MENTOR MemoryShape Breast Implant 3341505Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00081317005384), received between Mar 20, 2019 and Dec 4, 2025 — classified as 16 injuries.

The most frequently reported specific device problem is “Material Rupture” (6 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryDec 4, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 650CC MENTOR MEMORYSHAPE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT REPORTED EXPERIENCING A RUPTURED LEFT IMPLANT WITH SILICONE IN THE LYMPH NODES AFTER HAVING A MAMMOGRAM, ULTRASOUND, AND CONSULTATION WITH A MEDICAL PROFESSIONAL. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. FOLLOW-UPS HAVE BEEN CONDUCTED, AND NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. IF MORE INFORMATION BECOMES AVAILABLE, MENTOR WILL SUBMIT A SUPPLEMENTAL REPORT ACCORDINGLY.

  Patient problems: Granuloma

  MAUDE report 23719678 ↗
• InjuryJan 15, 2025Migration; Migration

  A FEMALE PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH MENTOR MEMORYSHAPE 650CC SILICONE PROSTHESES EXPERIENCED BILATERAL DEVICE MIGRATION, COUPLED WITH RIGHT-SIDED PAIN AND POSTOPERATIVE WRINKLING. THE PATIENT REPORTED SEVERE TWISTING PAIN IN THE RIGHT BREAST AND CREASING ON THE LEFT SIDE, NOTING THAT THE IMPLANTS BEGAN TWISTING AND MOVING IN EARLY 2017. IT WAS NOT UNTIL THE SUMMER OF 2023 THAT THE PATIENT WAS EVALUATED BY A PROVIDER WITH PRIOR EXPERIENCE IN PLASTIC SURGERY, WHO IDENTIFIED THE CAUSE OF HER LONG-STANDING PAIN. AT THE TIME OF THIS REPORT, MENTOR HAS NOT RECEIVED ANY INFORMATION REGARDING EXPLANTATION OR A SCHEDULED EXPLANTATION DATE, ALTHOUGH THIS REPORT SPECIFICALLY PERTAINS TO THE RIGHT SIDE.

  Patient problems: Breast Discomfort/Pain; Wrinkling

  MAUDE report 21161328 ↗
• InjuryJan 15, 2025Migration; Migration

  A FEMALE PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH MENTOR MEMORYSHAPE 650CC SILICONE PROSTHESES EXPERIENCED BILATERAL DEVICE MIGRATION, COUPLED WITH RIGHT-SIDED PAIN AND POSTOPERATIVE WRINKLING. THE PATIENT REPORTED SEVERE TWISTING PAIN IN THE RIGHT BREAST AND CREASING ON THE LEFT SIDE, NOTING THAT THE IMPLANTS BEGAN TWISTING AND MOVING IN EARLY 2017. IT WAS NOT UNTIL THE SUMMER OF 2023 THAT THE PATIENT WAS EVALUATED BY A PROVIDER WITH PRIOR EXPERIENCE IN PLASTIC SURGERY, WHO IDENTIFIED THE CAUSE OF HER LONG-STANDING PAIN. AT THE TIME OF THIS REPORT, MENTOR HAS NOT RECEIVED ANY INFORMATION REGARDING EXPLANTATION OR A SCHEDULED EXPLANTATION DATE, ALTHOUGH THIS REPORT SPECIFICALLY PERTAINS TO THE LEFT SIDE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 21161178 ↗
• InjuryApr 13, 2022Migration; Migration

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT WHO UNDERWENT BREAST AUGMENTATION REVISION SURGERY WITH TWO 375CC MENTOR MEMORYSHAPE BREAST IMPLANTS EXPERIENCED DEVICE MIGRATION POST PROCEDURE. 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: Deformity/ Disfigurement

  MAUDE report 14108162 ↗
• InjuryJan 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE WHO UNDERWENT AN UNSPECIFIED BREAST SURGERY WITH A MENTOR MEMORYSHAPE, 650CC SILICONE BREAST IMPLANT EXPERIENCED LEFT-SIDED ASYMMETRY ISSUE POSTOPERATIVELY. AS A RESULT, PATIENT SCHEDULED FOR REMOVAL ON (B)(6) 2022.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 13283181 ↗
• InjurySep 3, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE WHO UNDERWENT BREAST RECONSTRUCTION REVISION EXPERIENCED RIGHT SIDED RUPTURE POST PROCEDURE. THE IMPLANT WAS ACCIDENTALLY PUNCTURED BY A NEEDLE AND BEGAN TO APPEAR SMALLER AFTERWARD. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Injury

