MENTOR MemoryGel Breast Implant 3505480BCRecalls & reported problems

Summary

The FDA's MAUDE database contains 226 adverse event reports that list this exact device (DI 00081317006978), received between Aug 16, 2018 and Aug 13, 2026 — classified as 217 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (72 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 226 reports, in the reporter's own words as published by the FDA.

• InjuryAug 13, 2026Material Rupture

  It was reported that a patient with MENTOR MemoryGel Breast Implants experienced rupture on the left side post-operatively, which was confirmed during a physical exam. As a result, the patient underwent device removal and replacement.

  Patient problems: Capsular Contracture; No Clinical Signs, Symptoms or Conditions

  MAUDE report 50240667 ↗
• InjuryJul 29, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient implanted with a 480cc 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 50071159 ↗
• InjuryMay 27, 2026Migration

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH TWO 480CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED BILATERAL CAPSULAR CONTRACTURE AND A DEVICE MIGRATION ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2026.

  Patient problems: Capsular Contracture

  MAUDE report 25304124 ↗
• InjuryMay 19, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A MENTOR MEMORYGEL BREAST IMPLANT GEL BREAST PROSTHESIS THAT RUPTURED POST IMPLANTATION. RUPTURE OF THE PATIENT¿S RIGHT BREAST PROSTHESIS WAS DIAGNOSED VIA A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 25224863 ↗
• InjuryMay 18, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT WITH MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED BILATERAL RUPTURE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT DEVICE REMOVAL AND REPLACEMENT. THIS REPORT IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 25201907 ↗
• InjuryApr 2, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 480 CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT DEVELOPED LEFT BREAST CAPSULAR CONTRACTURE (BAKER GRADE III) AND BILATERAL BREAST PAIN. AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL AND REPLACEMENT SURGERY ON (B)(6) 2026. THE REPLACEMENT DEVICES WERE TWO MENTOR GEL IMPLANTS. THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Breast Discomfort/Pain

  MAUDE report 24765092 ↗
• InjuryMar 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE WITH MENTOR MEMORYGEL BREAST IMPLANT GEL BREAST PROSTHESES DEVELOPED BAKER GRADE IV CAPSULAR CONTRACTURE IN HER RIGHT BREAST POST IMPLANTATION. THE CAPSULAR CONTRACTURE WAS DIAGNOSED VIA A PHYSICAL EXAM. ADDITIONALLY, THE PATIENT DEVELOPED BILATERAL BREAST ASYMMETRY. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH MENTOR MEMORYGEL BREAST IMPLANT GEL BREAST PROSTHESES. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT BREAST PROSTHESIS. REFER TO MANUFACTURER REPORT NUMBER 1645337-2025-12915 FOR THE REPORT FOR THE PATIENT¿S RIGHT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 24706799 ↗
• InjuryMar 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 56-YEAR-OLD ASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A 480CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED CAPSULAR CONTRACTURE (BAKER GRADE 4) ON THE RIGHT SIDE POST-OPERATIVELY. THE BREAST WAS FIRMER AND PAINFUL. THE PATIENT ATTEMPTED AGGRESSIVE MASSAGING, HOWEVER IT WAS UNSUCCESSFUL. THE PATIENT WAS UNABLE TO TOLERATE SINGULAIR AS WELL AS OVER THE COUNTER MEDICATION. THE PATIENT DEVELOPED A RASH DUE TO BOTH MEDICATIONS. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Capsular Contracture

  MAUDE report 24583536 ↗
• InjuryJan 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 41-YEAR-OLD HISPANIC FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 480CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED CAPSULAR CONTRACTURE (BAKER GRADE 4) ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS DIAGNOSED WITH A PHYSICAL EXAM. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Capsular Contracture

  MAUDE report 24228620 ↗
• InjuryJan 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 480CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA PHYSICAL EXAMINATION, WITH LEFT BREAST CAPSULAR CONTRACTURE (BAKER GRADE III). AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL AND REPLACEMENT SURGERY ON (B)(6) 2026.

