MENTOR CPX 3 Breast Tissue Expander with Suturing Tabs 3547315Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00081317003779), received between Sep 24, 2019 and Jan 3, 2020 — classified as 4 injuries.

The most frequently reported specific device problem is “Off-Label Use” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJan 3, 2020Off-Label Use; Material Rupture; Off-Label Use; Material Rupture

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT WHO UNDERWENT PRIMARY BREAST RECONSTRUCTION SURGERY WITH 650CC MENTOR CPX 3 BREAST TISSUE EXPANDER WITH SUTURING TABS EXPERIENCED BILATERAL SWELLING, CHRONIC PAIN, FATIGUE, LACK OF SLEEP, INSOMNIA, EDEMA, AVID LYMPH NODES, LEFT SIDED BREAST PAIN AND LEFT SIDED DEFLATION POST PROCEDURE. PATIENT ALSO HAD TISSUE EXPANDERS IN FOR MORE THAN 6 YEARS. AS A RESULT, PATIENT HAD AN EXPLANTATION ON (B)(6) 2019. THIS REPORT IS FOR THE LEFT SIDED DEVICE. SEE 1645337-2020-00200 FOR CONTRALATERAL PROSTHESIS REPORT.

  Patient problems: Capsular Contracture; No Code Available

  MAUDE report 9547503 ↗
• InjuryJan 3, 2020Off-Label Use; Off-Label Use

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT WHO UNDERWENT PRIMARY BREAST RECONSTRUCTION SURGERY WITH 650CC MENTOR CPX 3 BREAST TISSUE EXPANDER WITH SUTURING TABS EXPERIENCED BILATERAL SWELLING, CHRONIC PAIN, FATIGUE, LACK OF SLEEP, INSOMNIA, EDEMA, AVID LYMPH NODES, LEFT SIDED BREAST PAIN AND LEFT SIDED DEFLATION POST PROCEDURE. PATIENT ALSO HAD TISSUE EXPANDERS IN FOR MORE THAN 6 YEARS. AS A RESULT, PATIENT HAD AN EXPLANTATION ON (B)(6) 2019. THIS IS FOR RIGHT SIDED DEVICE. SEE 1645337-2020-00204 FOR CONTRALATERAL PROSTHESIS REPORT.

  Patient problems: Capsular Contracture; Local Reaction; No Code Available

  MAUDE report 9547372 ↗
• InjurySep 24, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDWATCH NUMBER: MW5088755. IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT AN UNSPECIFIED BREAST RECONSTRUCTION WITH A 650CC MENTOR CPX 3 BREAST TISSUE EXPANDER WITH SUTURING TABS AND EXPERIENCED POSTOPERATIVE RIGHT-SIDED EARLY ONSET SEROMA AND LEFT-SIDED DEFLATION. THE SEROMA NEEDED TO BE ASPIRATED, AND THE RIGHT-SIDED TISSUE EXPANDER WAS REMOVED. THE PATIENT REPORTED THAT THE LEFT-SIDED DEFLATED TISSUE EXPANDER HAS BEEN IMPLANTED FOR SIX YEARS, AND AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THE RIGHT-SIDED EXPLANTATION DATE WAS ESTIMATED BASED ON AVAILABLE INFORMATION, IF NEW INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED AS APPLICABLE. THIS MEDWATCH REPORT IS FOR THE RIGHT-SIDED IMPLANT.

  Patient problems: No Code Available; Seroma

  MAUDE report 9111943 ↗
• InjurySep 24, 2019Off-Label Use; Material Rupture; Off-Label Use; Material Rupture

  MEDWATCH NUMBER: MW5088755 IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT AN UNSPECIFIED BREAST RECONSTRUCTION WITH A 650CC MENTOR CPX 3 BREAST TISSUE EXPANDER WITH SUTURING TABS AND EXPERIENCED POSTOPERATIVE RIGHT-SIDED EARLY ONSET SEROMA AND LEFT-SIDED DEFLATION. THE SEROMA NEEDED TO BE ASPIRATED, AND THE RIGHT-SIDED TISSUE EXPANDER WAS REMOVED. THE PATIENT REPORTED THAT THE LEFT-SIDED DEFLATED TISSUE EXPANDER HAS BEEN IMPLANTED FOR SIX YEARS, AND AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS MEDWATCH REPORT IS FOR THE LEFT-SIDED IMPLANT.

  Patient problems: No Code Available

  MAUDE report 9111937 ↗