MENTOR Smooth Round Moderate Profile

Description of Event or Problem

It was reported that a patient implanted with a 250cc MENTOR Smooth Round Moderate Profile saline breast prosthesis experienced a deflation on the left side post-operatively. As a result, the patient underwent explantation on (b)(6) 2026.

Additional Manufacturer Narrative

Photo Evaluation Summary:Upon visual evaluation of the image provided in the complaint, the implant was observed deflated. As the product involved in this complaint was not received, the device could not be analyzed according to our procedures. Mentor also performed a manufacturing record evaluation related to the reported complaint for the finished device lot number. No manufacturing non-conformances were identified as part of this evaluation. 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: 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).