Covidien recalls Parietex composite parastomal mesh (PCOPM15/20) due to reported hernia recurrence after surgery. Patients should monitor for discomfort or bulging and consult their healthcare provider.
The firm is issuing this voluntary removal following receipt of reports of parastomal mesh failure identified several years following parastomal hernia repair using the modified Sugarbaker repair technique. In these reports, product 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, worldwide, a total of ten reports of mesh failure following use of the product in the last five years. Patients who have received a Parietex" composite parastomal 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.
Covidien is recalling Parietex Composite Parastomal Mesh (PCOPM15 and PCOPM20) because it has failed in some patients years after hernia repair, causing hernia recurrence. This may require additional surgery and can cause discomfort or bulging.
The mesh can fail years after surgery, leading to hernia recurrence that may require additional surgery. This happens in some patients who used the product with the modified Sugarbaker repair technique.
Patients who received Parietex composite parastomal mesh for parastomal hernia repair are affected. Those with hernia recurrence symptoms like discomfort or bulging should monitor closely with their healthcare provider.
The product is labeled as Parietex Composite Parastomal Mesh with product numbers PCOPM15 or PCOPM20. It was sold in specific lots listed in the recall notice.
Check for discomfort, bulging, or changes in skin over the surgical area.
Continue regular check-ups with your doctor for signs of hernia recurrence.
Covidien received reports of mesh failure causing hernia recurrence years after surgery, requiring additional treatment.
Symptoms may include discomfort, localized pain-free or painful bulging, and possible skin changes.
No specific remedy is stated in the recall notice; patients should monitor and consult their healthcare provider.
We’ve drafted a message you can send Parietex to request your refund or repair — edit it as you like.
Subject: Recall Z-0461-2019 — Parietex Parietex Hello, I own a Parietex that is covered by recall Z-0461-2019 from Parietex. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
