MENTOR MemoryGel Breast Implant 3507555MCRecalls & reported problems

Summary

The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 00081317004257), received between Sep 26, 2019 and Sep 11, 2026 — classified as 38 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Rupture” (28 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 25 most recent of 39 reports, in the reporter's own words as published by the FDA.

• InjurySep 11, 2026Material Rupture

  It was reported that a patient with MENTOR MemoryGel Breast Implants experienced bilateral capsular contracture Baker Grade III-IV along with bilateral rupture post-operatively, which was confirmed during a physical exam. As a result, the patient is scheduled for removal on (b)(6) 2026.This report is for the left breast prosthesis.

  Patient problems: Capsular Contracture

  MAUDE report 50735415 ↗
• InjuryMar 26, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 555CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH A RUPTURED LEFT IMPLANT DURING A PHYSICAL EXAM. MAGNETIC RESONANCE IMAGING WAS ALSO CONDUCTED. AS A RESULT, THE PATIENT UNDERWENT LEFT-SIDED EXCHANGE WITH A MENTOR GEL IMPLANT ON (B)(6) 2026.

  Patient problems: Capsular Contracture; Deformity/ Disfigurement

  MAUDE report 24706577 ↗
• InjuryJan 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 555CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED CAPSULAR CONTRACTURE BAKER GRADE 3 ON THE LEFT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025.

  Patient problems: Capsular Contracture

  MAUDE report 23966315 ↗
• InjuryDec 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 555CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT REPORTED EXPERIENCING A RUPTURED LEFT BREAST IMPLANT WHICH HAS CONFIRMED USING MAMMOGRAM, ULTRASOUND, AND MAGNETIC RESONANCE IMAGING. MAGNETIC RESONANCE IMAGING ALSO IDENTIFIED A QUESTIONABLE MASS IN THE RIGHT BREAST WITH A RECOMMENDATION FOR FURTHER EVALUATION WITH ADDITIONAL IMAGING. A PHYSICAL EXAM WAS CONDUCTED AND BARLEY ANY RIGHT DISTORTION WAS NOTED. THE EXAM ALSO NOTED THERE WERE NO MASSES IN EITHER BREAST. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXCHANGE WITH MENTOR GEL IMPLANTS ON (B)(6) 2025. THIS REPORT IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Breast Mass; Deformity/ Disfigurement

  MAUDE report 23811935 ↗
• InjurySep 17, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 555CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED CAPSULAR CONTRACTURE BAKER GRADE 3 AND A RUPTURE 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: Capsular Contracture

  MAUDE report 23075224 ↗
• InjuryFeb 25, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH MENTOR MEMORYGEL BREAST IMPLANTS 555CC AND EXPERIENCED RUPTURE ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH A SIMILAR DEVICE ON (B)(6) 2025.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 21461187 ↗
• InjuryFeb 21, 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 WITH A 555CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED LEFT SIDED BAKER GRADE II CAPSULAR CONTRACTURE AND LEFT SIDED RUPTURE WITH PSEUDOPTOSIS BILATERALLY POST PROCEDURE. THIS WAS ACCOMPANIED BY HARDENING AND ASYMMETRY. THE RUPTURE WAS DISCOVERED DURING EXPLANT. AS A RESULT, LEFT PARTIAL CAPSULOTOMY, MASTOPEXY, AND REPLACEMENT WITH NON-MENTOR IMPLANTS WAS PERFORMED ON (B)(6) 2024.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 21434858 ↗
• InjuryFeb 6, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT BREAST AUGMENTATION WITH A 555CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED LEFT SIDED BAKER GRADE II CAPSULAR CONTRACTURE AND LEFT SIDED RUPTURE WITH PSEUDOPTOSIS POST PROCEDURE. THIS WAS ACCOMPANIED BY HARDENING AND ASYMMETRY. THE RUPTURE WAS DISCOVERED DURING EXPLANT. AS A RESULT, LEFT PARTIAL CAPSULOTOMY, MASTOPEXY, AND REPLACEMENT WITH NON-MENTOR IMPLANTS WAS PERFORMED ON (B)(6) 2024.

  Patient problems: Capsular Contracture

  MAUDE report 21323741 ↗
• InjuryFeb 21, 2024Material Rupture; Adverse Event Without Identified Device or Use Problem; Material Rupture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 555CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH BILATERALLY RUPTURED BREAST IMPLANTS DURING AN IN-OFFICE VISIT WITH A MEDICAL PROFESSIONAL. MAGNETIC RESONANCE IMAGING WAS ALSO CONDUCTED. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT WITH 450CC MENTOR MEMORYGEL BREAST IMPLANTS ON (B)(6) 2024. REFER TO MANUFACTURING REPORT NUMBER 1645337-2024-02079 FOR THE CONTRALATERAL EVENT.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18750567 ↗
• InjuryFeb 21, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 555CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH BILATERALLY RUPTURED BREAST IMPLANTS DURING AN IN-OFFICE VISIT WITH A MEDICAL PROFESSIONAL. MAGNETIC RESONANCE IMAGING WAS ALSO CONDUCTED. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT WITH 450CC MENTOR MEMORYGEL BREAST IMPLANTS ON (B)(6) 2024. REFER TO MANUFACTURING REPORT NUMBER 1645337-2024-02080 FOR THE CONTRALATERAL EVENT.

