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How to insert and remove IMPLANON®
INSTRUCTIONS FOR INSERTION AND REMOVAL
The basis for successful use and subsequent removal of IMPLANON® (etonogestrel implant) 68 mg is a correct and carefully performed subdermal insertion of the single rod implant in accordance with the instructions. If the implant is placed improperly leading to deep location or migration, it will be more difficult to remove than a correctly placed subdermal implant. All healthcare providers performing insertions and removals of IMPLANON® must receive instruction and training, and where appropriate, supervision prior to inserting or removing IMPLANON®.
Information concerning the insertion and removal of IMPLANON® will be sent upon request free of charge [Schering-Plough Corporation, telephone: 1-877-IMPLANON (1-877-467-5266)].
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INSERTION PROCEDURE
Prior to inserting IMPLANON® (etonogestrel implant)
68 mg carefully read the instructions for insertion and removal (see below) as well as the full Prescribing Information.
Place IMPLANON® subdermally. Both you and your patient should be able to feel IMPLANON® under her skin after placement.
Follow instructions carefully. All healthcare providers must receive training before inserting or removing IMPLANON®. Proper IMPLANON® insertion will facilitate removal. Correct timing of insertion is important. (See "When to insert IMPLANON®", in the Dosage and Administration section) . Perform a history and physical examination, including a gynecologic examination, before IMPLANON® insertion. Ensure that the patient understands the risks and benefits of IMPLANON® before insertion. Provide the patient with a copy of the Patient labeling included in packaging. Have the patient review and complete a consent form and maintain it with the patient's chart.
Exclude pregnancy before insertion.
Insert IMPLANON® under aseptic conditions.
The following equipment is needed for IMPLANON® insertion
- An examination table for the patient to lie on
- Sterile surgical drapes, talc-free sterile gloves, antiseptic solution, sterile marker (optional)
- Local anesthetic, needles, and syringe
- Sterile gauze, adhesive bandage, pressure bandage
An applicator and its parts are shown in the following diagrams (Figures 3a and 3b).
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The procedure used for IMPLANON® insertion is opposite from that of an injection. The obturator keeps IMPLANON® in place while the cannula is retracted. The obturator must remain fixed in place while the cannula with needle is retracted from the arm. Do not push the obturator.
1. Confirm that the patient does not have allergies to IMPLANON®, as well as the antiseptic and anesthetic to be used during insertion.
2. Have the patient lie on her back on the examination table with her non-dominant arm flexed at the elbow and externally rotated so that her wrist is parallel to her ear or her hand is positioned next to her head (Figure 4).
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3. Identify the insertion site, which is at the inner side of the non-dominant upper arm about 8-10 cm (3 to 4 inches) above the medial epicondyle of the humerus (Fig. 5). IMPLANON® should be inserted subdermally just under the skin to avoid the large blood vessels and nerves that lie deeper in the subcutaneous tissue of the sulcus between the biceps and triceps muscles.
4. Mark the insertion site with a sterile marker. Make two marks: first, mark the spot where the IMPLANON® rod will be inserted, and second, mark a spot a few centimeters proximal to the first mark (Figure 5). This second mark will later serve as a direction guide during IMPLANON® insertion.
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5. Clean the insertion site with an antiseptic solution.
6. Anesthetize the insertion area (for example, with anesthetic spray or by injecting 2 cc of 1% lidocaine just under the skin along the planned insertion tunnel).
7. Carefully remove the IMPLANON® applicator from its blister. Keep the shield on the needle and look for the IMPLANON® rod, seen as a white cylinder inside the needle tip.
8. If you don't see the IMPLANON® rod, tap the top of the needle shield against a firm surface to bring the implant into the needle tip.
9. Following visual confirmation, lower the IMPLANON® rod back into the needle by tapping it back into the needle tip. Then remove the needle shield, while holding the applicator upright.
10. Note that IMPLANON® can fall out of the needle. Therefore, after you remove the needle shield, keep the applicator in the upright position until the moment of insertion.
11. Keep the IMPLANON® needle and rod sterile. If contamination occurs, use a new package of IMPLANON® with a new sterile applicator.
12. Apply counter-traction to the skin around the proposed insertion (Figure 6).
13. At a slight angle (not greater than 20º), insert only the tip of the needle with the beveled side up into the insertion site (Figure 7).
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14. Lower the applicator to a horizontal position. Lift the skin up with the tip of the needle, but keep the needle in the subdermal connective tissue (Figure 8).
15. While "tenting" (lifting) the skin, gently insert the needle to its full length. Keep the needle parallel to the surface of the skin during insertion (Figure 9).
