MENTOR MEMORYGEL BREAST IMPLANT (MENTOR TEXAS) — Injury
A report was filed categorized as an injury involving the Mentor MemoryGel Breast Implant manufactured by Mentor Texas. The source provides minimal detail regarding the specific nature or severity of the injury.
This affects the manufacturer, Mentor Texas, and regulatory professionals managing class III implantable devices, specifically silicone gel-filled breast implants.
For regulatory professionals, this entry underscores the ongoing post-market surveillance requirements for high-risk implantable devices. This report may necessitate internal review of the device's Instructions for Use (IFU) or an update to the manufacturer's adverse event trending data to determine if the injury represents a known complication or a new risk profile.
Regulatory and QA teams should ensure that all reported injuries are cross-referenced with existing Risk Management Files to confirm the severity and frequency remain within established thresholds. Clinical operations should verify that post-market clinical follow-up (PMCF) data collection is robust enough to capture similar adverse events.
Event type: Injury. Device: MENTOR MEMORYGEL BREAST IMPLANT by MENTOR TEXAS.
Open in openFDA / FDA.gov