MENTOR MemoryShape Breast Implant 3341302Recalls & reported problems

Summary

The FDA's MAUDE database contains 95 adverse event reports that list this exact device (DI 00081317005223), received between May 10, 2019 and Mar 30, 2026 — classified as 94 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Rupture” (13 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 25 most recent of 95 reports, in the reporter's own words as published by the FDA.

• InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 60-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A 355 CC (RIGHT) MENTOR MEMORYSHAPE BREAST IMPLANT AND A 495 CC (LEFT) MENTOR MEMORYSHAPE BREAST IMPLANT AND EXPERIENCED BILATERAL BREAST ASYMMETRY/BREAST PTOSIS POST-OPERATIVELY. IT WAS ALSO REPORTED THAT THE PATIENT EXPERIENCED A RUPTURE AND PROGRESSIVE SWELLING ON THE RIGHT SIDE. THE PATIENT HAD UNDERGONE NEEDLE ASPIRATION WHICH WAS NEGATIVE FOR ANY PATHOLOGY OR INFECTION. AS A RESULT, THE PATIENT UNDERWENT BILATERAL DEVICE EXPLANTATION ON (B)(6) 2026 AND REPLACED WITH TWO 440 CC MENTOR MEMORYGEL BOOST BREAST IMPLANTS. THIS REPORT IS FOR THE LEFT SIDE DEVICE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 24718734 ↗
• InjuryDec 16, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT WITH MENTOR MEMORYSHAPE BREAST IMPLANTS EXPERIENCED SEROMA AND RUPTURE ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT DEVICE REMOVAL AND REPLACEMENT.

  Patient problems: Seroma

  MAUDE report 23818375 ↗
• InjurySep 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO MENTOR MEMORYSHAPE BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA PHYSICAL EXAMINATION, WITH BILATERAL BREAST CAPSULAR CONTRACTURES (BAKER GRADE III). 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: Capsular Contracture

  MAUDE report 23030720 ↗
• InjuryAug 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT, AS PART OF A CLINICAL STUDY, BREAST AUGMENTATION REVISION WITH A 495CC MENTOR MEMORYSHAPE BREAST IMPLANT ON THE LEFT BREAST. POST-OPERATIVELY, THE PATIENT SUFFERED LEFT BREAST CONTOUR DEFORMITY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Wrinkling

  MAUDE report 22868978 ↗
• InjuryAug 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT, AS PART OF A CLINICAL STUDY, BREAST AUGMENTATION WITH TWO 495CC MENTOR MEMORYSHAPE BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT SUFFERED RIGHT BREAST ASYMMETRY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 22730158 ↗
• InjuryJun 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH MENTOR MEMORYSHAPE BREAST IMPLANTS 495CC AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE BAKER GRADE II ALONG WITH GRANULOMA AND RUPTURE ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED VIA MAMMOGRAM/ULTRASOUND. AS A RESULT, THE PATIENT IS SCHEDULED FOR REMOVAL ON (B)(6) 2025. THIS REPORT IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 22141889 ↗
• InjuryMay 27, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 47-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH TWO 495 MENTOR MEMORYSHAPE BREAST IMPLANTS AND EXPERIENCED BILATERAL RUPTURES POST-OPERATIVELY, WHICH WAS DIAGNOSED WITH A PHYSICAL EXAM AND MRI. AS A RESULT, THE PATIENT UNDERWENT AN EXPLANTATION ON (B)(6) 2025. THIS REPORT IS FOR THE LEFT SIDE DEVICE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 22091082 ↗
• InjuryMay 27, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 47-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH TWO 495 MENTOR MEMORYSHAPE BREAST IMPLANTS AND EXPERIENCED BILATERAL RUPTURES POST-OPERATIVELY, WHICH WAS DIAGNOSED WITH A PHYSICAL EXAM AND MRI. AS A RESULT, THE PATIENT UNDERWENT AN EXPLANTATION ON (B)(6) 2025. THIS REPORT IS FOR THE RIGHT-SIDE DEVICE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 22091079 ↗
• InjuryMay 12, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT BREAST AUGMENTATION WITH 495CC MENTOR MEMORYSHAPE BREAST IMPLANTS EXPERIENCED BILATERAL RUPTURE, CHEST PAIN, AND RIGHT SIDED BAKER GRADE IV CAPSULAR CONTRACTURE POST PROCEDURE. THE RUPTURE AS FOUND THROUGH ULTRASOUND. AS A RESULT, THE DEVICES WERE EXPLANTED ON (B)(6) 2025.

