MENTOR MemoryGel Breast Implant 3503751BCRecalls & reported problems
Mentor Texas L.P. · Smooth Round Moderate Plus Profile Gel-Filled Breast Implant, 375cc |Smooth|Round|Silicone| · Class 3 · Implant
All models of MENTOR MemoryGel Breast Implants (368) · MENTOR MemoryGel Breast Implant (211)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This is the Mentor MemoryGel breast implant, a silicone gel-filled implant. The 1,674 reports often describe the implant rupturing, and many mention hardening of the scar tissue around the implant, changes in breast shape, and pain. The records include no deaths, 1,662 injuries and 11 malfunctions, and no recalls name this device. Reports fell to 93 in the last 12 months from 196 in the 12 months before.
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
- 1,671
- Deaths reported
- 0
- Injuries reported
- 1,661
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1,671 adverse event reports that list this exact device (DI 00081317000310), received between May 1, 2018 and Sep 29, 2026 — classified as 1,661 injuries, 9 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (843 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Material Rupture843
- Adverse Event Without Identified Device or Use Problem820
- Migration49
- Appropriate Device Problem Term/Code Not Available28
- Gel Leak11
- Off-Label Use9
- Material Discolored6
- Material Deformation5
Patient problems
- Capsular Contracture792
- Deformity/ Disfigurement507
- No Code Available326
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available98
- Pain66
- Breast Discomfort/Pain64
- Autoimmune Reaction28
- Wrinkling21
Recent adverse event reports
The 25 most recent of 1,671 reports, in the reporter's own words as published by the FDA.
InjurySep 29, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50935750 ↗InjurySep 28, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50926465 ↗InjurySep 23, 2026Migration
Patient problems: Wrinkling
MAUDE report 50873097 ↗InjurySep 23, 2026Material Rupture
It was reported that a patient underwent an unspecified breast surgery with an unspecified Mentor gel breast prosthesis (left device) and a MENTOR MemoryGel Breast Implant gel breast prosthesis (right device) when the right breast prosthesis ruptured post implantation. Additionally, the patient developed a loss of energy and feels lethargic. At the time of this report, Mentor has received no information regarding explantation or an expected explantation date.This MedWatch report is for the patient¿s right breast prosthesis.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50872956 ↗InjurySep 23, 2026Material Rupture
It was reported that a patient implanted with two 375cc MENTOR MemoryGel Breast Implant experienced bilateral ruptures and capsular contracture (Baker Grade 3) post-operatively. As a result, the patient underwent explantation on (b)(6)2026.
Patient problems: Capsular Contracture
MAUDE report 50871405 ↗InjurySep 23, 2026Material Rupture
It was reported that a patient implanted with two 375cc MENTOR MemoryGel Breast Implant experienced bilateral ruptures and capsular contracture (Baker Grade 3) post-operatively. As a result, the patient underwent explantation on (b)(6) 2026.
Patient problems: Capsular Contracture
MAUDE report 50871403 ↗InjurySep 22, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Capsular Contracture
MAUDE report 50857493 ↗InjurySep 22, 2026Adverse Event Without Identified Device or Use Problem
It was reported that a 61-year-old Caucasian female patient underwent a breast augmentation revision with two 375cc MENTOR MemoryGel Breast Implants and experienced bilateral capsular contracture (baker grade 3 on the right and 4 on the left side) post-operatively, which was diagnosed with a physical exam. 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: Capsular Contracture
MAUDE report 50857487 ↗InjurySep 16, 2026Material Rupture
It was reported that a patient underwent breast augmentation revision with two 375cc MENTOR MemoryGel Breast Implants. Post-operatively, the patient suffered right breast implant rupture. As a result, the patient has been scheduled for breast implant removal surgery on(b)(6)2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50792468 ↗InjurySep 15, 2026Adverse Event Without Identified Device or Use Problem
It was reported that a patient implanted with TWO MENTOR MemoryGel Breast Implant experienced bilateral capsular contracture Baker Grade 4 post-operatively. As a result, the patient underwent explantation on(b)(6)2026.
