MENTOR MemoryShape Breast Implant 3341307Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00081317004950), received between Dec 1, 2020 and Aug 22, 2025 — classified as 7 injuries.

The most frequently reported specific device problem is “Material Rupture” (3 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryAug 22, 2025Gel Leak; Material Rupture; Gel Leak; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 370CC MENTOR MEMORYSHAPE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT HAD CONCERNS OF A BULGE ON THE RIGHT SIDE. ULTRASOUND IMAGING WAS CONDUCTED AND SHE WAS DIAGNOSED WITH A RUPTURED RIGHT IMPLANT WITH GEL BLEED. AS A RESULT, THE PATIENT WAS SCHEDULED FOR IMPLANT REMOVAL ON (B)(6) 2025. THE DATE OF EVENT WAS PROVIDED TO MENTOR AS A BEST ESTIMATE. 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 22874514 ↗
• InjuryMay 15, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH TWO 370CC MENTOR MEMORYSHAPE BREAST IMPLANTS EXPERIENCED BILATERAL RUPTURES AND CAPSULAR CONTRACTURE (BAKER GRADE 4) POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025.

  Patient problems: Capsular Contracture

  MAUDE report 22029235 ↗
• InjuryMay 15, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH TWO 370CC MENTOR MEMORYSHAPE BREAST IMPLANTS EXPERIENCED BILATERAL RUPTURES AND CAPSULAR CONTRACTURE (BAKER GRADE 4) POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025.

  Patient problems: Capsular Contracture

  MAUDE report 22029233 ↗
• InjuryJun 27, 2023Adverse 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 SURGERY WITH IMPLANTATION OF A 370CC MENTOR MEMORYSHAPE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT PRESENTED WITH RIGHT-SIDED BREAST CANCER WHICH REQUIRED A PARTIAL MASTECTOMY [PARTIAL] /LUMPECTOMY. THE DEVICE WAS NOT REPORTED TO HAVE BEEN REMOVED DURING THE SURGICAL INTERVENTION.

  Patient problems: Breast Cancer

  MAUDE report 17212609 ↗
• InjuryMar 3, 2023Adverse 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 RECONSTRUCTION WITH A MENTOR MEMORYSHAPE BREAST IMPLANT 370CC AND EXPERIENCED ASYMMETRY AND WRINKLING ON THE LEFT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT REMOVAL ON (B)(6) 2016.

  Patient problems: Breast Cancer; Deformity/ Disfigurement; Wrinkling

  MAUDE report 16479746 ↗
• InjuryMar 3, 2023Adverse 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 RECONSTRUCTION WITH A MENTOR MEMORYSHAPE BREAST IMPLANT 370CC AND EXPERIENCED ASYMMETRY AND WRINKLING ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT REMOVAL ON (B)(6) 2016.

  Patient problems: Breast Cancer; Deformity/ Disfigurement; Wrinkling

  MAUDE report 16479745 ↗
• InjuryDec 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS EVENT IS ASSOCIATED WITH THE GLOW STUDY# (B)(4). IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH A 330CC MENTOR MEMORYSHAPE BREAST IMPLANT ON THE LEFT SIDE, AND WITH 370CC MENTOR MEMORYSHAPE BREAST IMPLANT ON RIGHT SIDE ON (B)(6) 2015, AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE; BAKER GRADE III POSTOPERATIVELY. AS A RESULT, THE PATIENT WILL UNDERGO BILATERAL EXPLANTATION ON (B)(6) 2020. THIS REPORT IS FOR THE PATIENT¿S RIGHT-SIDED DEVICE.

  Patient problems: Capsular Contracture

  MAUDE report 10931087 ↗