MENTOR MemoryGel Breast Implant 3507255MCRecalls & reported problems

Summary

The FDA's MAUDE database contains 225 adverse event reports that list this exact device (DI 00081317004127), received between Jan 25, 2018 and Sep 14, 2026 — classified as 220 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (113 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 225 reports, in the reporter's own words as published by the FDA.

• InjurySep 14, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Wrinkling

  MAUDE report 50763116 ↗
• InjuryJul 29, 2026Material Rupture

  It was reported that a patient implanted with a 255cc MENTOR MemoryGel Breast Implant 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50071217 ↗
• InjuryMay 13, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 255CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED CAPSULAR CONTRACTURE (BAKER GRADE 3) AND A RUPTURE ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2026.

  Patient problems: Capsular Contracture

  MAUDE report 25162427 ↗
• InjuryMay 1, 2026Adverse Event Without Identified Device or Use Problem

  A FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE UTILIZING MENTOR MEMORYGEL, 255 CC ON THE RIGHT, AND 235 CC ON THE LEFT SIDE SILICONE PROSTHESIS. POSTOPERATIVELY, SHE EXPERIENCED BILATERAL CAPSULAR CONTRACTURES GRADE III ON THE LEFT, AND IV ON THE RIGHT. THE ISSUE WAS CONFIRMED THROUGH MRI EXAMINATION. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REPLACEMENTS PER FOLLOWING: R: 2096483-116 / 350-7235MC, L: 2102233-120 / 350-7235MC ON (B)(6) 2026. THIS REPORT RELATES TO THE RIGHT SIDE.

  Patient problems: Capsular Contracture

  MAUDE report 25055991 ↗
• InjuryApr 30, 2026Adverse Event Without Identified Device or Use Problem

  A FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE UTILIZING MENTOR MEMORYGEL, 255CC ON THE RIGHT, AND 235CC ON THE LEFT SIDE SILICONE PROSTHESIS. POSTOPERATIVELY, SHE EXPERIENCED BILATERAL CAPSULAR CONTRACTURES GRADE III ON THE LEFT, AND IV ON THE RIGHT. THE ISSUE WAS CONFIRMED THROUGH MRI EXAMINATION. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REPLACEMENTS PER FOLLOWING: R: 2096483-116 / 350-7235MC, L: 2102233-120 / 350-7235MC ON (B)(6) 2026. THIS REPORT RELATES TO THE LEFT SIDE.

  Patient problems: Capsular Contracture

  MAUDE report 25051156 ↗
• InjuryMar 3, 2026Material Rupture

  IT WAS REPORTED THAT A 47-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH TWO 255CC MENTOR MEMORYGEL BREAST IMPLANTS AND EXPERIENCED A RUPTURE ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS DIAGNOSED WITH A PHYSICAL EXAM AND MRI. IT WAS ALSO REPORTED THAT THE PATIENT EXPERIENCED BILATERAL BREAST PTOSIS AND HAD A BREAST MASS (OVAL MASS IN THE ANTERIOR) ON THE LEFT SIDE THAT WAS PREVIOUSLY BIOPSIED. THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2026 AND REPLACED WITH TWO 300CC MENTOR MEMORYGEL BREAST IMPLANTS. THIS REPORT IS FOR THE RIGHT-SIDE DEVICE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 24500560 ↗
• InjuryMar 3, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 47-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH TWO 255CC MENTOR MEMORYGEL BREAST IMPLANTS AND EXPERIENCED A RUPTURE ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS DIAGNOSED WITH A PHYSICAL EXAM AND MRI. IT WAS ALSO REPORTED THAT THE PATIENT EXPERIENCED BILATERAL BREAST PTOSIS AND HAD A BREAST MASS (OVAL MASS IN THE ANTERIOR) ON THE LEFT SIDE THAT WAS PREVIOUSLY BIOPSIED. THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2026 AND REPLACED WITH TWO 300CC MENTOR MEMORYGEL BREAST IMPLANTS. THIS REPORT IS FOR THE LEFT SIDE DEVICE.

