Earfold By Allergan – Procedure Instructions: Insertion & Removal

Use Instructions

Insertion – How To?

1. Before procedure, advise patient of risks and benefits as well as other treatment options.
2. Advise patient there may be differences in outcome with the device versus with the positioner.
3. Put patient in front of mirror.
4. Attach traceability labels to patient records.
5. Examine Prefold positioner for damage, then immerse in 70% isopropyl alcohol for at least one minute. Allow to air dry.
6. Clean patient’s ears with isopropyl alcohol, both disinfecting and removing any loose skin cells and grease.
7. Gently push ear’s helical rim toward head until you see the desired position for the antihelical fold. Draw curved lines showing the apex of the proposed antihelical fold.
8. Place small piece of double-sided tape in location that allows creation of the antihelical fold, at the superior crus, lower on the antihelix, or at both sites. Where you place the tape depends on the prominence cause, that is, absent or poor development of antihelix in upper third of ear.
9. Fold ear back to create antihelical fold, then place Prefold positioner onto tape, holding antihelical fold in place. Refer to instruction leaflet for diagram. If tape cannot sufficiently hold Prefold positioner in place, use an extra piece of tape on top.
10. Place more positioners along proposed antihelical fold until patient is satisfied with the appearance of their ears. You may need to reposition the Prefold positioner up or down the ear instead of adding more positioners.
11. You may wish to take photographs of the positions.
12. To continue with the implantation procedure that day, carefully peel back proximal edge of tape until the implant edge is revealed. Using a surgical marking pen, draw a line on the skin for the position of the proximal edge, toward the helical rim, of the implant. Repeat for the distal edge, toward the conchal bowl. Ensure positioner is at a 90° angle to the desired antihelical fold curve.
13. Remove tape and positioner.
14. Draw parallel lines connecting proximal and distal edge lines, which will indicate intended position of implant.
15. Rinse Prefold positioners in warm tap water for 30 seconds or longer to remove visible soil, then immerse in 70% isopropyl alcohol for at least one minute. Allow to air dry then return to storage vial. Do not sterilize the positioners since this may change their shape, impairing their ability to simulate the Earfold’s outcome.
16. Have patient lay down, face up.
17. Apply standard bactericidal fungicidal agent to ear and surrounding area, being careful not to remove markings. Drape to create sterile field.
18. Mark insertion position 90° to planned antihelical fold position. This could be over the superior crus or just below takeoff of inferior crus. Refer to diagram in product leaflet.
19. Administer local anesthetic to ear and wait for it to take effect. You can use infiltration anesthesia with hydrodissection.
20. Remove device and introducer from package in sterile environment with talc-free gloved hands. Do not expose to lint, talc, sponge, towel, skin oils, or other contaminants. Keep covered in inner package to prevent contact with contaminants.
21. Examine implant and positioner for damage. Verify expiry date.
22. Make 8-10 mm incision on ear at least 3 mm from proximal edge of position marked for implant. You can also hide incisions in the skin crease of the helical rim.
23. Using blunt-tipped, curved scissors or a similar instrument, create a tunnel subcutaneously. This should be a few millimeters longer than introducer length or implant may be positioned incorrectly. The tunnel should be wide enough to allow the device to sit flush on cartilage.
24. Repeat this step if implanting more than one device.
25. Remove loaded introducer from sterile packaging, remove protective plastic sleeve from introducer tip, and insert into subcutaneous tunnel. Do not press release button yet.
26. Introducer’s upper edge has dimple marking implant’s proximal edge. Palpate dimple through skin and position over proximal edge of desired antihelical fold position. Once positioned, squeeze introducer tip onto anterior surface of cartilage, with moderate firmness, using thumb and index finger of other hand. This ensures tines are correctly engaged with cartilage before implant is deployed. Push introducer release mechanism downward and forward to disengage lock and deploy proximal edge of implant. Push whole introducer forward a few millimeters to disengage distal edge. You should hear or feel two clicks corresponding to successful release of proximal and distal edges.
27. Withdraw and properly dispose of introducer.
28. Run finger along antihelical fold to ensure implant is flush against cartilage. If not, remove and repeat insertion with a new preloaded introducer.
29. Evaluate the correction. If you have not achieved the desired results, consider removing implant and inserting new implant in a slightly different position.
30. Using fine, absorbable sutures, lose incision with one or two interrupted stitches.
31. If necessary, repeat to insert an additional implant. Only use the minimum number of implants needed since the risk of complications increases with more implants.
32. Use wound closure strips. No other dressings are required.

Removal How To?

Although device is designed to be permanent, you may need to remove implant if there are complications or unsatisfactory results.

1. If replacing with new implant, mark location of new implant before removing existing implant.
2. Open incision. If the implant has been in place long enough for a capsule to form, open the capsule.
3. Dissect skin overlying implant using fine tenotomy scissors or a small hemostat.
4. Using hemostat, lift implant’s proximal edge off cartilage.
5. Firmly grasp implant’s free edge with hemostat.
6. Using hemostat, peel implant away from cartilage, ensuring tines have disengaged before attempting to remove hemostat from subcutaneous tunnel.
7. Remove implant from subcutaneous tunnel by pulling hemostat away from head.
8. Properly dispose of used implant.
9. If desired, insert a new implant.
10. If needed, close incision with one or two interrupted stitches using fine absorbable sutures.
11. Dress incision with wound closure strips or adhesive dressing.
12. If you are unable to remove the device in this manner, make incision directly over device to remove.