MENTOR MemoryGel Breast Implant 3507235MCRecalls & reported problems

Summary

The FDA's MAUDE database contains 143 adverse event reports that list this exact device (DI 00081317004110), received between Sep 19, 2019 and Aug 7, 2026 — classified as 138 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (58 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 143 reports, in the reporter's own words as published by the FDA.

• InjuryAug 7, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a 55-year-old female patient underwent a primary breast augmentation with a 235cc MENTOR MemoryGel Breast Implant and experienced capsular contracture (baker grade 3) on the right side post-operatively, which was diagnosed with a physical exam. As a result, the patient is to undergo device explantation on (b)(6), 2026.

  Patient problems: Capsular Contracture

  MAUDE report 50180256 ↗
• InjuryAug 6, 2026Material Rupture

  It was reported that a patient underwent a Breast Augmentation Revision Surgery with implantation of a 235cc MENTOR MemoryGel Breast Implant prosthesis. Post-operatively, the patient was diagnosed with bilaterally ruptured implants using an undisclosed methodology. As a result, the patient underwent bilateral exchange with Mentor gel implants on (b)(6) 2026.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50161038 ↗
• InjuryJul 28, 2026Adverse Event Without Identified Device or Use Problem

  A female patient who underwent a Breast Reconstruction Revision with MENTOR MemoryGel , 235cc Silicone prosthesis experienced left sided capsular contracture grade III post operation. The issue was diagnosed through physical examination. As a result, the patient underwent unilateral replacement with L: (b)(6) on (b)(6) 2026.

  Patient problems: Capsular Contracture

  MAUDE report 50060698 ↗
• InjuryJul 28, 2026Off-Label Use

  A female patient underwent breast augmentation with a MENTOR MemoryGel 235¿cc silicone prosthesis following a prior unilateral mastectomy; during the operation the surgeon determined the correct implant for the contralateral (healthy) breast was unavailable and intentionally placed the available implant in an inverted (upside¿down) orientation on the right side to reduce projection and improve symmetry¿this constitutes off¿label use. The surgeon is concerned that the inverted placement may increase risk, although the patient currently reports no pain or other symptoms; she does note a squarish contour of the right breast when raising her right arm, consistent with the implant orientation.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 50059199 ↗
• InjuryMay 19, 2026Adverse 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 REPORTED BEING DIAGNOSED WITH LEFT BREAST BAKER GRADE III/IV CAPSULAR CONTRACTURE AND A RUPTURED RIGHT IMPLANT BY A MEDICAL PROFESSIONAL. AS A RESULT, THE PATIENT WAS SCHEDULED FOR BILATERAL IMPLANT REMOVAL ON (B)(6) 2026. THIS REPORT IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 25222155 ↗
• InjuryMay 19, 2026Material Rupture

  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 REPORTED BEING DIAGNOSED WITH LEFT BREAST BAKER GRADE III/IV CAPSULAR CONTRACTURE AND A RUPTURED RIGHT IMPLANT BY A MEDICAL PROFESSIONAL. AS A RESULT, THE PATIENT WAS SCHEDULED FOR BILATERAL IMPLANT REMOVAL ON (B)(6) 2026. THIS REPORT IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 25222154 ↗
• InjuryMay 7, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WITH MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED CAPSULAR CONTRACTURE BAKER GRADE III ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING 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 25113515 ↗
• InjuryMar 17, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST SURGERY WITH IMPLANTATION OF A 235CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT EXPERIENCED A RUPTURE TO THE RIGHT IMPLANT AND UNDERWENT BILATERAL EXCHANGE WITH MENTOR GEL IMPLANTS ON (B)(6) 2026. FOLLOW-UPS ARE BEING CONDUCTED. IF MORE INFORMATION BECOMES AVAILABLE, MENTOR WILL SUBMIT A SUPPLEMENTAL REPORT ACCORDINGLY.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 24619791 ↗
• InjuryMar 17, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WITH MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED BILATERAL CAPSULAR CONTRACTURE BAKER GRADE II ALONG WITH RUPTURE ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT DEVICE REMOVAL. THIS REPORT IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 24619417 ↗
• InjuryFeb 27, 2026Material Rupture

