Recommended
More Related Content
Similar to Implant Insertion and Removal Procedures
Similar to Implant Insertion and Removal Procedures (20)
Recently uploaded
Recently uploaded (20)
Implant Insertion and Removal Procedures
- 2. Materials for Insertion • Sterile surgical drapes • Sterile gloves • Antiseptic solution • Surgical marker • Local anesthetic • Needles and syringe • Sterile gauze • Adhesive bandage • Pressure bandage The following equipment is needed for insertion:
- 3. Patient Insertion Position View applicator from the side and not from above the arm. Non-dominant arm flexed, hand underneath head. This position deflects ulnar nerve away from insertion site.
- 4. Insertion Step 1. Position and mark
- 5. Insertion Step 2. Clean and anesthetize (with epi recommended) Step 3. Open blister pack and remove cap - should see implant by looking into tip of needle (DO NOT touch slider) Step 4. Stretch skin toward elbow If the purple slider is released prematurely, restart the procedure with a new applicator
- 6. Insertion Step 5. Viewing from the side puncture the skin – bevel in only Step 6. Lower the applicator, lift the skin, slide needle in fully Readjust as needed Insert bevel on an angle Lower angle & lift skin Slide in – all the way
- 7. Insertion Step 7. Without moving applicator, move the slider fully back until it stops. Step 8. Bandage, verify position and have pt. palpate Step 9. Apply small bandage then pressure bandage over it
- 8. Insertion If applicator is moved during insertion or if purple slider is not moved fully back, implant may protrude from insertion site If implant is protruding, remove and perform new procedure at same insertion site using a new applicator Do not push protruding implant back into incision
- 9. Post-insertion Steps May remove: Pressure bandage in 24 hours Small adhesive bandage over insertion site after 3 to 5 days Complete Patient Alert Card and give to woman to keep Complete adhesive label and affix to woman’s medical record (and/or record batch number if electronic medical record)
- 10. If Implant is Not Palpable After Insertion May not have been inserted or inserted too deeply: Check applicator: Needle should be fully retracted and only purple tip of the obturator should be visible Use other methods to confirm the presence of implant. X-ray, CT scan, Ultrasound, MRI
- 11. Radiopaque Implant X-ray Localization Mansour D et al. Contraception 2010;82:243–9. Adapted with permission.
- 12. If Imaging Methods Fail to Locate the Implant Until presence of implant verified non-hormonal contraceptive method must be used Deeply-placed implants removed ASAP to avoid distant migration Serum etonogestrel assay can be requested to confirm presence of etonogestrel subdermal implant Contact Merck Canada for further guidance
- 13. Most Frequent Clinician-reported Events at Insertion (N=7364) * *Number of insertions; †26 (60%) were reported by a single clinician CI, confidence interval Reed S et al. Contraception 2019;100:31-6. 13 Insertion event Number* % incidence 95% CI Incorrect insertion 93 1.3 1.0–1.6 Deep insertion 65† 0.9 0.7–1.1 Partial insertion 27 0.4 0.2–0.5 Non-insertion 1 0.01 0.0–0.08 Insertion-related challenge Difficulty removing protection cap 93 1.3 1.0–1.5 Difficulty sliding needle to full length in skin 30 0.4 0.3–0.6 Difficulty handling the device/visualization 17 0.2 0.1–0.4 Real-world Evidence: Nexplanon Observational Risk Assessment (NORA) Study
- 14. • Sterile surgical drapes • Sterile gloves • Antiseptic solution • Surgical marker • Local anesthetic • Needles and syringe • Sterile scalpel • Forceps (straight and curved mosquito) • Sterile adhesive wound closure • Sterile gauze • Pressure bandage Removal The following equipment is needed for the implant removal:
- 15. Removal Step 1. Locate the implant and push down, mark the distal end Step 2. Clean, anesthetize (inject under implant!) Step 3. Push down, make parallel incision
- 16. Removal Step 4. Implant should pop through incision, grasp the implant with forceps, remove and confirm length Step 5. Dissect if needed Step 6. Insert new Nexplanon in same incision prn Step 7. Sterile adhesive wound closure and pressure bandage
- 17. After Removing the Implant Remove: Pressure bandage after 24 hours Sterile adhesive wound closure after 3 to 5 days Restart contraception immediately
- 18. Possible Factors Complicating Removal Implant not inserted correctly Implant inserted too deeply Implant not palpable Implant encased in fibrous tissue Implant has migrated
- 19. Removal of a Non-Palpable Implant Localization and removal of non-palpable implants is recommended ASAP Exploratory surgery is strongly discouraged Once localized, implant should be removed by HCP experienced in removing deeply placed implants, consider ultrasound guidance If not found consider radiographic examination of chest
Editor's Notes
- Explain that etonogestrel subdermal implant should be inserted under aseptic conditions. Display slide and review the materials needed for insertion of etonogestrel subdermal implant. An examination table for the woman to lie on Sterile surgical drapes Sterile gloves Antiseptic solution Surgical marker Local anesthetic Needles and syringe Sterile gauze Adhesive bandage Pressure bandage
