When Not To Implant?
- In patients with impaired healing, such as current smokers, diabetic patients, and those with autoimmune disorders such as Ehlers-Danlos Syndrome or Scleroderma.
- In patients with body dysmorphic disorder, history of deliberate self-harm, or other signs of psychological instability.
- In patients with active local or systemic infection.
- In patients with a known nickel or gold allergy.
- In patients who are pregnant.
- In patients who are breastfeeding.
- In patients with known coagulation issues. Treat or reverse these issues before implanting the device.
- In patients with active eczema or other skin conditions in the ear, which may be heavily contaminated with bacteria. Treat the skin and ensure it is blemish-free before insertion.
- In patients with a known or family history of keloid scarring. Advise patients of risks before insertion.
- In patients with altered cartilage from trauma or previous correction procedures. Not for use in those with weakened or damaged cartilage.
- In patients with scarred or damaged skin that would hinder the device's ability to create the anti-helical fold or impair healing, leaving implant exposed.
- Some patients may require additional procedures to achieve the desired aesthetic outcome.
- The effect of using this device for conchal bowl reduction is unknown.
- Patient should remove earrings before insertion and avoid use for three weeks in the earlobes and six weeks in the upper ear after the procedure.
- Patient should avoid smoking, e-cigarettes, nicotine patches, or nicotine chewing gum for three months before and three months after insertion. Nicotine causes blood vessels to constrict, which could reduce blood supply, increasing risk of complications such as wound infection, wound breakdown, and skin erosion.
- For at least three weeks after insertion, patient should avoid manipulating their ears and avoid sporting activities where the ears may face manipulation or trauma.
- Patient can wear a headband for six to eight weeks after insertion, but this is not essential.
- There may be swelling and bruising for up to six weeks.
- Patient should use caution with phones, earpieces, or headphones for three weeks after insertion, since these items are often dirty. Clean the item with a disinfecting wipe before use to reduce risk.
- Irritation can occur if implant is placed incorrectly or is prominent under skin. This could cause an increased risk of skin eroding over the implant. Consider removing implant and replacing as soon as possible. You can also remove and reconsider replacement later.
- Patient should inform other doctors about the implant, especially if having immunotherapy, cancer treatment, or MRI.
- According to non-clinical testing, patient can safely have MRI if static magnetic field is 1.5 Tesla or 3 Tesla, maximum spatial field gradient is 26,676 G/cm (266.76 T/m), and maximum whole body averaged specific absorption rate (SAR) is 4.0 W/kg for 15 minutes of scanning in First Level Operating Mode. This should produce maximum temperature rise of 0.3° C during 15 minutes of continuous scanning.
- Only use in clinical facility with sterile conditions. To reduce risk of infection, fully drape and prep operative site; wear facemask, surgical hat, and gloves; consider changing gloves between working on each ear; and consider giving patients one dose of antibiotics before the procedure and a short course of prophylactic antibiotics after.
- If performing additional surgical procedures for prominent ear correction, such as chonchal bowl reduction or concho-mastoid sutures, mark intended location of implant before entering sterile procedure room but insert implant after the other surgical procedure.
- Do not deploy implant with anything other than the introducer provided.
- Do not reload device into introducer.
- Keep extra Earfold devices on hand for every procedure.
- Only for use by physicians who have specific training.
- For single use only. Do not reuse or resterilize implant or introducer. This carries an infection risk, and cleaning and resterilization procedures may compromise device material and design.