MENTOR MemoryGel Breast Implant 3503001BCRecalls & reported problems
Mentor Texas L.P. · Smooth Round Moderate Plus Profile Gel-Filled Breast Implant, 300cc |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 1,748 reports, 1,727 involve an injury, and many describe the implant rupturing, hardened scar tissue forming around it, and breast deformity. Reports fell from 204 in the prior 12 months to 87 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
- 1,752
- Deaths reported
- 0
- Injuries reported
- 1,732
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1,752 adverse event reports that list this exact device (DI 00081317000280), received between Feb 28, 2018 and Sep 30, 2026 — classified as 1,732 injuries, 20 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (780 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 Problem978
- Material Rupture780
- Migration57
- Appropriate Device Problem Term/Code Not Available30
- Off-Label Use10
- Gel Leak9
- Material Discolored6
- Use of Device Problem5
Patient problems
- Capsular Contracture895
- Deformity/ Disfigurement488
- No Code Available356
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available66
- Pain61
- Breast Discomfort/Pain50
- Breast Mass38
- No Clinical Signs, Symptoms or Conditions36
Recent adverse event reports
The 25 most recent of 1,752 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Capsular Contracture
MAUDE report 50949884 ↗InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Capsular Contracture
MAUDE report 50949879 ↗InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Capsular Contracture
MAUDE report 50923502 ↗InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Capsular Contracture
MAUDE report 50923500 ↗InjurySep 23, 2026Material Rupture
It was reported that a patient underwent breast augmentation revision with two 300cc MENTOR MemoryGel Breast Implants. Post-operatively, the patient was diagnosed, via mammogram, with left breast implant rupture. As a result, the patient underwent breast implant removal surgery on (b)(6)2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50871237 ↗InjurySep 21, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50848662 ↗InjurySep 21, 2026Material Rupture
It was reported that a patient underwent a Primary Breast Augmentation Surgery with implantation of a 300cc MENTOR MemoryGel Breast Implant prosthesis. Post-operatively, the patient was diagnosed with bilaterally ruptured implants during a physical exam. Magnetic Resonance Imaging was also conducted. As a result, the patient was scheduled for bilateral implant removal on (b)(6)2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50842927 ↗InjurySep 21, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50842921 ↗InjurySep 16, 2026Adverse Event Without Identified Device or Use Problem
It was reported that a patient underwent a Breast Reconstruction Revision Surgery with implantation of a 300cc MENTOR MemoryGel Breast Implant prosthesis. Post-operatively, the patient was diagnosed with right breast Baker Grade IV Capsular Contracture by a medical professional using the patient's symptoms. As a result, the patient underwent bilateral exchange with Mentor gel implants on (b)(6) 2026.
Patient problems: Capsular Contracture
MAUDE report 50794182 ↗InjurySep 10, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Capsular Contracture
MAUDE report 50721337 ↗InjurySep 9, 2026Material Rupture
It was reported that a 57-year-old Caucasian female patient underwent a primary breast augmentation with two 300cc MENTOR MemoryGel Breast Implants and experienced bilateral rupture post-operatively, which was diagnosed with an ultrasound. At the time of this report, Mentor has received no information regarding explantation or an expected explantation date.This report is for the left side device.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50695003 ↗InjurySep 9, 2026Material Rupture
It was reported that a 57-year-old Caucasian female patient underwent a primary breast augmentation with two 300cc MENTOR MemoryGel Breast Implants and experienced bilateral rupture post-operatively, which was diagnosed with an ultrasound. 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 50695002 ↗InjuryAug 6, 2026Material Rupture
A female patient who underwent Breast Augmentation Revision with MENTOR MemoryGel, 300cc Silicone prosthesis experienced left sided silent ruptures post implantation. The issue was confirmed through MRI examination. At the time of this report, Mentor received no information regarding explantation or an expected explantation date.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50164321 ↗InjuryJul 29, 2026Material Rupture
It was reported that a female patient underwent a breast augmentation revision with a 300cc MENTOR MemoryGel Breast Implant and experienced a rupture on the left side post-operatively. As a result, the patient underwent explantation on (b)(6) 2026, and replaced with a Mentor breast prosthesis.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50077803 ↗InjuryJul 8, 2026Material Rupture
IT WAS REPORTED THAT A 44-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH 300CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED BREAST IMPLANT RUPTURE ON HER RIGHT SIDE POSTOPERATIVELY; DIAGNOSED AFTER PHYSICAL EXAM. 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: No Clinical Signs, Symptoms or Conditions
MAUDE report 25746829 ↗InjuryJun 5, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH IMPLANTATION OF A 300CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH BILATERAL BAKER GRADE III CAPSULAR CONTRACTURE BY A MEDICAL PROFESSIONAL USING THE PATIENT'S SYMPTOMS. 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: Capsular Contracture
MAUDE report 25416774 ↗InjuryMay 19, 2026Migration
IT WAS REPORTED THAT A 30-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 300CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED DEVICE MIGRATION, BREAST PTOSIS, AND ASYMMETRY ON THE LEFT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2026 AND REPLACED WITH A 435CC MENTOR MEMORYGEL BOOST BREAST IMPLANT.
