Device Dossier

Perma-Hand Virgin Silk Non-Abosrbable Suture - Suture, silk

Device Dossier for Perma-Hand Virgin Silk Non-Abosrbable Suture - Suture, silk (Silk suture, sterile, Class III, sponsor Johnson & Johnson Medical). ARTG…

Intended purpose

Indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.

Functional description

Nonabsorbable, sterile, surgical suture. Available with or without needles. Silk suture elicits an initial inflammatory reaction in tissues which is followed by gradual encapsulation of the suture by fibrous connective tissues. Whilst Silk is not absorbed, progressive degradation of the proteinaceous Silk fibre in vivo will result in a gradual loss of strength over time.

TGA Public Summary