MENTOR MemoryGel Breast Implant 3501504BCRecalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00081317000402), received between Nov 25, 2019 and Mar 5, 2026 — classified as 23 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• InjuryMar 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH TWO 150CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT DEVELOPED BILATERAL BREAST CAPSULAR CONTRACTURES (BAKER GRADE II ON THE LEFT AND BAKER GRADE III ON THE RIGHT). 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 24526661 ↗
• InjuryMar 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH TWO 150CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT DEVELOPED BILATERAL BREAST CAPSULAR CONTRACTURES (BAKER GRADE II ON THE LEFT AND BAKER GRADE III ON THE RIGHT). 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: Capsular Contracture

  MAUDE report 24526660 ↗
• InjuryMar 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT BREAST AUGMENTATION REVISION WITH A 150CC MENTOR MEMORYGEL BREAST IMPLANT (LEFT) AND A 175CC MENTOR MEMORYGEL BREAST IMPLANT (RIGHT) EXPERIENCED BILATERAL BAKER GRADE III CAPSULAR CONTRACTURE POST PROCEDURE. AS A RESULT, REPLACEMENT WITH MENTOR GEL WAS PERFORMED ON (B)(6) 2022.

  Patient problems: Capsular Contracture

  MAUDE report 21579690 ↗
• InjuryJun 25, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST PROSTHESIS IMPLANTATION SURGERY WITH TWO MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT SUFFERED BILATERAL BREAST IMPLANT RUPTURES AND BILATERAL CAPSULAR CONTRACTURES (BAKER GRADE UNSPECIFIED). THE PATIENT HAS BREAST DEFORMITY. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT SURGERY ON (B)(6) 2024. THE REPLACEMENT DEVICES WERE: (LEFT) 150CC MENTOR MEMORYGEL BREAST IMPLANT, CATALOG: 3501504BC, LOT: 9913970, SN: (B)(6) AND (RIGHT) 200CC MENTOR MEMORYGEL BREAST IMPLANT, CATALOG: 3502004BC, LOT: 9762821, SN: (B)(6). THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 19609998 ↗
• InjuryMay 14, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH 150CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT EXPERIENCED PAIN UNDERNEATH HER LEFT ARM. THE PATIENT ALSO REPORTED THAT HER LEFT IMPLANT LOOKED LIKE IT HAD FALLEN OUT OF HER IMPLANT POCKET. THE PATIENT HAD A MAGNETIC RESONANCE IMAGING EXAM, WHICH IDENTIFIED AN INTRACAPSULAR RUPTURE OF HER RIGHT PROSTHESIS. AS A RESULT, THE PATIENT IS SCHEDULED FOR REMOVAL SURGERY ON (B)(6) 2024. THIS REPORT IS FOR THE RIGHT IMPLANT.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 19314231 ↗
• InjuryMay 14, 2024Migration; Migration

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH 150CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT EXPERIENCED PAIN UNDERNEATH HER LEFT ARM. THE PATIENT ALSO REPORTED THAT HER LEFT IMPLANT LOOKED LIKE IT HAD FALLEN OUT OF HER IMPLANT POCKET. THE PATIENT HAD A MAGNETIC RESONANCE IMAGING EXAM, WHICH IDENTIFIED AN INTRACAPSULAR RUPTURE OF HER RIGHT PROSTHESIS. AS A RESULT, THE PATIENT IS SCHEDULED FOR REMOVAL SURGERY ON (B)(6) 2024. THIS REPORT IS FOR THE LEFT IMPLANT.

