MENTOR MemoryShape Breast Implant 3341309Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 00081317005094), received between Aug 21, 2019 and Nov 25, 2024 — classified as 29 injuries.

The most frequently reported specific device problem is “Material Rupture” (7 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 29 reports, in the reporter's own words as published by the FDA.

• InjuryNov 25, 2024Material Rupture; Migration; Material Rupture; Migration

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH A MENTOR MEMORYSHAPE BREAST IMPLANT 445CC GEL BREAST PROSTHESIS THAT POSSIBLY RUPTURED POST IMPLANTATION. THE PATIENT NOTICED THAT HER LEFT BREAST FALLS TO THE SIDE AND SHE HAS TO SLEEP WITH A BRA TO SUPPORT IT. AN ULTRASOUND WAS PERFORMED AND IT DIAGNOSED POSSIBLE PARTIAL RUPTURE OF THE LEFT BREAST PROSTHESIS. AS A RESULT, THE PATIENT IS SCHEDULED TO UNDERGO EXPLANTATION ON (B)(6) 2025.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 20776309 ↗
• InjurySep 27, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT BREAST AUGMENTATION REVISION WITH A 445CC MENTOR MEMORYSHAPE BREAST IMPLANT EXPERIENCED SPONTANEOUS LEFT SIDED RUPTURE POST PROCEDURE. THE RUPTURE WAS DIAGNOSED THROUGH A PHYSICAL. AS A RESULT, EXPLANT IS PLANNED FOR (B)(6) 2024.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 20322545 ↗
• InjurySep 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH TWO MENTOR MEMORY SHAPE BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT SUFFERED LEFT BREAST CAPSULAR CONTRACTURE (BAKER GRADE III) AND RIGHT BREAST IMPLANT RUPTURE. AS A RESULT, THE PATIENT UNDERWENT BILATERAL BREAST IMPLANT REMOVAL AND REPLACEMENT SURGERY ON (B)(6) 2024. THE REPLACEMENT DEVICES WERE NON-MENTOR. THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 20263163 ↗
• InjuryMar 6, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 445CC (LEFT), 495CC (RIGHT), MENTOR MEMORYSHAPE BREAST IMPLANT EXPERIENCED BILATERAL RUPTURES, CAPSULAR CONTRACTURE (BAKER GRADE 4) POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6)2024. THIS REPORT IS FOR THE LEFT SIDE DEVICE.

  Patient problems: Capsular Contracture

  MAUDE report 18851858 ↗
• InjuryFeb 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT REVISION BREAST AUGMENTATION WITH 445CC MENTOR MEMORYSHAPE BREAST IMPLANT ON BOTH SIDES AND EXPERIENCED BILATERAL RIPPLING, AND RIGHT SIDE DEVICE MIGRATION. THE PATIENT HAS CONSULTED WITH THE HEALTHCARE PROFESSIONAL. 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-SIDED DEVICE.

  Patient problems: Wrinkling

  MAUDE report 18744187 ↗
• InjuryFeb 20, 2024Migration; Migration

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT REVISION BREAST AUGMENTATION WITH 445CC MENTOR MEMORYSHAPE BREAST IMPLANT ON BOTH SIDES AND EXPERIENCED BILATERAL RIPPLING, AND RIGHT SIDE DEVICE MIGRATION. THE PATIENT HAS CONSULTED WITH THE HEALTHCARE PROFESSIONAL. 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-SIDED DEVICE.

  Patient problems: Wrinkling

  MAUDE report 18744185 ↗
• InjuryJan 4, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE WHO UNDERWENT AN UNSPECIFIED BREAST SURGERY WITH A MENTOR MEMORYSHAPE, 445CC, SILICONE PROSTHESIS EXPERIENCED RIGHT SIDED SILENT RUPTURE POST PROCEDURE. AS A RESULT, PATIENT UNDERWENT BILATERAL REPLACEMENT AS FOLLOW: R/ CAT: SHPX-700, SN: (B)(6), L/ CAT:SHPX700, SN: (B)(6) ON (B)(6) 2023.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18447952 ↗
• InjuryAug 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 61-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT PRIMARY BREAST RECONSTRUCTION SURGERY WITH 445CC MENTOR MEMORYSHAPE BREAST IMPLANT AND EXPERIENCED SKIN PUCKERING ON THE LEFT SIDE POSTOPERATIVELY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Wrinkling

