MENTOR MemoryShape Breast Implant 3341404Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00081317024262), received between Oct 8, 2019 and Jul 24, 2025 — classified as 22 injuries.

The most frequently reported specific device problem is “Migration” (2 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• InjuryJul 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE WITH A MENTOR MEMORYSHAPE BREAST IMPLANT 680CC GEL BREAST PROSTHESIS SUFFERED FROM DELAYED WOUND HEALING IN HER RIGHT BREAST POST IMPLANTATION. AS A RESULT, THE PATIENT UNDERWENT AN UNSPECIFIED SURGICAL INTERVENTION TO ADDRESS THE ISSUE ON (B)(6) 2020. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Deformity/ Disfigurement; Impaired Healing

  MAUDE report 22594482 ↗
• InjuryMar 12, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 51-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A 680CC MENTOR MEMORYSHAPE BREAST IMPLANT AND EXPERIENCED CAPSULAR CONTRACTURE (BAKER GRADE UNKNOWN) AND A RUPTURE ON THE RIGHT SIDE POST-OPERATIVELY. THERE WAS TIGHTNESS ON THE RIGHT BREAST. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025 AND REPLACED WITH A 680CC MENTOR MEMORYSHAPE BREAST IMPLANT (CATALOG NUMBER 3341404) WITH SERIAL NUMBER (B)(6).

  Patient problems: Capsular Contracture

  MAUDE report 21586860 ↗
• InjuryApr 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 680CC MENTOR MEMORYSHAPE BREAST IMPLANT EXPERIENCED SWOLLEN LYMPH NODES AND FLUID COLLECTION ON THE LEFT SIDE POST-OPERATIVELY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Swollen Lymph Nodes/Glands

  MAUDE report 19156174 ↗
• InjuryDec 29, 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 RECONSTRUCTION PROCEDURE WITH MENTOR MEMORYSHAPE BREAST IMPLANT 680CC GEL BREAST PROSTHESES DEVELOPED WRINKLING AND ASYMMETRY IN BOTH BREASTS POST IMPLANTATION. AS A RESULT, THE PATIENT UNDERWENT AN UNSPECIFIED SURGICAL INTERVENTION ON (B)(6) 2020. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT BREAST PROSTHESIS.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Breast Discomfort/Pain; Deformity/ Disfigurement; Wrinkling

  MAUDE report 16072015 ↗
• InjuryDec 29, 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 RECONSTRUCTION PROCEDURE WITH MENTOR MEMORYSHAPE BREAST IMPLANT 680CC GEL BREAST PROSTHESES DEVELOPED WRINKLING AND ASYMMETRY IN BOTH BREASTS POST IMPLANTATION. AS A RESULT, THE PATIENT UNDERWENT AN UNSPECIFIED SURGICAL INTERVENTION ON (B)(6) 2020. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT BREAST PROSTHESIS.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Deformity/ Disfigurement; Pain; Wrinkling

  MAUDE report 16072003 ↗
• InjuryOct 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST REVISION RECONSTRUCTION SURGERY WITH 680CC MENTOR MEMORYSHAPE BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT EXPERIENCED AN INFECTION ON THE LEFT SIDE, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT REMOVAL ON AN UNDISCLOSED DATE. THIS REPORT IS FOR THE LEFT DEVICE. REFER TO MANUFACTURING REPORT NUMBER 1645337-2022-12657 AND 1645337-2022-12660 FOR THE CONTRALATERAL EVENTS.

  Patient problems: Post Operative Wound Infection

  MAUDE report 15639445 ↗
• InjuryOct 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST REVISION RECONSTRUCTION SURGERY WITH 680CC MENTOR MEMORYSHAPE BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT EXPERIENCED AN INFECTION ON THE RIGHT SIDE, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT REMOVAL ON (B)(6) 2021 AND REPLACEMENT WITH A 680CC MENTOR MEMORYSHAPE BREAST IMPLANT ON (B)(6) 2021. THIS REPORT IS FOR THE RIGHT DEVICE. REFER TO MANUFACTURING REPORT NUMBER 1645337-2022-12661 FOR THE CONTRALATERAL EVENT.

  Patient problems: Post Operative Wound Infection

  MAUDE report 15639441 ↗
• InjuryOct 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST REVISION RECONSTRUCTION SURGERY WITH A 680CC MENTOR MEMORYSHAPE BREAST IMPLANT. POST-OPERATIVELY, THE PATIENT EXPERIENCED AN INFECTION ON THE RIGHT SIDE, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT REMOVAL ON (B)(6) 2021. THIS REPORT IS FOR THE RIGHT DEVICE. REFER TO MANUFACTURING REPORT NUMBER 1645337-2022-12661 FOR THE CONTRALATERAL EVENT.

