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MENTOR MemoryShape Breast Implant 3341407Recalls & reported problems

Mentor Texas L.P. · Low Height, Moderate Plus Profile Silicone Gel-Filled Breast Implant, 465cc |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 00081317004974), received between Jul 30, 2019 and Oct 18, 2022 — classified as 3 injuries.

The most frequently reported specific device problem is “Migration” (1 report).

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

  • Adverse Event Without Identified Device or Use Problem2
  • Migration1

Patient problems

  • Autoimmune Reaction2
  • Breast Discomfort/Pain1
  • Pain1

Recent adverse event reports

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

  • InjuryOct 18, 2022Migration; Migration

    THIS EVENT IS ASSOCIATED WITH THE GLOW CLINICAL TRIAL. IT WAS REPORTED THAT A CAUCASIAN FEMALE PATIENT WHO UNDERWENT BREAST AUGMENTATION SURGERY WITH A 465CC MENTOR MEMORYSHAPE BREAST IMPLANT EXPERIENCED RIGHT SIDED BREAST PAIN AND DEVICE MIGRATION POST PROCEDURE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

    Patient problems: Breast Discomfort/Pain

    MAUDE report 15622024 ↗
  • InjuryJul 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST SURGERY WITH MENTOR MEMORYGEL BREAST IMPLANT 465CC AND EXPERIENCED BILATERAL AUTOIMMUNE DISORDER AND BREAST PAIN ON THE LEFT SIDE POST-OPERATIONAL. SYMPTOMS INCLUDED FATIGUE, STOMACH PROBLEMS, WIDE SPREAD PAIN, B12 DEFICIENCY, IRRITABLE BOWEL SYNDROME, ARTHRITIS, SWOLLEN GLANDS, PAIN IN RIBS, HEADACHES, NIGHT SWEATS AND SKIN RASHES. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT IS FOR THE RIGHT SIDE.

    Patient problems: Autoimmune Reaction

    MAUDE report 8843431 ↗
  • InjuryJul 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST SURGERY WITH MENTOR MEMORYGEL BREAST IMPLANTS 465CC AND EXPERIENCED BILATERAL AUTOIMMUNE DISORDER AND BREAST PAIN ON THE LEFT SIDE POST-OPERATIONAL. SYMPTOMS INCLUDED FATIGUE, STOMACH PROBLEMS, WIDE SPREAD PAIN, B12 DEFICIENCY, IRRITABLE BOWEL SYNDROME, ARTHRITIS, SWOLLEN GLANDS, PAIN IN RIBS, HEADACHES, NIGHT SWEATS AND SKIN RASHES. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT IS FOR THE LEFT SIDE.

    Patient problems: Autoimmune Reaction; Pain

    MAUDE report 8843430 ↗

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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