MENTOR MemoryGel Breast Implant 3504504BCRecalls & reported problems
Mentor Texas L.P. · Smooth Round High Profile Gel-Filled Breast Implant, 450cc |Smooth|Round|Silicone| · 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 is a silicone gel-filled implant used in breast augmentation. Of its 1,750 reports, 1,735 involve an injury, and many describe the implant rupturing, hardened scar tissue forming around it, and breast deformity. Some describe wounds with the implant exposed. Reports fell from 183 in the prior 12 months to 115 in the latest 12 months. There are no deaths reported, and 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
- 1,754
- Deaths reported
- 0
- Injuries reported
- 1,740
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1,754 adverse event reports that list this exact device (DI 00081317000525), received between Feb 7, 2018 and Sep 28, 2026 — classified as 1,740 injuries, 14 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (720 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
- Adverse Event Without Identified Device or Use Problem1,061
- Material Rupture720
- Migration53
- Appropriate Device Problem Term/Code Not Available25
- Off-Label Use6
- Use of Device Problem6
- Defective Device4
- Gel Leak3
Patient problems
- Capsular Contracture965
- Deformity/ Disfigurement461
- No Code Available327
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available89
- Breast Discomfort/Pain85
- Pain55
- Wrinkling31
- No Clinical Signs, Symptoms or Conditions26
Recent adverse event reports
The 25 most recent of 1,754 reports, in the reporter's own words as published by the FDA.
InjurySep 28, 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. As a result, the patient underwent device removal.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50915553 ↗InjurySep 25, 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. As a result, the patient underwent device removal.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50898825 ↗InjurySep 24, 2026Material Rupture
It was reported that a patient underwent a primary breast augmentation procedure with a MENTOR MemoryGel Breast Implant gel breast prosthesis that ruptured post implantation. The patient noticed something ¿felt wrong¿ with her left breast and had an MRI performed that diagnosed breast prosthesis rupture. As a result, the patient is scheduled to undergo explantation.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50876957 ↗InjurySep 23, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50875343 ↗InjurySep 23, 2026Material Rupture
It was reported that a patient underwent primary breast augmentation with a 450cc MENTOR MemoryGel Breast Implant on the left breast. Post-operatively, the patient was diagnosed, via ultrasound and mammogram, with left breast implant rupture. 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 50872471 ↗InjurySep 23, 2026Material Rupture
It was reported that a 46-year-old Caucasian female patient underwent a primary breast augmentation with a 450cc MENTOR MemoryGel Breast Implant and experienced capsular contracture (baker grade 3) and a rupture on the right side post-operatively. The rupture was diagnosed during surgery. The patient underwent explantation on (b)(6) 2026, and replaced with a 470cc MENTOR MemoryGel BOOST Breast Implant.
Patient problems: Capsular Contracture
MAUDE report 50870597 ↗InjurySep 22, 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 reported experiencing a ruptured left implant after consulting with a medical professional. 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: No Clinical Signs, Symptoms or Conditions
MAUDE report 50858594 ↗InjurySep 22, 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 was diagnosed with a ruptured left implant and Capsular Contracture (a Baker Grade was not provided) by a medical professional. As a result, the patient underwent bilateral exchange with Mentor gel implants on (b)(6) 2026.
Patient problems: Capsular Contracture
MAUDE report 50858445 ↗InjurySep 16, 2026Material Rupture
It was reported that a 48-year-old Caucasian female patient underwent a primary breast augmentation with a 550cc (Left) MENTOR MemoryGel Breast Implant and a 450cc (Right) MENTOR MemoryGel Breast Implant and experienced bilateral rupture post-operatively, which was diagnosed with a Magnetic Resonance Imaging. At the time of this report, Mentor has received no information regarding explantation or an expected explantation date.This report is for the right side device.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50792747 ↗InjurySep 15, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Capsular Contracture
MAUDE report 50782132 ↗InjurySep 11, 2026Adverse Event Without Identified Device or Use Problem
It was reported that a patient underwent primary breast augmentation with a 450cc MENTOR MemoryGel Breast Implant on the right breast. Post-operatively, the patient developed right breast capsular contracture (baker grade III). At the time of this report, Mentor has received no information regarding explantation or an expected explantation date.
