Voluntary recall of selected Covidien Parietex™ Composite Parastomal Mesh with reports of failure

Covidien Pte Ltd would like to inform healthcare professionals of the voluntary recall of selected lots of the Parietex™ Composite Parastomal Mesh (item codes PCOPM15; PCOPM20) following receipt of reports of failure identified several years after parastomal hernia repair using the modified Sugarbaker repair technique. In the reports received, Parietex™ Composite Parastomal Mesh failure led to hernia recurrence requiring additional surgical treatment. Symptoms of hernia recurrence may include discomfort, localized pain-free or painful bulging, and possible changes in the overlying skin. Medtronic has received ten reports of mesh failure following use of the affected devices internationally in the last five years. Healthcare professionals are advised to quarantine and return all unused units of the affected medical devices to Medtronic Pte Ltd. In addition, healthcare professionals are advised to monitor patients who have received a Parietex™ Composite Parastomal Mesh for the treatment of parastomal hernia for any hernia recurrence.

Only abstracts of the Dear Healthcare Professional Letters (DHCPL) are provided on this website. Details of these letters can be found in the MOH Alert System, which is accessible via the Health Professionals Portal (HPP), a one-stop portal for all healthcare professionals in Singapore. Dentists, medical doctors and pharmacists may access HPP at https://hpp.moh.gov.sg and follow the procedures below to access the MOH Alert system.

Step 1: Select your profession under ‘For Healthcare Professionals’.

Step 2: Click on ‘Useful links’.

Step 3: Click on ‘MOH Alert’ and log in via Singpass.

Step 4: Click on ‘Drug Alerts’ or ‘Med Device Alerts’ to view the DHCPLs.