Patient problems: Capsular Contracture
MAUDE report 50775551 ↗InjurySep 2, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50569839 ↗InjuryAug 7, 2026Material Rupture
It was reported that a patient with MENTOR MemoryGel Breast Implants experienced rupture along with scarring on the right side post-operatively, which was confirmed during a physical exam. As a result, the patient underwent device removal.
Patient problems: Scar Tissue
MAUDE report 50176832 ↗InjuryJul 28, 2026Adverse Event Without Identified Device or Use Problem
It was reported that a patient underwent primary breast augmentation with two 375cc MENTOR MemoryGel Breast Implants. Post-operatively, the patient developed right breast capsular contracture (baker grade unknown). At the time of this report, Mentor has received no information regarding explantation or an expected explantation date.
Patient problems: Capsular Contracture
MAUDE report 50059555 ↗InjuryJul 27, 2026Material Rupture
It was reported that a 48-year-old Caucasian female patient underwent a primary breast augmentation with a 375cc 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: Capsular Contracture
MAUDE report 50012108 ↗InjuryJun 11, 2026Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT DEVELOPED LEFT BREAST CAPSULAR CONTRACTURE AND SUFFERED POSSIBLE BILATERAL BREAST IMPLANT RUPTURES. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS.
Patient problems: Deformity/ Disfigurement
MAUDE report 25480762 ↗InjuryJun 10, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT WITH MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN 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: Capsular Contracture
MAUDE report 25456687 ↗InjuryJun 8, 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 RIGHT BREAST PROSTHESIS WAS DIAGNOSED VIA CT SCAN AND VIA MAMMOGRAM. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.
Patient problems: Deformity/ Disfigurement
MAUDE report 25434665 ↗InjuryJun 4, 2026Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA MRI, WITH BILATERAL BREAST IMPLANT RUPTURES. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS.
Patient problems: Deformity/ Disfigurement
MAUDE report 25402123 ↗InjuryMay 29, 2026Material Rupture
A FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH A MENTOR MEMORYGEL ,375CC ON THE LEFT, 400CC ON THE RIGHT, SILICONE PROSTHESIS, DEVELOPED BILATERAL SILENT RUPTURES POSTOPERATIVE. THE MRI EXAMINATION DIAGNOSED THE ISSUE. 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: Deformity/ Disfigurement
MAUDE report 25333434 ↗InjuryMay 12, 2026Material Rupture
IT WAS REPORTED THAT A PATIENT WITH MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED BREAST PAIN AND 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: Breast Discomfort/Pain
MAUDE report 25153470 ↗InjuryMay 11, 2026Migration
IT WAS REPORTED THAT A 43-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 375CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED DEVICE MIGRATION ON THE RIGHT SIDE POST-OPERATIVELY. IT WAS REPORTED THAT THE RIGHT BREAST PROSTHESIS WAS SLIGHTLY LOWER THAN THE CONTRALATERAL SIDE. THE BREAST PROSTHESIS WAS FOLDED WITH A TRAVERSE SUPERIOR POLE CREASE. THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2026, AND REPLACED WITH A 480CC MENTOR MEMORYGEL BOOST BREAST IMPLANT.
Patient problems: Deformity/ Disfigurement
MAUDE report 25145145 ↗InjuryMay 8, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A 36-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 375CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED CAPSULAR CONTRACTURE (BAKER GRADE 4) ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS DIAGNOSED WITH 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 25130284 ↗InjuryMay 8, 2026Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 375CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH A RUPTURED LEFT IMPLANT USING ULTRASOUND, MAMMOGRAM, AND 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 25129799 ↗InjuryApr 29, 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 IS SCHEDULED FOR REMOVAL ON (B)(6) 2026.
Patient problems: Deformity/ Disfigurement
MAUDE report 25032820 ↗InjuryApr 24, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH TWO 375CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA PHYSICAL EXAMINATION, WITH LEFT 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 24990130 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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