Silhouette Soft
Silhouette Soft is the technology advanced performance suture for highly skilled practitioners and has received EU MDR Class III Certification
GET IN TOUCHIntroducing Silhouette Soft thread lift
Silhouette Soft is the technology advanced performance suture for highly skilled practitioners and has received EU MDR Class III Certification
GET IN TOUCHResorbable PLLA threads with patented bidirectional cone technology provide instant lift and enhanced contours – whilst stimulating gradual and sustained tissue regeneration by boosting your natural collagen production.
MAKE AN ENQUIRYIndication:
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:
*Although the combination use of Silhouette with other aesthetic procedures has been reported in literature, the safety of such combination treatments has not been formally established. Combination use should be done at the treating healthcare providers discretion and only where sufficient healing has occurred between each treatment where they treat the same areas of the face.
Please review here the Silhouette Soft Summary of Safety and Clinical Performance (SSCP – Switzerland only)
2195 Sinclair Pharma US Inc., 18 Technology Drive, Unit 134, Irvine, California, 92618, USA.
CorWeb.03
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@sinclair.com