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Policy & Procedures

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POLICY & PROCEDURE PROTOCOL

INJECTORS

PURPOSE

The purpose of this Policy and Procedure Protocol is to ensure the safe and effective treatment of patients undergoing injectiors for the augmentation of the soft tissues and the reduction of lines and wrinkles.

SCOPE

The protocol applies to all Aesthetic Health Care Providers.

SETTING

Injectors should be performed in an appropriate facility under the direction of a physician/provider in accordance with local state statutes.

QUALIFICATIONS

Licensed and Registered Physicians, Physician Assistants, Nurse Practitioners and Nurses with appropriate education, training and privileges are eligible to perform these treatments in accordance with this protocol (check state guidelines for scope of practice). The treating Aesthetic Health Care Provider should be familiar with the manufacturer’s package insert for each injector, which is included as an appendix to the manual. Injectors have been classified as a medical device and the performance of such treatments is the practice of medicine.

ADMINISTRATION

Injectors may be assed by any properly credentialed individual(s) under the direction of this protocol and/or a licensed physician/provider.

PATIENT ASSESSMENT

Patients should be properly consulted and assessed for appropriate indications and contraindications for treatment, and a record of that assessment should be documented in the patient’s medical record. INFORMED VERBAL AND WRITTEN CONSENTS SHOULD BE OBTAINED PRIOR TO PROCEEDING WITH TREATMENT. Patients will be consulted regarding any common adverse reactions to the medical device, treatment procedures, post treatment care and expectations following the procedure. Patients should also be informed regarding possible side effects and complications associated with treatment. Compliance with the Health Insurance Portability and Accountability Act (“HIPAA”) should be followed in relation to patient care.

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INDICATIONS

Injectors are indicated for the temporary treatment of facial lines, scars, creases, and other depressed contour irregularities not amenable to other treatments. Injectors is indicated for deep (subcutaneous and/or supraperiosteal) injection for cheek augmentation to correct age-related volume deficit in the mid-face in adults over the age of 18. In addition, it is used off label for the augmentation of the volume of the soft tissues in locations such as the lips, malar regions, brows, earlobes, and tear troughs. The injectors are approved by the FDA for the treatment of moderate to severe wrinkles and folds. It is indicated for deep (subcutaneous and/or supraperiosteal) injection for cheek augmentation to correct age-related volume deficit in the mid-face in adults over the age of 18. For the purposes of this protocol, the only areas authorized for treatment under the direction of the delegating/supervising physician or licensed provider should be those areas in which the physician/provider has determined the Aesthetic Health Care Provider has demonstrated appropriate skill, knowledge, and judgement in the use injectors.

CONTRADICTIONS, WARNINGS & PRECAUTIONS

A review of the patient’s medical history including, but not limited to, medical problems, allergies, history of previous treatments, and procedures at the site of the treatment area should be conducted during the patient’s assessment. Upon review of the assessment, the following protocols related to indications, contraindications and exclusions should be observed (see package inserts for individual product prescribing information).

The injectors is contraindicated in the following conditions (see package inserts for product information and individual prescribing recommendations):

*Pregnancy and breast feeding
*The presence of infection or any other inflammatory condition at the proposed treatment site
*A history of hypersensitivity or allergic reaction to previous injectiors
*A history of repeated unsuccessful treatments with injectors
*A history of hypersensitivity or allergic reaction to gram-positive bacteria or products containing gram-positive

bacteria proteins
*A history of anaphylaxis or anaphylactoid reaction to injector medications 

*A history of non-compliance with post-injection instructions
*Intoxication or influence of illicit drugs
*Immunodeficiency such as active viral infection
*Poorly controlled diabetes
*Use of chronic anticoagulation1
*Use with caution in patients on immunosuppressive therapy

Patients with any of the above conditions should be excluded from treatment until the condition is controlled or resolved. 1. Patients taking chronic anticoagulation drugs should provide approval for treatment from their primary care physician/provider.

PRE-TREATMENT

For the prevention of herpes outbreak, standing orders for antiviral medications are on file (see standing drug order).

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TECHNIQUES​

1. Once the area to be treated is defined, and an appropriate examination is completed, the patient is seated. If topical anesthetic is to be used, it is applied liberally to the treatment areas and should be allowed to work for at least 15 minutes prior to injection.

2. The appropriate syringe of the dermal filler for the treatment area is opened and removed from its package. The needle is attached in accordance with the manufacturer’s instructions. Use of this needle should minimize the chances of dislodging the needle while injecting the viscous dermal filler. The material in the syringe should be inspected, and if it is not clear and lacking particulate matter (except in the case of Radiesse®), it should not be used, and it should be returned to the manufacturer for a refund. A different syringe of injectors should then be selected for this treatment. Once selected, the adhesive patient record label from the syringe or packaging should be removed and placed in the appropriate location on the treatment record in the patient’s chart or transferred to the electronic record (keep consistent with clinical charting).

3. The treatment area should be prepped by cleansing and removing the topical anesthetic and/or makeup.

4. Correct injection technique is critical to the success of the procedure in achieving the desired results. The needle should be inserted into the treatment site with the tip ending up at an appropriate depth within the skin. The injectors should then be injected using slow, even pressure watching for the lifting and filling of tissues in the area being injected. OVERCORRECTION (more product than deficit/overfilled) IS GENERALLY NOT NEEDED AND IS TO BE AVOIDED.

5. Once the injection site is appropriately filled, the needle is inserted into the next adjacent location, and the process is repeated. Care should be taken to adequately assess the entire area to be treated with the selected amount of injectors to ensure even and symmetrical distribution of the material.

6. Once the injection is completed, the treated areas should be gently massaged, compressing the material into a “strip” or flattening it into a smooth contour, as opposed to allowing it to remain in clumps or beads. More vigorous massage may result in additional swelling, bruising or dispersement of the filler material.

7. The patient should be informed that the treated area may remain swollen, irregular in shape, and bruised for several days. Ice or a cold compress can be applied intermittently the first 48 hours post treatment.

8. The patient should be advised to allow healing for at least two weeks before any assessment is made of final volume and contour. If the outcome is satisfactory, no further treatment is indicated. If the outcome is unsatisfactory, the appropriate Aesthetic Health Care Provider should be contacted to arrange for an evaluation of the patient. If the patient desires further correction the procedure may be repeated, adding only the appropriate amount of dermal filler to bring the volume to the desired level.