  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 RIGHT BREAST BAKER GRADE III CAPSULAR CONTRACTURE BY A MEDICAL PROFESSIONAL. AS A RESULT, THE PATIENT UNDERWENT BILATERAL IMPLANT EXCHANGE WITH MENTOR GEL IMPLANTS ON (B)(6) 2025. FURTHERMORE, DURING THE SURGERY, BILATERALLY RUPTURED IMPLANTS WERE DISCOVERED. THERE WAS NO REPORTED PROCEDURAL DELAY OR PATIENT HARM/CONSEQUENCE DUE TO THE FINDING. THIS REPORT IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 24475360 ↗
• InjuryFeb 4, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH A MENTOR MEMORYGEL BREAST IMPLANT GEL BREAST PROSTHESIS DEVELOPED BAKER GRADE IV CAPSULAR CONTRACTURE IN HER RIGHT BREAST POST IMPLANTATION. THE CAPSULAR CONTRACTURE WAS DIAGNOSED DURING AN OFFICE VISIT. AS A RESULT, THE PATIENT IS SCHEDULED TO UNDERGO EXPLANTATION.

  Patient problems: Capsular Contracture

  MAUDE report 24261235 ↗
• InjuryJan 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST RECONSTRUCTION REVISION SURGERY WITH IMPLANTATION OF A 235CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH AN INFECTION OF THE LEFT BREAST USING ULTRASOUND IMAGING. AS A RESULT, THE PATIENT UNDERWENT LEFT-SIDED EXCHANGE WITH A MENTOR GEL IMPLANT ON (B)(6) 2025.

  Patient problems: Post Operative Wound Infection

  MAUDE report 24027239 ↗
• InjuryJan 6, 2026Material Rupture

  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 A RIGHT BREAST BAKER GRADE III CAPSULAR CONTRACTURE BY A MEDICAL PROFESSIONAL. AS A RESULT, THE PATIENT UNDERWENT BILATERAL IMPLANT EXCHANGE WITH MENTOR GEL IMPLANTS ON (B)(6) 2025. FURTHERMORE, DURING THE SURGERY, A RUPTURED RIGHT IMPLANT WAS DISCOVERED. THERE WAS NO REPORTED PROCEDURAL DELAY OR PATIENT HARM/CONSEQUENCE DUE TO THE FINDING.

  Patient problems: Capsular Contracture

  MAUDE report 23980968 ↗
• InjuryJan 6, 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: Deformity/ Disfigurement

  MAUDE report 23978307 ↗
• InjuryOct 22, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH A 235CC MENTOR MEMORYGEL BREAST IMPLANT ON THE LEFT BREAST. POST-OPERATIVELY, THE PATIENT SELF-DIAGNOSED A POSSIBLE LEFT BREAST IMPLANT LEAK. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 23361159 ↗
• InjuryOct 17, 2025Material Deformation; Material Deformation

  A FEMALE PATIENT WHO UNDERWENT A BREAST AUGMENTATION REVISION WITH A MENTOR MEMORYGEL, 235 CC, SILICONE PROSTHESIS EXPERIENCES LEFT SIDED FOLDED IMPLANT POST OPERATION. THE ISSUE WAS DIAGNOSED THROUGH PHYSICAL EXAMINATION. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 23324623 ↗
• InjurySep 18, 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 235CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH RIGHT BREAST BAKER GRADE IV CAPSULAR CONTRACTURE DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXCHANGE WITH MENTOR GEL IMPLANTS ON (B)(6) 2025. 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 23089257 ↗
• InjurySep 5, 2025Migration; Migration

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION WITH A 235CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED CAPSULAR CONTRACTURE (BAKER GRADE 3) AND DEVICE MIGRATION ON THE LEFT SIDE POST-OPERATIVELY. THE PATIENT WAS SUPERIORLY DISPLACED. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025, AND REPLACED WITH A 255CC MENTOR MEMORYGEL BREAST IMPLANT (CATALOG NUMBER 3507255MC) WITH LOT NUMBER 2044788.

