Selected Safety Information
- Complications related to insertion and removal procedures, such as pain, paresthesias, bleeding, hematoma, scarring, or infection, may occur. If NEXPLANON is inserted too deeply (intramuscular or in the fascia), neural or vascular injury may occur. Implant removal may be difficult or impossible if the implant is not inserted correctly, inserted too deeply, not palpable, encased in fibrous tissue, or has migrated. Deep insertions may lead to difficult localization of the implant and may also result in the need for a surgical procedure in an operating room in order to remove the implant.
Insertion of NEXPLANON
The basis for successful use and subsequent removal of NEXPLANON is a correct and carefully performed subdermal insertion of the single, rod-shaped implant in accordance with the instructions. Both the health care provider and the woman should be able to feel the implant under the skin after placement.
All health care providers performing insertions and/or removals of NEXPLANON should receive instructions and training prior to inserting or removing the implant. Information concerning the insertion and removal of NEXPLANON will be sent upon request free of charge [1-877-467-5266].
Preparation
Preparation
Before insertion of NEXPLANON, the health care provider should confirm that:
The woman is not pregnant nor has any other contraindication for the use of NEXPLANON (see Contraindications)
The woman has had a medical history and physical examination including a gynecologic examination, performed
The woman understands the benefits and risks of NEXPLANON
The woman has received a copy of the Patient Labeling included in packaging
The woman has reviewed and completed a consent form to be maintained with the woman’s chart
The woman does not have allergies to the antiseptic and anesthetic to be used during insertion
Equipment needed
The following equipment is needed for the implant insertion:
An examination table for the woman to lie on
Sterile surgical drapes, sterile gloves, antiseptic solution, sterile marker (optional)
Local anesthetic, needles, and syringe
Sterile gauze, adhesive bandage, pressure bandage
Insertion procedure
Step 1.
Have the woman 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 1).Step 2.
Step 3.
Make two marks with a sterile marker: first, mark the spot where the etonogestrel implant will be inserted, and second, mark a spot a few centimeters proximal to the first mark (Figure 2). This second mark will later serve as a direction guide during insertion.Step 4.
Step 5.
Step 6.
Step 7.
Hold the applicator just above the needle at the textured surface area. Remove the transparent protection cap by sliding it horizontally in the direction of the arrow away from the needle (Figure 3). If the cap does not come off easily, the applicator should not be used. You can see the white colored implant by looking into the tip of the needle. Do not touch the purple slider until you have fully inserted the needle subdermally, as it will retract the needle and prematurely release the implant from the applicator.Step 8.
With your free hand stretch the skin around the insertion site with thumb and index finger (Figure 4).Step 9.
Puncture skin with the tip of the needle angled about 30° (Figure 5).Step 10.
Lower the applicator to a horizontal position. While lifting the skin with the tip of the needle (Figure 6), slide the needle to its full length. You may feel slight resistance but do not exert excessive force. If the needle is not inserted to its full length, the implant will not be inserted properly.
You can best see movement of the needle if you are seated and are looking at the applicator from the side and NOT from above. In this position, you can clearly see the insertion site and the movement of the needle just under the skin.
Step 11.
Keep the applicator in the same position with the needle inserted to its full length. If needed, you may use your free hand to keep the applicator in the same position during the following procedure. Unblock the purple slider by pushing it slightly down. Move the slider fully back until it stops (Figure 7). The implant is now in its final subdermal position, and the needle is locked inside the body of the applicator. The applicator can now be removed. If the applicator is not kept in the same position during this procedure or if the purple slider is not completely moved to the back, the implant will not be inserted properly.Step 12.
Always verify the presence of the implant in the woman’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 (Figure 8).
If you cannot feel the implant or are in doubt of its presence,
Check the applicator. The needle should be fully retracted and only the purple tip of the obturator should be visible.
Use other methods to confirm the presence of the implant. Suitable methods are: two-dimensional x-ray, x-ray computerized tomography (CT scan), ultrasound scanning (USS) with a high-frequency linear array transducer (10 MHz or greater) or magnetic resonance imaging (MRI). If these methods fail, call 1-877-467-5266 for information on the procedure for measuring etonogestrel blood levels.
Step 13.
Step 14.
Step 15.
Step 16.
Selected Safety Information
About NEXPLANON (etonogestrel implant) 68 mg (continued)
- After starting NEXPLANON, women are likely to have changes in their menstrual bleeding pattern. These may include changes in frequency, intensity, or duration. Abnormal bleeding should be evaluated as needed to exclude pathologic conditions or pregnancy. In clinical studies of the non-radiopaque etonogestrel implant, reports of changes in bleeding pattern were the most common reason for stopping treatment (11.1%). Women should be counseled regarding bleeding pattern changes that they may experience.
- Be alert to the possibility of an ectopic pregnancy in women using NEXPLANON who become pregnant or complain of lower abdominal pain.
- The use of combination hormonal contraceptives increases the risk of vascular events, including arterial events (strokes and myocardial infarctions) or deep venous thrombotic events (venous thromboembolism, deep venous thrombosis, retinal vein thrombosis, and pulmonary embolism). It is recommended that women with risk factors known to increase the risk of venous and arterial thromboembolism be carefully assessed. There have been postmarketing reports of serious arterial and venous thromboembolic events, including cases of pulmonary emboli (some fatal), deep vein thrombosis, myocardial infarction, and strokes, in women using the non-radiopaque etonogestrel implant. NEXPLANON should be removed in the event of a thrombosis. Due to the risk of thromboembolism associated with pregnancy and immediately following delivery, NEXPLANON should not be used prior to 21 days postpartum. Women with a history of thromboembolic disorders should be made aware of the possibility of a recurrence. Consider removal of the NEXPLANON implant in case of long-term immobilization due to surgery or illness.
