MENTOR MemoryGel Breast Implant 3507450BCRecalls & reported problems
Mentor Texas L.P. · Smooth Round Moderate Profile Gel-Filled Breast Implant, 450cc · Class 3 · Implant
All models of MENTOR MemoryGel Breast Implants (368) · MENTOR MemoryGel Breast Implant (211)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Mentor MemoryGel breast implant, a silicone gel-filled prosthesis, has 340 reports, all of them injuries, and no deaths. The reports mostly describe ruptured implants, with deformity, scar tissue hardening around the implant, and pain, and several describe removal and replacement surgery. Reports in the last 12 months number 11, down from 29 in the previous 12 months. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 342
- Deaths reported
- 0
- Injuries reported
- 342
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 342 adverse event reports that list this exact device (DI 00081317000143), received between Feb 22, 2018 and Sep 29, 2026 — classified as 342 injuries.
The most frequently reported specific device problem is “Material Rupture” (254 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.
Reports received per month
Most reported problems
Device problems
- Material Rupture254
- Adverse Event Without Identified Device or Use Problem95
- Appropriate Device Problem Term/Code Not Available6
- Migration5
- Material Discolored2
- Use of Device Problem2
- Contamination /Decontamination Problem1
- Gel Leak1
Patient problems
- Deformity/ Disfigurement130
- Capsular Contracture114
- No Code Available99
- Pain19
- Breast Discomfort/Pain18
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available12
- Autoimmune Reaction7
- Cyst(s)7
Recent adverse event reports
The 25 most recent of 342 reports, in the reporter's own words as published by the FDA.
InjurySep 29, 2026Material Rupture
It was reported that a patient with MENTOR MemoryGel Breast Implants experienced rupture 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: No Clinical Signs, Symptoms or Conditions
MAUDE report 50937387 ↗InjurySep 22, 2026Adverse Event Without Identified Device or Use Problem
It was reported that a patient implanted with a 450cc MENTOR MemoryGel Breast Implant experienced capsular contracture Baker Grade 2 on the left side post-operatively. The patient required surgical intervention to treat, after which, the patient underwent explantation on (b)(6), 2026.
Patient problems: Capsular Contracture
MAUDE report 50854510 ↗InjuryAug 6, 2026Material Rupture; Use of Device Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50165431 ↗InjuryJul 31, 2026Material Rupture
It was reported that a patient underwent a primary breast augmentation procedure with MENTOR MemoryGel Breast Implant gel breast prostheses when the right breast prosthesis ruptured post implantation. Additionally, the patient developed bilateral Baker Grade IV capsular contracture. 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 right breast prosthesis.
Patient problems: Capsular Contracture
MAUDE report 50106526 ↗InjuryJul 31, 2026Adverse Event Without Identified Device or Use Problem
It was reported that a patient underwent a primary breast augmentation procedure with MENTOR MemoryGel Breast Implant gel breast prostheses when the right breast prosthesis ruptured post implantation. Additionally, the patient developed bilateral Baker Grade IV capsular contracture. 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.
Patient problems: Capsular Contracture
MAUDE report 50106519 ↗InjuryFeb 6, 2026Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 450CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT DESIRED A SIZE EXCHANGE TO GO SMALLER. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXCHANGE WITH ALLERGAN (NON-MENTOR) IMPLANTS ON (B)(6) 2026. HOWEVER, DURING THE REVISION SURGERY, A RUPTURED RIGHT IMPLANT WAS DISCOVERED. THERE WERE NO REPORTED PROCEDURAL DELAYS OR PATIENT HARMS/CONSEQUENCES DUE TO THE FINDING.
Patient problems: Deformity/ Disfigurement
MAUDE report 24282826 ↗InjuryDec 4, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH MENTOR MEMORYGEL BREAST IMPLANT 450CC BREAST PROSTHESES THAT BILATERALLY RUPTURED POST IMPLANTATION. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH MENTOR MEMORYGEL BREAST IMPLANT 400CC GEL BREAST PROSTHESES ON (B)(6) 2025. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT BREAST PROSTHESIS.
