Possible complications

Minor complications

As with any other filler, treatment with Aquamid® may cause transient pain, oedema, redness, minor haematoma, and other minor side effects.
Patients should be informed that there is a small risk of transient oedema and tenderness occurring near the injection site within the first 1-2 days after injection. If not caused by infection, the symptoms will be self-limiting and disappear within a couple of days.

Important complication

A tingling sensation, redness, swelling or other changes in the injected area within the first weeks after injection are usually the first sign of infection. In the event of complications with Aquamid® an infection must always be suspected. These are NOT an allergic reaction 5.

Never corticosteroids

Complications, such as swelling, should NEVER be treated with corticosteroids or NSAIDs as they are absolutely contraindicated 4,5 because they prolong recovery time.

Treat with antibiotics

The patient must immediately be treated with high-dose, broad-spectrum antibiotics, Clarithromycin 500 mg p.o. plus Moxifloxazin 400 mg p.o. twice daily. The treatment should be administered for 10-14 days. If no reduction in symptoms after three days is registered, the patient should be switched to the following combination: Clindamycin 600 mg p.o. plus Tetracyclin 500 mg p.o. twice daily. This combination may act against bacteria otherwise resistant to Clarithromycin and Moxifloxacin.

Continue antibiotics treatment

Usually the infections must be treated for longer than normally required. The sooner the high-dose, broad spectrum antibiotic treatment is initiated, the faster the patients recover 5.

If you choose to use a prophylactic treatment, the following combination is recommended: Azithromycin 500 mg p.o. and Moxifloxacin 400 mg p.o. administered as a single dose 2 – 6 hours prior to injection. The above combination of antibiotics will reach a high concentration in the tissue and should be given only once.

In case of complications, please refer to our Treatment Guidelines.

Incident report form

If you need further advice, please fill in the Incident Report Form and send it to your local Aquamid® distributor or fill in the on-line form . If you have any questions, please do not hesitate to contact your local Aquamid® distributor or Contura.

What is the difference between the human body’s normal foreign body reaction and a foreign body infection?

Foreign body reaction

A foreign body reaction is a normal response to any foreign material introduced into  he human body. This reaction may be weak or strong, depending on the nature of the foreign material. A strong reaction may, if left untreated, give persistent symptoms with ensuing fibrosis, as seen in granulomas. A weak foreign body reaction does not give any initial symptoms and it slowly disappears over time 4,5. As documented in studies, Aquamid® injections only cause a weak foreign body reaction, characterized by a thin layer of macrophages and a few giant cells surrounding the hydrogel 4. Due to this weak response, Aquamid® is not associated with any symptoms of a strong foreign body reaction and no granuloma formation will occur 4,5.

Foreign body infection

Contamination of tissues with bacteria in the presence of a foreign body gives rise to a low-grade infection. The symptoms are mostly discreet, and the classic signs of infection, such as redness, oedema, pulsation and pain may be absent. The amount of bacteria is generally small and difficult to detect by microscopy or culture, and in many cases the micro-organisms are only detectable by PCR and DNA sequencing. At the same time biopsies show an increased foreign body reaction induced by the bacteria. These infections must be treated with antibiotics for longer than normally required with infections not associated with a foreign body. The symptoms can be spread in a wider area that the bacteria itself due to lateralization of the inflammatory process with involvement of surrounding tissues and lymph nodes. Hence, even if all available detection tests for bacteria are negative (the material may be insufficient), a bacterial infection must always be suspected and treatment with a broad-spectrum antibiotic must be initiated 4,5.