MENTOR MemoryShape Breast Implant 3541608Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00081317005520), received between Jun 27, 2019 and Jan 6, 2025 — classified as 14 injuries.

The most frequently reported specific device problem is “Material Rupture” (10 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryJan 6, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 640CC MENTOR MEMORYSHAPE BREAST IMPLANT EXPERIENCED A RUPTURE ON THE LEFT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2024.

  Patient problems: Crushing Injury; Deformity/ Disfigurement

  MAUDE report 21081600 ↗
• InjuryNov 4, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 640CC MENTOR MEMORYSHAPE BREAST IMPLANT EXPERIENCED A RUPTURE REQUIRING IMPLANT SITE FLUID COLLECTION ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2024.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20605068 ↗
• InjuryAug 20, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION SURGERY WITH IMPLANTATION OF A 640CC MENTOR MEMORYSHAPE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH BILATERALLY RUPTURED BREAST IMPLANTS DURING AN IN-OFFICE VISIT WITH A MEDICAL PROFESSIONAL. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT WITH 740CC (LEFT-SIDED) AND 775CC (RIGHT-SIDED) MENTOR MEMORYGEL BOOST BREAST IMPLANTS ON (B)(6) 2024. THIS REPORT IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 20008834 ↗
• InjuryMay 6, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION SURGERY WITH A 640CC MENTOR MEMORYSHAPE BREAST IMPLANT. POST-OPERATIVELY, THE PATIENT FELT A LUMP IN HER RIGHT BREAST. THE PATIENT UNDERWENT MAGNETIC RESONANCE IMAGING AND A SONOGRAM WHICH CONFIRMED THAT THE PATIENT EXPERIENCED A RUPTURE OF HER RIGHT PROSTHESIS. AT THE TIME OF THIS REPORT, MENTOR HAS NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 19249664 ↗
• InjurySep 6, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT WHO UNDERWENT BREAST AUGMENTATION REVISION WITH 640CC MENTOR MEMORYSHAPE BREAST IMPLANTS EXPERIENCED BILATERAL RUPTURE POST PROCEDURE. AS A RESULT, EXPLANT WAS PERFORMED ON (B)(6) 2023. SEE 1645337-2023-10482 FOR CONTRALATERAL PROSTHESIS REPORT.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 17694810 ↗
• InjurySep 6, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT WHO UNDERWENT BREAST AUGMENTATION REVISION WITH 640CC MENTOR MEMORYSHAPE BREAST IMPLANTS EXPERIENCED BILATERAL RUPTURE POST PROCEDURE. AS A RESULT, EXPLANT WAS PERFORMED ON (B)(6) 2023. SEE 1645337-2023-10492 FOR CONTRALATERAL PROSTHESIS REPORT.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 17694274 ↗
• InjurySep 6, 2022Material Deformation; Material Deformation

  IT WAS REPORTED THAT A 49-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH MENTOR MEMORYSHAPE BREAST IMPLANT 640 CC GEL BREAST PROSTHESES AND SUFFERED SEVERAL UNEXPLAINED SYSTEMIC SYMPTOMS, INCLUDING BODY ACHES, FATIGUE, MUSCLE WEAKNESS, AND BRAIN FOG. THE ROOT CAUSE OF THE PATIENT¿S SYMPTOMS IS UNCLEAR. ADDITIONALLY, IT WAS REPORTED THAT ONE OF THE BREAST PROSTHESES HAD RUPTURED AND THAT THE OTHER BREAST PROSTHESIS APPEARS DEFORMED. 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 15362985 ↗
• InjurySep 6, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 49-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH MENTOR MEMORYSHAPE BREAST IMPLANT 640 CC GEL BREAST PROSTHESES AND SUFFERED SEVERAL UNEXPLAINED SYSTEMIC SYMPTOMS, INCLUDING BODY ACHES, FATIGUE, MUSCLE WEAKNESS, AND BRAIN FOG. THE ROOT CAUSE OF THE PATIENT¿S SYMPTOMS IS UNCLEAR. ADDITIONALLY, IT WAS REPORTED THAT ONE OF THE BREAST PROSTHESES HAD RUPTURED AND THAT THE OTHER BREAST PROSTHESIS APPEARS DEFORMED. 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 15362938 ↗
• InjuryOct 20, 2020Material Rupture; Adverse Event Without Identified Device or Use Problem; Material Rupture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6)-YEAR-OLD CAUCASIAN FEMALE WHO UNDERWENT PRIMARY BREAST RECONSTRUCTION WITH A MENTOR MEMORYSHAPE¿ 640CC SILICONE PROSTHESIS EXPERIENCED BILATERAL RUPTURE AND BILATERAL BREAST LUMPS POST PROCEDURE. THE PATIENT REPORTED HEADACHES, A BIT OF VERTIGO/TUNNEL VISION, HAIR LOSS, DRY SKIN AND HAIR. THE ISSUES HAS NOT BEEN CONFIRMED BY THE PHYSICIAN. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT BELONGS TO RIGHT PROSTHESIS.

