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Information Update - Status of non-absorbable synthetic surgical mesh for the transvaginal repair of pelvic organ prolapse in Canada

Friday, July 26, 2019 General News

Manufacturer

Medical Device Name

Licence Number

Status

Boston Scientific Corporation

Uphold LITE Vaginal Support System with Capio SLIM

98223

  • Company stopped sale and initiated a recall of unused product in May 2019.
  • Company has indicated it will cancel its licence once the recall is complete.

Coloplast A/S

Exair Anterior and Posterior Compartment Prolapse Repair System

81556

  • Company cancelled its licence in May 2019.
  • No product is available in Canada (company stopped sale in May 2016).

Restorelle Polypropylene Mesh

Sold under two trade names:

  • Restorelle DirectFix Anterior
  • Restorelle DirectFix Posterior

87285

  • Company cancelled its licence in June 2019 (affects both Restorelle DirectFix Anterior and DirectFix Posterior).
  • Company stopped sale and is notifying physicians of the revised recommended patient population for any unused DirectFix Anterior.
  • Company stopped sale and initiated a recall of unused DirectFix Posterior in July 2019.

Cousin Biotech

Implants pour le Traitement du Prolapsus Biomesh Soft Prolaps

77395

  • Company cancelled its licence in May 2019
  • No product is available in Canada (no sales in Canada since January 2014)
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