  Patient problems: Breast Discomfort/Pain; Deformity/ Disfigurement

  MAUDE report 18750564 ↗
• InjuryJan 24, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNSPECIFIED BREAST SURGERY WITH MENTOR MEMORYGEL BREAST IMPLANT 555CC GEL BREAST PROSTHESES THAT BOTH RUPTURED POST IMPLANTATION. 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: Deformity/ Disfigurement

  MAUDE report 18576842 ↗
• InjuryJan 24, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNSPECIFIED BREAST SURGERY WITH MENTOR MEMORYGEL BREAST IMPLANT 555CC GEL BREAST PROSTHESES THAT BOTH RUPTURED POST IMPLANTATION. 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: Deformity/ Disfigurement

  MAUDE report 18576840 ↗
• InjuryOct 30, 2023Material Rupture; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Material Rupture; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT BREAST AUGMENTATION WITH 555CC MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED BILATERAL CAPSULAR CONTRACTURE, BILATERAL PTOSIS, AND RIGHT SIDED RUPTURE POST PROCEDURE. THE RIGHT SIDED CAPSULAR CONTRACTURE WAS BAKER GRADE III. THE LEFT SIDED CAPSULAR CONTRACTURE WAS BAKER GRADE II. THE RIGHT SIDED RUPTURE WAS DISCOVERED WITH EXPLANT. EXPLANT AND REPLACEMENT WITH MENTOR GEL WAS PERFORMED ON (B)(6) 2023. SEE 1645337-2023-12830 FOR CONTRALATERAL PROSTHESIS REPORT.

  Patient problems: Capsular Contracture

  MAUDE report 18033521 ↗
• InjuryOct 30, 2023Material Rupture; Adverse Event Without Identified Device or Use Problem; Material Rupture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT BREAST AUGMENTATION WITH 555CC MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED BILATERAL CAPSULAR CONTRACTURE, BILATERAL PTOSIS, AND RIGHT SIDED RUPTURE POST PROCEDURE. THE RIGHT SIDED CAPSULAR CONTRACTURE WAS BAKER GRADE III. THE LEFT SIDED CAPSULAR CONTRACTURE WAS BAKER GRADE II. THE RIGHT SIDED RUPTURE WAS DISCOVERED WITH EXPLANT. EXPLANT AND REPLACEMENT WITH MENTOR GEL WAS PERFORMED ON (B)(6) 2023. SEE 1645337-2023-12831 FOR CONTRALATERAL PROSTHESIS REPORT.

  Patient problems: Capsular Contracture

  MAUDE report 18033485 ↗
• InjuryOct 4, 2023Material 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 PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 555CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT REPORTED EXPERIENCING ITCHY AND TENDER BREASTS, AND OBSERVED THE SHAPE OF HER BREASTS HAD CHANGED. MAGNETIC RESONANCE IMAGING WAS PERFORMED WHICH INDICATED BILATERALLY RUPTURED BREAST IMPLANTS. A CONSULTATION WITH A MEDICAL PROFESSIONAL HAS BEEN CONDUCTED; HOWEVER, AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. SEVERAL FOLLOW-UPS HAVE BEEN CONDUCTED, AND NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. IF MORE INFORMATION BECOMES AVAILABLE, MENTOR WILL SUBMIT A SUPPLEMENTAL REPORT ACCORDINGLY. REFER TO MANUFACTURING REPORT NUMBER (B)(4) FOR THE CONTRALATERAL EVENT.

  Patient problems: Breast Discomfort/Pain; Deformity/ Disfigurement; Skin Inflammation/ Irritation

  MAUDE report 17873777 ↗
• InjuryOct 4, 2023Material 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 PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 555CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT REPORTED EXPERIENCING ITCHY AND TENDER BREASTS, AND OBSERVED THE SHAPE OF HER BREASTS HAD CHANGED. MAGNETIC RESONANCE IMAGING WAS PERFORMED WHICH INDICATED BILATERALLY RUPTURED BREAST IMPLANTS. A CONSULTATION WITH A MEDICAL PROFESSIONAL HAS BEEN CONDUCTED; HOWEVER, AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. SEVERAL FOLLOW-UPS HAVE BEEN CONDUCTED, AND NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. IF MORE INFORMATION BECOMES AVAILABLE, MENTOR WILL SUBMIT A SUPPLEMENTAL REPORT ACCORDINGLY. REFER TO MANUFACTURING REPORT NUMBER 1645337-2023-11786 FOR THE CONTRALATERAL EVENT.