Patient problems: Deformity/ Disfigurement
MAUDE report 23720383 ↗InjuryDec 4, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH MENTOR MEMORYGEL BREAST IMPLANT 450CC BREAST PROSTHESES THAT BILATERALLY RUPTURED POST IMPLANTATION. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH MENTOR MEMORYGEL BREAST IMPLANT 400CC GEL BREAST PROSTHESES ON (B)(6) 2025. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT BREAST PROSTHESIS.
Patient problems: Deformity/ Disfigurement
MAUDE report 23720382 ↗InjuryDec 3, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT IMPLANTED WITH TWO MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED BILATERAL RUPTURES AND CAPSULAR CONTRACTURE 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: Capsular Contracture
MAUDE report 23706057 ↗InjuryNov 21, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH A MENTOR MEMORYGEL BREAST IMPLANT 450CC GEL BREAST PROSTHESIS THAT RUPTURED POST IMPLANTATION. RUPTURE OF THE PATIENT¿S RIGHT BREAST PROSTHESIS WAS REPORTED. ADDITIONALLY, THE PATIENT DEVELOPED PAIN AND DISCOMFORT IN HER RIGHT BREAST. AS A RESULT, THE PATIENT IS SCHEDULED TO UNDERGO EXPLANTATION ON (B)(6) 2026.
Patient problems: Breast Discomfort/Pain; Capsular Contracture
MAUDE report 23621399 ↗InjuryNov 19, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT IMPLANTED WITH TWO 450CC MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED BILATERAL CAPSULAR CONTRACTURE, GENERALIZED ILLNESS SYMPTOMS, AND 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Capsular Contracture
MAUDE report 23595745 ↗InjuryNov 19, 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 450CC MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED BILATERAL CAPSULAR CONTRACTURE, GENERALIZED ILLNESS SYMPTOMS, AND 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Capsular Contracture
MAUDE report 23595744 ↗InjuryNov 19, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT A 58-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT REVISION BREAST AUGMENTATION WITH 450CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED BREAST IMPLANT RUPTURE ON HER RIGHT SIDE POSTOPERATIVELY. THE PATIENT HAS CONSULTED WITH THE HEALTHCARE PROFESSIONAL. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.
Patient problems: Deformity/ Disfigurement
MAUDE report 23593090 ↗InjuryOct 20, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 450CC 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 23341853 ↗InjurySep 9, 2025Material Rupture; Adverse Event Without Identified Device or Use Problem; Material Rupture; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 450CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT REPORTED EXPERIENCING BILATERAL BREAST PAIN, LEFT BREAST SHOOTING PAINS AND TINGLING/ITCHING SENSATION, AND A LEFT IMPLANT THAT NEVER DROPPED WHICH APPEARED DISFIGURED. SHE WAS DIAGNOSED WITH A RUPTURED LEFT IMPLANT USING ULTRASOUND AND MAGNETIC RESONANCE IMAGING. A CONSULTATION WITH A MEDICAL PROFESSIONAL WAS SCHEDULED. 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: Breast Discomfort/Pain; Capsular Contracture
MAUDE report 23005872 ↗InjurySep 9, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 450CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT REPORTED EXPERIENCING BILATERAL BREAST PAIN, LEFT BREAST SHOOTING PAINS AND TINGLING/ITCHING SENSATION, AND A LEFT IMPLANT THAT NEVER DROPPED WHICH APPEARED DISFIGURED. SHE WAS DIAGNOSED WITH A RUPTURED LEFT IMPLANT USING ULTRASOUND AND MAGNETIC RESONANCE IMAGING. A CONSULTATION WITH A MEDICAL PROFESSIONAL WAS SCHEDULED. 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 LEFT BREAST PROSTHESIS.
Patient problems: Breast Discomfort/Pain; Capsular Contracture; Deformity/ Disfigurement; Paresthesia
MAUDE report 23005871 ↗InjuryAug 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A 56-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION WITH A 450CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED GRADE 3 BREAST PTOSIS AND CAPSULAR CONTRACTURE (BAKER GRADE 3) ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025, AND REPLACED WITH A 500CC MENTOR MEMORYGEL BREAST IMPLANT (CATALOG NUMBER 3505001BC).
Patient problems: Capsular Contracture
MAUDE report 22853422 ↗InjuryAug 19, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT WITH MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED DEFLATION 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. THE REPORTED IMPLANTATION DATE IS PRIOR TO THE DEVICE MANUFACTURE DATE. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THE CORRECT DATE OF IMPLANTATION OR DEVICE LOT NUMBER, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Patient problems: Deformity/ Disfigurement
MAUDE report 22842498 ↗InjuryAug 18, 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 450CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED BILATERAL BREAST PAIN POST-OPERATIVELY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.
