MENTOR MemoryShape Breast Implant 3541258Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 00081317005469), received between Jul 19, 2019 and Jun 27, 2025 — classified as 28 injuries.

The most frequently reported specific device problem is “Material Rupture” (8 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 28 reports, in the reporter's own words as published by the FDA.

• InjuryJun 27, 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 RECONSTRUCTION WITH A 315CC MENTOR MEMORYSHAPE BREAST IMPLANT ON THE RIGHT BREAST. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA PHYSICAL EXAMINATION, WITH RIGHT BREAST CAPSULAR CONTRACTURE (BAKER GRADE IV). AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Capsular Contracture

  MAUDE report 22343483 ↗
• InjuryJun 23, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 39-YEAR-OLD HISPANIC FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A 315CC (LEFT) MENTOR MEMORYSHAPE BREAST IMPLANT AND A 280CC (RIGHT) MENTOR MEMORYSHAPE BREAST IMPLANT AND EXPERIENCED BILATERAL RUPTURES POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025. THIS REPORT IS FOR THE LEFT SIDE DEVICE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 22310555 ↗
• InjuryApr 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT BREAST AUGMENTATION WITH 315CC MENTOR MEMORYSHAPE BREAST IMPLANTS EXPERIENCED DISSATISFACTION WITH THE PROCEDURAL OUTCOME. AS A RESULT, EXPLANT WAS PERFORMED ON (B)(6) 2021. THIS PATIENT WAS PART OF A POST APPROVAL STUDY.

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

  MAUDE report 21774360 ↗
• InjuryApr 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT BREAST AUGMENTATION WITH 315CC MENTOR MEMORYSHAPE BREAST IMPLANTS EXPERIENCED DISSATISFACTION WITH THE PROCEDURAL OUTCOME. AS A RESULT, EXPLANT WAS PERFORMED ON (B)(6) 2021. THIS PATIENT WAS PART OF A POST APPROVAL STUDY.

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

  MAUDE report 21774355 ↗
• InjuryDec 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS EVENT IS ASSOCIATED WITH THE GLOW CLINICAL TRIAL (SUBJECT ID: (B)(6)). IT WAS REPORTED THAT A CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION WITH TWO 315CC MENTOR MEMORYSHAPE BREAST IMPLANTS AND DURING THE PATIENT¿S 5TH-YEAR FOLLOW-UP POST-OPERATIVE VISIT, THE PATIENT REPORTED ACUTE PROMYELOCYTIC LEUKEMIA, WHICH WAS TREATED WITH CHEMOTHERAPY. IT¿S UNCLEAR IF THIS IS RELATED TO THE BREAST OR STUDY DEVICE SINCE THE PRINCIPAL INVESTIGATOR¿S ASSESSMENT WAS NOT ENTERED. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. SHOULD MORE INFORMATION BECOME AVAILABLE, MENTOR WILL SUBMIT A SUPPLEMENTAL REPORT ACCORDINGLY. THIS REPORT IS FOR THE LEFT SIDE DEVICE.

  Patient problems: Cancer

  MAUDE report 18374820 ↗
• InjuryDec 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS EVENT IS ASSOCIATED WITH THE GLOW CLINICAL TRIAL (SUBJECT ID: (B)(6). IT WAS REPORTED THAT A CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION WITH TWO 315CC MENTOR MEMORYSHAPE BREAST IMPLANTS AND DURING THE PATIENT¿S 5TH-YEAR FOLLOW-UP POST-OPERATIVE VISIT, THE PATIENT REPORTED ACUTE PROMYELOCYTIC LEUKEMIA, WHICH WAS TREATED WITH CHEMOTHERAPY. IT¿S UNCLEAR IF THIS IS RELATED TO THE BREAST OR STUDY DEVICE SINCE THE PRINCIPAL INVESTIGATOR¿S ASSESSMENT WAS NOT ENTERED. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. SHOULD MORE INFORMATION BECOME AVAILABLE, MENTOR WILL SUBMIT A SUPPLEMENTAL REPORT ACCORDINGLY. THIS REPORT IS FOR THE RIGHT SIDE DEVICE.

  Patient problems: Cancer

  MAUDE report 18374819 ↗
• InjurySep 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A CAUCASIAN FEMALE PATIENT WHO UNDERWENT A BREAST AUGMENTATION PROCEDURE WITH A MENTOR MEMORYSHAPE BREAST IMPLANT 315CC GEL BREAST PROSTHESIS DEVELOPED A SMALL REACTION AT THE SUTURE SITE ON THE RIGHT BREAST POST IMPLANTATION. THE REACTION WAS TREATED WITH AUGMENTIN AND THE AREA WAS CLEANED WITH PEROXIDE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Local Reaction

  MAUDE report 15363525 ↗
• InjuryAug 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A CAUCASIAN FEMALE WHO UNDERWENT A BREAST AUGMENTATION REVISION WITH A MENTOR MEMORYSHAPE, 315CC SILICONE BREAST IMPLANT EXPERIENCED BILATERAL NEOPLASM MALIGNANT POSTOPERATIVE. 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. THE INFORMATION PROVIDED IN CRF (IMEDIDATA).

