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MENTOR MemoryShape Breast Implant 3341357Recalls & reported problems

Mentor Texas L.P. · Low Height, Moderate Plus Profile Silicone Gel-Filled Breast Implant, 415cc |Textured|Contour|Silicone| · Class 3 · Implant

All models of MENTOR MemoryShape Breast Implant (65)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
3
Deaths reported
0
Injuries reported
3
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00081317004967), received between Dec 5, 2019 and Jan 2, 2020 — classified as 3 injuries.

The most frequently reported specific device problem is “Migration” (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

Device problems

  • Migration2
  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • Capsular Contracture3
  • No Code Available3

Recent adverse event reports

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

  • InjuryJan 2, 2020Migration; Migration

    IT WAS REPORTED THAT A (B)(6) YEAR-OLD FEMALE PATIENT WHO UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH MENTOR MEMORYSHAPE BREAST IMPLANT 415CC GEL BREAST PROSTHESES DEVELOPED CAPSULAR CONTRACTURE (BAKER GRADE UNKNOWN) IN BOTH OF HER BREASTS. THE PATIENT REPORTED FEELING PAIN AND THAT SHE COULD FEEL HER IMPLANTS FLIP WHILE DOING CHORES, WHILE BENDING, AND WHILE SLEEPING ON HER SIDE. AS A RESULT, THE PATIENT UNDERWENT A SURGICAL INTERVENTION TO FLIP AND ADJUST THE BREAST PROSTHESES. 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 BREAST PROSTHESIS.

    Patient problems: Capsular Contracture; No Code Available

    MAUDE report 9541192 ↗
  • InjuryJan 2, 2020Migration; Migration

    IT WAS REPORTED THAT A (B)(6) YEAR-OLD FEMALE PATIENT WHO UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH MENTOR MEMORYSHAPE BREAST IMPLANT 415CC GEL BREAST PROSTHESES DEVELOPED CAPSULAR CONTRACTURE (BAKER GRADE UNKNOWN) IN BOTH OF HER BREASTS. THE PATIENT REPORTED FEELING PAIN AND THAT SHE COULD FEEL HER IMPLANTS FLIP WHILE DOING CHORES, WHILE BENDING, AND WHILE SLEEPING ON HER SIDE. AS A RESULT, THE PATIENT UNDERWENT A SURGICAL INTERVENTION TO FLIP AND ADJUST THE BREAST PROSTHESES. 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 BREAST PROSTHESIS.

    Patient problems: Capsular Contracture; No Code Available

    MAUDE report 9541189 ↗
  • InjuryDec 5, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT A (B)(6) FEMALE WHO UNDERWENT BREAST AUGMENTATION REVISION WITH A 415CC MENTOR MEMORYSHAPE BREAST IMPLANT EXPERIENCED RIGHT SIDED BAKER GRADE III CAPSULAR CONTRACTURE POST PROCEDURE. THE CAPSULAR CONTRACTURE WAS CONFIRMED THROUGH A PHYSICAL EXAMINATION. AS A RESULT, THE DEVICE WAS EXPLANTED ON (B)(6) 2018. ON (B)(6) 2019, MENTOR BECAME AWARE THAT PREVIOUSLY-SUBMITTED PSR REFERENCE (B)(4) WERE DUPLICATED. ANY ADDITIONAL EVENT INFORMATION RECEIVED WILL BE REPORTED UNDER THIS MANUFACTURER'S REPORT NUMBER AS APPLICABLE. THIS REPORT CONTAINS SUPPLEMENTAL INFORMATION FOR MENTOR PSR REFERENCE NUMBER (B)(4).

    Patient problems: Capsular Contracture; No Code Available

    MAUDE report 9417837 ↗

Other Prosthesis, breast, noninflatable, internal, silicone gel-filled devices

All Prosthesis, breast, noninflatable, internal, silicone gel-filled devices →

Sources and updates

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