MENTOR MemoryShape Breast Implant 3541508Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00081317005513), received between Aug 30, 2019 and Oct 6, 2022 — classified as 14 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryOct 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 UNDERWENT A BREAST AUGMENTATION SURGERY WITH 530CC MENTOR MEMORY SHAPE BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT EXPERIENCED BILATERAL PTOSIS AND PAIN IN HER NECK, BREASTS, AND BACK, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT REMOVAL ON (B)(6)2022. REFER TO MANUFACTURING REPORT NUMBER 1645337-2022-11861 FOR THE CONTRALATERAL EVENT.

  Patient problems: Breast Discomfort/Pain; Deformity/ Disfigurement; Pain

  MAUDE report 15555883 ↗
• InjuryOct 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 UNDERWENT A BREAST AUGMENTATION SURGERY WITH 530CC MENTOR MEMORYSHAPE BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT EXPERIENCED BILATERAL PTOSIS AND PAIN IN HER NECK, BREASTS, AND BACK, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT REMOVAL ON (B)(6) 2022. REFER TO MANUFACTURING REPORT NUMBER 1645337-2022-11862 FOR THE CONTRALATERAL EVENT.

  Patient problems: Breast Discomfort/Pain; Deformity/ Disfigurement; Pain

  MAUDE report 15555805 ↗
• InjuryMar 24, 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 WHO UNDERWENT BREAST RECONSTRUCTION WITH 530CC MENTOR MEMORYSHAPE BREAST IMPLANT EXPERIENCED BILATERAL PTOSIS WITH ASYMMETRIC APPEARANCE POST PROCEDURE. AS A RESULT, REPLACEMENT WITH 465CC MENTOR MEMORYGEL BREAST IMPLANTS WAS PERFORMED ON (B)(6) 2022. SEE 1645337-2022-03214 FOR CONTRALATERAL PROSTHESIS REPORT.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 13877205 ↗
• InjuryMar 24, 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 WHO UNDERWENT BREAST RECONSTRUCTION WITH 530CC MENTOR MEMORYSHAPE BREAST IMPLANT EXPERIENCED BILATERAL PTOSIS WITH ASYMMETRIC APPEARANCE POST PROCEDURE. AS A RESULT, REPLACEMENT WITH 465CC MENTOR MEMORYGEL BREAST IMPLANTS WAS PERFORMED ON JANUARY 20, 2022. SEE 1645337-2022-03219 FOR CONTRALATERAL PROSTHESIS REPORT.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 13877169 ↗
• InjuryJan 7, 2021Material Rupture; Adverse Event Without Identified Device or Use Problem; Migration; Material Rupture; Adverse Event Without Identified Device or Use Problem; Migration

  IT WAS REPORTED THAT A CAUCASIAN FEMALE UNDERWENT BREAST AUGMENTATION WITH 530CC MENTOR MEMORYSHAPE BREAST IMPLANTS AND EXPERIENCED BILATERAL SEROMA POSTOPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT BILATERAL DRAINAGE ON (B)(6) 2020. THIS REPORT IS FOR THE PATIENT'S LEFT-SIDED DEVICE.

  Patient problems: Seroma

  MAUDE report 11136415 ↗
• InjuryJan 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A CAUCASIAN FEMALE UNDERWENT BREAST AUGMENTATION WITH 530CC MENTOR MEMORYSHAPE BREAST IMPLANTS AND EXPERIENCED BILATERAL SEROMA POSTOPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT BILATERAL DRAINAGE ON (B)(6) 2020. THIS REPORT IS FOR THE PATIENT'S RIGHT-SIDED DEVICE.

  Patient problems: Seroma

  MAUDE report 11136357 ↗
• InjuryDec 23, 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 UNDERWENT A BREAST AUGMENTATION WITH A MENTOR MEMORYSHAPE BREAST IMPLANT 530CC AND EXPERIENCED SEROMA ON THE LEFT SIDE POST-OPERATIVELY. THE PATIENT UNDERWENT ASPIRATION OF THE FLUID ON (B)(6)2017. THE PATIENT THEN UNDERWENT REMOVAL AND REPLACEMENT WITH A MENTOR GEL BREAST IMPLANT (7492170-039) ON (B)(6) 2017.

  Patient problems: Post Operative Wound Infection; Seroma

  MAUDE report 11068775 ↗
• InjuryJun 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA FDA MEDWATCH NUMBER: MW5094094 THAT A FEMALE PATIENT OF UNKNOWN AGE AND RACE UNDERWENT PRIMARY BREAST RECONSTRUCTION SURGERY WITH 530CC MENTOR MEMORYSHAPE BREAST IMPLANT ON BOTH SIDES AND EXPERIENCED LEFT SIDE BREAST IMPLANT RUPTURE, AND BILATERAL CAPSULAR CONTRACTURE; BAKER GRADE UNKNOWN. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH CATALOG NUMBER 3506504BC; SERIAL NUMBER (B)(4) ON THE LEFT SIDE, AND WITH CATALOG NUMBER 3506504BC; SERIAL NUMBER (B)(4) ON THE RIGHT SIDE ON (B)(6) 2019. THIS REPORT IS FOR THE PATIENT¿S RIGHT-SIDED DEVICE.

