MENTOR MemoryShape Breast Implant 3341159Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00081317005063), received between Aug 23, 2019 and Sep 3, 2025 — classified as 12 injuries.

The most frequently reported specific device problem is “Material Rupture” (4 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjurySep 3, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 400CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED CAPSULAR CONTRACTURE (BAKER GRADE 4) AND A RUPTURE ON THE LEFT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025.

  Patient problems: Capsular Contracture

  MAUDE report 22954543 ↗
• InjurySep 3, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 305CC MENTOR MEMORYSHAPE BREAST IMPLANT EXPERIENCED A RUPTURE ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 22954251 ↗
• InjuryNov 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS EVENT IS ASSOCIATED WITH THE MNT-MEN-15-003 CLINICAL TRIAL, PARTICIPANT 430-126. IT WAS REPORTED THAT A CAUCASIAN FEMALE PATIENT UNDERWENT BREAST AUGMENTATION PROCEDURE WITH 305CC MENTOR MEMORYSHAPE BREAST IMPLANT (MENTOR GLOW STUDY GEL DEVICES) ON (B)(6) 2018, AND EXPERIENCED AUTOIMMUNE DISORDER OF RAYNAUD¿S PHENOMENON. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT-SIDED DEVICE.

  Patient problems: Autoimmune Disorder

  MAUDE report 18220672 ↗
• InjuryNov 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS EVENT IS ASSOCIATED WITH THE (B)(4) CLINICAL TRIAL, PARTICIPANT (B)(6). IT WAS REPORTED THAT A CAUCASIAN FEMALE PATIENT UNDERWENT BREAST AUGMENTATION PROCEDURE WITH 305CC MENTOR MEMORYSHAPE BREAST IMPLANT (MENTOR GLOW STUDY GEL DEVICES) ON (B)(6) 2018, AND EXPERIENCED AUTOIMMUNE DISORDER OF RAYNAUD¿S PHENOMENON. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT-SIDED DEVICE.

  Patient problems: Autoimmune Disorder

  MAUDE report 18220670 ↗
• InjuryOct 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 42-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 270CC (LEFT) AND A 305CC (RIGHT) MENTOR MEMORYSHAPE BREAST IMPLANTS AND EXPERIENCED A RUPTURE ON THE LEFT SIDE AND ANISOMASTIA ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2022. THIS REPORT IS FOR THE RIGHT SIDE DEVICE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 15565984 ↗
• InjuryAug 31, 2021Migration; Migration

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT UNDERWENT UNSPECIFIED BREAST SURGERY WITH 305CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED LEFT SIDE DEVICE MIGRATION AND PAIN. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Pain

  MAUDE report 12394909 ↗
• InjuryOct 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH 305CC MENTOR MEMORYSHAPE BREAST IMPLANTS EXPERIENCED BILATERAL BAKER GRADE III CAPSULAR CONTRACTURE POST PROCEDURE. THE CAPSULAR CONTRACTURES WERE CONFIRMED THROUGH A PHYSICAL EXAMINATION. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. SEE 1645337-2020-13459 FOR CONTRALATERAL PROSTHESIS REPORT.

  Patient problems: Capsular Contracture

  MAUDE report 10715818 ↗
• InjuryOct 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH 305CC MENTOR MEMORYSHAPE BREAST IMPLANTS EXPERIENCED BILATERAL BAKER GRADE III CAPSULAR CONTRACTURE POST PROCEDURE. THE CAPSULAR CONTRACTURES WERE CONFIRMED THROUGH A PHYSICAL EXAMINATION. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. SEE 1645337-2020-13458 FOR CONTRALATERAL PROSTHESIS REPORT.

  Patient problems: Capsular Contracture

  MAUDE report 10715817 ↗
• InjuryAug 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH A 350CC MENTOR MEMORYSHAPE BREAST IMPLANT EXPERIENCED LEFT SIDED CAPSULAR CONTRACTURE (BAKER GRADE UNKNOWN) POST PROCEDURE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME, IF ADDITIONAL INFORMATION BECOMES AVAILABLE IN THE FUTURE, THEN A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: Capsular Contracture

  MAUDE report 10376326 ↗
• InjuryMay 12, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT BREAST SURGERY WITH 305CC MENTOR MEMORY SHAPE BREAST IMPLANTS AND EXPERIENCED A CAR ACCIDENT RESULTING IN A UNILATERAL RUPTURE ON THE RIGHT SIDE POSTOPERATIVELY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Injury; No Code Available

  MAUDE report 10050087 ↗
• InjuryDec 4, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE UNDERWENT BREAST AUGMENTATION REVISION WITH A 305CC MENTOR MEMORYSHAPE BREAST IMPLANT AND EXPERIENCED RIGHT SIDED CAPSULAR CONTRACTURE POST PROCEDURE. THE CAPSULAR CONTRACTURE WAS DIAGNOSED THROUGH ULTRASOUND AND MAMMOGRAPHY. THE BAKER¿S GRADE OF THE CAPSULAR CONTRACTURE IS NOT KNOWN. AS A RESULT, AN EXPLANT WAS PERFORMED ON (B)(6) 2019. THIS REPORT CONTAINS SUPPLEMENTAL INFORMATION FOR MENTOR PSR REFERENCE NUMBER (B)(4). ADDITIONAL INFORMATION FOR THIS EVENT WAS RECEIVED ON (B)(6) 2019.

  Patient problems: Capsular Contracture; No Code Available

  MAUDE report 9413685 ↗
• InjuryAug 23, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH A MENTOR MEMORYSHAPE BREAST IMPLANT 305CC AND EXPERIENCED LATE ONSET SEROMA. THE SIDE THE SEROMA OCCURRED ON IS UNKNOWN. THE PATIENT HAD AN ULTRASOUND WITH ASPIRATION OF THE FLUID FOR CYTOLOGY AND CD30. THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH MENTOR MEMORYGEL BREAST IMPLANTS 375CC, CATALOG NUMBER 3503754BC, SERIAL NUMBER (B)(4), LOT NUMBER 7720300 (L) AND 425CC, CATALOG NUMBER 3504254BC, SERIAL NUMBER (B)(4), LOT NUMBER 7715622 (R) ON (B)(6) 2019. IN THE ABSENCE OF CLARIFYING INFORMATION, THE LEFT SIDE WILL BE THE DEFAULT COMPLAINT SIDE. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: Capsular Contracture; No Code Available; Seroma

  MAUDE report 8927990 ↗