Patient problems: Capsular Contracture
MAUDE report 50725331 ↗InjurySep 10, 2026Migration
Patient problems: Deformity/ Disfigurement
MAUDE report 50720374 ↗InjurySep 8, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Capsular Contracture
MAUDE report 50680123 ↗InjurySep 8, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Capsular Contracture
MAUDE report 50680122 ↗InjuryAug 25, 2026Material Rupture
It was reported that a 58-year-old Caucasian female patient underwent a breast augmentation revision with a 450cc MENTOR MemoryGel Breast Implant and experienced a rupture on the right side post-operatively, which was diagnosed intraoperatively. It was reported that the patient had also experienced a local reaction. The patient had a right breast lumpectomy to biopsy a suspicious area that turned out to be benign. After that procedure, the patient had developed right breast erythema and some malaise. The patient was admitted for IV antibiotics where the redness was resolved. The patient underwent explantation on (b)(6) 2026, and replaced with a Mentor breast prosthesis.
Patient problems: Local Reaction
MAUDE report 50442271 ↗InjuryAug 5, 2026Adverse Event Without Identified Device or Use Problem
A female patient who underwent a Breast Augmentation Revision with MENTOR MemoryGel 450cc Silicone prosthesis experienced left sided capsular contracture grade III post implantation. At the time of this report, Mentor has received no information regarding explantation or an expected explantation date.
Patient problems: Capsular Contracture
MAUDE report 50147028 ↗InjuryAug 3, 2026Migration
It was reported that a 46-year-old Caucasian female patient underwent a breast augmentation with a 450cc MENTOR MemoryGel Breast Implant and experienced device migration on the right side post-operatively. The patient had significant lateral displacement. As a result, the patient underwent explantation on (b)(6) 2026, and replaced with a Mentor breast prosthesis.
Patient problems: Deformity/ Disfigurement
MAUDE report 50124395 ↗InjuryAug 3, 2026Material Rupture
It was reported that a patient underwent a primary breast augmentation procedure with a MENTOR MemoryGel Breast Implant gel breast prosthesis that ruptured post implantation. Rupture of the patient¿s left breast prosthesis was confirmed by a healthcare professional. As a result, the patient underwent explantation.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50124010 ↗InjuryJul 27, 2026Material Rupture
It was reported that a patient underwent primary breast augmentation with two 450cc MENTOR MemoryGel Breast Implants. Post-operatively, the patient was diagnosed with left breast implant rupture and also developed left breast capsular contracture. As a result, the patient has been scheduled for breast implant removal surgery on (b)(6) 2026.
Patient problems: Capsular Contracture
MAUDE report 50045138 ↗InjuryJun 4, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 450CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT DEVELOPED LEFT BREAST CAPSULAR CONTRACTURE (BAKER GRADE UNSPECIFIED). AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2026.
Patient problems: Capsular Contracture
MAUDE report 25402498 ↗InjuryMay 27, 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: Deformity/ Disfigurement
MAUDE report 25299899 ↗InjuryMay 26, 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. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.
Patient problems: Deformity/ Disfigurement
MAUDE report 25285258 ↗InjuryMay 21, 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 WAS DIAGNOSED WITH BILATERALLY RUPTURED IMPLANTS USING MAGNETIC RESONANCE IMAGING. AS A RESULT, THE PATIENT WAS SCHEDULED FOR BILATERAL IMPLANT REMOVAL ON (B)(6) 2026.
Patient problems: Deformity/ Disfigurement
MAUDE report 25249428 ↗InjuryMay 21, 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 WAS DIAGNOSED WITH BILATERALLY RUPTURED IMPLANTS USING MAGNETIC RESONANCE IMAGING. AS A RESULT, THE PATIENT WAS SCHEDULED FOR BILATERAL IMPLANT REMOVAL ON (B)(6) 2026.
Patient problems: Deformity/ Disfigurement
MAUDE report 25249427 ↗InjuryMay 20, 2026Material Rupture
IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 450CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED A RUPTURE ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2026.
Patient problems: Deformity/ Disfigurement
MAUDE report 25231257 ↗
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 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
- MENTOR MemoryGel Breast Implant 3503751BCMentor Texas L.P. · Prosthesis, breast, noninflatable, internal, silicone gel-filled1,671 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