  Patient problems: Breast Mass; Deformity/ Disfigurement

  MAUDE report 24500559 ↗
• InjuryFeb 12, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 255CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH A RUPTURED RIGHT IMPLANT USING COMPUTERIZED TOMOGRAPHY IMAGING. 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.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 24322818 ↗
• InjuryFeb 12, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH IMPLANTATION OF A 255CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH A RUPTURED RIGHT IMPLANT USING MAGNETIC RESONANCE IMAGING. 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.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 24322708 ↗
• InjuryJan 27, 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 BILATERAL CAPSULAR CONTRACTURE POST IMPLANTATION (BAKER GRADE IV IN LEFT BREAST, BAKER GRADE II-III IN RIGHT BREAST). THE CAPSULAR CONTRACTURE WAS DIAGNOSED VIA A HEALTHCARE PROFESSIONAL¿S EXAM. AS A RESULT, THE PATIENT UNDERWENT UNILATERAL EXPLANTATION OF THE LEFT BREAST PROSTHESIS AND REPLACEMENT WITH AN ALLERGAN GEL BREAST PROSTHESIS. THE RIGHT BREAST PROSTHESIS WAS NOT EXPLANTED. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT BREAST PROSTHESIS. REFER TO MANUFACTURER REPORT NUMBER 1645337-2026-00453 FOR THE REPORT FOR THE PATIENT¿S LEFT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 24196230 ↗
• InjuryJan 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE WITH A MENTOR GEL BREAST PROSTHESIS DEVELOPED BAKER GRADE IV CAPSULAR CONTRACTURE IN HER LEFT BREAST POST IMPLANTATION. THE CAPSULAR CONTRACTURE WAS DIAGNOSED VIA A HEALTHCARE PROFESSIONAL¿S EXAM. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION.

  Patient problems: Capsular Contracture

  MAUDE report 24045907 ↗
• InjuryJan 12, 2026Material Rupture

  IT WAS REPORTED THAT A 53-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 255CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED A RUPTURE AND BREAST PAIN ON THE LEFT SIDE POST-OPERATIVELY. THE PATIENT HAD SHARP PAINS AND SPASMS. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Breast Discomfort/Pain

  MAUDE report 24044977 ↗
• InjuryJan 12, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Post Operative Wound Infection

  MAUDE report 24039850 ↗
• InjuryJan 5, 2026Material Rupture

  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) 2025.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 23966599 ↗
• InjuryJan 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION WITH A 255CC MENTOR MEMORYGEL BREAST IMPLANT ON THE LEFT BREAST. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA ULTRASOUND, WITH LEFT BREAST INFECTION. AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL AND REPLACEMENT SURGERY ON (B)(6) 2025. THE REPLACEMENT DEVICE WAS A MENTOR GEL IMPLANT.

  Patient problems: Post Operative Wound Infection

  MAUDE report 23954661 ↗
• InjuryDec 31, 2025Adverse 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 A PRIMARY BREAST AUGMENTATION WITH A 255CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED CAPSULAR CONTRACTURE (BAKER GRADE UNKNOWN) ON THE LEFT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT POSSIBLY UNDERWENT EXPLANTATION IN (B)(6) 2016. THE EXACT DATE IS UNKNOWN.

  Patient problems: Capsular Contracture

  MAUDE report 23935675 ↗
• InjuryDec 30, 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 255CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH A RUPTURED LEFT BREAST IMPLANT USING AN MAGNETIC RESONANCE IMAGING, LEFT BREAST BAKER GRADE III CAPSULAR CONTRACTURE, AND BILATERAL BREAST ASYMMETRY. MAMMOGRAM AND ULTRASOUND IMAGING WERE ALSO CONDUCTED WHICH IDENTIFIED SUSPICIOUS CALCIFICATIONS AND A MASS IN THE LEFT BREAST. BIOPSIES WERE RECOMMEND FOR FURTHER EVALUATION. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXCHANGE WITH MENTOR GEL IMPLANTS ON (B)(6) 2025. DURING THE SURGERY, A CYSTIC MASS OF THE RIGHT BREAST WAS DISCOVERED WHICH WAS RELEASED. THIS REPORT IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Cyst(s); Deformity/ Disfigurement

  MAUDE report 23927960 ↗
• InjuryDec 26, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 49-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 255CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED CAPSULAR CONTRACTURE (BAKER GRADE 3) AND A RUPTURE ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) , 2025, AND REPLACED WITH A 200CC MENTOR MEMORYGEL BREAST IMPLANT.

