MENTOR MemoryGel Breast Implant 3542357MCRecalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00081317004363), received between Aug 1, 2019 and Aug 26, 2026 — classified as 18 injuries.

The most frequently reported specific device problem is “Material Rupture” (8 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjuryAug 26, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient implanted with a 235cc MENTOR MemoryGel Breast Implant experienced capsular contracture Baker Grade 3 on the right side post-operatively. As a result, the patient underwent explantation on (b)(6), 2026.

  Patient problems: Capsular Contracture

  MAUDE report 50455780 ↗
• InjuryAug 27, 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 235CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH BILATERAL BAKER GRADE III CAPSULAR CONTRACTURE DURING A PHYSICAL EXAM. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. FOLLOW-UPS HAVE BEEN CONDUCTED, AND NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. IF MORE INFORMATION BECOMES AVAILABLE, MENTOR WILL SUBMIT A SUPPLEMENTAL REPORT ACCORDINGLY. THIS REPORT IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 22907473 ↗
• InjuryOct 29, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT BREAST AUGMENTATION WITH A 235CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED LEFT SIDED RUPTURE POST PROCEDURE. AS A RESULT, EXPLANT WAS PERFORMED ON AN UNKNOWN DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 20563414 ↗
• InjuryJun 1, 2023Material Rupture; Material Deformation; Material Rupture; Material Deformation

  IT WAS REPORTED THAT A 69-YEAR-OLD CAUCASIAN PATIENT WHO UNDERWENT A BREAST AUGMENTATION REVISION WITH A MENTOR MEMORYGEL, 235CC SILICONE PROSTHESIS EXPERIENCED RIGHT-SIDED SILENT RUPTURE POST PROCEDURE. THE MRI EXAMINATION CONFIRMED THE ISSUE. AS A RESULT, PATIENT SCHEDULED FOR REMOVAL ON (B)(6) 2023.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 17038587 ↗
• InjuryApr 10, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 41-YEAR OLD CAUCASIAN FEMALE PATIENT UNDERWENT BREAST PROSTHESIS IMPLANTATION SURGERY WITH A 235CC MENTOR MEMORYGEL BREAST IMPLANT ON THE LEFT BREAST SUFFERED A LEFT BREAST THAT HAD INCREASED IN SIZE, POST-OPERATIVELY. ULTRASOUND AND MAMMOGRAM DIAGNOSED A POSSIBLE LEFT BREAST IMPLANT RUPTURE. AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT EXPLANTATION SURGERY ON (B)(6) 2023.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 16705638 ↗
• InjuryApr 4, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION PROCEDURE WITH A MENTOR MEMORYGEL BREAST IMPLANT 190CC GEL BREAST PROSTHESIS (LEFT DEVICE) AND A MENTOR MEMORYGEL BREAST IMPLANT 235CC GEL BREAST PROSTHESIS (RIGHT DEVICE) THAT BOTH RUPTURED POST IMPLANTATION. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION ON AN UNKNOWN DATE. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 16678411 ↗
• InjuryMar 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT WHO UNDERWENT BREAST AUGMENTATION SURGERY WITH A 235CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED CAPSULAR CONTRACTURE BAKER GRADE III ON AN UNSPECIFIED SIDE POST PROCEDURE. AS A RESULT, PATIENT HAD AN EXPLANTATION ON AN UNSPECIFIED DATE.

  Patient problems: Capsular Contracture

  MAUDE report 13913765 ↗
• InjuryDec 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT, WHO'S UNDERGONE BREAST AUGMENTATION REVISION WITH TWO 235CC MENTOR MEMORYGEL BREAST IMPLANTS, SUFFERED BILATERAL BREAST CAPSULAR CONTRACTURES (BAKER GRADE III), POST-PROCEDURE. THE CAPSULAR CONTRACTURES WERE DIAGNOSED VIA WAVE EXAMINATION. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL AND THEN BILATERAL REPLACEMENT WITH TWO UNSPECIFIED IMPLANTS ON (B)(6) 2020. THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 11092267 ↗
• InjuryDec 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT, WHO'S UNDERGONE BREAST AUGMENTATION REVISION WITH TWO 235CC MENTOR MEMORYGEL BREAST IMPLANTS, SUFFERED BILATERAL BREAST CAPSULAR CONTRACTURES (BAKER GRADE III), POST-PROCEDURE. THE CAPSULAR CONTRACTURES WERE DIAGNOSED VIA WAVE EXAMINATION. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL AND THEN BILATERAL REPLACEMENT WITH TWO UNSPECIFIED IMPLANTS ON (B)(6) 2020. THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 11092261 ↗
• InjurySep 25, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH 235CC MENTOR MEMORYGEL BREAST IMPLANTS AND EXPERIENCED BILATERAL RUPTURE POSTOPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT BILATERAL DEVICE REMOVAL ON (B)(6) 2020. THIS REPORT IS FOR THE PATIENT'S RIGHT-SIDED DEVICE.

  Patient problems: No Code Available

  MAUDE report 10589910 ↗
• InjurySep 25, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH 235CC MENTOR MEMORYGEL BREAST IMPLANTS AND EXPERIENCED BILATERAL RUPTURE POSTOPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT BILATERAL DEVICE REMOVAL ON (B)(6) 2020. THIS REPORT IS FOR THE PATIENT'S LEFT-SIDED DEVICE.