  Patient problems: Breast Discomfort/Pain

  MAUDE report 22003296 ↗
• InjuryMay 12, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT BREAST AUGMENTATION WITH 495CC MENTOR MEMORYSHAPE BREAST IMPLANTS EXPERIENCED BILATERAL RUPTURE, CHEST PAIN, AND RIGHT SIDED BAKER GRADE IV CAPSULAR CONTRACTURE POST PROCEDURE. THE RUPTURE AS FOUND THROUGH ULTRASOUND. AS A RESULT, THE DEVICES WERE EXPLANTED ON (B)(6) 2025.

  Patient problems: Capsular Contracture

  MAUDE report 22003291 ↗
• InjuryMay 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST PROSTHESIS IMPLANTATION SURGERY WITH TWO 495CC MENTOR MEMORYSHAPE BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT SUFFERED LEFT BREAST RIPPLING AND HAD TO HAVE DRAINS FOR MONTHS. AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2015.

  Patient problems: Wrinkling

  MAUDE report 21982333 ↗
• InjuryMar 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HIS EVENT IS ASSOCIATED WITH THE GLOW CLINICAL TRIAL. R SIDE: SN (B)(6), L SIDE: SN (B)(6) DOI: (B)(6) 2015. DURING THE 10 YEAR FOLLOW-UP VISIT THE PATIENT REPORTED DISSATISFACTION WITH PROCEDURE OUTCOME. AT THIS TIME, MENTOR HAS RECEIVED VERY LIMITED INFORMATION REGARDING THIS EVENT, BASED ON THE INFORMATION PROVIDED IN EDC (IMEDIDATA) THE PATIENT SUFFERED BREAST RIPPLING (WRINKLING). AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS CASE WILL BE RE-ASSESSED AND NOTES WILL BE UPDATED. THIS REPORT RELATES TO THE LEFT SIDE.

  Patient problems: Wrinkling

  MAUDE report 21599541 ↗
• InjuryMar 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS EVENT IS ASSOCIATED WITH THE GLOW CLINICAL TRIAL. R SIDE: SN(B)(6), L SIDE: SN (B)(6) DOI: 24 JUN 2015 DURING THE 10 YEAR FOLLOW-UP VISIT THE PATIENT REPORTED DISSATISFACTION WITH PROCEDURE OUTCOME. AT THIS TIME, MENTOR HAS RECEIVED VERY LIMITED INFORMATION REGARDING THIS EVENT, BASED ON THE INFORMATION PROVIDED IN EDC (IMEDIDATA) THE PATIENT SUFFERED BREAST RIPPLING (WRINKLING). AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS CASE WILL BE RE-ASSESSED AND NOTES WILL BE UPDATED.. THIS REPORT RELATES TO THE RIGHT SIDE.

  Patient problems: Wrinkling

  MAUDE report 21599473 ↗
• InjuryFeb 18, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH MENTOR MEMORYSHAPE BREAST IMPLANTS 495CC AND EXPERIENCED RUPTURE ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED VIA MAMMOGRAM/ULTRASOUND. AS A RESULT, THE PATIENT IS SCHEDULED FOR REMOVAL ON (B)(6), 2025.