  MAUDE report 10490915 ↗
• InjuryJul 17, 2020Adverse 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 A BREAST SURGERY WITH A 650 CC MENTOR MEMORYSHAPE BREAST IMPLANT AND EXPERIENCED POSTOPERATIVE LEFT-SIDED SEROMA. AS A RESULT, THE PATIENT UNDERWENT A SURGICAL INTERVENTION FOR SEROMA DRAINAGE AND UNILATERAL REMOVAL AND REPLACEMENT WITH AN UNSPECIFIED MENTOR GEL BREAST IMPLANT ON (B)(6) 2020.

  Patient problems: No Code Available; Seroma

  MAUDE report 10289888 ↗
• InjuryDec 23, 2019Material Rupture; Material Rupture

  THIS REPORT CONTAINS SUPPLEMENTAL INFORMATION FOR MENTOR PSR SUBMISSION REFERENCE NUMBER (B)(4). IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT UNDERWENT PRIMARY BREAST RECONSTRUCTION WITH A 650CC MENTOR MEMORYSHAPE BREAST IMPLANT AND SUFFERED CHRONIC RIGHT-SIDED BREAST PAIN POSTOPERATIVELY. AS A RESULT, THE PATIENT HAD THE DEVICE EXPLANTED ON (B)(6) 2019. UPON EXPLANT, THE DEVICE WAS FOUND TO BE RUPTURED. THE PATIENT USED AN ALLERGAN REPLACEMENT DEVICE.

  Patient problems: No Code Available; Pain

  MAUDE report 9512205 ↗
• InjuryNov 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT WHO UNDERWENT BREAST SURGERY WITH TWO 650CC MENTOR MEMORYSHAPE BREAST IMPLANTS EXPERIENCED BILATERAL PAIN AND DISCOMFORT POST PROCEDURE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT IS FOR THE LEFT SIDED DEVICE. SEE 1645337-2019-24468 FOR CONTRALATERAL PROSTHESIS REPORT.

  Patient problems: Pain

  MAUDE report 9369793 ↗
• InjuryNov 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT WHO UNDERWENT BREAST SURGERY WITH TWO 650CC MENTOR MEMORYSHAPE BREAST IMPLANTS EXPERIENCED BILATERAL PAIN AND DISCOMFORT POST PROCEDURE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT IS FOR THE RIGHT SIDED DEVICE. SEE 1645337-2019-24467 FOR CONTRALATERAL PROSTHESIS REPORT.

  Patient problems: Pain

  MAUDE report 9369790 ↗
• InjuryJun 12, 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 REVISION WITH MENTOR MEMORYSHAPE¿650CC SILICONE BREAST IMPLANTS WHICH PATIENT BELIEVES HER LEFT SIDE IS RUPTURED, AND AS A RESULT IMPLANT HAS DROPPED. HER RIGHT SIDE HAS WRINKLED AND FEELS LIKE A BUBBLE. THESE ISSUES OCCURRED AFTER IMPLANTATION. 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: Wrinkling

  MAUDE report 8691412 ↗
• InjuryJun 12, 2019Migration or Expulsion of Device; Off-Label Use; Material Rupture; Migration; Migration or Expulsion of Device; Off-Label Use; Material Rupture; Migration

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH MENTOR MEMORYSHAPE¿650CC SILICONE BREAST IMPLANTS WHICH PATIENT BELIEVES HER LEFT SIDE IS RUPTURED, AND AS A RESULT IMPLANT HAS DROPPED. HER RIGHT SIDE HAS WRINKLED AND FEELS LIKE A BUBBLE. THESE ISSUES OCCURRED AFTER IMPLANTATION. 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: Capsular Contracture; No Code Available

  MAUDE report 8691393 ↗
• InjuryMay 17, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE UNDERWENT WHO PRIMARY BREAST RECONSTRUCTION WITH 650CC MENTOR MEMORYSHAPE BREAST IMPLANTS ISSUES ON EACH BREAST POST PROCEDURE. THE LEFT BREAST WAS SWELLING AND HANGING LOWER THAN THE RIGHT BREAST. THE RIGHT BREAST BEGAN TO FEEL LUMPY AND THE PATIENT EXPERIENCED BURNING AND TENDERNESS UNDER THE LOWER RIGHT BREAST AREA. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT RELATES TO THE LEFT PROSTHESIS. SEE 1645337-2019-12137 FOR CONTRALATERAL PROSTHESIS REPORT.

