MENTOR MemoryGel Breast Implant

Description of Event or Problem

It was reported that a patient implanted with a 425cc MENTOR MemoryGel Breast Implant experienced a rupture post-operatively. As a result, the patient underwent explantation on (b)(6) 2026.

Additional Manufacturer Narrative

Device Evaluation Summary:Since the lot number corresponding to the right-side rupture was not provided, it was not possible to determine which device corresponded to the Right-side breast implant, therefore, both products were analyzed.The product was returned to Mentor for evaluation, where a thorough investigation was conducted.Visual analysis of the returned device revealed that the breast implant B was found to be ruptured. In addition, siltex cracking was observed at the edge of the rupture.The evaluation determined that the possible cause of the ruptures is consistent with normal wear. Siltex cracking is defined as a material separation occurring in the Siltex layer and can eventually progress through the shell of Siltex devices. Siltex Cracking is ultimately a result of high stresses.As part of Mentor's quality process, all devices are manufactured, inspected, and released according to approved specifications. Based on the results of this investigation, it was determined that the product met the manufacturing release criteria, and that normal wear may have caused the observed defect. No corrective and preventive action (CAPA) is required now.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post market surveillance.Manufacturer¿s reference number:(b)(4).