  Patient problems: Breast Discomfort/Pain; Deformity/ Disfigurement

  MAUDE report 19314187 ↗
• InjuryMay 6, 2024Adverse Event Without Identified Device or Use Problem; Migration; Adverse Event Without Identified Device or Use Problem; Migration

  IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT SUFFERED RIGHT BREAST PAIN, RIGHT BREAST CAPSULAR CONTRACTURE (BAKER GRADE III), LEFT BREAST BOTTOMING OUT AND BILATERAL BREAST PTOSIS. AS A RESULT, THE PATIENT UNDERWENT BILATERAL BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2024. THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture; Deformity/ Disfigurement

  MAUDE report 19255034 ↗
• InjuryNov 15, 2023Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 150CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6), 2023.

  Patient problems: Capsular Contracture

  MAUDE report 18142770 ↗
• InjuryOct 18, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST PROSTHESIS IMPLANTATION SURGERY WITH A 150CC MENTOR MEMORYGEL BREAST IMPLANT ON THE LEFT BREAST. POST-OPERATIVELY, THE PATIENT SUFFERED LEFT BREAST IMPLANT RUPTURE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 17962104 ↗
• InjuryJul 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 WHO UNDERWENT A BREAST AUGMENTATION PROCEDURE WITH A MENTOR MEMORYGEL BREAST IMPLANT 150CC GEL BREAST PROSTHESIS DEVELOPED CAPSULAR CONTRACTURE (BAKER GRADE UNKNOWN) IN HER LEFT BREAST POST IMPLANTATION. AS A RESULT, THE PATIENT UNDERWENT UNILATERAL EXPLANTATION AND REPLACEMENT WITH A MENTOR MEMORYGEL BREAST IMPLANT 150CC GEL BREAST PROSTHESIS ON (B)(6) 2022.

  Patient problems: Capsular Contracture

  MAUDE report 17253134 ↗
• InjuryJul 3, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 40-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST IMPLANTATION PROCEDURE WITH UNSPECIFIED MENTOR GEL BREAST IMPLANTS AND EXPERIENCED BILATERAL RUPTURE, AS A RESULT, THE PATIENT UNDERWENT REMOVAL ON (B)(6) 2013. THIS REPORT IS FOR THE SECOND OF TWO DEVICES. SEE MANUFACTURER REPORT NUMBER 1645337-2023-01886 FOR CONTRALATERAL SIDE.

  Patient problems: Capsular Contracture

  MAUDE report 17248293 ↗
• InjuryJun 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 26-YEAR-OLD FEMALE WHO UNDERWENT BREAST AUGMENTATION WITH 150CC MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED BILATERAL CAPSULAR CONTRACTURE AND LEFT SIDED DEVICE EXTRUSION POST PROCEDURE. THE RIGHT SIDED CAPSULAR CONTRACTURE WAS BAKER GRADE III. THE LEFT SIDED CAPSULAR CONTRACTURE WAS BAKER GRADE II. THERE WAS WOUND BREAKDOWN IN THE LEFT IMPLANT LEAVING IT EXPOSED. AS A RESULT, REPLACEMENT WITH NEW 150CC MENTOR MEMORYGEL BREAST IMPLANTS WAS PERFORMED ON (B)(6) 2023. SEE 1645337-2023-07579 FOR CONTRALATERAL PROSTHESIS REPORT.

  Patient problems: Capsular Contracture; Pocket Erosion

  MAUDE report 17210662 ↗
• InjuryJun 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 26-YEAR-OLD FEMALE WHO UNDERWENT BREAST AUGMENTATION WITH 150CC MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED BILATERAL CAPSULAR CONTRACTURE AND LEFT SIDED DEVICE EXTRUSION POST PROCEDURE. THE RIGHT SIDED CAPSULAR CONTRACTURE WAS BAKER GRADE III. THE LEFT SIDED CAPSULAR CONTRACTURE WAS BAKER GRADE II. THERE WAS WOUND BREAKDOWN IN THE LEFT IMPLANT LEAVING IT EXPOSED. AS A RESULT, REPLACEMENT WITH NEW 150CC MENTOR MEMORYGEL BREAST IMPLANTS WAS PERFORMED ON (B)(6) 2023. SEE 1645337-2023-07578 FOR CONTRALATERAL PROSTHESIS REPORT.