  Patient problems: Breast Discomfort/Pain; Deformity/ Disfigurement; Skin Inflammation/ Irritation

  MAUDE report 17873775 ↗
• InjurySep 6, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE WITH A MENTOR MEMORYGEL BREAST IMPLANT 555CC GEL BREAST PROSTHESIS THAT RUPTURED POST IMPLANTATION. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2023. TWO SERIAL NUMBERS WERE REPORTED TO MENTOR: LEFT DEVICE: SERIAL #(B)(6). RIGHT DEVICE: SERIAL #(B)(6). IT WAS NOT SPECIFIED IF THE RUPTURED DEVICE WAS FROM THE LEFT BREAST OR THE RIGHT BREAST. IF CLARIFICATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 17694333 ↗
• InjuryJun 6, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 59-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 555CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT EXPERIENCED A RUPTURED LEFT BREAST IMPLANT. MAMMOGRAM AND MAGNETIC RESONANCE IMAGING HAVE BEEN CONDUCTED IN ADDITION TO A CONSULTATION WITH A MEDICAL PROFESSIONAL. AS A RESULT, THE PATIENT IS SCHEDULED FOR REMOVAL ON (B)(6) 2023.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 17073676 ↗
• InjuryMar 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 50-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH 555CC MENTOR MEMORYGEL BREAST IMPLANT ON BOTH SIDES AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE; BAKER GRADE III/IV POSTOPERATIVELY; DIAGNOSED AFTER PHYSICAL EXAM. THE PATIENT HAS CONSULTED WITH THE HEALTHCARE PROFESSIONAL. AS A RESULT, THE PATIENT WILL UNDERGO REPLACEMENT SURGERY ON (B)(6) 2023. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT-SIDED DEVICE.

  Patient problems: Capsular Contracture

  MAUDE report 16571924 ↗
• InjuryMar 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 50-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH 555CC MENTOR MEMORYGEL BREAST IMPLANT ON BOTH SIDES AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE; BAKER GRADE III/IV POSTOPERATIVELY; DIAGNOSED AFTER PHYSICAL EXAM. THE PATIENT HAS CONSULTED WITH THE HEALTHCARE PROFESSIONAL. AS A RESULT, THE PATIENT WILL UNDERGO REPLACEMENT SURGERY ON (B)(6), 2023. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT-SIDED DEVICE.

  Patient problems: Capsular Contracture

  MAUDE report 16571851 ↗
• InjuryJul 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 62-YEAR-OLD CAUCASIAN FEMALE PATIENT WHO UNDERWENT BREAST AUGMENTATION REVISION SURGERY WITH TWO 555CC MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED BILATERAL CAPSULAR CONTRACTURE BAKER GRADE III ON THE LEFT AND BAKER GRADE IV ON THE RIGHT POST PROCEDURE. AS A RESULT, PATIENT HAD AN EXPLANTATION ON (B)(6) 2022. THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 14938676 ↗
• InjuryJul 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 62-YEAR-OLD CAUCASIAN FEMALE PATIENT WHO UNDERWENT BREAST AUGMENTATION REVISION SURGERY WITH TWO 555CC MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED BILATERAL CAPSULAR CONTRACTURE BAKER GRADE III ON THE LEFT AND BAKER GRADE IV ON THE RIGHT POST PROCEDURE. AS A RESULT, PATIENT HAD AN EXPLANTATION ON (B)(6) 2022. THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 14938524 ↗
• InjuryJun 8, 2022Gel Leak; Material Rupture; Migration; Gel Leak; Material Rupture; Migration

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH IMPLANTATION OF A 555CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH A RUPTURED RIGHT BREAST IMPLANT USING ULTRASOUND IMAGING. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH 675CC MENTOR MEMORYGEL BREAST IMPLANTS ON (B)(6) 2022.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 14633743 ↗
• InjuryMar 28, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR OLD CAUCASIAN FEMALE PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH TWO 555CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT SUFFERED A RIGHT BREAST THAT LOOKS WEIRD, OUT OF PLACE, ACHY, LOOKS FLAT ON TOP, POSSIBLY RUPTURED OR LEAKING AND HAVE SHIFTED. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Breast Discomfort/Pain; Deformity/ Disfigurement

  MAUDE report 13932626 ↗
• InjuryJan 12, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) HISPANIC FEMALE PATIENT, WHO'S UNDERGONE PRIMARY BREAST AUGMENTATION WITH TWO 555CC MENTOR MEMORYGEL BREAST IMPLANTS, SUFFERED RIGHT BREAST IMPLANT RUPTURE, POST-PROCEDURE. THE PATIENT WAS REPORTEDLY INVOLVED IN AN AUTO ACCIDENT. THE RUPTURE WAS DIAGNOSED VIA CAT SCAN. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT ON (B)(6) 2021. THE REPLACEMENTS WERE: (RIGHT) 650CC MENTOR MEMORYGEL BREAST IMPLANT CATALOG: 3506504BC LOT: 7666803 SN: (B)(4) AND (LEFT) 650CC MENTOR MEMORYGEL BREAST IMPLANT CATALOG: 3506504BC LOT: 9526990 SN: (B)(4).

  Patient problems: Crushing Injury

  MAUDE report 13239328 ↗