  MAUDE report 17586486 ↗
• InjuryMar 2, 2023Migration; Migration

  IT WAS REPORTED THAT A 39-YEAR-OLD FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH A 445CC MENTOR MEMORYSHAPE BREAST IMPLANT. POST-OPERATIVELY, THE PATIENT EXPERIENCED MALROTATION OF HER RIGHT PROSTHESIS, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT FOR REMOVAL ON (B)(6) 2023.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 16473072 ↗
• InjuryNov 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 51-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH TWO 445CC MENTOR MEMORYSHAPE BREAST IMPLANT AND EXPERIENCED BILATERAL BREAST PAIN AND PARESTHESIA POST-OPERATIVELY. 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 DEVICE.

  Patient problems: Breast Discomfort/Pain; Paresthesia

  MAUDE report 15776091 ↗
• InjuryNov 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 51-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH TWO 445CC MENTOR MEMORYSHAPE BREAST IMPLANT AND EXPERIENCED BILATERAL BREAST PAIN AND PARESTHESIA POST-OPERATIVELY. 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 DEVICE.

  Patient problems: Breast Discomfort/Pain; Paresthesia

  MAUDE report 15774246 ↗
• 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 445CC GEL BREAST PROSTHESIS DEVELOPED AN INFECTION IN HER LEFT BREAST POST IMPLANTATION. AS A RESULT, THE PATIENT WAS TREATED WITH BACTRIM DS AND CIPROFLOXACIN. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Post Operative Wound Infection

  MAUDE report 15366722 ↗
• InjuryAug 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION WITH A 445CC MENTOR MEMORYSHAPE BREAST IMPLANT AND EXPERIENCED IMPLANT SITE HEMATOMA ON THE RIGHT SIDE POST-OPERATIVELY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Hematoma

  MAUDE report 15166867 ↗
• InjuryApr 22, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT WHO UNDERWENT A BREAST AUGMENTATION REVISION WITH MENTOR MEMORYSHAPE, 445CC SILICONE BREAST IMPLANT HAS EXPERIENCED RIGHT-SIDED IMPLANT RUPTURE, BILATERAL WRINKLING, AND BILATERAL PTOSIS POSTOPERATIVELY. THE REPORT INDICATED THE FOLLOWING: GEL RUPTURE, SHAPE, SIZE, RIPPLING AND PRE-PECTORAL POSITION. THE RUPTURE WAS DISCOVERED DURING SURGERY. AS A RESULT, PATIENT UNDERWENT BILATERAL MASTOPEXY AND, REPLACEMENTS AS FOLLOW: L/ CAT#: SMPX270, (B)(4) R/ CAT#: SMPX270, (B)(4) ON (B)(6) 2022. THIS REPORT RELATES TO THE RIGHT PROSTHESIS.

  Patient problems: Deformity/ Disfigurement; Wrinkling

  MAUDE report 14187044 ↗
• InjuryApr 22, 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 A BREAST AUGMENTATION REVISION WITH MENTOR MEMORYSHAPE, 445CC SILICONE BREAST IMPLANT HAS EXPERIENCED RIGHT-SIDED IMPLANT RUPTURE, BILATERAL WRINKLING, AND BILATERAL PTOSIS POSTOPERATIVELY. THE REPORT INDICATED THE FOLLOWING: GEL RUPTURE, SHAPE, SIZE, RIPPLING AND PRE-PECTORAL POSITION. THE RUPTURE WAS DISCOVERED DURING SURGERY. AS A RESULT, PATIENT UNDERWENT BILATERAL MASTOPEXY AND, REPLACEMENTS AS FOLLOW: L/ CAT#: SMPX270, SN#: (B)(4), R/ CAT#: SMPX270, SN#: (B)(4), ON (B)(6) 2022. THIS REPORT RELATES TO THE LEFT PROSTHESIS.

