MENTOR MemoryGel Breast Implant 3542557MCRecalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00081317004370), received between Dec 2, 2019 and Sep 10, 2026 — classified as 20 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• InjurySep 10, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient underwent breast augmentation revision with two 255cc MENTOR MemoryGel Breast Implants. Post-operatively, the patient developed bilateral breast capsular contractures (baker grade III on the right and unknown baker grade on the left). 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: Capsular Contracture

  MAUDE report 50709798 ↗
• InjurySep 10, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient underwent breast augmentation revision with two 255cc MENTOR MemoryGel Breast Implants. Post-operatively, the patient developed bilateral breast capsular contractures (baker grade III on the right and unknown baker grade on the left). 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 left breast prosthesis.

  Patient problems: Capsular Contracture

  MAUDE report 50709766 ↗
• InjuryAug 5, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient underwent breast augmentation revision with two 255cc MENTOR MemoryGel Breast Implants. Post-operatively, the patient developed bilateral breast capsular contractures (baker grades III). 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 left breast prosthesis.

  Patient problems: Capsular Contracture

  MAUDE report 50150350 ↗
• InjuryJul 8, 2025Migration; Migration

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE WITH MENTOR MEMORYGEL BREAST IMPLANT 255CC GEL BREAST PROSTHESES DEVELOPED BAKER GRADE IV CAPSULAR CONTRACTURE IN BOTH BREASTS POST IMPLANTATION. ADDITIONALLY, THE PATIENT SUFFERED FROM DISPLACEMENT OF BOTH BREAST PROSTHESES. LASTLY, IT WAS REPORTED THAT PATIENT HAD ADDITIONAL SURGERIES PERFORMED, SOME OF WHICH HAVE BEEN CHARACTERIZED BY TREATMENT OF SEROMA. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH MENTOR MEMORYGEL BOOST BREAST IMPLANT 265CC GEL BREAST PROSTHESES ON (B)(6) 2025. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture; Seroma

  MAUDE report 22454134 ↗
• InjuryJul 8, 2025Migration; Migration

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE WITH MENTOR MEMORYGEL BREAST IMPLANT 255CC GEL BREAST PROSTHESES DEVELOPED BAKER GRADE IV CAPSULAR CONTRACTURE IN BOTH BREASTS POST IMPLANTATION. ADDITIONALLY, THE PATIENT SUFFERED FROM DISPLACEMENT OF BOTH BREAST PROSTHESES. LASTLY, IT WAS REPORTED THAT PATIENT HAD ADDITIONAL SURGERIES PERFORMED, SOME OF WHICH HAVE BEEN CHARACTERIZED BY TREATMENT OF SEROMA. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH MENTOR MEMORYGEL BOOST BREAST IMPLANT 265CC GEL BREAST PROSTHESES ON (B)(6) 2025. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture; Seroma

  MAUDE report 22454122 ↗
• InjuryJun 13, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH A MENTOR MEMORYGEL BREAST IMPLANT 255CC GEL BREAST PROSTHESIS THAT RUPTURED POST IMPLANTATION. RUPTURE OF THE PATIENT¿S RIGHT BREAST PROSTHESIS WAS REPORTED. ADDITIONALLY, THE PATIENT DEVELOPED SWELLING AND PAIN IN THE RIGHT BREAST. AS A RESULT, THE PATIENT IS SCHEDULED TO UNDERGO EXPLANTATION ON (B)(6) 2025.

  Patient problems: Local Reaction

  MAUDE report 22205155 ↗
• InjuryNov 20, 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 255CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED DISSATISFACTION WITH THE OUTCOME POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2024.

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

  MAUDE report 20735763 ↗
• InjuryOct 22, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 255CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED A RUPTURE AND BREAST PAIN ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2024.

  Patient problems: Breast Discomfort/Pain

  MAUDE report 20507842 ↗
• InjuryMay 24, 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 255CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED ASYMMETRY ON AN UNSPECIFIED SIDE POST-OPERATIVELY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. MENTOR WAS PROVIDED TWO SERIAL NUMBERS (B)(6) BUT IT IS UNKNOWN WHICH SERIAL WAS THE IMPACTED DEVICE. IF FURTHER INFORMATION IS RECEIVED, A SUPPLEMENTAL WILL BE SENT.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 19392269 ↗
• InjuryNov 28, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT SUFFERED BILATERAL BREAST IMPLANT DROOPING. THE PATIENT'S DOCTOR ALSO WANTED THE PATIENT TO GET AN ULTRASOUND TO CONFIRM LEAKING ON THE LEFT SIDE. 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: Deformity/ Disfigurement

  MAUDE report 18221124 ↗
• InjuryNov 1, 2023Material Rupture; Appropriate Device Problem Term/Code Not Available; Material Rupture; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 255CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED A RUPTURE ON THE LEFT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2023.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18049030 ↗
• InjuryJul 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 69-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A 225CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED CAPSULAR CONTRACTURE, BAKER GRADE 3 ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2023.

