MENTOR CPX 2 Breast Tissue Expander 3546113Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00081317002208), received between Mar 30, 2018 and Sep 11, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Material Rupture” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjurySep 11, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION PROCEDURE WITH A MENTOR MEMORYGEL BREAST IMPLANT 650CC GEL BREAST PROSTHESIS (LEFT DEVICE) AND A MENTOR CPX 2 BREAST TISSUE EXPANDER 450CC DEVICE (RIGHT DEVICE) THAT BOTH RUPTURED POST IMPLANTATION. BILATERAL RUPTURE WAS DIAGNOSED VIA A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH MENTOR MEMORYGEL BREAST IMPLANT 800CC GEL BREAST PROSTHESES ON (B)(6)2023. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 17721945 ↗
• InjuryMar 30, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS COMPLAINT IS FROM A LITERATURE SOURCE. INITIALLY CURRENT EVENT WAS COVERED IN (B)(4). ADDITIONAL INFORMATION WAS RECEIVED FROM AUTHOR ON (B)(6) 2018. DETAILS OF 7 PATIENTS WERE PROVIDED, THEREFORE CURRENT REPORT IS TO REPORT COMPLICATION OF PATIENT #5, OTHER 6 PATIENTS ARE SUBMITTED TO FDA SEPARATELY. IT WAS REPORTED THAT PATIENT #5 IN THE POST INTERVENTION GROUP UNDERWENT BREAST RECONSTRUCTION SURGERY AND SUFFERED INFECTION RESULTING IN EXPLANTATION. INFECTIONS OCCURRED WITHIN THE FIRST 6 WEEKS FOLLOWING SURGERY. MENTOR DEVICE WITH CATALOG 354-6113, LOT 6700786 WAS USED. DATE OF INFECTION WAS (B)(6) 2013. INFECTION WAS PROCEDURE RELATED, NO BODY IMPAIRMENT WAS INVOLVED. PATIENT REQUIRED HOSPITALIZATION, SURGERY, ANTIBIOTICS AND FULLY RECOVERED. TITLE: ¿ABSORBABLE ANTIBIOTIC BEADS PROPHYLAXIS IN IMMEDIATE BREAST RECONSTRUCTION.¿ THE PURPOSE OF THIS STUDY WAS TO EVALUATE THE EFFECTS OF THIS PROTOCOL MODIFICATION ON PERIPROSTHETIC INFECTION RATES THAT RESULTED IN EXPLANTATION OF THE EXPANDER. THE STUDY WAS CONDUCTED FROM DEC 2012 TO JUNE 2016.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 7385577 ↗