  Patient problems: Capsular Contracture

  MAUDE report 22986487 ↗
• InjuryJul 30, 2025Gel Leak; Gel Leak

  A FEMALE PATIENT WHO UNDERWENT BREAST AUGMENTATION REVISION WITH MENTOR MEMORYGEL, 235CC SILICONE PROSTHESIS EXPERIENCE LEFT SIDED SILENT RUPTURE, AND RIGHT SIDED GEL BLEED POST PROCEDURE. THE RUPTURE WAS DISCOVERED DURING THE SURGERY. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REPLACEMENTS AS FOLLOWS: RIGHT (B)(6), LEFT SN (B)(6) ON (B)(6) 2025. THIS REPORT RELATES TO THE RIGHT SIDE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 22671444 ↗
• InjuryJul 7, 2025Adverse Event Without Identified Device or Use Problem; Migration; Adverse Event Without Identified Device or Use Problem; Migration

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION WITH A 235CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED CAPSULAR CONTRACTURE (BAKER GRADE 3) ON THE RIGHT SIDE POST-OPERATIVELY. THE PATIENT¿S BREAST WAS DESCRIBED TO BE FIRMER AND HIGHER. THE PATIENT WAS REPORTED TO BE USING SINGULAIR TO HELP WITH THE CAPSULAR CONTRACTURE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Capsular Contracture

  MAUDE report 22429030 ↗
• InjuryJul 3, 2025Material Rupture; Material Rupture

  A FEMALE PATIENT WHO UNDERWENT BREAST AUGMENTATION REVISION WITH MENTOR MEMORYGEL, 235CC SILICONE PROSTHESIS EXPERIENCE LEFT SIDED SILENT RUPTURE POST PROCEDURE. THE RUPTURE WAS DISCOVERED DURING THE SURGERY. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REPLACEMENTS AS FOLLOWS: RIGHT (B)(6), LEFT SN (B)(6) ON (B)(6) 2025.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 22397827 ↗
• InjuryJul 1, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 59-YEAR-OLD FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH TWO 235CC MENTOR MEMORYGEL BREAST IMPLANTS AND EXPERIENCED BILATERAL RUPTURES AND CAPSULAR CONTRACTURE (BAKER GRADE 2 RIGHT AND BAKER GRADE 3 ON THE LEFT) POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT BILATERAL DEVICE EXPLANTATION ON (B)(6) 2025. THIS REPORT IS FOR THE RIGHT-SIDE DEVICE.

  Patient problems: Capsular Contracture

  MAUDE report 22376462 ↗
• InjuryJul 1, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 59-YEAR-OLD FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH TWO 235CC MENTOR MEMORYGEL BREAST IMPLANTS AND EXPERIENCED BILATERAL RUPTURES AND CAPSULAR CONTRACTURE (BAKER GRADE 2 RIGHT AND BAKER GRADE 3 ON THE LEFT) POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT BILATERAL DEVICE EXPLANTATION ON (B)(6) 2025. THIS REPORT IS FOR THE LEFT SIDE DEVICE.

  Patient problems: Capsular Contracture

  MAUDE report 22376461 ↗
• InjuryMay 1, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 43-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A 425CC (LEFT) AND A 235CC (RIGHT) MENTOR MEMORYGEL BREAST IMPLANTAND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE (BAKER GRADE UNKNOWN), BILATERAL BREAST PTOSIS, AND BILATERAL RUPTURES POST-OPERATIVELY. THE PATIENT FELT HARDNESS ON THE BREASTS. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025, AND REPLACED WITH TWO MENTOR BREAST PROSTHESES (SERIAL NUMBER (B)(6) ON THE LEFT AND SERIAL NUMBER (B)(6) ON THE RIGHT). THIS REPORT IS FOR THE RIGHT SIDE DEVICE.

  Patient problems: Capsular Contracture

  MAUDE report 21946640 ↗
• InjuryApr 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION WITH TWO 235CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT DEVELOPED RIGHT BREAST SCAR TETHERING AND MILD CAPSULAR CONTRACTURE. AS A RESULT, THE PATIENT UNDERWENT SCAR REVISION, RELEASE OF TETHERING, AND CAPSULOTOMY ON (B)(6) 2024. HOWEVER, THE CAPSULAR CONTRACTURE RETURNED AND WAS DIAGNOSED ON (B)(6) 2024. IT WAS DIAGNOSED AS BAKER GRADE IV AND ACCOMPANIED BY BREAST PAIN, DEFORMITY, AND THE BREAST SITTING HIGHER. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Capsular Contracture

  MAUDE report 21740900 ↗