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16. If IMPLANON® is placed too deeply, the removal process can be difficult or impossible. If the needle is not inserted to its full length, the implant may protrude from the insertion site and fall out.
17. Break the seal of the applicator by pressing the obturator support (Figure 10).
18. Turn the obturator 90º in either direction with respect to the needle (Figure 11).
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19. While holding the obturator fixed in place on the arm, fully retract the cannula (Figure 12). Note: This procedure is opposite from an injection. Do not push the obturator. By holding the obturator fixed in place on the arm and fully retracting the cannula, IMPLANON® will be left in its correct subdermal position. Do not simultaneously retract the obturator and cannula from the patient's arm.
20. Confirm that IMPLANON® has been inserted by checking the tip of needle for the absence of IMPLANON®. After IMPLANON® insertion, the grooved tip of the obturator will be visible inside the needle (Figure 13).
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21. Always verify the presence of IMPLANON® in the patient's arm immediately after insertion by palpation. By palpating both ends of the implant, you should be able to confirm the presence of the 4 cm rod.
22. Place a small adhesive bandage over the insertion site. Request that the patient palpate IMPLANON®.
23. If you cannot feel IMPLANON® as a 4 cm long rod, confirm its presence using other methods. Suitable methods to locate IMPLANON™ are: ultrasound (US) with a high-frequency linear array transducer (10 MHz or greater) or magnetic resonance imaging (MRI). Please note that the IMPLANON® rod is not radio-opaque and cannot be seen by X-ray or CT scan. If ultrasound and MRI fail, call 1-877-IMPLANON (1-877-467-5266) for information on the procedure for measuring ENG blood levels. Until you confirm proper IMPLANON® insertion, your patient must use a non-hormonal contraceptive method.
24. Apply a pressure bandage with sterile gauze to minimize bruising. The patient may remove the pressure bandage in 24 hours and the small bandage over the insertion site in three to five days.
25. Complete the USER CARD and give it to the patient to keep. Also, complete the Patient Chart Label and affix it to the patient's medical record.
26. The applicator is for single use only. Dispose of the applicator in accordance with the Center for Disease Control and Prevention guidelines for handling of hazardous waste.
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REMOVAL PROCEDURE
Before initiating the removal procedure, the healthcare provider may consult the USER CARD that is kept by the patient and/or the Patient Chart Label. The arm in which IMPLANON® (etonogestrel implant) 68 mg is located should be indicated on the USER CARD and the Patient Chart Label. IMPLANON® should have been inserted in the medial aspect of the upper non-dominant arm. Prior to removing IMPLANON®, carefully read the instructions for removal. Find IMPLANON® by palpation. If IMPLANON® cannot be palpated, use either ultrasound with a high-frequency linear array transducer (10 MHz or greater) or magnetic resonance imaging to localize the implant. Consider conducting difficult removals with ultrasound guidance. Only remove a non-palpable implant once the location of IMPLANON® has been established. If these imaging methods fail, call 1-877-IMPLANON (1-877-467-5266) for further instructions.
There have been occasional reports of migration of the implant; usually this involves minor movement relative to the original position. This may complicate localization of the implant by palpation, ultrasound or magnetic resonance imaging, and removal may require a larger incision and more time.
Exploratory surgery without knowledge of the exact location of the implant is strongly 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.
The patient's position for removal is similar to the position for insertion. Use aseptic technique.
The following equipment is needed for removal
- An examination table for the patient to lie on
- Sterile surgical drapes, talc-free sterile gloves, antiseptic solution, sterile marker (optional)
- Local anesthetic, needles, and syringe
- Sterile scalpel, forceps (straight and curved mosquito)
- Skin closure, sterile gauze, adhesive bandage and pressure bandages
1. IMPLANON® must only be removed by a healthcare provider who has been instructed and trained in the IMPLANON® removal technique.
2. The arm in which IMPLANON® is located should be indicated on the USER CARD and the Patient Chart Label. IMPLANON® should be in the medial aspect of the upper non-dominant arm.
3. After confirming that the patient does not have any allergies to the antiseptic, wash the patient's arm and apply an antiseptic. Locate IMPLANON® by palpation and mark the end closest to the elbow, for example, with a sterile marker (Figure a).
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4. After determining the absence of allergies to the anesthetic agent or related drugs, anesthetize the arm, for example, with 0.5 to 1 cc 1% lidocaine at the site where the incision will be made (near the tip of IMPLANON® that is closest to the elbow) (Figure b). Be sure to inject the local anesthetic under IMPLANON® to keep the implant close to the skin surface.
5. Make a 2-3 mm incision in the longitudinal direction of the arm at the tip of the implant closest to the elbow (Figure c).