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

  MAUDE report 15209621 ↗
• InjuryAug 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A CAUCASIAN FEMALE WHO UNDERWENT A BREAST AUGMENTATION REVISION WITH A MENTOR MEMORYSHAPE,315CC SILICONE BREAST IMPLANT EXPERIENCED BILATERAL NEOPLASM MALIGNANT POSTOPERATIVE. 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. THE INFORMATION PROVIDED IN CRF (IMEDIDATA).

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

  MAUDE report 15209585 ↗
• InjuryAug 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A CAUCASIAN FEMALE WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH A 315CC MENTOR MEMORYSHAPE BREAST IMPLANT EXPERIENCED RIGHT SIDED BREAST PAIN POST PROCEDURE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS EVENT INVOLVED A PATIENT ENROLLED IN A CLINICAL STUDY.

  Patient problems: Breast Discomfort/Pain

  MAUDE report 15161420 ↗
• InjuryJul 20, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 64-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH A MENTOR MEMORYSHAPE BREAST IMPLANT 315CC AND EXPERIENCED RUPTURE ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED VIA ULTRASOUND. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 15069856 ↗
• InjuryJul 3, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH A MENTOR MEMORYSHAPE BREAST IMPLANT 315CC GEL BREAST PROSTHESIS THAT RUPTURED POST IMPLANTATION. RUPTURE OF THE PATIENT¿S LEFT BREAST PROSTHESIS WAS DIAGNOSED VIA MRI. AS A RESULT, THE PATIENT IS SCHEDULED TO UNDERGO EXPLANTATION ON (B)(6) 2022.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 14902255 ↗
• InjuryMay 10, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE WHO UNDERWENT BREAST AUGMENTATION REVISION WITH A 315CC MENTOR MEMORYSHAPE BREAST IMPLANT EXPERIENCED LEFT SIDED RUPTURE POST PROCEDURE. THE RUPTURE WAS DIAGNOSED THROUGH A PHYSICAL AND MAGNETIC RESONANCE IMAGING. AS A RESULT, AN EXPLANT IS PLANNED FOR (B)(6) 2022.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 14350398 ↗
• InjuryMar 9, 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 WHO UNDERWENT PRIMARY BREAST AUGMENTATION SURGERY WITH TWO 315CC MENTOR MEMORYSHAPE BREAST IMPLANTS EXPERIENCED BILATERAL BREAST PAIN 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 LEFT BREAST PROSTHESIS.

  Patient problems: Breast Discomfort/Pain

  MAUDE report 13713260 ↗
• InjuryMar 9, 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 WHO UNDERWENT PRIMARY BREAST AUGMENTATION SURGERY WITH TWO 315CC MENTOR MEMORYSHAPE BREAST IMPLANTS EXPERIENCED BILATERAL BREAST PAIN 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: Breast Discomfort/Pain

  MAUDE report 13713256 ↗
• InjuryNov 19, 2021Migration; Migration

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE WHO UNDERWENT BREAST AUGMENTATION REVISION WITH A 315CC MENTOR MEMORYSHAPE BREAST IMPLANT EXPERIENCED RIGHT SIDED DEVICE MIGRATION POST PROCEDURE. THE DEVICE FLIPPED, INVERTED, AND TURNED UPSIDE DOWN. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 12848744 ↗
• InjuryOct 27, 2021Adverse 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 PATIENT WHO UNDERWENT AN UNSPECIFIED BREAST SURGERY WITH A MENTOR MEMORYSHAPE BREAST IMPLANT 315CC GEL BREAST PROSTHESIS (LEFT DEVICE) AND A MENTOR MEMORYSHAPE BREAST IMPLANT 355CC GEL BREAST PROSTHESIS (RIGHT DEVICE) IS DISSATISFIED WITH THE SHAPE OF HER BREASTS. IT WAS REPORTED THAT THE SHAPE IS NOT GOOD AND THAT THERE ARE BUBBLES. ADDITIONALLY, THE PATIENT IS FEELING A HIGH AMOUNT OF DISCOMFORT IN HER BREASTS. 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; Pain; Wrinkling