  Patient problems: No Code Available

  MAUDE report 10589907 ↗
• InjuryFeb 5, 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 BREAST AUGMENTATION REVISION WITH A 235CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED POSTOPERATIVE UNILATERAL CAPSULAR CONTRACTURE (BAKER GRADE III). THE DIAGNOSIS WAS CONFIRMED BY A PHYSICIAN UPON EXAMINATION. AS A RESULT, THE PATIENT'S IMPACTED DEVICE WAS EXPLANTED ON (B)(6) 2020.

  Patient problems: Capsular Contracture; No Code Available

  MAUDE report 9673472 ↗
• InjuryJan 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) HISPANIC FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 235CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS AND EXPERIENCED POSTOPERATIVE RIGHT-SIDED BREAST MASS. THE PATIENT FELT A LUMP IN HER RIGHT BREAST IN (B)(6) 2019 AND HAD MAMMOGRAM DONE ON (B)(6) 2019. THE RESULT IS CURRENTLY PENDING. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Breast Mass

  MAUDE report 9566226 ↗
• InjuryOct 16, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT CONTAINS SUPPLEMENTAL INFORMATION FOR MENTOR PSR REFERENCE NUMBER (B)(4). THIS EVENT WAS PREVIOUSLY REPORTED TO THE FDA UNDER MW5084887. IT WAS REPORTED THAT A (B)(6) YEAR OLD CAUCASIAN FEMALE PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH 235CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED MOOD SWINGS, ANXIETY, DEPRESSION, WEIGHT GAIN, SCIATICA, LEG PAIN, COGNITIVE DYSFUNCTION, BRITTLE FINGER NAILS, FATIGUE UPPER ABDOMEN PAIN, GI/DIGESTIVE ISSUES, ORAL THRUSH, CHEST PAIN, DECREASE IN MOTOR FUNCTIONS, BLURRY VISION, DRY SKIN, BODY ACNE, INSOMNIA, TINNITUS, CANDIDA, MUSCLE CRAMPING, TWITCHING, CHARLIE HORSES IN LEFT CALF, BREAST PAIN, SLOW WOUND HEALING, FULL BODY INFLAMMATION, SUICIDAL THOUGHTS, MIGRAINES, PREMENSTRUAL DYSPHORIC DISORDER AND HEADACHES 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.

  Patient problems: No Code Available

  MAUDE report 9195401 ↗
• InjuryOct 16, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT CONTAINS SUPPLEMENTAL INFORMATION FOR MENTOR PSR REFERENCE NUMBER (B)(4). THIS EVENT WAS PREVIOUSLY REPORTED TO THE FDA UNDER MW5084887. IT WAS REPORTED THAT A (B)(6) YEAR OLD CAUCASIAN FEMALE PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH 235CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED MOOD SWINGS, ANXIETY, DEPRESSION, WEIGHT GAIN, SCIATICA, LEG PAIN, COGNITIVE DYSFUNCTION, BRITTLE FINGER NAILS, FATIGUE UPPER ABDOMEN PAIN, GI/DIGESTIVE ISSUES, ORAL THRUSH, CHEST PAIN, DECREASE IN MOTOR FUNCTIONS, BLURRY VISION, DRY SKIN, BODY ACNE, INSOMNIA, TINNITUS, CANDIDA, MUSCLE CRAMPING, TWITCHING, CHARLIE HORSES IN LEFT CALF, BREAST PAIN, SLOW WOUND HEALING, FULL BODY INFLAMMATION, SUICIDAL THOUGHTS, MIGRAINES, PREMENSTRUAL DYSPHORIC DISORDER AND HEADACHES 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.

  Patient problems: No Code Available

  MAUDE report 9195372 ↗
• InjuryAug 8, 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 MEMORYGEL BREAST IMPLANT 235CC AND EXPERIENCED CAPSULAR CONTRACTURE BAKER GRADE ON THE LEFT SIDE. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH UNSPECIFIED MENTOR GEL BREAST IMPLANTS ON (B)(6) 2019.

  Patient problems: Capsular Contracture; No Code Available

  MAUDE report 8876419 ↗
• InjuryAug 1, 2019Material Rupture; Adverse Event Without Identified Device or Use Problem; Material Rupture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) YEAR OLD FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH A 235CC MENTOR MEMORYGEL BREAST IMPLANT AND WAS PRESENTED WITH BILATERAL BREAST IMPLANT RUPTURE CONFIRMED BY MRI. AS A RESULT, THE DEVICES WERE EXPLANTED ON (B)(6) 2019. THIS REPORT IS FOR THE PATIENT¿S LEFT-SIDED DEVICE.

  Patient problems: No Code Available

  MAUDE report 8852002 ↗
• InjuryAug 1, 2019Material Rupture; Adverse Event Without Identified Device or Use Problem; Material Rupture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH A 235CC MENTOR MEMORYGEL BREAST IMPLANT AND WAS PRESENTED WITH BILATERAL BREAST IMPLANT RUPTURE CONFIRMED BY MRI. AS A RESULT, THE DEVICES WERE EXPLANTED ON (B)(6) 2019. THIS REPORT IS FOR THE PATIENT¿S RIGHT-SIDED DEVICE.

  Patient problems: No Code Available

  MAUDE report 8852001 ↗