  Patient problems: Capsular Contracture; Deformity/ Disfigurement; Granuloma

  MAUDE report 21404332 ↗
• InjuryNov 5, 2024Migration; Migration

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST RECONSTRUCTION REVISION WITH TWO UNKNOWN MENTOR GEL IMPLANTS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA MRI, WITH RIGHT BREAST IMPLANT RUPTURE. AS A RESULT, THE PATIENT UNDERWENT BILATERAL BREAST IMPLANT REMOVAL AND REPLACEMENT SURGERY ON (B)(6) 2024. DURING THE SURGERY, THE LEFT BREAST IMPLANT WAS ALSO DIAGNOSED TO BE MALPOSITIONED. SUBSEQUENTLY, THE PATIENT'S IMPLANTS WERE REPLACED WITH THE FOLLOWING DEVICES: (RIGHT) 545CC MENTOR MEMORYGEL BOOST BREAST IMPLANT CATALOG: SHPB545 LOT: 9818539 SN: (B)(6) AND (LEFT) 545CC MENTOR MEMORYGEL BOOST BREAST IMPLANT CATALOG: SHPB545 LOT: 9989182 SN: (B)(6). THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 20612594 ↗
• InjurySep 19, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST RECONSTRUCTION REVISION WITH TWO UNKNOWN MENTOR GEL IMPLANTS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA MRI, WITH RIGHT BREAST IMPLANT RUPTURE. AS A RESULT, THE PATIENT HAS BEEN SCHEDULED FOR BREAST IMPLANT REMOVAL SURGERY ON OCTOBER 17, 2024.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 20254507 ↗
• InjuryAug 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST IMPLANTATION PROCEDURE WITH MENTOR MEMORYSHAPE BREAST IMPLANTS 495CC AND EXPERIENCED BREAST PAIN ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. 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 20090971 ↗
• InjuryAug 9, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION REVISION WITH MENTOR MEMORYSHAPE BREAST IMPLANTS 495CC AND SUFFERED SEVERAL UNEXPLAINED SYSTEMIC SYMPTOMS, INCLUDING INFLAMMATION ALONG WITH OTHER UNSPECIFIED SYMPTOMS. DEVICE RUPTURE ON THE LEFT SIDE WAS DISCOVERED VIA CT/MRI SCANS. THE ROOT CAUSE OF THE PATIENT¿S SYMPTOMS IS UNCLEAR. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH NON-MENTOR DEVICES ON (B)(6) 2024. THIS REPORT IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 19952286 ↗
• InjuryAug 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION REVISION WITH MENTOR MEMORYSHAPE BREAST IMPLANTS 495CC AND SUFFERED SEVERAL UNEXPLAINED SYSTEMIC SYMPTOMS, INCLUDING INFLAMMATION ALONG WITH OTHER UNSPECIFIED SYMPTOMS. DEVICE RUPTURE ON THE LEFT SIDE WAS DISCOVERED VIA CT/MRI SCANS. THE ROOT CAUSE OF THE PATIENT¿S SYMPTOMS IS UNCLEAR. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH NON-MENTOR DEVICES ON (B)(6) 2024. THIS REPORT IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 19951956 ↗
• InjuryJul 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH MED WATCH-5155030, MW5155031, A FEMALE WHO UNDERWENT A BREAST RECONSTRUCTION PRIMARY WITH MENTOR MEMORYSHAPE 495CC, SILICONE PROSTHESIS EXPERIENCED UNEXPLAINED SYSTEMATIC SYMPTOMS POSTOPERATIVE, INCLUDING FATIGUE, HAIR LOSS, MUSCLE WEAKNESS, TINNITUS, BURNING SENSATION, DIZZINESS, ANXIETY, ARTHRALGIA], DEPRESSION, IRREGULAR PULSE, COGNITIVE CHANGES, WEIGHT CHANGES, WRINKLING, UNSPECIFIED RESPIRATORY PROBLEM, EYE / VISION PROBLEM, PREMATURE MENOPAUSE, BREAST DISCOMFORT/PAIN. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT IS ONE OF THE TWO REPORTS.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 19841306 ↗
• InjuryJun 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION WITH MENTOR MEMORYSHAPE BREAST IMPLANTS 495CC AND EXPERIENCED RIPPLING AND ASYMMETRY (SIDE UNKNOWN) POST-OPERATIVELY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THE IMPLANT INFORMATION WAS PROVIDED FOR BOTH BREAST PROSTHESES; HOWEVER, IT IS UNCLEAR WHICH IS THE IMPACTED PRODUCT. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THE CORRECT COMPLAINT DEVICE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: Deformity/ Disfigurement; Wrinkling

  MAUDE report 19481830 ↗
• InjuryMay 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST RECONSTRUCTION SURGERY WITH A 495CC MENTOR MEMORYSHAPE BREAST IMPLANT. POST-OPERATIVELY, THE PATIENT EXPERIENCED BREAST WRINKLING ON AN UNDISCLOSED SIDE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. SERIAL NUMBERS FOR TWO DEVICES WERE PROVIDED, BUT THE SIDE OF THE COMPLICATION WAS NOT DISCLOSED. AS SUCH, BOTH SERIAL NUMBERS WERE POPULATED IN THE SERIAL NUMBER FIELD. THE CATALOG AND BRAND NAME FOR BOTH DEVICES IS THE SAME. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: Wrinkling

  MAUDE report 19392233 ↗
• InjuryMar 1, 2024Migration; Migration

  IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST RECONSTRUCTION WITH TWO 495CC MENTOR MEMORYSHAPE BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT SUFFERED BILATERAL BREAST PAIN, SKIN CONDITIONS, AIR BUBBLES AND MOVEMENT. 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: Breast Discomfort/Pain; Skin Inflammation/ Irritation

  MAUDE report 18817057 ↗
• InjuryMar 1, 2024Migration; Migration

  IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST RECONSTRUCTION WITH TWO 495CC MENTOR MEMORYSHAPE BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT SUFFERED BILATERAL BREAST PAIN, SKIN CONDITIONS, AIR BUBBLES AND MOVEMENT. 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: Breast Discomfort/Pain; Skin Inflammation/ Irritation

  MAUDE report 18817038 ↗
• InjurySep 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE WHO UNDERWENT A BREAST AUGMENTATION REVISION WITH A MENTOR MEMORYSHAPE, 495CC SILICONE PROSTHESIS EXPERIENCED RIGHT--SIDED CAPSULAR CONTRACTURE UNKNOWN GRADE POST OPERATIVE. THE ISSUE WAS DIAGNOSED THROUGH PHYSICAL EXAMINATION. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Capsular Contracture

  MAUDE report 17745968 ↗