MENTOR MemoryShape Breast Implant 3341405Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00081317005360), received between Dec 27, 2019 and Feb 5, 2026 — classified as 17 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 5, 2026Material Rupture

  IT WAS REPORTED THAT A 44-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 475CC (LEFT) MENTOR MEMORYSHAPE BREAST IMPLANT AND A 525CC (RIGHT) MENTOR MEMORYSHAPE BREAST IMPLANT AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE (BAKER GRADE 2) POST-OPERATIVELY. THE PATIENT ALSO EXPERIENCED A RUPTURE ON THE RIGHT SIDE. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2026 AND REPLACED WITH A 585CC MENTOR MEMORYGEL BOOST BREAST IMPLANT AND A 545CC MENTOR MEMORYGEL BOOST BREAST IMPLANT. THIS REPORT IS FOR THE RIGHT-SIDE DEVICE.

  Patient problems: Capsular Contracture

  MAUDE report 24272058 ↗
• InjuryDec 20, 2024Material Rupture; Adverse Event Without Identified Device or Use Problem; Material Rupture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF AN UNDISCLOSED MENTOR GEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT REPORTED EXPERIENCING A RUPTURED LEFT BREAST IMPLANT WHICH A MEDICAL PROFESSIONAL CONFIRMED WITH MENTOR. MAGNETIC RESONANCE IMAGING WAS ALSO CONDUCTED. AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL WITHOUT REPLACEMENT ON (B)(6) 2024. SEVERAL 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: Deformity/ Disfigurement

  MAUDE report 20987472 ↗
• InjuryOct 17, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH MENTOR MEMORYSHAPE BREAST IMPLANTS 525CC AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE BAKER GRADE IV ALONG WITH BILATERAL RUPTURE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT IS SCHEDULED FOR REMOVAL ON (B)(6) 2024. THIS REPORT IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 20474988 ↗
• InjuryOct 17, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH MENTOR MEMORYSHAPE BREAST IMPLANTS 525CC AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE BAKER GRADE IV ALONG WITH BILATERAL RUPTURE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT IS SCHEDULED FOR REMOVAL ON (B)(6) 2024. THIS REPORT IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 20474422 ↗
• InjuryMar 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO HAD A 525CC MENTOR MEMORYSHAPE BREAST IMPLANT PLACED EXPERIENCED RIGHT RUPTURE WITH GRANULOMA FORMATION AND BILATERAL PTOSIS POST PROCEDURE. AS A RESULT, EXPLANT AND REPLACEMENT WITH MENTOR GEL WAS PERFORMED ON (B)(6) 2024. THE RIGHT SIDED ISSUES WERE REPORTED INITIALLY UNDER 1645337-2023-13042. ON FEBRUARY 9, 2024 MENTOR RECEIVED ADDITIONAL INFORMATION AND INITIAL AWARENESS OF BILATERAL ISSUES. THIS REPORT RELATES TO THE LEFT PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18818507 ↗
• InjuryNov 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT WHO UNDERWENT A BREAST AUGMENTATION REVISION WITH A MENTOR MEMORYSHAPE, 525CC SILICONE BREAST IMPLANT EXPERIENCED RIGHT SIDED CAPSULAR CONTRACTURE GRADE UNKNOWN POSTOPERATIVE. THE ISSUE WAS DIAGNOSED THROUGH OFFICE VISITATION. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Capsular Contracture

  MAUDE report 18085116 ↗
• InjuryNov 2, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT WHO HAD A 525CC MENTOR MEMORYSHAPE BREAST IMPLANT PLACED EXPERIENCED UNILATERAL RUPTURE WITH GRANULOMA FORMATION POST PROCEDURE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. TWO LOT AND SERIAL NUMBERS WERE PROVIDED, HOWEVER, THE ONE BELONGING TO THE EVENT COULD NOT BE DETERMINED. THIS IS REFLECTED IN SECTION D.

  Patient problems: Granuloma

  MAUDE report 18061744 ↗
• InjuryMay 25, 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 UNDERWENT BREAST AUGMENTATION REVISION WITH TWO 525CC MENTOR MEMORYSHAPE BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA PHYSICAL EXAMINATION, WITH RIGHT BREAST CAPSULAR CONTRACTURE (BAKER GRADE III). THE BREAST WAS DISTORTED, HIGH, FIRM AND HAD TENDERNESS. AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2022.

  Patient problems: Capsular Contracture

  MAUDE report 14498984 ↗
• InjuryJan 13, 2022Material Rupture; Appropriate Device Problem Term/Code Not Available; Material Rupture; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION WITH A 525CC MENTOR MEMORYSHAPE BREAST IMPLANT AND EXPERIENCED BREAST PAIN AND A RUPTURE ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2021.