  Patient problems: Breast Mass; No Code Available; Wrinkling

  MAUDE report 10705873 ↗
• InjuryOct 20, 2020Material Rupture; Adverse Event Without Identified Device or Use Problem; Material Rupture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6)-YEAR-OLD CAUCASIAN FEMALE WHO UNDERWENT PRIMARY BREAST RECONSTRUCTION WITH A MENTOR MEMORYSHAPE¿ 640CC SILICONE PROSTHESIS EXPERIENCED BILATERAL RUPTURE AND BILATERAL BREAST LUMPS POST PROCEDURE. THE PATIENT REPORTED HEADACHES, A BIT OF VERTIGO/TUNNEL VISION, HAIR LOSS, DRY SKIN AND HAIR. THE ISSUES HAS NOT BEEN CONFIRMED BY THE PHYSICIAN. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT BELONGS TO LEFT PROSTHESIS.

  Patient problems: Breast Mass; No Code Available; Wrinkling

  MAUDE report 10705821 ↗
• InjurySep 10, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD FEMALE PATIENT UNDERWENT UNSPECIFIED BREAST SURGERY WITH 640CC MENTOR MEMORYSHAPE BREAST IMPLANT AND WAS PRESENTED WITH RIGHT SIDE BREAST IMPLANT RUPTURE. 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 8980155 ↗
• InjuryAug 30, 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 PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH MENTOR MEMORYSHAPE BREAST IMPLANT 640CC (LEFT) AND MENTOR MEMORYSHAPE BREAST IMPLANT 530CC (RIGHT) AND EXPERIENCED BILATERAL BREAST PAIN POST-OPERATIVELY, WHICH WAS CONFIRMED BY A PHYSICIAN. 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: Pain

  MAUDE report 8950599 ↗
• InjuryJun 27, 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 FEMALE PATIENT WHO UNDERWENT A BREAST RECONSTRUCTION REVISION PROCEDURE WITH MENTOR MEMORYSHAPE BREAST IMPLANT 640CC GEL BREAST PROSTHESES DEVELOPED PAIN IN BOTH OF HER BREASTS. SHE REPORTED THAT IT IS PAINFUL FOR HER TO WEAR A BRA AND THAT THERE IS TENDERNESS UNDER THE BREAST FOLD. IN ADDITION, THE PATIENT HAS A SMALL MASS UNDERNEATH HER LEFT BREAST¿S AREOLA. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS MEDWATCH REPORT IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Breast Mass; Pain

  MAUDE report 8742275 ↗
• InjuryJun 27, 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 FEMALE PATIENT WHO UNDERWENT A BREAST RECONSTRUCTION REVISION PROCEDURE WITH MENTOR MEMORYSHAPE BREAST IMPLANT 640CC GEL BREAST PROSTHESES DEVELOPED PAIN IN BOTH OF HER BREASTS. SHE REPORTED THAT IT IS PAINFUL FOR HER TO WEAR A BRA AND THAT THERE IS TENDERNESS UNDER THE BREAST FOLD. IN ADDITION, THE PATIENT HAS A SMALL MASS UNDERNEATH HER LEFT BREAST¿S AREOLA. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS MEDWATCH REPORT IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Pain

  MAUDE report 8742273 ↗