  Patient problems: Capsular Contracture

  MAUDE report 17261812 ↗
• InjuryMar 27, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 64-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION PRIMARY WITH A MENTOR MEMORYGEL, 595CC,ON THE LEFT, AND, 255CC ON THE RIGHT, SILICONE BREAST IMPLANT EXPERIENCED BILATERAL SILENT RUPTURES POST PROCEDURE. THE ISSUE WAS DIAGNOSED THROUGH ULTRASOUND EXAMINATION. AS A RESULT, PATIENT UNDERWENT BILATERAL REPLACEMENTS AS FOLLOW: LEFT CATALOG NUMBER 3545957, SERIAL NUMBER: (B)(4), RIGHT CATALOG 354-2557, SERIAL NUMBER: (B)(4) ON (B)(6) 2023. THIS REPORT RELATES TO THE RIGHT PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 16619776 ↗
• InjuryFeb 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE WHO UNDERWENT A BREAST AUGMENTATION PRIMARY WITH A MENTOR MEMORYGEL, 255CC BREAST IMPLANT EXPERIENCED RIGHT SIDED RUPTURE, AND BILATERAL CAPSULAR CONTRACTURE GRADE II POST PROCEDURE. AN MRI EXAMINATION CONFIRMED THE RUPTURE. AS A RESULT, PATIENT UNDERWENT BILATERAL REPLACEMENTS AS FOLLOW: L/ CAT#: 3507255MC, SN#: (B)(4), R/ CAT#: 3507255MC, SN#: (B)(4) ON (B)(6) 2022. THIS REPORT RELATES TO THE LEFT PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 13592548 ↗
• InjuryJan 12, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE WHO UNDERWENT A BREAST AUGMENTATION PRIMARY WITH A MENTOR MEMORYGEL, 255CC BREAST IMPLANT EXPERIENCED RIGHT SIDED RUPTURE POST PROCEDURE. AN MRI EXAMINATION CONFIRMED THE RUPTURE. AS A RESULT, PATIENT SCHEDULED FOR AN EXPLANT ON (B)(6) 2022.

  Patient problems: Capsular Contracture; Deformity/ Disfigurement

  MAUDE report 13237520 ↗
• InjuryJun 12, 2020Gel Leak; Gel Leak

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD (B)(6) FEMALE PATIENT WHO UNDERWENT A BREAST AUGMENTATION REVISION WITH TWO 255CC TEXTURED MENTOR MEMORYGEL BREAST IMPLANTS HAS EXPERIENCED POSTOPERATIVE BILATERAL GRADE III CAPSULAR CONTRACTURE, LEFT-SIDED IMPLANT-SITE HEMATOMA, AND RIGHT-SIDED IMPLANT GEL BLEED. PATIENT DEVELOPED HEMATOMA ON THE LEFT SIDE INITIALLY, AND HEMATOMA EVACUATION WAS PERFORMED ONE WEEK AFTER AUGMENTATION SURGERY. PATIENT THEN PRESENTED WITH BILATERAL BREASTS THAT ARE FIRM TO TOUCH, AND THE SURFACE IS IRREGULAR WITH MALPOSITION OF THE IMPLANTS. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION AND REPLACEMENT WITH 150CC MENTOR MEMORYGEL BREAST IMPLANT, CATALOG # 3507150MC, LEFT SERIAL # (B)(4) AND RIGHT SERIAL # (B)(4) ON (B)(6) 2020. THIS MEDWATCH REPORT IS FOR THE RIGHT-SIDED IMPLANT.

  Patient problems: Capsular Contracture; No Code Available

  MAUDE report 10151183 ↗
• InjuryJun 12, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD (B)(6) FEMALE PATIENT WHO UNDERWENT A BREAST AUGMENTATION REVISION WITH TWO 255CC TEXTURED MENTOR MEMORYGEL BREAST IMPLANTS HAS EXPERIENCED POSTOPERATIVE BILATERAL GRADE III CAPSULAR CONTRACTURE, LEFT-SIDED IMPLANT-SITE HEMATOMA, AND RIGHT-SIDED IMPLANT GEL BLEED. PATIENT DEVELOPED HEMATOMA ON THE LEFT SIDE INITIALLY, AND HEMATOMA EVACUATION WAS PERFORMED ONE WEEK AFTER AUGMENTATION SURGERY. PATIENT THEN PRESENTED WITH BILATERAL BREASTS THAT ARE FIRM TO TOUCH, AND THE SURFACE IS IRREGULAR WITH MALPOSITION OF THE IMPLANTS. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION AND REPLACEMENT WITH 150CC MENTOR MEMORYGEL BREAST IMPLANT, CATALOG # 3507150MC, LEFT SERIAL # (B)(4) AND RIGHT SERIAL # (B)(4) ON (B)(6) 2020. THIS MEDWATCH REPORT IS FOR THE LEFT-SIDED IMPLANT.

  Patient problems: Capsular Contracture; Hematoma; No Code Available

  MAUDE report 10151180 ↗
• InjuryApr 8, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A MENTOR MEMORYGEL BREAST IMPLANT 25CC AND EXPERIENCED RUPTURE ON THE LEFT SIDE POSTOPERATIVELY. THE RUPTURE WAS CONFIRMED VIA ULTRASOUND. AS A RESULT, THE PATIENT UNDERWENT REMOVAL ON (B)(6) 2019

  Patient problems: No Code Available

  MAUDE report 9933934 ↗
• InjuryDec 2, 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 PRIMARY WITH MENTOR MEMORYGEL BREAST IMPLANTS 255CC AND EXPERIENCED BILATERAL BREAST PAIN. THE PATIENT UNDERWENT AN ULTRASOUND, BUT NOTHING CONCERNING WAS FOUND. THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH NON-MENTOR BREAST IMPLANTS ON (B)(6) 2019. THIS REPORT IS FOR THE RIGHT SIDE.

  Patient problems: No Code Available; Pain

  MAUDE report 9398094 ↗
• InjuryDec 2, 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 PRIMARY WITH MENTOR MEMORYGEL BREAST IMPLANTS 255CC AND EXPERIENCED BILATERAL BREAST PAIN. THE PATIENT UNDERWENT AN ULTRASOUND, BUT NOTHING CONCERNING WAS FOUND. THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH NON-MENTOR BREAST IMPLANTS ON (B)(6) 2019. THIS REPORT IS FOR THE LEFT SIDE.

  Patient problems: No Code Available; Pain

  MAUDE report 9398085 ↗