  Patient problems: Breast Discomfort/Pain

  MAUDE report 13253047 ↗
• InjuryJun 3, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT REVISION BREAST AUGMENTATION WITH 525CC MENTOR MEMORYSHAPE BREAST IMPLANT ON BOTH SIDES AND EXPERIENCED BILATERAL DEFORMITY. IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGICAL INTERVENTION WHERE THE SCAR TISSUE WAS OPENED UP AND TENSION WAS REMOVED AROUND THE IMPLANT; LOTS OF PUCKERING, LINES OF TUCKERING, LOTS OF SCAR TISSUE; DOUBLE ENCAPSULATED (EARLY STAGES). PATIENT HAD A PROCEDURE WHERE THEY DID A SCAR TISSUE REVISION AND IT WAS CONFIRMED THAT THE IMPLANTS WERE NOT REMOVED FROM THE PATIENT'S BODY. 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11935854 ↗
• InjuryJun 3, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT REVISION BREAST AUGMENTATION WITH 525CC MENTOR MEMORY SHAPE BREAST IMPLANT ON BOTH SIDES AND EXPERIENCED BILATERAL DEFORMITY. IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGICAL INTERVENTION WHERE THE SCAR TISSUE WAS OPENED UP AND TENSION WAS REMOVED AROUND THE IMPLANT; LOTS OF PUCKERING, LINES OF TUCKERING, LOTS OF SCAR TISSUE; DOUBLE ENCAPSULATED (EARLY STAGES). PATIENT HAD A PROCEDURE WHERE THEY DID A SCAR TISSUE REVISION AND IT WAS CONFIRMED THAT THE IMPLANTS WERE NOT REMOVED FROM THE PATIENT'S BODY. 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11935853 ↗
• InjuryDec 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED (VIA FDA MEDWATCH MW5097122) THAT A (B)(6)-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION PROCEDURE WITH MENTOR MEMORYSHAPE BREAST IMPLANT 525CC GEL BREAST PROSTHESES AND SUFFERED SEVERAL UNEXPLAINED SYSTEMIC SYMPTOMS, INCLUDING TRANSVERSE MYELITIS, SPINAL CORD C5-C6 LESION, LESIONS IN THORACIC AREA, CHRONIC PAIN, LOSS OF STRENGTH FROM WAIST DOWN, LOSS OF BALANCE, BLOOD PRESSURE ISSUES, NUMBNESS, TINGLING, AND SPASMS IN LEGS AND FEET. 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 EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT BREAST PROSTHESIS.

  Patient problems: Autoimmune Disorder

  MAUDE report 11052923 ↗
• InjuryDec 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED (VIA FDA MEDWATCH MW5097122) THAT A (B)(6)-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION PROCEDURE WITH MENTOR MEMORYSHAPE BREAST IMPLANT 525CC GEL BREAST PROSTHESES AND SUFFERED SEVERAL UNEXPLAINED SYSTEMIC SYMPTOMS, INCLUDING TRANSVERSE MYELITIS, SPINAL CORD C5-C6 LESION, LESIONS IN THORACIC AREA, CHRONIC PAIN, LOSS OF STRENGTH FROM WAIST DOWN, LOSS OF BALANCE, BLOOD PRESSURE ISSUES, NUMBNESS, TINGLING, AND SPASMS IN LEGS AND FEET. 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 EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT BREAST PROSTHESIS.

  Patient problems: Autoimmune Disorder

  MAUDE report 11052781 ↗
• InjuryOct 7, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD FEMALE WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH A MENTOR MEMORYSHAPE 525CC SILICONE PROSTHESIS EXPERIENCED RIGHT SIDED RUPTURE POST PROCEDURE. AN MRI EXAMINATION WAS PERFORMED AND RUPTURE WAS DIAGNOSED. AS A RESULT, AN EXPLANT WAS PERFORMED ON (B)(6) 2020.

  Patient problems: No Code Available

  MAUDE report 10643840 ↗
• InjuryAug 13, 2020Migration; Migration

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION PRIMARY WITH A MENTOR MEMORYSHAPE BREAST IMPLANT 525CC (L) AND AN UNSPECIFIED MENTOR BREAST IMPLANT (R) AND EXPERIENCED BILATERAL BREAST PAIN, BILATERAL IMPLANT MIGRATION AND ANISOMASTIA ON THE RIGHT SIDE 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 BREAST PROSTHESIS. THE PATIENT REPORTED THAT SHE HAD SALINE IMPLANTS, BUT REPORTED A GEL DEVICE SERIAL NUMBER FOR THE LEFT SIDE. GEL DEVICES WILL BE REPORTED UNTIL FURTHER CLARIFICATION IS RECEIVED.

  Patient problems: Pain

  MAUDE report 10403969 ↗
• InjuryDec 27, 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 WHO UNDERWENT BREAST AUGMENTATION REVISION WITH TWO 525CC MENTOR MEMORYSHAPE BREAST IMPLANTS, SUFFERED BILATERAL RIPPLING, POST-OPERATIVELY. 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: Wrinkling

  MAUDE report 9527616 ↗
• InjuryDec 27, 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 WHO UNDERWENT BREAST AUGMENTATION REVISION WITH TWO 525CC MENTOR MEMORYSHAPE BREAST IMPLANTS, SUFFERED BILATERAL RIPPLING, POST-OPERATIVELY. 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: Wrinkling

  MAUDE report 9527614 ↗