- Position Woman Prior to Insertion To help make sure the implant is inserted just under the skin, the healthcare providers should be positioned to see the advancement of the needle by viewing the applicator from the side and not from above the arm. From the side view, the insertion site and the movement of the needle just under the skin can be clearly visualized. 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 hand is underneath her head (or as close as possible). Please note that for illustrative purposes, Figure depicts the left inner arm.
- Display slide with images of insertion site: Emphasize: Before inserting the etonogestrel subdermal implant (etonogestrel implant) implant, identify the insertion site, which is at the inner side of the non-dominant upper arm. The insertion site is overlying the triceps muscle about 8-10 cm (3-4 inches) from the medial epicondyle of the humerus and 3-5 cm (1.25-2 inches) posterior to the sulcus (groove) between the biceps and triceps muscles. This location is intended to avoid the large blood vessels and nerves lying within and surrounding the sulcus. If it is not possible to insert the implant in this location (eg, in women with thin arms), it should be inserted as far posterior from the sulcus as possible. 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 hand is underneath her head (or as close as possible) Display slide on marking insertion site: Emphasize: Mark the insertion site with a surgical marker. Make two marks: First, mark the spot where the etonogestrel subdermal implant will be inserted Second, mark a spot at 5 centimeters (2 inches) proximal (toward the shoulder) to the first mark as a guiding mark After marking the arm, confirm the site is in the correct location on the inner side of the arm
- Mention backups that you can get from Merck rep– they will give 2 Clean the skin from the insertion site to the guiding mark with an antiseptic solution Anesthetize the insertion area (for example, with anesthetic spray or by injecting 2 mL of 1% lidocaine just under the skin along the planned insertion tunnel) Explain steps of insertion procedure: Remove the sterile preloaded disposable etonogestrel subdermal implant applicator carrying the implant from its blister The applicator should not be used if sterility is in question Hold the applicator just above the needle at the textured surface area and remove the transparent protection cap by sliding it horizontally in the direction of the arrow away from the needle If the cap does not come off easily, the applicator should not be used You should see the white colored implant by looking into the tip of the needle Emphasize: Do not touch the purple slider until you have fully inserted the needle subdermally, as doing so will retract the needle and prematurely release the implant from the applicator If the purple slider is released prematurely, restart the procedure with a new applicator Emphasize: To help make sure the implant is inserted just under the skin, you should position yourself to see the advancement of the needle by viewing the applicator from the side and not from above the arm. From the side view, you can clearly see the insertion site and the movement of the needle just under the skin Describe next steps: With your free hand, stretch the skin around the insertion site towards the elbow
- Emphasize that the needle should be inserted until the bevel (slanted opening of the tip) is just under the skin (and no further). If you insert the needle past the bevel, withdraw it until only the bevel is beneath the skin. Describe next steps: Lower the applicator to a nearly horizontal position. To facilitate subdermal placement, lift the skin with the needle while sliding the needle to its full length. You may feel slight resistance but do not exert excessive force. Emphasize that if the needle is not inserted to its full length, the implant will not be inserted properly. If the needle tip emerges from the skin before needle insertion is complete, the needle should be pulled back and be readjusted to subdermal position before completing the insertion procedure. Emphasize that the needle should be inserted until the bevel (slanted opening of the tip) is just under the skin (and no further). If you insert the needle past the bevel, withdraw it until only the bevel is beneath the skin. Describe next steps: Lower the applicator to a nearly horizontal position. To facilitate subdermal placement, lift the skin with the needle while sliding the needle to its full length. You may feel slight resistance but do not exert excessive force. Emphasize that if the needle is not inserted to its full length, the implant will not be inserted properly. If the needle tip emerges from the skin before needle insertion is complete, the needle should be pulled back and be readjusted to subdermal position before completing the insertion procedure.