  MAUDE report 12706049 ↗
• InjuryJun 29, 2021Adverse 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 PATIENT, WHO'S UNDERGONE PRIMARY BREAST AUGMENTATION WITH TWO 315CC MENTOR MEMORYSHAPE BREAST IMPLANTS, SUFFERED BILATERAL BREAST CAPSULAR CONTRACTURES (BAKER GRADE III ON THE LEFT AND BAKER GRADE IV ON THE RIGHT), POST-PROCEDURE. THE CAPSULAR CONTRACTURES WERE DIAGNOSED VIA PHYSICAL EXAMINATION. AS A RESULT, THE PATIENT WAS SCHEDULED FOR BILATERAL IMPLANT EXPLANTATION SURGERY ON (B)(6) 2021. THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 12089349 ↗
• InjuryJun 29, 2021Adverse 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 PATIENT, WHO'S UNDERGONE PRIMARY BREAST AUGMENTATION WITH TWO 315CC MENTOR MEMORYSHAPE BREAST IMPLANTS, SUFFERED BILATERAL BREAST CAPSULAR CONTRACTURES (BAKER GRADE III ON THE LEFT AND BAKER GRADE IV ON THE RIGHT), POST-PROCEDURE. THE CAPSULAR CONTRACTURES WERE DIAGNOSED VIA PHYSICAL EXAMINATION. AS A RESULT, THE PATIENT WAS SCHEDULED FOR BILATERAL IMPLANT EXPLANTATION SURGERY ON (B)(6) 2021. THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 12089348 ↗
• InjuryJul 31, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) YEAR OLD FEMALE PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 315CC MENTOR MEMORYSHAPE BREAST IMPLANTS, SUFFERED UNILATERAL CAPSULAR CONTRACTURE; BAKER GRADE III ON AN UNSPECIFIED SIDE, POST-PROCEDURE. THE CAPSULAR CONTRACTURE WAS DIAGNOSED BY A DOCTOR. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THE FOLLOWING LOT NUMBERS AND SERIAL NUMBERS WERE PROVIDED BUT IT WAS NOT SPECIFIED WHICH BREAST HAD THE CAPSULAR CONTRACTURE: (LEFT: CATALOG: 3541258 LOT: 6750182 SN: (B)(4) AND RIGHT: CATALOG: 3541258 LOT: 6755946 SN: (B)(4)). FOLLOW-UPS WERE PERFORMED BUT NO INFORMATION WAS RECEIVED. IF CLARIFICATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: Capsular Contracture

  MAUDE report 10353012 ↗
• InjuryJan 29, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BEAST AUGMENTATION WITH MENTOR MEMORYSHAPE 315CC SILICONE BREAST IMPLANTS WHICH THE LEFT SIDE RUPTURED AFTER IMPLANTATION. THE ISSUE WAS CONFIRMED BY THE PHYSICIAN. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: No Code Available

  MAUDE report 9643847 ↗
• InjuryDec 3, 2019Material Rupture

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH MENTOR MEMORYSHAPE BREAST IMPLANT 315CC AND EXPERIENCED BILATERAL PTOSIS AND A RUPTURE ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED BY A PHYSICIAN. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH MENTOR MEMORYGEL BREAST IMPLANT 200CC, CATALOG# 3502001BC, SERIAL# (B)(4) (LEFT), (B)(4) (RIGHT) ON (B)(6)2019. THIS REPORT IS FOR THE LEFT SIDE DEVICE.

  Patient problems: No Code Available

  MAUDE report 9404106 ↗
• InjuryDec 3, 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 PRIMARY BREAST AUGMENTATION WITH MENTOR MEMORYSHAPE BREAST IMPLANT 315CC AND EXPERIENCED BILATERAL PTOSIS AND A RUPTURE ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED BY A PHYSICIAN. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH MENTOR MEMORYGEL BREAST IMPLANT 200CC, CATALOG# 3502001BC, SERIAL# (B)(4) (LEFT), (B)(4) (RIGHT) ON (B)(6)2019. THIS REPORT IS FOR THE RIGHT SIDE DEVICE.

  Patient problems: No Code Available

  MAUDE report 9404088 ↗
• InjuryNov 2, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH A MENTOR MEMORYSHAPE BREAST IMPLANT 315CC AND EXPERIENCED RIGHT RUPTURE AND BREAST PAIN ON THE RIGHT BREAST. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: No Code Available; Pain

  MAUDE report 9269776 ↗
• InjuryOct 24, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH MENTOR MEMORYSHAPE¿ 3175CC , SILICONE BREAST IMPLANTS WHICH THE RIGHT SIDE RUPTURED AFTER IMPLANTATION. THE ISSUE WAS CONFIRMED BY THE PHYSICIAN VIA MRI EXAMINATION. THE REPORT ALSO INDICATED LARGE LUMP ON RIGHT SIDE OF THE BREAST ALMOST IN THE ARMPIT, AND SMALLER LUMPS ELSEWHERE ON THE BREAST. BREAST SLIGHTLY SWOLLEN, HARD AND MISSHAPEN. AS A RESULT PATIENT SCHEDULED FOR DEVICE REMOVAL AND REPLACEMENT WITH ANOTHER MENTOR DEVICE ON (B)(6) 2019.

  Patient problems: Breast Mass; No Code Available

  MAUDE report 9232692 ↗