The purpose of this informed consent form is to provide written information regarding the risks and potential adverse outcomes relating to the procedure named above. This material serves as a supplement to the discussion you have with your doctor. It is important that you fully understand this information, so please read this document thoroughly. If you have any questions regarding the procedure, please address your concerns with your doctor at the time of your consultation.
What is being injected? This procedure involves the injection of a fat dissolving solution for the purpose of treating of submental (under chin) fat. This treatment is indicated for improvement in the appearance of moderate to severe fullness associated with submental fat, also called “double chin,” in adults. Although common, the safe and effective use of this product for the treatment of subcutaneous fat outside the submental region has not been established and is off label. Multiple treatments are usually required and will be given at least 1 month apart.
Risks of injection: Trauma during the procedure is caused by needles and/or cannulas passing through tissue, and includes bleeding, bruising, haematoma (a larger collection of blood in the skin, outside of blood vessels), damage to underlying structures including veins, arteries, nerves, salivary glands, lymph nodes, bone, muscle and other soft tissue structures are possible. In rare cases this could cause continuous problems in appearance, sensation or function and may require medical intervention to treat or may be permanent. Most traumatic injuries heal completely on their own.
Infection: Bacterial, viral or fungal infections can occur post any invasive procedure. Infections can cause redness and swelling and resolve or progress into abscesses which can be slower to recover. These problems may resolve in time, but medical intervention may be required in some cases, and long-term effects may persist in rare cases.
Reactions: Reactions rarely occur but can include an immediate reaction causing swelling, and rarely life-threatening anaphylaxis requiring emergency treatment. Delayed hypersensitivity reactions can also occur. These types of reactions may require treatment and may leave permanent effects on the appearance, of the areas affected.
Common Side effects- Fat dissolving injections commonly cause prolonged swelling bruising, pain, numbness, redness, and temporary areas of hardness in the treatment area. Injections may also cause tingling, nodule, itching, skin tightness, and headache. These side effects typically resolve without treatment and do not commonly result in patients discontinuing treatment.
Uncommon Side effects – Uncommon but potential side-effects include but are not limited to:
- Nerve injury: Injury to the marginal mandibular nerve may result in an uneven smile or facial muscle weakness (4% of cases). In clinical trials, these all resolved without treatment in an average of 6 weeks
- Swallowing Difficulty: Injections may temporarily cause trouble swallowing (2% of cases)
- Skin Effects: Although exceedingly rare, injections may cause superficial skin ulcers and/or alopecia (patches of hair loss) in the treatment area.
Results: Approximately 50% of neck fat is below the muscle. These injections do not target this fat, and therefore residual fullness may remain. Patient must be aware that there is a possibility of unsatisfactory result from this treatment and that the procedure may result in asymmetry in the treatment area and/or prominence of platysmal (neck muscle) bands. Clinical trials show multiple treatments are necessary to produce results, and that increase in body weight may diminish the effects of treatment.
Dissatisfaction: With all treatments the precise degree of improvement cannot be guaranteed. The outcome’s subjective nature also means dissatisfaction is apossible outcome regardless of effectiveness of treatment. It must be understood that additional treatments may be necessary to acquire the desired effect, and further charges will apply if more product is required.
Contraindications: This treatment is contraindicated when there is an infection at the injection site. There are no studies on safety during pregnancy or breast feeding. If you are pregnant or breast feeding then you should not proceed with treatment.
POST CARE INSTRUCTIONS - Fat Dissolving
During the first 48-72 hours after your treatment you may experience redness, swelling bruising and tenderness in the treated areas. This is normal and will pass quickly.
The following guidelines are recommended during the first 24-48 hours following your treatment.
- It is best to keep the area free of cosmetics and avoid using moisturizers with active ingredients such as AHA, BHA or retinoid creams. Mineral make-up is fine to use.
- Try to avoid touching the area for 6 hours after treatment.
- Apply cool compresses, and bruise cream to the treated areas to relieve swelling and possible bruising.
- A chin strap pressure garment may also be recommended by your treating doctor
- Avoid drinking alcohol as it dilates blood vessels and may increase bruising and swelling.
- Avoid strenuous exercise and extremes of hot e.g. Spa/sauna.
- You may take Panadol or similar medication if treated areas are tender. However, avoid Aspirin, ibuprofen or Nurofen or other anti-inflammatories.
If you have any issues or concerns following your procedure, please call the clinic and your treating doctor will get back to you as soon as possible.