  Patient problems: Post Operative Wound Infection

  MAUDE report 15639440 ↗
• InjuryFeb 10, 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, AS PART OF A CLINICAL STUDY, BREAST RECONSTRUCTION REVISION WITH TWO 680CC MENTOR MEMORYSHAPE BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT SUFFERED BILATERAL BREAST WRINKLING AND RIGHT BREAST CAPSULAR CONTRACTURE (BAKER GRADE IV). AS A RESULT, THE PATIENT UNDERWENT SURGICAL INTERVENTION ON (B)(6) 2021. FAT GRAFTING WERE PERFORMED ON BOTH BREASTS AND RIGHT BREAST CAPSULECTOMY. 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: Capsular Contracture

  MAUDE report 13510297 ↗
• InjuryFeb 10, 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, AS PART OF A CLINICAL STUDY, BREAST RECONSTRUCTION REVISION WITH TWO 680CC MENTOR MEMORYSHAPE BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT SUFFERED BILATERAL BREAST WRINKLING AND RIGHT BREAST CAPSULAR CONTRACTURE (BAKER GRADE IV). AS A RESULT, THE PATIENT UNDERWENT SURGICAL INTERVENTION ON (B)(6) 2021. FAT GRAFTING WERE PERFORMED ON BOTH BREASTS AND RIGHT BREAST CAPSULECTOMY. 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 13510296 ↗
• InjuryJul 21, 2021Adverse 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 SURGERY WITH A MENTOR MEMORYSHAPE BREAST IMPLANT 680CC. ON (B)(6) 2021, SHE PRESENTED WITH SEROMA ON THE LEFT SIDE, WHICH REQUIRED SURGICAL INTERVENTION ¿ SEROMA ASPIRATION ON (B)(6) 2021. THE PRINCIPAL INVESTIGATOR ASSESSED THIS EVENT AS SEVERE IN SEVERITY, SERIOUS, POSSIBLY RELATED TO THE DEVICE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Seroma

  MAUDE report 12207331 ↗
• InjuryJun 28, 2021Adverse 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 REVISION PROCEDURE WITH A MENTOR MEMORYGEL BREAST IMPLANT 450CC GEL BREAST PROSTHESIS (LEFT DEVICE) AND A MENTOR MEMORYSHAPE BREAST IMPLANT 680CC GEL BREAST PROSTHESIS (RIGHT DEVICE) DEVELOPED BILATERAL BREAST ASYMMETRY. AS A RESULT, THE PATIEN UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH A MENTOR MEMORYSHAPE BREAST IMPLANT 555CC GEL BREAST PROSTHESIS (LEFT DEVICE) AND A MENTOR MEMORYSHAPE BREAST IMPLANT 680CC GEL BREAST PROSTHESIS (RIGHT DEVICE) ON (B)(6) 2020. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement; Impaired Healing; Wrinkling

  MAUDE report 12081395 ↗
• InjuryJun 24, 2021Adverse 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 TWO 680CC MENTOR MEMORYSHAPE BREAST IMPLANT PROSTHESES AND EXPERIENCED POSTOPERATIVE BILATERAL CUTANEOUS CONTOUR DEFORMITY. BILATERAL WRINKLING WAS OBSERVED ON (B)(6) 2020 . AS A RESULT, THE PATIENT UNDERWENT A SURGICAL INTERVENTION FOR BILATERAL FAT GRAFTING ON (B)(6) 2020 . THIS IS THE SECOND BILATERAL WRINKLING THAT THE PATIENT EXPERIENCED WITH THE SAME DEVICES. FOR THE FIRST BILATERAL WRINKLING EVENT, PLEASE REFER TO MANUFACTURE REPORT NUMBER 1645337-2021-07162. THIS REPORT IS FOR THE RIGHT-SIDED PROSTHESIS.

  Patient problems: Wrinkling

  MAUDE report 12059893 ↗
• InjuryJun 24, 2021Adverse 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 TWO 680CC MENTOR MEMORYSHAPE BREAST IMPLANT PROSTHESES AND EXPERIENCED POSTOPERATIVE BILATERAL CUTANEOUS CONTOUR DEFORMITY. BILATERAL WRINKLING WAS OBSERVED ON (B)(6) 2020. AS A RESULT, THE PATIENT UNDERWENT A SURGICAL INTERVENTION FOR BILATERAL FAT GRAFTING ON (B)(6) 2020. THIS IS THE SECOND BILATERAL WRINKLING THAT THE PATIENT EXPERIENCED WITH THE SAME DEVICES. FOR THE FIRST BILATERAL WRINKLING EVENT, PLEASE REFER TO MANUFACTURE REPORT NUMBER 1645337-2021-07025. THIS REPORT IS FOR THE LEFT-SIDED PROSTHESIS.