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6. Gently push IMPLANON® toward the incision until the tip is visible. Grasp the implant with forceps (preferably curved mosquito forceps) and pull it out gently (Figure d).
7. If IMPLANON® is encapsulated, make an incision into the tissue sheath and then remove IMPLANON® with the forceps (Figures e and f).
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8. If the tip of the implant is still not visible after gently pushing it towards the incision (as in step 6), gently insert a forceps into the incision and grasp the implant (Figures g and h). Turn the forceps around (Figure h).
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9. With a second forceps carefully dissect the tissue around IMPLANON® and then remove IMPLANON® (Figure i). Be sure to remove the IMPLANON® rod entirely. Confirm that the entire rod, which is 4 cm long, has been removed by measuring its length.
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If the patient would like to continue using IMPLANON®, insert a new IMPLANON® rod immediately after the old IMPLANON® rod is removed. The new IMPLANON® can be inserted in the same arm, and through the same incision, or a new IMPLANON® can be inserted in the other arm.
If the patient does not wish to continue using IMPLANON® and does not want to become pregnant, recommend another contraceptive method.
10. After removing IMPLANON®, close the incision with a butterfly closure and apply an adhesive bandage.
11. Apply a pressure bandage with sterile gauze to minimize bruising.
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Indication
IMPLANON® (etonogestrel implant) is indicated for women for the prevention of pregnancy.
IMPLANON® must be removed by the end of the third year and may be replaced by a new IMPLANON® at the time of removal, if continued contraceptive protection is desired.
Important Safety Information
Women should be informed that this product does not protect against infection from HIV (the virus that causes AIDS) or other sexually transmitted diseases.
Serious consequences may be associated with the insertion and removal of IMPLANON®. IMPLANON® should be inserted subdermally so that it is palpable after insertion. Failure to insert IMPLANON® properly may go unnoticed unless the implant is palpated immediately after insertion. Deep insertions may lead to difficult or impossible removals. Failure to remove IMPLANON® may result in infertility, ectopic pregnancy, or inability to stop a drug-related adverse event. Undetected failure to insert IMPLANON® may lead to an unintended pregnancy.
In clinical trials, 1.0% of patients had complications at implant insertion and 1.7% had complications at implant removal. Deep insertions may result in the need for a surgical procedure in an operating room in order to remove IMPLANON®. When IMPLANON® is inserted too deeply, this may cause neural or vascular damage. Too deep insertions have been associated with paraesthesia and migration of the implant and, in rare cases, with intravascular insertion. In postmarketing use, there have been cases of failure to localize and remove the implant, probably due to deep insertion. All healthcare providers performing insertions and/or removals of IMPLANON® must receive instruction and training and, where appropriate, supervision prior to inserting or removing IMPLANON®.
IMPLANON® should not be used in women who have the following conditions: known or suspected pregnancy, current or past history of thrombosis or thromboembolic disorders, hepatic tumors (benign or malignant), active liver disease, undiagnosed abnormal genital bleeding, known or suspected carcinoma of the breast (or a personal history of breast cancer), or hypersensitivity to any of the components of IMPLANON®.
Pregnancy must be excluded before inserting IMPLANON®.
The use of IMPLANON® and other progestin-only hormonal contraceptives have been associated with ectopic pregnancy, bleeding irregularities, and ovarian cysts. The use of hormonal contraceptives is associated with increased risks of several serious cardiovascular conditions including myocardial infarction, stroke, venous thromboembolism, deep venous thrombosis, retinal vein thrombosis, and pulmonary embolism. There have been postmarketing reports of serious thromboembolic events, including cases of pulmonary emboli (some fatal) and strokes, in patients using IMPLANON®. IMPLANON® should be removed in the event of a thrombosis. Consider removal of IMPLANON® in case of long-term immobilization due to surgery or illness. Women with a history of thromboembolic disorders should be made aware of the possibility of a recurrence.
Cigarette smoking increases the risk of serious cardiovascular side effects from the use of hormonal contraceptives. This risk increases with age (women over 35 years of age) and with heavy smoking. Women who use hormonal contraceptives should be advised not to smoke.
In clinical trials including 942 patients, bleeding irregularities (11%) were the most common adverse event causing discontinuation of IMPLANON®. Adverse events reported in >5% of subjects include headache, vaginitis, weight increase, acne, breast pain, upper respiratory tract infection, abdominal pain, pharyngitis, leukorrhea, influenza-like symptoms, dizziness, dysmenorrhea, back pain, emotional lability, nausea, pain, nervousness, sinusitis, depression, and insertion site pain.
Please see full Prescribing Information.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
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