  Patient problems: Capsular Contracture; No Code Available

  MAUDE report 10154965 ↗
• InjuryJun 15, 2020Material Rupture; Material Rupture

  IT WAS REPORTED VIA FDA MEDWATCH NUMBER: MW5094094 THAT A FEMALE PATIENT OF UNKNOWN AGE AND RACE UNDERWENT PRIMARY BREAST RECONSTRUCTION SURGERY WITH 530CC MENTOR MEMORYSHAPE BREAST IMPLANT ON BOTH SIDES AND EXPERIENCED LEFT SIDE BREAST IMPLANT RUPTURE, AND BILATERAL CAPSULAR CONTRACTURE; BAKER GRADE UNKNOWN. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH CATALOG NUMBER 3506504BC; SERIAL NUMBER (B)(4) ON THE LEFT SIDE, AND WITH CATALOG NUMBER 3506504BC; SERIAL NUMBER (B)(4) ON THE RIGHT SIDE ON (B)(6) 2019. THIS REPORT IS FOR THE PATIENT¿S LEFT-SIDED DEVICE.

  Patient problems: Capsular Contracture; No Code Available

  MAUDE report 10154963 ↗
• InjuryDec 11, 2019Material Discolored; Device Contamination with Chemical or Other Material; Material Discolored; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A 65-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT UNSPECIFIED BREAST RECONSTRUCTION SURGERY IN WITH A 530CC MENTOR MEMORYSHAPE BREAST IMPLANT AND WAS IN A MOTORCYCLE ACCIDENT IN 2017 AND STARTED WITH PAIN IN HER RIGHT BREAST WHICH LEAD TO THE REMOVAL OF BILATERAL IMPLANTS. THE ONLY AFFECTED IMPLANT IS HER RIGHT. IMAGING SUGGESTED RUPTURE, WHICH IN CONJUNCTION WITH INCREASING BREAST PAIN AND A CHANGE IN THE SHAPE OF THE BREAST NECESSITATED INTERVENTION. PER INFORMATION RECEIVED, SHE HAS FULLY RECOVERED SINCE HAVING HER IMPLANTS REPLACED ON (B)(6) 2019. THE RIGHT SIDE WAS REPLACED WITH CATALOG NUMBER: 3506001BC, AND SERIAL NUMBER: (B)(6)

  Patient problems: Injury; No Code Available; Pain

  MAUDE report 9454064 ↗
• InjuryOct 10, 2019Adverse 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 A BREAST AUGMENTATION REVISION WITH A MENTOR MEMORYSHAPE BREAST IMPLANT 530CC AND EXPERIENCED PAIN, TIGHTNESS, SEROMA ON THE LEFT BREAST IMPLANT. IN ADDITION, THE PATIENT EXPERIENCED BILATERAL CAPSULAR CONTRACTURE BAKER GRADE III THAT WAS DIAGNOSED DURING SURGERY ON (B)(6) 2019. AS A RESULT, THE PATIENT HAD UNDERGONE REMOVAL AND REPLACEMENT WITH MENTOR MEMORYGEL BREAST IMPLANT 550CC ON THE LEFT SIDE AND WITH MENTOR MEMORYGEL BREAST IMPLANT 575CC ON THE RIGHT BREAST IMPLANT ON (B)(6) 2019. THIS MEDWATCH IS FOR THE LEFT BREAST IMPLANT.

  Patient problems: Capsular Contracture; No Code Available; Seroma

  MAUDE report 9175198 ↗
• InjuryOct 10, 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 BREAST AUGMENTATION REVISION WITH A MENTOR MEMORYSHAPE BREAST IMPLANT 530CC AND EXPERIENCED PAIN, TIGHTNESS, SEROMA ON THE LEFT BREAST IMPLANT. IN ADDITION, THE PATIENT EXPERIENCED BILATERAL CAPSULAR CONTRACTURE BAKER GRADE III THAT WAS DIAGNOSED DURING SURGERY ON (B)(6) 2019. AS A RESULT, THE PATIENT HAD UNDERGONE REMOVAL AND REPLACEMENT WITH MENTOR MEMORYGEL BREAST IMPLANT 550CC ON THE LEFT SIDE AND WITH MENTOR MEMORYGEL BREAST IMPLANT 575CC ON THE RIGHT BREAST IMPLANT ON (B)(6) 2019. THIS MEDWATCH IS FOR THE RIGHT BREAST IMPLANT.

  Patient problems: Capsular Contracture; No Code Available

  MAUDE report 9175187 ↗
• InjuryOct 8, 2019Material Rupture; Material Rupture

  THIS REPORT CONTAINS SUPPLEMENTAL INFORMATION FOR MENTOR PSR REFERENCE NUMBER (B)(4). THIS DEVICE REPORT IS BEING SUBMITTED LATE AS A RESULT OF EXEMPTION TRANSITION PERIOD FOLLOWING THE REVOCATION OF MENTOR¿S PSR EXEMPTION #E2007003. IT WAS REPORTED THAT A (B)(6) YEAR OLD CAUCASIAN FEMALE UNDERWENT A PRIMARY BREAST RECONSTRUCTION WITH A 530CC MENTOR MEMORYSHAPE BREAST IMPLANT AND EXPERIENCED RUPTURE ON THE LEFT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT DEVICE REMOVAL ON (B)(6) 2019.

  Patient problems: No Code Available

  MAUDE report 9168947 ↗
• 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 RIGHT SIDE DEVICE.

  Patient problems: Pain

  MAUDE report 8950607 ↗