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: 2019-07-26
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