  Patient problems: Capsular Contracture

  MAUDE report 24049593 ↗
• InjuryJan 7, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH TWO 480CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA ULTRASOUND, WITH BILATERAL BREAST CAPSULAR CONTRACTURES (BAKER GRADE IV). AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL AND REPLACEMENT SURGERY ON (B)(6) 2025. THE REPLACEMENT DEVICES WERE TWO MENTOR GEL IMPLANTS. THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 23995267 ↗
• InjuryJan 7, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH TWO 480CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA ULTRASOUND, WITH BILATERAL BREAST CAPSULAR CONTRACTURES (BAKER GRADE IV). AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL AND REPLACEMENT SURGERY ON (B)(6) 2025. THE REPLACEMENT DEVICES WERE TWO MENTOR GEL IMPLANTS. THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 23995252 ↗
• InjuryJan 6, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT A BREAST AUGMENTATION PROCEDURE WITH MENTOR GEL BREAST PROSTHESES EXPERIENCED SIGNIFICANT AND ONGOING HEALTH COMPLICATIONS, INCLUDING THE DEVELOPMENT OF AUTOIMMUNE-RELATED SYMPTOMS AND CONDITIONS. NO SPECIFIC HEALTH COMPLICATION OR AUTOIMMUNE DISEASE WAS REPORTED. ADDITIONALLY, THE PATIENT DESIRED LARGER BREAST PROSTHESES. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH ALLERGAN GEL BREAST PROSTHESES. DURING EXPLANT SURGERY, IT WAS OBSERVED THAT BOTH REMOVED BREAST PROSTHESES WERE RUPTURED. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT BREAST PROSTHESIS.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 23980210 ↗
• InjuryJan 6, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT A BREAST AUGMENTATION PROCEDURE WITH MENTOR GEL BREAST PROSTHESES EXPERIENCED SIGNIFICANT AND ONGOING HEALTH COMPLICATIONS, INCLUDING THE DEVELOPMENT OF AUTOIMMUNE-RELATED SYMPTOMS AND CONDITIONS. NO SPECIFIC HEALTH COMPLICATION OR AUTOIMMUNE DISEASE WAS REPORTED. ADDITIONALLY, THE PATIENT DESIRED LARGER BREAST PROSTHESES. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH ALLERGAN GEL BREAST PROSTHESES. DURING EXPLANT SURGERY, IT WAS OBSERVED THAT BOTH REMOVED BREAST PROSTHESES WERE RUPTURED. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT BREAST PROSTHESIS.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 23980201 ↗
• InjuryJan 2, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT WITH MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED RUPTURE ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT DEVICE REMOVAL AND REPLACEMENT WITH NON MENTOR BREAST IMPLANTS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 23949742 ↗
• InjuryDec 23, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH IMPLANTATION OF A 480CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH A RUPTURED LEFT IMPLANT USING MAGNETIC RESONANCE IMAGING. AS A RESULT, THE PATIENT UNDERWENT LEFT-SIDED EXCHANGE WITH A MENTOR GEL IMPLANT ON (B)(6) 2025.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 23882322 ↗
• InjuryNov 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE WITH A MENTOR MEMORYGEL BREAST IMPLANT 480CC GEL BREAST PROSTHESIS DEVELOPED BAKER GRADE IV CAPSULAR CONTRACTURE IN HER RIGHT BREAST POST IMPLANTATION. THE CAPSULAR CONTRACTURE WAS DIAGNOSED VIA A PHYSICAL EXAM. AS A RESULT, THE PATIENT IS SCHEDULED TO UNDERGO EXPLANTATION ON (B)(6) 2025.

  Patient problems: Capsular Contracture

  MAUDE report 23609317 ↗
• InjuryNov 19, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 480CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED A RUPTURE ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 23597487 ↗
• InjuryNov 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH TWO MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED BILATERAL CAPSULAR CONTRACTURE 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 23513403 ↗
• InjuryOct 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT INVOLVED IN A CLINICAL TRIAL UNDERWENT A BREAST SURGERY WITH IMPLANTATION OF A 480CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT REPORTED ASYMMETRY ISSUES DURING A FOLLOW-UP WITH A MEDICAL PROFESSIONAL. THE AFFECTED SIDE WAS NOT INDICATED. AT A LATER TIME, THE PATIENT PRESENTED WITH BILATERAL HYPERTROPHIC SCARRING. THE PRINCIPAL INVESTIGATOR ASSESSED THIS EVENT AS MILD IN SEVERITY, NOT SERIOUS. THE RELATIONSHIP TO THE STUDY DEVICE IS UNKNOWN. THE EVENTS WERE TREATED WITH ¿SILICONE SHEETING¿. THE EVENT WAS RESOLVED. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Deformity/ Disfigurement; Scar Tissue