- Display slide which describes the final steps of the insertion process. Emphasize: Keep the applicator in the same position with the needle inserted to its full length. If needed, you may use your free hand to stabilize the applicator. Describe next steps: Unlock the purple slider by pushing it slightly down Move the slider fully back until it stops Emphasize: Do not move the applicator while moving the purple slider 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 Verify the Presence of the Implant Apply a small adhesive bandage over the insertion site. Apply sterile gauze with a pressure bandage to minimize bruising Emphasize: 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.
- Emphasize that if the applicator is not kept in the same position during this procedure or if the purple slider is not moved fully back until it stops, the implant will not be inserted properly and may protrude from the insertion site If the implant is protruding from the insertion site, remove the implant and perform a new procedure at the same insertion site using a new applicator Do not push the protruding implant back into the incision
- Review each of the post-insertion steps as described on slide. Tell participants to refer to the Prescribing Information if they have any questions about counseling the woman regarding follow-up care. You may wish to remind participants to counsel women to leave the pressure bandage in place for the recommended 24-hour period as its primary purpose is to minimize bruising at the insertion site.
- Display slide Emphasize that if you cannot feel the implant or are in doubt of its presence, the implant may not have been inserted or it may have been inserted deeply Review next steps: 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 Review suitable methods for localization
- Display slide and tell participants that it shows examples of implants localized via the use of X-ray. Make sure participants are able to identify the location of the implant on each of the 3 examples. Make the following points: The implant in the examples is radiopaque, that’s why it is visible with X-ray. The way the implant looks on the X-ray may vary a bit depending on the angle of the X-ray. In the third example, the implant is visible even though the angle of projection makes it appear as though it is projected on the bone.
- Review the information regarding the etonogestrel (ENG) assay technique by displaying and discussing slide. Emphasize the purpose and use of an ENG assay is to confirm the presence of the implant but not its location. Remind participants that they should contact their local Merck office in any situation in which an ENG assay may be required. They will assist you with detailed prescription of the procedure.
- In the NORA study, 85 HCPs reported a total of 208 insertion-related events involving 189 patients during 7364 insertions, including 93 incorrect insertions. One HCP reported 26 of these (all deep insertions). There were 65 deep insertions, defined as non-palpable implants following insertion, implants within muscle or adjacent to the deep fascia overlying the muscle, and injury to a nerve or blood vessel during insertion. Deep insertions did not result in serious injuries. Over 60% were due to the single HCP with 26 incorrect insertions. The non-insertion was initially unrecognized. There was no difference in incorrect insertion rates based on HCP prior experience (<5 insertions vs ≥5 insertions) or physician vs non-physician. The most common insertion-related challenge was difficulty in removing the protection cap. Reference Reed S, Do Minh T, Lange JA, Koro C, Fox M, Heinemann K. Real world data on Nexplanon® procedure-related events: final results from the Nexplanon Observational Risk Assessment study (NORA). Contraception 2019;100:31-36.