Patient problems: Deformity/ Disfigurement
MAUDE report 25224690 ↗InjuryMay 5, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 300CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH A RUPTURED LEFT IMPLANT BY A MEDICAL PROFESSIONAL. AS A RESULT, THE PATIENT UNDERWENT IMPLANT REMOVAL ON (B)(6) 2026. HOWEVER, THE EXPLANTED DEVICE WAS REPORTED INTACT AND THE RUPTURE WAS NOT CONFIRMED.
Patient problems: Deformity/ Disfigurement
MAUDE report 25085842 ↗InjuryMay 5, 2026Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE WITH MENTOR MEMORYGEL BREAST IMPLANT GEL BREAST PROSTHESES THAT BOTH RUPTURED POST IMPLANTATION. 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: Deformity/ Disfigurement
MAUDE report 25076294 ↗InjuryMay 5, 2026Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE WITH MENTOR MEMORYGEL BREAST IMPLANT GEL BREAST PROSTHESES THAT BOTH RUPTURED POST IMPLANTATION. 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: Deformity/ Disfigurement
MAUDE report 25076293 ↗InjuryApr 30, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A 35-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A 300CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED CAPSULAR CONTRACTURE (BAKER GRADE 3) ON THE LEFT 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 25052524 ↗InjuryApr 29, 2026Adverse Event Without Identified Device or Use Problem
A FEMALE PATIENT UNDERWENT AN UNSPECIFIED BREAST SURGERY PROCEDURE UTILIZING MENTOR MEMORYGEL, XTR 650CC SILICONE PROSTHESIS. POSTOPERATIVELY, SHE EXPERIENCED BILATERAL CAPSULAR CONTRACTURES, GRADE III GRADE. THE PHYSICAL EXAMINATION DIAGNOSED THE ISSUES. AT THE TIME OF THIS REPORT, MENTOR RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT RELATES TO THE LEFT SIDE.
Patient problems: Capsular Contracture
MAUDE report 25035977 ↗InjuryApr 29, 2026Material Discolored; Material Rupture
IT WAS REPORTED THAT A PATIENT WITH MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED RUPTURE AND DISCOLORATION ON THE LEFT 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 25031474 ↗InjuryApr 24, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT WHO UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH MENTOR MEMORYGEL BREAST IMPLANT GEL BREAST PROSTHESES DEVELOPED BAKER GRADE III CAPSULAR CONTRACTURE IN BOTH BREASTS POST IMPLANTATION. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT BREAST PROSTHESIS.
Patient problems: Capsular Contracture
MAUDE report 24990920 ↗InjuryApr 24, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT WHO UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH MENTOR MEMORYGEL BREAST IMPLANT GEL BREAST PROSTHESES DEVELOPED BAKER GRADE III CAPSULAR CONTRACTURE IN BOTH BREASTS POST IMPLANTATION. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT BREAST PROSTHESIS.
Patient problems: Capsular Contracture
MAUDE report 24990911 ↗
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 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.
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