal may require a larger incision and more time.
• If the woman would like to continue using Implanon, a new implant may be inserted immediately after the old implant is removed (see section 4.2.5 How to replace Implanon).
• If the woman does not wish to continue using Implanon and does not want to become pregnant, another contraceptive method should be recommended.
4.2.5 How to replace Implanon
• Replacement of Implanon should only be performed under aseptic conditions and only by a physician who is familiar with the insertion and removal procedure.
• Immediate replacement can be done after removal of the previous implant as described in section 4.2.4 'How to remove Implanon'.
• The procedure to replace Implanon is similar to the insertion procedure described in section 4.2.2 'How to insert Implanon'. The new implant can be inserted in the same arm, and often through the same incision from which the previous implant was removed. If the same incision is being used, the instructions below must also be taken into account.
• The small incision of the removal procedure can be used as the entrance for the needle of the new applicator.
• Anaesthetize the insertion site with 2 ml lidocaine (1%) applied just under the skin commencing at the removal incision along the 'insertion canal'.
• During replacement inserting the needle to its full length is crucial; failure to do so will result in a partly visible implant in the removal incision in the skin.
• Close the incision with a butterfly closure.
• Apply a sterile gauze with a pressure bandage to prevent bruising. Let the woman keep the bandage in place for at least 48 hours to allow the removal incision to heal.