  Patient problems: Local Reaction; No Code Available

  MAUDE report 8620307 ↗
• InjuryMay 17, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6)-YEAR-OLD CAUCASIAN FEMALE UNDERWENT WHO PRIMARY BREAST RECONSTRUCTION WITH 650 CC MENTOR MEMORYSHAPE BREAST IMPLANTS ISSUES ON EACH BREAST POST PROCEDURE. THE LEFT BREAST WAS SWELLING AND HANGING LOWER THAN THE RIGHT BREAST. THE RIGHT BREAST BEGAN TO FEEL LUMPY AND THE PATIENT EXPERIENCED BURNING AND TENDERNESS UNDER THE LOWER RIGHT BREAST AREA. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT RELATES TO THE RIGHT PROSTHESIS. SEE 1645337-2019-12138 FOR CONTRALATERAL PROSTHESIS REPORT.

  Patient problems: Neurological Deficit/Dysfunction; Wrinkling

  MAUDE report 8620304 ↗
• InjuryMar 20, 2019Material Rupture; Adverse Event Without Identified Device or Use Problem; Material Rupture; Adverse Event Without Identified Device or Use Problem

  A PATIENT HAS REPORTED THAT UNDERWENT A BREAST SURGERY RECONSTRUCTION PROCEDURE WITH MENTOR¿S BREAST IMPLANTS (CPG 321) HAS DEVELOPED CAPSULAR CONTRACTURE ASSOCIATED WITH BREAST IMPLANT. THE PATIENTS HAS ALSO REPORTED UNEXPLAINED SYSTEMIC SYMPTOMS, WHICH INCLUDED BUT NOT LIMITED TO FATIGUE, ANXIETY DEPRESSION, STRESS, MUSCULAR AND JOINT PAIN, NEURASTHENIA, PARAESTHESIA, HAIR LOSS, MEMORY LOSS, FEVER, SWEATING, SLEEPING DISORDER, MENTAL CONCENTRATION IMPAIRED COGNITIVE AND DERMATOLOGICAL SYMPTOMS. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. SHOULD MORE INFORMATION BECOME AVAILABLE, THIS CASE WILL BE RE-ASSESSED AND NOTES WILL BE UPDATED. 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: Capsular Contracture; Granuloma; No Code Available

  MAUDE report 8438375 ↗
• InjuryMar 20, 2019Material Rupture; Adverse Event Without Identified Device or Use Problem; Material Rupture; Adverse Event Without Identified Device or Use Problem

  A PATIENT HAS REPORTED THAT UNDERWENT A BREAST SURGERY RECONSTRUCTION PROCEDURE WITH MENTOR¿S BREAST IMPLANTS (B)(4) HAS DEVELOPED CAPSULAR CONTRACTURE ASSOCIATED WITH BREAST IMPLANT THE PATIENTS HAS ALSO REPORTED UNEXPLAINED SYSTEMIC SYMPTOMS, WHICH INCLUDED BUT NOT LIMITED TO FATIGUE, ANXIETY DEPRESSION, STRESS, MUSCULAR AND JOINT PAIN, , NEURASTHENIA, PARAESTHESIA, HAIR LOSS, , MEMORY LOSS, FEVER, SWEATING, SLEEPING DISORDER, MENTAL CONCENTRATION IMPAIRED COGNITIVE AND DERMATOLOGICAL SYMPTOMS. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. SHOULD MORE INFORMATION BECOME AVAILABLE, THIS CASE WILL BE RE-ASSESSED AND NOTES WILL BE UPDATED. 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: Capsular Contracture; Granuloma; No Code Available

  MAUDE report 8438354 ↗