  Patient problems: Capsular Contracture

  MAUDE report 23899250 ↗
• InjuryDec 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH IMPLANTATION OF A 255CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH RIGHT BREAST 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.

  Patient problems: Capsular Contracture

  MAUDE report 23719922 ↗
• MalfunctionNov 26, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A 57-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH UNKNOWN SIZE UNKNOWN GEL IMPLANTS AND EXPERIENCED BREAST IMPLANT RUPTURE ON HER RIGHT SIDE. THE PATIENT UNDERWENT BILATERAL REPLACEMENT SURGERY WITH CATALOG NUMBER 3503251BC; SERIAL NUMBER (B)(6) ON THE LEFT SIDE, AND WITH CATALOG NUMBER 3503501BC; SERIAL NUMBER (B)(6) ON THE RIGHT SIDE ON (B)(6) 2025. ON NOVEMBER 10, 2025, THE MENTOR FAILURE ANALYSIS LAB RECEIVED TWO DEVICES FOR EVALUATION. ACCORDING TO THE INFORMATION RECEIVED, THE PATIENT EXPERIENCED DEFLATION OF THE RIGHT-SIDE IMPLANT. NO PRODUCT QUALITY ISSUES WERE REPORTED FOR THE LEFT-SIDE DEVICE. MENTOR IS AWARE THAT THE DATE OF IMPLANT IS BEFORE THE MANUFACTURE DATE OF LOT 6713581. HOWEVER, FOLLOW-UPS HAVE BEEN COMPLETED AND NO RESPONSE HAS BEEN RECEIVED REGARDING THE DATE. IF ANY CLARIFICATION OR INFORMATION IS RECEIVED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. SINCE NO SERIAL NUMBER WAS AVAILABLE ON THE RETURNED DEVICES, IT WAS NOT POSSIBLE TO DETERMINE WHICH DEVICE CORRESPONDED TO THE RIGHT-SIDE BREAST IMPLANT, THEREFORE, BOTH DEVICES WERE ANALYZED. FOR REPORTING PURPOSES, THIS REPORT DETAILS EVALUATION O

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23659797 ↗
• InjuryNov 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FEMALE PATIENT WHO UNDERWENT BREAST AUGMENTATION PRIMARY WITH MENTOR MEMORYGEL 255CC SILICONE PROSTHESIS EXPERIENCES LEFT SIDED CAPSULAR UNKNOWN GRADE POST OPERATION. AS A RESULT, THE PATIENT SCHEDULED FOR BILATERAL REMOVAL SURGERY ON (B)(6) 2025.

  Patient problems: Capsular Contracture

  MAUDE report 23618610 ↗
• InjuryNov 18, 2025Adverse Event Without Identified Device or Use Problem; Migration; Adverse Event Without Identified Device or Use Problem; Migration

  IT WAS REPORTED THAT A 42-YEAR-OLD FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH 255CC MENTOR MEMORYGEL BREAST IMPLANTS AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE (BAKER GRADE 3-4) POST-OPERATIVELY, WHICH WAS DIAGNOSED WITH AN EXAM. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025. THIS REPORT IS FOR THE RIGHT SIDE DEVICE.

  Patient problems: Capsular Contracture

  MAUDE report 23589984 ↗
• InjuryNov 18, 2025Adverse Event Without Identified Device or Use Problem; Migration; Adverse Event Without Identified Device or Use Problem; Migration

  IT WAS REPORTED THAT A 42-YEAR-OLD FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH 255CC MENTOR MEMORYGEL BREAST IMPLANTS AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE (BAKER GRADE 3-4) POST-OPERATIVELY, WHICH WAS DIAGNOSED WITH AN EXAM. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025. THIS REPORT IS FOR THE LEFT SIDE DEVICE.

  Patient problems: Capsular Contracture

  MAUDE report 23589983 ↗
• InjuryNov 14, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 40-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 255CC (LEFT) MENTOR MEMORYGEL BREAST IMPLANT AND A 275CC (RIGHT) MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED BILATERAL RUPTURE POST-OPERATIVELY, WHICH WAS DIAGNOSED WITH A PHYSICAL. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025. THIS REPORT IS FOR THE LEFT SIDE DEVICE.

  Patient problems: Cyst(s); Deformity/ Disfigurement

  MAUDE report 23560702 ↗
• InjuryNov 7, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 51-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 255CC 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 23503926 ↗