  Patient problems: Wrinkling

  MAUDE report 12059883 ↗
• InjuryJun 23, 2021Adverse 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 TWO 680CC MENTOR MEMORYSHAPE BREAST IMPLANT PROSTHESES AND EXPERIENCED POSTOPERATIVE BILATERAL CUTANEOUS CONTOUR DEFORMITY. BILATERAL WRINKLING WAS OBSERVED ON (B)(6) 2020. AS A RESULT, THE PATIENT UNDERWENT A SURGICAL INTERVENTION FOR BILATERAL FAT GRAFTING ON (B)(6) 2020. THIS REPORT IS FOR THE LEFT-SIDED PROSTHESIS.

  Patient problems: Breast Mass; Deformity/ Disfigurement; Wrinkling

  MAUDE report 12055277 ↗
• InjuryJun 23, 2021Adverse 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 TWO 680CC MENTOR MEMORYSHAPE BREAST IMPLANT PROSTHESES AND EXPERIENCED POSTOPERATIVE BILATERAL CUTANEOUS CONTOUR DEFORMITY. BILATERAL WRINKLING WAS OBSERVED ON (B)(6) 2020 . AS A RESULT, THE PATIENT UNDERWENT A SURGICAL INTERVENTION FOR BILATERAL FAT GRAFTING ON (B)(6) 2020 . THIS REPORT IS FOR THE RIGHT-SIDED PROSTHESIS.

  Patient problems: Post Operative Wound Infection; Wrinkling

  MAUDE report 12054963 ↗
• InjuryJun 18, 2021Adverse 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 680CC AND SUFFERED FROM A CUTANEOUS CONTOUR DEFORMITY ON THE LEFT SIDE. ON (B)(6) 2020, SHE PRESENTED WITH WRINKLING, WHICH REQUIRED SURGICAL INTERVENTION: FAT GRAFTING ON (B)(6) 2020. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Wrinkling

  MAUDE report 12029060 ↗
• InjuryFeb 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 UNDERWENT PRIMARY BREAST RECONSTRUCTION WITH 680CC MENTOR MEMORYSHAPE BREAST IMPLANTS AND EXPERIENCED INFECTION ON THE LEFT SIDE AND BILATERAL COMFORTLESS AND NUMBNESS POSTOPERATIVELY. AS A RESULT, THE PATIENT IS SCHEDULED TO UNDERGO BILATERAL DEVICE REMOVAL ON (B)(6) 2021. THIS REPORT IS FOR THE PATIENT'S RIGHT-SIDED DEVICE.

  Patient problems: Pain; Paresthesia

  MAUDE report 11382415 ↗
• InjuryFeb 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 UNDERWENT PRIMARY BREAST RECONSTRUCTION WITH 680CC MENTOR MEMORYSHAPE BREAST IMPLANTS AND EXPERIENCED INFECTION ON THE LEFT SIDE AND BILATERAL COMFORTLESS AND NUMBNESS POSTOPERATIVELY. AS A RESULT, THE PATIENT IS SCHEDULED TO UNDERGO BILATERAL DEVICE REMOVAL ON (B)(6) 2021. THIS REPORT IS FOR THE PATIENT'S LEFT-SIDED DEVICE.

  Patient problems: Pain; Paresthesia; Post Operative Wound Infection

  MAUDE report 11382399 ↗
• InjuryFeb 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A CAUCASIAN FEMALE WHO UNDERWENT BREAST AUGMENTATION REVISION WITH A MENTOR MEMORYSHAPE 680CC SILICONE PROSTHESIS EXPERIENCED LEFT SIDED SEROMA POST PROCEDURE. AS A RESULT, DOCTOR PERFORMED INCISION FOR THE DRAINAGE, AND THE ISSUE WAS RESOLVED. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Post Operative Wound Infection; Seroma

  MAUDE report 11287684 ↗
• InjuryOct 8, 2019Migration; Migration

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT AN UNKNOWN BREAST RECONSTRUCTION SURGERY WITH MENTOR MEMORYSHAPE,680CC SILICONE BREAST IMPLANTS WHICH BILATERALLY MIGRATED AFTER IMPLANTATION. AS A RESULT PATIENT HAD THEM REMOVED AND REPLACED WITH OTHER GEL DEVICES ON (B)(6) 2019. THIS REPORT IS FOR THE RIGHT SIDE.

  Patient problems: No Code Available

  MAUDE report 9167094 ↗
• InjuryOct 8, 2019Migration; Migration

  IT WAS REPORTED THAT A (B)(6) YEAR OLD CAUCASIAN FEMALE PATIENT UNDERWENT AN UNKNOWN BREAST RECONSTRUCTION SURGERY WITH MENTOR MEMORYSHAPE, 680CC SILICONE BREAST IMPLANTS WHICH BILATERALLY MIGRATED AFTER IMPLANTATION. AS A RESULT PATIENT HAD THEM REMOVED AND REPLACED WITH OTHER GEL DEVICES ON (B)(6) 2019. THIS REPORT IS FOR THE LEFT SIDE.

  Patient problems: No Code Available

  MAUDE report 9167037 ↗