  Patient problems: Capsular Contracture

  MAUDE report 17210661 ↗
• InjuryFeb 21, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 40-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST IMPLANTATION PROCEDURE WITH UNSPECIFIED MENTOR GEL BREAST IMPLANT AND EXPERIENCED RUPTURE (SIDE UNKNOWN) POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A MAMMOGRAM. AS A RESULT, THE PATIENT UNDERWENT DEVICE REMOVAL AND REPLACEMENT ON AN UNSPECIFIED DATE

  Patient problems: Deformity/ Disfigurement

  MAUDE report 16410683 ↗
• InjuryAug 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 60-YEAR-OLD CAUCASIAN FEMALE PATIENT WHO UNDERWENT BREAST AUGMENTATION REVISION SURGERY WITH A 150CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED RIGHT SIDED CAPSULAR CONTRACTURE BAKER GRADE IV POST PROCEDURE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Capsular Contracture

  MAUDE report 15216299 ↗
• InjuryMay 3, 2021Adverse 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 A PRIMARY BREAST AUGMENTATION PROCEDURE WITH A MENTOR MEMORYGEL BREAST IMPLANT 150CC GEL BREAST PROSTHESIS (LEFT DEVICE) AND A MENTOR MEMORYGEL BREAST IMPLANT 175CC GEL BREAST PROSTHESIS (RIGHT DEVICE) DEVELOPED CAPSULAR CONTRACTURE IN BOTH OF HER BREASTS (BAKER GRADE IV IN LEFT BREAST, BAKER GRADE II IN RIGHT BREAST). BILATERAL CAPSULAR CONTRACTURE WAS DIAGNOSED VIA A PHYSICAL. AS A RESULT, THE PATIENT IS SCHEDULED TO UNDERGO BILATERAL EXPLANTATION ON (B)(6) 2021. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 11766961 ↗
• InjuryMay 28, 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 FEMALE PATIENT UNDERWENT A REVISION BREAST AUGMENTATION WITH TWO 150CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESES AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE (GRADE UNKNOWN) AND LEFT-SIDED BREAST MASS POSTOPERATIVELY. THE PATIENT FELT PRESSURE AND HARDNESS BILATERALLY WITHIN THE FIRST MONTH OF THE IMPLANTATION. THE PAIN ON THE LEFT SIDE WAS MORE SEVERE THAN THE RIGHT SIDE. AS A RESULT, THE PATIENT UNDERWENT REMOVAL WITHOUT REPLACEMENT ON (B)(6) 2018. THIS REPORT IS FOR THE LEFT PROSTHESIS.

  Patient problems: Breast Mass; Capsular Contracture; No Code Available

  MAUDE report 10099414 ↗
• InjuryMay 28, 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 FEMALE PATIENT UNDERWENT A REVISION BREAST AUGMENTATION WITH TWO 150CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESES AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE (GRADE UNKNOWN) AND LEFT-SIDED BREAST MASS POSTOPERATIVELY. THE PATIENT FELT PRESSURE AND HARDNESS BILATERALLY WITHIN THE FIRST MONTH OF THE IMPLANTATION. THE PAIN ON THE LEFT SIDE WAS MORE SEVERE THAN THE RIGHT SIDE. AS A RESULT, THE PATIENT UNDERWENT REMOVAL WITHOUT REPLACEMENT ON (B)(6) 2018. THIS REPORT IS FOR THE RIGHT PROSTHESIS.