Patient problems: Breast Discomfort/Pain; Capsular Contracture; Deformity/ Disfigurement
MAUDE report 22833653 ↗InjuryAug 18, 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 450CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED BILATERAL BREAST PAIN POST-OPERATIVELY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.
Patient problems: Breast Discomfort/Pain; Capsular Contracture; Deformity/ Disfigurement
MAUDE report 22833651 ↗InjuryAug 9, 2025No Apparent Adverse Event; No Apparent Adverse Event
A MENTOR MEMORYGEL BREAST IMPLANT 450CC GEL BREAST PROSTHESIS WAS RECEIVED BY THE MENTOR ANALYSIS LAB WITHOUT A COMPLAINT IN REGARD TO THE PRODUCT QUALITY OR PATIENT ISSUES. AS A RESULT, THE DEVICE WAS TESTED AND DETERMINED TO HAVE A REPORTABLE FAILURE MODE.
Patient problems: Deformity/ Disfigurement; Insufficient Information
MAUDE report 22766694 ↗InjuryAug 6, 2025Material Rupture; Material Rupture
A FEMALE PATIENT WHO UNDERWENT A BREAST AUGMENTATION PRIMARY WITH A MENTOR MEMORYGEL, 450CC SILICONE PROSTHESIS EXPERIENCE RIGHT SIDED SILENT RUPTURE POST PROCEDURE. THE ISSUE WAS DIAGNOSED THROUGH THE PHYSICAL AND ULTRASOUND EXAMINATION. AS A RESULT, THE PATIENT SCHEDULED FOR BILATERAL REMOVAL SURGERY ON (B)(6) 2025.
Patient problems: Deformity/ Disfigurement
MAUDE report 22732166 ↗InjuryJul 10, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT A 56-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION WITH A 450CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED A RUPTURE ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT IS TO UNDERGO DEVICE EXPLANTATION ON (B)(6) 2025.
Patient problems: Capsular Contracture; Deformity/ Disfigurement
MAUDE report 22473731 ↗InjuryJul 1, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT IMPLANTED WITH TWO 450CC MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED BILATERAL RUPTURES AND CAPSULAR CONTRACTURE (BAKER GRADE 4) POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2024.
Patient problems: Capsular Contracture
MAUDE report 22375110 ↗InjuryJul 1, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT IMPLANTED WITH TWO 450CC MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED BILATERAL RUPTURES AND CAPSULAR CONTRACTURE (BAKER GRADE 4) POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2024.
Patient problems: Capsular Contracture
MAUDE report 22375052 ↗
Other Prosthesis, breast, noninflatable, internal, silicone gel-filled devices
- MENTOR MemoryGel Breast Implant 3503501BCMentor Texas L.P. · Prosthesis, breast, noninflatable, internal, silicone gel-filled2,167 reports
- MENTOR MemoryGel Breast Implant 3504001BCMentor Texas L.P. · Prosthesis, breast, noninflatable, internal, silicone gel-filled2,130 reports
- MENTOR MemoryGel Breast Implant 3504004BCMentor Texas L.P. · Prosthesis, breast, noninflatable, internal, silicone gel-filled2,012 reports
- MENTOR MemoryGel Breast Implant 3504504BCMentor Texas L.P. · Prosthesis, breast, noninflatable, internal, silicone gel-filled1,754 reports
- MENTOR MemoryGel Breast Implant 3503001BCMentor Texas L.P. · Prosthesis, breast, noninflatable, internal, silicone gel-filled1,752 reports
- MENTOR MemoryGel Breast Implant 3503504BCMentor Texas L.P. · Prosthesis, breast, noninflatable, internal, silicone gel-filled1,749 reports
- MENTOR MemoryGel Breast Implant 3504501BCMentor Texas L.P. · Prosthesis, breast, noninflatable, internal, silicone gel-filled1,690 reports
- MENTOR MemoryGel Breast Implant 3503251BCMentor Texas L.P. · Prosthesis, breast, noninflatable, internal, silicone gel-filled1,684 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page