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
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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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