Coloplast A/S Restorelle Adverse Report to FDA

A Coloplast Restorelle Y Mesh implanted in 2023 was removed in 2024 after the patient developed pain radiating down her leg, her urinary analysis was positive for leukocytes and bacteria. It was documented that the patient had discitis, infected sacrocolpopexy Y Mesh and sepsis as a complication of the implanted mesh. There was purulent drainage along right pelvic sidewall and along mesh. Post procedure there was continued pain and a plan to return to operating room for washout/debridement, but the patient reportedly died due to complications stemming from the infection. Follow the link to learn more about the death that was reported to the FDA for investigation and further investigation.