Aqualyx safety has become a topic of increasing interest among aesthetic medicine professionals, driven by the growing demand for non-invasive body contouring procedures. Aqualyx, a CE-marked injectable compound designed to break down fat cells, has gained traction for its ability to target stubborn fat without surgery. But how safe is Aqualyx really when administered in a clinical setting by trained professionals? This article presents an evidence-based clinical review tailored for medical practitioners.

1. Background and Composition

Aqualyx is an injectable medical device developed and approved in the European Union since 2009. It is formulated with:

• Sodium deoxycholate 0.7% in gel matrix
• Galactose-based polysaccharide
• Buffered saline solution (CE-marked)

The active ingredient promotes adipocytolysis, the breakdown of fat cell membranes, leading to cellular elimination through the lymphatic system.

2. Efficacy and Clinical Protocol

The typical treatment protocol includes:

1. Initial evaluation (pinch test <3 cm or >3 cm)
2. Deep subcutaneous injections using a 24G long needle
3. Ultrasound-assisted administration for even distribution
4. 4–6 treatment sessions, spaced every 4–6 weeks

Multiple European observational studies have reported successful fat volume reduction, especially in areas like the submental region, abdomen, and flanks, with low rates of complications.

3. Aqualyx Safety Profile

3.1 Common Mild Side Effects

These effects are considered normal physiological responses to intralipotherapy and typically do not require medical intervention.

3.2 Rare Severe Adverse Events

3.3 Identified Risk Factors

• Incorrect injection depth (too superficial)
• Excessive volume or too frequent sessions
• Older patients (>60 years)
• Non-sterile or non-clinical settings

4. Case Reports and Clinical Importance

4.1 Skin Necrosis from Improper Technique

Documented case: bilateral thigh necrosis after a single Aqualyx vial (8 mL) injected superficially and without ultrasound guidance. Recovery required 3 months with residual scarring.

4.2 UK Adverse Event (2023)

A patient developed a large abdominal abscess after receiving 16 Aqualyx injections in a beauty salon. No prior assessment or sterile technique. Required emergency surgery and long-term follow-up.

These reports highlight the essential role of clinical expertise and sterile environments in ensuring Aqualyx safety.

5. Aqualyx vs. Kybella (ATX‑101)

While both products share similar mechanisms, Kybella is FDA-approved only for the chin, whereas Aqualyx is used more broadly in Europe under clinical discretion.

6. Clinical Recommendations for Aqualyx Safety

To ensure optimal safety and efficacy, the following guidelines are essential:

1. Patient Selection
   • Stable BMI
   • Good skin elasticity
   • Localized fat (pinchable)
   • No hepatic disease, no autoimmune conditions
   • Not pregnant or breastfeeding
2. Professional Certification
   • Only licensed physicians or certified nurses with specific training in intralipotherapy should administer Aqualyx.
3. Correct Technique
   • Deep subcutaneous injection using fanning technique
   • Use of ultrasound guidance to ensure safe and even distribution
   • Avoid superficial dermal planes
   • Allow 4–6 weeks between sessions
4. Post-Treatment Care
   • Compression garments for 48–72 hours
   • Manual lymphatic drainage if needed
   • Monitor for signs of infection or adverse tissue response
5. Informed Consent
   • Fully explain all potential risks, including rare complications
   • Educate the patient on warning signs and when to seek follow-up

7. Conclusion: Aqualyx Safety in Clinical Practice

• Aqualyx is safe when used correctly by certified professionals in sterile, clinical environments.
• Mild side effects are common and manageable.
• Severe complications are very rare, but real—emphasizing the need for medical oversight.
• The product is not FDA-approved in the U.S. and should not be used outside the scope of clinical expertise.
• For medical professionals, Aqualyx offers an effective, minimally invasive alternative for targeted fat reduction, provided proper protocols are followed.

References and Scientific Sources on Aqualyx Safety

The information in this article is supported by peer-reviewed publications, regulatory advisories, and clinical guidelines. Below is a curated list of sources that provide further evidence regarding the safety and use of Aqualyx in aesthetic medicine:

1. Amore R., et al. Intralipotherapy, the State of the Art.
   https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5096534/
2. Di Toro G. & Rauso R. Skin Necrosis Following Adipocitolitic Solution Injections.
   https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9142263/
3. Leonardi R., et al. Intralipotherapy, the State of the Art – A Multicenter Experience.
   https://iris.unipa.it/retrieve/handle/10447/280963/546766/Leonardi.pdf
4. Rauso R., Salti G. Skin Necrosis from Adipocytolytic Injections.
   https://www.researchgate.net/publication/283306496
5. Ultrasound-Guided Lipolysis Study (2020).
   https://www.researchgate.net/publication/347810970
6. Harley Street MD. 7 Myths About Aqualyx Fat Removal Treatment.
   https://harleystreet-md.co.uk/blog/myths-fat-removal-treatments/
7. Healthline. Aqualyx Injections: Procedure, Side Effects & Cost.
   https://www.healthline.com/health/aqualyx
8. U.S. Food & Drug Administration (FDA). Fat-Dissolving Injections Warning.
   https://www.fda.gov/drugs/buying-using-medicine-safely/using-fat-dissolving-injections-are-not-fda-approved-can-be-harmful
9. Med Supply Solutions. Aqualyx FDA Approval Status.
   https://www.medsupplysolutions.com/blog/aqualyx/aqualyx-fda-approval/