MENTOR MemoryShape Breast Implant 3341459Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00081317005124), received between Sep 5, 2018 and Sep 28, 2026 — classified as 11 injuries.

The most frequently reported specific device problem is “Material Rupture” (5 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 16, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjurySep 28, 2026Material Rupture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50925216 ↗
• InjuryNov 18, 2025Migration; Migration

  IT WAS REPORTED THAT A 63-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH TWO 615CC MENTOR MEMORYSHAPE BREAST IMPLANTS AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE (BAKER GRADE 4), BILATERAL DEVICE MIGRATIONS, AND A RUPTURE ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025 AND REPLACED WITH A NON-MENTOR DEVICES (ALLERGAN). IT WAS REPORTED THAT IN 2019, THE PATIENT UNDERWENT A BREAST LIFT AND CAPSULORRHAPHY WITH POSSIBLE MESH REPLACEMENT. THIS REPORT IS FOR THE LEFT SIDE DEVICE.

  Patient problems: Capsular Contracture

  MAUDE report 23588541 ↗
• InjuryNov 18, 2025Material Rupture; Migration; Material Rupture; Migration

  IT WAS REPORTED THAT A 63-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH TWO 615CC MENTOR MEMORYSHAPE BREAST IMPLANTS AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE (BAKER GRADE 4), BILATERAL DEVICE MIGRATIONS, AND A RUPTURE ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025, AND REPLACED WITH A NON-MENTOR DEVICES (ALLERGAN). IT WAS REPORTED THAT IN 2019, THE PATIENT UNDERWENT A BREAST LIFT AND CAPSULORRHAPHY WITH POSSIBLE MESH REPLACEMENT. THIS REPORT IS FOR THE RIGHT SIDE DEVICE.

  Patient problems: Capsular Contracture

  MAUDE report 23588529 ↗
• InjurySep 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT BREAST RECONSTRUCTION WITH A 615CC MENTOR MEMORYSHAPE BREAST IMPLANT EXPERIENCED LEFT SIDED CUTANEOUS CONTOUR DEFORMITY POST PROCEDURE. AN UNSPECIFIED SURGICAL INTERVENTION WAS PERFORMED. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS PATIENT WAS PART OF A POST APPROVAL STUDY.

  Patient problems: Wrinkling

  MAUDE report 17746946 ↗
• InjuryNov 16, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION WITH TWO 615CC MENTOR MEMORYSHAPE BREAST IMPLANTS AND EXPERIENCED BILATERAL BREAST PAIN, CUTANEOUS CONTOUR DEFORMITY, AND RUPTURE SIDE POST-OPERATIVELY. AT THE TIME OF THIS REPORT, HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT IS FOR THE RIGHT SIDE DEVICE.

  Patient problems: Breast Discomfort/Pain; Wrinkling

  MAUDE report 15811276 ↗
• InjuryNov 16, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION WITH TWO 615CC MENTOR MEMORYSHAPE BREAST IMPLANTS AND EXPERIENCED BILATERAL BREAST PAIN, CUTANEOUS CONTOUR DEFORMITY, AND RUPTURE SIDE POST-OPERATIVELY. AT THE TIME OF THIS REPORT, HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT IS FOR THE LEFT SIDE DEVICE.

  Patient problems: Breast Discomfort/Pain; Wrinkling

  MAUDE report 15810053 ↗
• InjuryFeb 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH TWO 615CC MENTOR MEMORYSHAPE BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT EXPERIENCED ANNOYING ITCHING INSIDE OF THE RIGHT BREAST. MRI REPORTED NORMAL. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 13510355 ↗
• InjurySep 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT WHO UNDERWENT PRIMARY BREAST RECONSTRUCTION WITH TWO 615CC MENTOR MEMORYSHAPE BREAST IMPLANTS, SUFFERED BILATERAL PAIN UNDER THE ARMPIT AND ALSO FELT POCKETS OF FLUID, POST-OPERATIVELY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Local Reaction

  MAUDE report 8957861 ↗
• InjurySep 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT WHO UNDERWENT PRIMARY BREAST RECONSTRUCTION WITH TWO 615CC MENTOR MEMORYSHAPE BREAST IMPLANTS, SUFFERED BILATERAL PAIN UNDER THE ARMPIT AND ALSO FELT POCKETS OF FLUID, POST-OPERATIVELY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Local Reaction

  MAUDE report 8957859 ↗
• InjuryJul 30, 2019Material Rupture; Adverse Event Without Identified Device or Use Problem; Material Rupture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD FEMALE UNDERWENT A BREAST RECONSTRUCTION REVISION WITH A MENTOR MEMORYSHAPE BREAST IMPLANT 615CC AND EXPERIENCED BREAST PAIN AND CUTANEOUS CONTOUR DEFORMITY ON THE LEFT SIDE POST-OPERATIONAL. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: No Code Available; Pain; Wrinkling

  MAUDE report 8842242 ↗
• InjurySep 5, 2018Fungus in Device Environment; Fungus in Device Environment

  IT WAS REPORTED THAT A PATIENT WAS GOING TO UNDERGO BREAST IMPLANTATION PROCEDURE OF UNKNOWN TYPE WITH A GEL MENTOR MEMORYSHAPE BREAST IMPLANT 615CC AND IT WAS DISCOVERED THAT THE IMPLANT WAS RECEIVED WITH MOLD INSIDE THE BOX. THERE WAS NO PATIENT CONTACT WITH IMPLANT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7846740 ↗