Device Dossier

MERSILK Braided Silk Non-Absorbable Suture - Silk suture, sterile

Device Dossier for MERSILK Braided Silk Non-Absorbable Suture - Silk suture, sterile (Silk suture, sterile, Class III, sponsor Johnson & Johnson…

Intended purpose

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

Functional description

Non-absorbable, sterile, braided surgical suture. Available undyed or dyed versions, 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 with zero strength occurring between approximately 3 and 6 months.

TGA Public Summary