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This policy was updated in August 2018.

Indication:

The EU approved intended use is: Silhouette Soft is a resorbable sterile implantable single-use device intended to be used in adult patients for facial and neck reconstruction in the treatment of facial morphological asymmetry and ptosis, including but not limited to:

Indication:

The EU approved intended use is: Silhouette Soft is a resorbable sterile implantable single-use device intended to be used in adult patients for facial and neck reconstruction in the treatment of facial morphological asymmetry and ptosis, including but not limited to:

The effects of facial ptosis or paralysis (e.g. Bell’s palsy, benign or malignant tumours, iatrogenic injury, Varicella-zoster virus associated facial palsy, trauma, and congenital palsy).

Morphological asymmetry (e.g. congenital anomalies, trauma to the face or the temporomandibular joint).

IMPORTANT SAFETY CONSIDERATIONS

Like all procedures of this type there is a possibility of adverse events, although not everybody experiences them. These adverse events include infection, minimal acute inflammatory tissue reaction, pain (which may be temporary or persistent in nature), swelling and oedema, transient haematoma or bruising and transient rippling or dimple formation.

Other potential adverse events include ecchymosis, sensory/motor nerve injury, asymmetry, banding, thread migrations and palpable thread ends/knots. Material sensitivity/allergic reactions in patients following surgery may occur. The onset of any adverse event must be reported immediately. Please contact the local Sinclair representative or authorised Silhouette distributor. Alternatively send the details to quality@sinclairpharma.com