- Display slide and review the materials needed for removal of etonogestrel subdermal implant An examination table for the woman to lie on Sterile surgical drapes Sterile gloves Antiseptic solution Surgical marker Local anesthetic Needles and syringe Sterile scalpel Forceps (straight and curved mosquito) Skin closure Sterile gauze Pressure bandage
- Review:. Have the woman lie on her back on the table. The arm should be positioned with the elbow flexed and the hand underneath the head (or as close as possible). Locate the implant by palpation. Push down the end of the implant closest to the shoulder to stabilize it; a bulge should appear indicating the tip of the implant that is closest to the elbow. Emphasize: If the tip does not pop up, removal of the implant may be more challenging and should be performed by providers experienced with removing deeper implants. Contact the local Merck office for further information. Exact location of implant in the arm should be verified by palpation If not use other methods to localize and consider referral if deep or migrated Mark the distal end (end closest to the elbow), for example, with a surgical marker. Review: Clean the site with an antiseptic solution. Anesthetize the site, for example, with 0.5 to 1 mL 1% lidocaine, where the incision will be made (near the tip of etonogestrel subdermal implant that is closest to the elbow). Emphasize: Be sure to inject the local anesthetic under the implant to keep the implant close to the skin surface. Injection of local anesthetic over the implant may make removal more difficult. Review: Push down the end of the implant closest to the shoulder to stabilize it throughout the procedure. Starting over the tip of the implant closest to the elbow, make a longitudinal (parallel to the implant) incision of 2 mm towards the elbow. Take care not to cut the tip of the implant. NOTE: If desired, you may wish to ask participants to follow along by using the dummy arm they were given earlier and using the process described to identify the distal end of an implant they inserted earlier. Make sure participants understand where to make the longitudinal incision and approximately how deep the incision should be.
- Be sure to tell participants what to do if they encounter adherent tissue that is interfering with visualization or removal of the implant. The tip of the implant should pop out of the incision. If it does not, gently push the implant towards the incision until the tip is visible. If needed, gently remove adherent tissue from the tip of the implant using blunt dissection. If the implant tip is not exposed following blunt dissection, make an incision into the tissue sheath and then remove the implant with the forceps If the tip of the implant does not become visible in the incision, insert forceps (preferably curved mosquito forceps, with the tips pointed up) superficially into the incision Gently grasp the implant and then flip the forceps over into your other hand With a second pair of forceps carefully dissect the tissue around the implant and grasp the implant The implant can then be removed. If the implant cannot be grasped, stop the procedure and refer the woman to a healthcare provider experienced with complex removals or call 1-877-888-4231. Figure 18 Confirm that the entire implant, which is 4 cm long, has been removed by measuring its length. There have been reports of broken implants while in the patient’s arm. In some cases, difficult removal of the broken implant has been reported. If a partial implant (less than 4 cm) is removed, the remaining piece should be removed by following the instructions in section 2.3. If the woman would like to continue using NEXPLANON, a new implant may be inserted immediately after the old implant is removed using the same incision as long as the site is in the correct location Apply adhesive then pressure bandage with sterile gauze to minimize bruising.
- Display slide and review final post-removal steps. Emphasize: Bandaging and timing of removal The woman should restart contraception immediately after removal of the implant if continued contraceptive protection is desired.
- Display slide and introduce section on topic of Factors Complicating Removal Review slide
- Display slide on Removal of Non-Palpable implants Emphasize that exact location of the implant must be determined prior to a removal attempt; exploratory surgery is strongly discouraged. Instruct that once localized, the implant should be removed by a healthcare provider experienced in removing deeply placed implants and familiar with the anatomy of the arm. U/S guidance should be considered.
- Use insertion video prn