Medical device manufacturer, Medtronic, has issued a medical device safety alert concerning its Covidien Parietex Composite Parastomal Mesh [Description (Item Codes): Parietex composite Parastomal Mesh 15 cm (PCOPM15) and Parietex Composite Parastomal Mesh 20 cm (PCOPM20); Lot Numbers distributed in Hong Kong: PRG0380X, PQE0802X and PRG1022X].
The manufacturer received reports of Parietex composite parastomal mesh failure identified several years following parastomal hernia repair using the modified Sugarbaker repair technique. In these reports, the mesh failure led to hernia recurrence requiring additional surgical treatment.
According to the manufacturer, symptoms of hernia recurrence may include discomfort, localized pain-free or painful bulging, and possible changes in the overlying skin.
The manufacturer has received, worldwide, a total of ten reports of mesh failure following use of the affected products in the last five years.
The affected users are requested to quarantine and return any unused affected products. Patients who have received the affected mesh for the treatment of a parastomal hernia should continue to receive ongoing monitoring by their healthcare providers for the recurrence of a parastomal hernia.
Product removal is ongoing.
According to the local supplier, the affected products are distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 15 Oct 2018