Restorelle Polypropylene Mesh (2019-07-11)

Starting date:
July 11, 2019
Posting date:
July 26, 2019
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-70487

Last updated:

Affected Products

Restorelle Polypropylene Mesh

Reason

Health Canada has performed an assessment based on current clinical literature and believes that available evidence does not support long term safety and effectiveness of synthetic mesh for posterior repair of pelvic organ prolapse (POP).

Furthermore, Health Canada has determined that the use of synthetic mesh for the treatment of POP transvaginally, when used in the anterior and apical compartments, should be restricted to patients with recurrent pelvic organ prolapse, or patients with significant risk factors for recurrence, or for patients not amenable to or refuse other forms of treatments such as transabdominal surgery or native tissue repair.

Affected products

Restorelle Polypropylene Mesh

Lot or serial number

All lots.

Model or catalog number
  • 501450
  • 501460
Companies
Manufacturer
Coloplast A/S
Holtedam 1
Humlebaek
3050
DENMARK