  Patient problems: Capsular Contracture; No Code Available

  MAUDE report 10099413 ↗
• InjuryDec 19, 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 WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 150CC MENTOR MEMORYGEL BREAST IMPLANTS, SUFFERED BILATERAL BREAST CAPSULAR CONTRACTURE; BAKER GRADE IV, POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT ON (B)(6) 2018 WITH THE FOLLOWING DEVICES: (RIGHT) 300CC MENTOR MEMORYGEL BREAST IMPLANT CATALOG: 3503004BC, LOT: 7583723, SN: (B)(4) AND (LEFT) 300CC MENTOR MEMORYGEL BREAST IMPLANT CATALOG: 3503004BC, LOT: 7485135, SN: (B)(4). THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS. THIS REPORT CONTAINS SUPPLEMENTAL INFORMATION FOR MENTOR PSR REFERENCE NUMBER (B)(4).

  Patient problems: Capsular Contracture; No Code Available

  MAUDE report 9495042 ↗
• InjuryDec 19, 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 WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 150CC MENTOR MEMORYGEL BREAST IMPLANTS, SUFFERED BILATERAL BREAST CAPSULAR CONTRACTURE; BAKER GRADE IV, POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT ON (B)(6) 2018 WITH THE FOLLOWING DEVICES: (RIGHT) 300CC MENTOR MEMORYGEL BREAST IMPLANT CATALOG: 3503004BC, LOT: 7583723, SN: (B)(4) AND (LEFT) 300CC MENTOR MEMORYGEL BREAST IMPLANT CATALOG: 3503004BC, LOT: 7485135, SN: (B)(4). THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS. THIS REPORT CONTAINS SUPPLEMENTAL INFORMATION FOR MENTOR PSR REFERENCE NUMBER (B)(4). MENTOR BECAME AWARE THAT PSR SUBMISSION (B)(4) WAS A DUPLICATE OF THIS COMPLAINT FILE. ALL FURTHER SUPPLEMENTAL INFORMATION WITH BE SUBMITTED UNDER THIS COMPLAINT FILE.

  Patient problems: Capsular Contracture; No Code Available

  MAUDE report 9495020 ↗
• InjuryDec 18, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT WHO UNDERWENT BREAST AUGMENTATION REVISION SURGERY WITH 150CC MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED BILATERAL RUPTURE, FEELING ILL, SWELLING IN BODY, GREEN PUSS POURING FROM NIPPLE, BLOOD POURING FROM NIPPLE, POSSIBLE INFECTION, THROBBING CHEST, HUGE HOLE IN NIPPLE THAT GOES UNDERNEATH BREAST, DIZZINESS, RAW SKIN SHOWING, LIGHT HEADINESS, AND FAINTING POST PROCEDURE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT IS FOR THE LEFT SIDED DEVICE. SEE 1645337-2019-25843 FOR CONTRALATERAL PROSTHESIS REPORT.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9489481 ↗
• InjuryDec 18, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT WHO UNDERWENT BREAST AUGMENTATION REVISION SURGERY WITH 150CC MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED BILATERAL RUPTURE, FEELING ILL, SWELLING IN BODY, GREEN PUSS POURING FROM NIPPLE, BLOOD POURING FROM NIPPLE, POSSIBLE INFECTION, THROBBING CHEST, HUGE HOLE IN NIPPLE THAT GOES UNDERNEATH BREAST, DIZZINESS, RAW SKIN SHOWING, LIGHT HEADINESS, AND FAINTING POST PROCEDURE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT IS FOR THE RIGHT SIDED DEVICE. SEE 1645337-2019-25842 FOR CONTRALATERAL PROSTHESIS REPORT.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9489415 ↗
• InjuryNov 25, 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 150CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED POSTOPERATIVE LEFT-SIDED GRADE IV CAPSULAR CONTRACTURE AND FAT NECROSIS. THE DIAGNOSIS WAS CONFIRMED BY A HEALTHCARE PROFESSIONAL. AS A RESULT, THE PATIENT IS SCHEDULED TO UNDERGO REMOVAL AND REPLACEMENT WITH AN UNSPECIFIED IMPLANT ON (B)(6)2019.

  Patient problems: Capsular Contracture; Necrosis; No Code Available

  MAUDE report 9373790 ↗