MENTOR CPX 2 Breast Tissue Expander 3546112Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00081317002192), received between Dec 26, 2018 and Nov 21, 2024 — classified as 3 injuries.

The most frequently reported specific device problem is “Material Rupture” (2 reports).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryNov 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION SURGERY WITH IMPLANTATION OF A 350CC MENTOR CPX 2 BREAST TISSUE EXPANDER PROSTHESIS. POST-OPERATIVELY, THE PATIENT REPORTED HAVING HAD A POSITRON EMISSION TOMOGRAPHY (PET) SCAN PERFORMED WHICH INDICATED A PROMINENT LEFT BREAST LYMPH NODE. A BIOPSY AND EXCISION OF THE NODE WAS PERFORMED. AFTERWARDS, SHE BEGAN TO EXPERIENCE LEFT BREAST SWELLING AND PAIN. AS A RESULT, THE PATIENT UNDERWENT UNILATERAL LEFT BREAST IMPLANT REMOVAL WITHOUT REPLACEMENT ON (B)(6) 2024. DURING THE SURGERY, APPROXIMATELY 400CC OF FLUID WAS DRAINED FROM THE LEFT BREAST. SHE STATES A POTENTIAL DIAGNOSIS OF LEFT-SIDED BREAST IMPLANT ASSOCIATED ANAPLASTIC LARGE CELL LYMPHOMA (BIA-ALCL) PER THE HEALTH PROFESSIONALS SUSPICIONS. PATHOLOGY RESULTS HAVE NOT BEEN PROVIDED AS OF YET. FOLLOW-UPS ARE BEING CONDUCTED. IF MORE INFORMATION BECOMES AVAILABLE, MENTOR WILL SUBMIT A SUPPLEMENTAL REPORT ACCORDINGLY.

  Patient problems: Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA ALCL); Lymphoma; Seroma; Swollen Lymph Nodes/Glands

  MAUDE report 20753443 ↗
• InjuryJun 4, 2021Off-Label Use; Material Rupture; Off-Label Use; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD FEMALE PATIENT UNDERWENT PRIMARY BREAST RECONSTRUCTION WITH A 350CC MENTOR CPX 2 BREAST TISSUE EXPANDER THAT DEFLATED POSTOPERATIVELY. AS A RESULT, THE PATIENT HAD THE DEVICE EXPLANTED ON (B)(6) 2021. THE PATIENT HAS SINCE RECOVERED FULLY. THE DEVICE WAS IMPLANTED ON (B)(6) 2016. THESE DEVICES ARE INDICATED FOR USE FOR A PERIOD OF SIX MONTHS, AND AS SUCH, THIS DEVICE WAS USED OFF-LABEL.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 11939939 ↗
• InjuryDec 26, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT BREAST RECONSTRUCTION WITH A 350 CC MENTOR CPX 2 BREAST TISSUE EXPANDER. THE EXPANDER WAS IMPLANTED AFTER THE PATIENT WENT THROUGH A BREAST CANCER SURGERY IN 2012 AND IT WAS REPORTED TO HAVE BEEN DEFECTIVE FROM THE BEGINNING AND ALSO HAD LEAKAGE. IT WAS ALSO REPORTED THAT THE PATIENT ASSUMED IT WAS PERFORATED DURING SURGERY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: No Code Available

  MAUDE report 8196710 ↗