MENTOR MemoryGel Breast Implant

Description of Event or Problem

It was reported that a patient who underwent a breast augmentation revision procedure with MENTOR MemoryGel Breast Implant gel breast prostheses developed wrinkling on both breasts post implantation. As a result, the patient underwent bilateral explantation and replacement with MENTOR MemoryGel BOOST Breast Implant gel breast prostheses.This MedWatch report is for the patient¿s right breast prosthesis.

Additional Manufacturer Narrative

Device Evaluation Summary:The investigation was completed on a photo of the suspect medical device because the physical device has not been received by Mentor.Upon visual evaluation of the image provided in the complaint, no apparent damage or visual anomalies were observed.As the product involved in this complaint was not received, the device could not be analyzed according to our procedures.Wrinkling is reported to occur more frequently in patients with one or more of the following: thin-skinned patients, patients with little or no subcutaneous fat, subglandular rather than submuscular placement, an implant that is too large relative to the breast pocket size or frame of the patient, overlying tissue that is minimal or of poor quality, and/or when capsular contracture is present.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: Since no malfunction was observed during the investigation. No corrective and preventive action (CAPA) is required now.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.Reason for device explant and/or reoperation: Wrinkling.Mentor is submitting this report pursuant to the provisions of 21 CFR, Part 803. This report may be based on information which Mentor has not been able to investigate or verify prior to the required reporting date. This report does not reflect a conclusion by FDA, Mentor, or its employees that the report constitutes an admission that the device, Mentor, or its employees caused or contributed to the potential event described in this report. If certain information is unknown, not available or does not apply, the section/field of the form is left blank.Manufacturer¿s reference number:(b)(4)