  Patient problems: Deformity/ Disfigurement; Wrinkling

  MAUDE report 14187032 ↗
• InjuryApr 11, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH 445CC MENTOR MEMORYSHAPE BREAST IMPLANT AND EXPERIENCED LEFT SIDE BREAST IMPLANT RUPTURE POSTOPERATIVELY. THE ISSUE WAS DIAGNOSED AFTER PHYSICAL, AND CONFIRMED VIA MAMMOGRAM, AND 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 14079719 ↗
• InjuryJan 19, 2022Adverse 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 UNDERWENT A PRIMARY BREAST AUGMENTATION WITH TWO MENTOR MEMORYSHAPE BREAST IMPLANT PROSTHESES (LEFT: 495CC, RIGHT: 445CC) AND EXPERIENCED BILATERAL GRADE IV CAPSULAR CONTRACTURE POSTOPERATIVELY. THE DIAGNOSIS WAS CONFIRMED BY A HEALTHCARE PROFESSIONAL. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING AN EXPECTED EXPLANTATION DATE. THIS REPORT IS FOR THE RIGHT-SIDED PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 13289387 ↗
• InjuryDec 15, 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 FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 445CC MENTOR MEMORYSHAPE BREAST IMPLANT AND EXPERIENCED A SEROMA ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED VIA AN OFFICE EXAM. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2022.

  Patient problems: Seroma

  MAUDE report 13012527 ↗
• InjurySep 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA 5102135 THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH TWO 445CC MENTOR MEMORYSHAPE BREAST IMPLANT PROSTHESES AND EXPERIENCED AUTOIMMUNE DISORDER POSTOPERATIVELY. THE PATIENT SUFFERED SEVERAL UNEXPLAINED SYSTEMIC SYMPTOMS, INCLUDING HEALTH DECLINE, WEAKNESS, FATIGUE, TREMORS, NEUROLOGICAL MOTOR ISSUES, MEMORY LOSS, LACK OF CONCENTRATION, DECREASED LIBIDO, BREAST PAIN, INSOMINIA, JOINT PAIN, LIMITED MOBILITTY, SYSTEMIC LUPUS ERYTHEMATOSUS (SLE), SINUS ISSUES, SKIN RASH, MIGRAINES, HAIR LOSS, VISION DISTURBANCES, MOOD CHANGES, INFLAMMATION, AND POSITIVE ANA. NO DEVICE ISSUE WAS REPORTED. THE ROOT CAUSE OF THE PATIENT¿S SYMPTOMS IS UNCLEAR. AS A RESULT, THE PATIENT IS SCHEDULED TO UNDERGO EXPLANTATION ON (B)(6) 2021. THE EVENT DATE WAS ESTIMATED AS (B)(6) 2018 BASED ON AVAILABLE INFORMATION. THIS REPORT IS FOR THE RIGHT-SIDED PROSTHESIS.

  Patient problems: Autoimmune Disorder

  MAUDE report 12485641 ↗
• InjurySep 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA 5102135 THAT A (B)(6) CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH TWO 445CC MENTOR MEMORYSHAPE BREAST IMPLANT PROSTHESES AND EXPERIENCED AUTOIMMUNE DISORDER POSTOPERATIVELY. THE PATIENT SUFFERED SEVERAL UNEXPLAINED SYSTEMIC SYMPTOMS, INCLUDING HEALTH DECLINE, WEAKNESS, FATIGUE, TREMORS, NEUROLOGICAL MOTOR ISSUES, MEMORY LOSS, LACK OF CONCENTRATION, DECREASED LIBIDO, BREAST PAIN, INSOMNIA, JOINT PAIN, LIMITED MOBILITY, SYSTEMIC LUPUS ERYTHEMATOSUS (SLE), SINUS ISSUES, SKIN RASH, MIGRAINES, HAIR LOSS, VISION DISTURBANCES, MOOD CHANGES, INFLAMMATION, AND POSITIVE ANA. NO DEVICE ISSUE WAS REPORTED. THE ROOT CAUSE OF THE PATIENTS SYMPTOMS IS UNCLEAR. AS A RESULT, THE PATIENT IS SCHEDULED TO UNDERGO EXPLANTATION ON (B)(6) 2021. THE EVENT DATE WAS ESTIMATED AS (B)(6) 2018 BASED ON AVAILABLE INFORMATION. THIS REPORT IS FOR THE LEFT-SIDED PROSTHESIS.