  MAUDE report 23319132 ↗
• InjurySep 9, 2025Use of Device Problem; Migration; Use of Device Problem; Migration

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH MENTOR MEMORYGEL BREAST IMPLANT 480CC GEL BREAST PROSTHESES WHEN THE LEFT BREAST PROSTHESIS RUPTURED POST IMPLANTATION. THE PATIENT HAD CHEST PAIN AND HAD A CT SCAN THAT DIAGNOSED LEFT BREAST PROSTHESIS RUPTURE. ADDITIONALLY, THE PATIENT SUFFERED FROM BILATERAL DISPLACEMENT OF THE BREAST PROSTHESES. AS A RESULT, THE PATIENT UNDERWENT UNILATERAL EXPLANTATION OF THE LEFT BREAST PROSTHESIS ON (B)(6) 2025. THE EXPLANTED DEVICE WAS REPLACED WITH A MENTOR MEMORYGEL BREAST IMPLANT 700CC GEL BREAST PROSTHESIS. LASTLY, THE PATIENT¿S RIGHT BREAST PROSTHESIS WAS REMOVED, THE BREAST POCKET WAS REPAIRED, AND THE DEVICE WAS RE-IMPLANTED IN THE PATIENT. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 23007385 ↗
• InjurySep 9, 2025Material Rupture; Migration; Material Rupture; Migration

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH MENTOR MEMORYGEL BREAST IMPLANT 480CC GEL BREAST PROSTHESES WHEN THE LEFT BREAST PROSTHESIS RUPTURED POST IMPLANTATION. THE PATIENT HAD CHEST PAIN AND HAD A CT SCAN THAT DIAGNOSED LEFT BREAST PROSTHESIS RUPTURE. ADDITIONALLY, THE PATIENT SUFFERED FROM BILATERAL DISPLACEMENT OF THE BREAST PROSTHESES. AS A RESULT, THE PATIENT UNDERWENT UNILATERAL EXPLANTATION OF THE LEFT BREAST PROSTHESIS ON (B)(6) 2025. THE EXPLANTED DEVICE WAS REPLACED WITH A MENTOR MEMORYGEL BREAST IMPLANT 700CC GEL BREAST PROSTHESIS. LASTLY, THE PATIENT¿S RIGHT BREAST PROSTHESIS WAS REMOVED, THE BREAST POCKET WAS REPAIRED, AND THE DEVICE WAS RE-IMPLANTED IN THE PATIENT. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT BREAST PROSTHESIS.

  Patient problems: Breast Discomfort/Pain

  MAUDE report 23007377 ↗
• InjurySep 8, 2025Migration; Migration

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH IMPLANTATION OF A 480CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, AN ADDITIONAL REVISION SURGERY TO CORRECT BOTTOMING OUT OF THE IMPLANTS WAS PERFORMED IN 2018. AT A LATER DATE, SHE EXPERIENCED A RIGHT-SIDED CONTOUR DEFORMITY. SHE WAS THEN DIAGNOSED WITH A RUPTURED LEFT BREAST IMPLANT USING MAGNETIC RESONANCE IMAGING. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXCHANGE WITH MOTIVA IMPLANTS ON (B)(6) 2025. THIS REPORT IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Wrinkling

  MAUDE report 22999504 ↗
• InjuryAug 22, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 38-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH 480CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED A RUPTURE ON THE RIGHT SIDE POST-OPERATIVELY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 22879426 ↗
• InjuryJul 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WITH MENTOR MEMORYGEL BREAST IMPLANTS AND EXPERIENCED CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT IS SCHEDULED FOR REMOVAL ON (B)(6) 2025.

  Patient problems: Capsular Contracture

  MAUDE report 22412702 ↗