  Patient problems: Autoimmune Disorder

  MAUDE report 12485640 ↗
• InjuryAug 25, 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 A BREAST AUGMENTATION REVISION PROCEDURE WITH MENTOR MEMORYSHAPE BREAST IMPLANT 445CC GEL BREAST PROSTHESES DEVELOPED BAKER GRADE III CAPSULAR CONTRACTURE IN BOTH OF HER BREASTS POST-IMPLANTATION. BILATERAL CAPSULAR CONTRACTURE WAS CONFIRMED BY A HEALTHCARE PROFESSIONAL. AS A RESULT, THE PATIENT IS SCHEDULED TO UNDERGO BILATERAL EXPLANTATION ON (B)(6) 2021. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 12368776 ↗
• InjuryAug 10, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD HISPANIC FEMALE WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH A 445CC MENTOR MEMORYSHAPE BREAST IMPLANT EXPERIENCED SYMPTOMS OF LEFT SIDED RUPTURE POST PROCEDURE. THE LEFT BREAST HAD FLATTENED AROUND THE NIPPLE AREA AND BECOME LUMPY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 12305245 ↗
• InjuryJun 25, 2021Adverse 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 A BREAST AUGMENTATION REVISION WITH 445CC MENTOR MEMORYSHAPE BREAST IMPLANT EXPERIENCED RIGHT-SIDED GRADE III CAPSULAR CONTRACTURE POSTOPERATIVELY. CAPSULAR CONTRACTURE WAS DIAGNOSED BY A HEALTHCARE PROFESSIONAL. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Capsular Contracture

  MAUDE report 12071781 ↗
• InjuryAug 1, 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 CAUCASIAN FEMALE PATIENT WHO UNDERWENT A REVISION BREAST RECONSTRUCTION WITH TWO 445CC MENTOR MEMORYSHAPE BREAST IMPLANT PROSTHESES EXPERIENCED POSTOPERATIVE BILATERAL SEROMA AND SUFFERED SEVERAL UNEXPLAINED SYSTEMIC SYMPTOMS, INCLUDING ALOPECIA, CYSTIC ACNE, AND CIRRHOSIS. NO DEVICE ISSUE SUCH AS RUPTURE WAS REPORTED. THE ROOT CAUSE OF THE PATIENT¿S SYMPTOMS IS UNCLEAR. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING AN EXPECTED EXPLANTATION DATE. THIS REPORT IS FOR THE RIGHT-SIDED PROSTHESIS.

  Patient problems: Capsular Contracture; No Code Available; Seroma

  MAUDE report 10354042 ↗
• InjuryAug 1, 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 CAUCASIAN FEMALE PATIENT WHO UNDERWENT A REVISION BREAST RECONSTRUCTION WITH TWO 445CC MENTOR MEMORYSHAPE BREAST IMPLANT PROSTHESES EXPERIENCED POSTOPERATIVE BILATERAL SEROMA AND SUFFERED SEVERAL UNEXPLAINED SYSTEMIC SYMPTOMS, INCLUDING ALOPECIA, CYSTIC ACNE, AND CIRRHOSIS. NO DEVICE ISSUE SUCH AS RUPTURE WAS REPORTED. THE ROOT CAUSE OF THE PATIENT¿S SYMPTOMS IS UNCLEAR. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING AN EXPECTED EXPLANTATION DATE. THIS REPORT IS FOR THE LEFT-SIDED PROSTHESIS.

  Patient problems: Capsular Contracture; No Code Available; Seroma

  MAUDE report 10354034 ↗