MENTOR MemoryGel Breast Implant 3503754BCRecalls & reported problems
Mentor Texas L.P. · Smooth Round High 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 18, 2026 from official FDA records · Editorial policy
Quick summary
This Mentor MemoryGel silicone gel breast implant is used in breast augmentation. Many of the 1,362 reports describe the implant rupturing, capsular contracture (hardening of the tissue around the implant), or the implant moving out of position. The reports include no deaths and 1,335 injuries. Reports fell from 164 in the prior 12 months to 77 in the latest 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
- 1,363
- Deaths reported
- 0
- Injuries reported
- 1,336
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1,363 adverse event reports that list this exact device (DI 00081317000495), received between Jan 19, 2018 and Sep 24, 2026 — classified as 1,336 injuries, 27 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (581 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 Problem776
- Material Rupture581
- Migration47
- Appropriate Device Problem Term/Code Not Available19
- Gel Leak9
- Off-Label Use8
- Material Deformation4
- Device Contamination with Chemical or Other Material3
Patient problems
- Capsular Contracture715
- Deformity/ Disfigurement365
- No Code Available247
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available68
- Breast Discomfort/Pain38
- Pain32
- Wrinkling30
- No Clinical Signs, Symptoms or Conditions27
Recent adverse event reports
The 25 most recent of 1,363 reports, in the reporter's own words as published by the FDA.
InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem
It was reported that a 32-year-old Caucasian female patient underwent primary breast augmentation with 375cc MENTOR MemoryGel Breast Implant and experienced capsular contracture; baker grade unknown on her left side postoperatively. It was reported that the patient had a closed capsulotomy performed. At the time of this report, Mentor has received no information regarding explantation or an expected explantation date.
Patient problems: Capsular Contracture
MAUDE report 50886355 ↗InjurySep 24, 2026Material Rupture
It was reported that a patient underwent breast augmentation revision with two 375cc MENTOR MemoryGel Breast Implants. Post-operatively, the patient underwent breast implant removal and replacement surgery on (b)(6) 2026, for unspecified reasons. During the surgery, the left breast implant was found to be ruptured. The replacement device was a Mentor gel implant.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50878371 ↗InjurySep 22, 2026Material Rupture
It was reported that a patient with MENTOR MemoryGel Breast Implants experienced capsular contracture Baker Grade III along with 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: Capsular Contracture
MAUDE report 50857193 ↗InjurySep 22, 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 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: Capsular Contracture
MAUDE report 50855674 ↗InjurySep 9, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50697697 ↗InjurySep 8, 2026Material Rupture
It was reported that a patient implanted with two MENTOR MemoryGel Breast Implants experienced a rupture and nipple sensations on the left side and soft tissue necrosis on the right side post-operatively. As a result, the patient underwent explantation on (b)(6)2026.
Patient problems: Nipple Sensation Changes
MAUDE report 50672066 ↗InjuryAug 14, 2026Material Rupture
It was reported that a patient underwent primary breast augmentation with two 375cc MENTOR MemoryGel Breast Implants. Post-operatively, the patient was diagnosed with left breast implant rupture. As a result, the patient underwent breast implant removal and replacement surgery on (b)(6) 2026. The replacement devices were two Mentor gel implants.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50246138 ↗InjuryAug 4, 2026Material Rupture
Patient problems: Capsular Contracture; Local Reaction
MAUDE report 50124644 ↗InjuryAug 3, 2026Material Rupture
It was reported that a patient implanted with a 375cc MENTOR MemoryGel Breast Implant 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: No Clinical Signs, Symptoms or Conditions
MAUDE report 50118850 ↗InjuryJul 30, 2026Material Rupture
It was reported that a patient with MENTOR MemoryGel Breast Implants experienced capsular contracture Baker Grade II along with 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: Capsular Contracture
MAUDE report 50086395 ↗InjuryJun 9, 2026Adverse Event Without Identified Device or Use Problem
A FEMALE PATIENT WITH A PRIOR BREAST AUGMENTATION PRIMARY USING MENTOR MEMORYGEL 375CC SILICONE PROSTHESIS PRESENTED POSTOPERATIVELY WITH LEFT SIDE CAPSULAR CONTRACTURE GRADE III. TELEHEALTH CALL EXAMINATION DIAGNOSED THE FINDINGS. AT THE TIME OF THIS REPORT, MENTOR RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.
Patient problems: Capsular Contracture
MAUDE report 25449098 ↗InjuryJun 1, 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 AND REPLACEMENT.
Patient problems: Deformity/ Disfigurement
MAUDE report 25348102 ↗InjuryMay 22, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A 40-YEAR-OLD FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 375CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED CAPSULAR CONTRACTURE (BAKER GRADE 3) ON THE LEFT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2026 AND REPLACED WITH A 480CC MENTOR MEMORYGEL BOOST BREAST IMPLANT.
Patient problems: Capsular Contracture
MAUDE report 25260217 ↗InjuryMay 8, 2026Migration
IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 375CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT HAD TO UNDERGO RIGHT BREAST REVISION TO LOWER THE IMPLANTS POSITION, ON AN UNSPECIFIED DATE WITHIN A YEAR OF IMPLANTATION. EVENTUALLY, THE PATIENT WAS DIAGNOSED, VIA MRI, WITH RIGHT BREAST IMPLANT RUPTURE AND BILATERAL MILD BOTTOMING OF THE BREASTS. AS A RESULT, THE PATIENT UNDERWENT RIGHT BREAST IMPLANT REMOVAL AND REPLACEMENT SURGERY ON (B)(6) 2026. FOR THE LEFT BREAST, 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 25128901 ↗InjuryApr 29, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 375CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED A CAPSULAR CONTRACTURE 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 25032118 ↗InjuryApr 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: Deformity/ Disfigurement
MAUDE report 25020620 ↗InjuryApr 24, 2026Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH IMPLANTATION OF A 375CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH A RUPTURED RIGHT IMPLANT DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXCHANGE WITH MENTOR GEL IMPLANTS ON (B)(6) 2026.
Patient problems: Deformity/ Disfigurement
MAUDE report 24988904 ↗InjuryApr 16, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT WITH MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED CAPSULAR CONTRACTURE BAKER GRADE IV ON THE RIGHT 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: Capsular Contracture
MAUDE report 24896287 ↗InjuryApr 11, 2026Material Rupture
A FEMALE PATIENT WHO UNDERWENT A BREAST SURGERY WITH A MENTOR MEMORYGEL XTRA 375CC EXPERIENCE LEFT SIDED SILENT RUPTURE POST OPERATION. THE ISSUE WAS DIAGNOSED THROUGH PHYSICAL EXAMINATION. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REPLACEMENTS WITH NON-MENTOR ON (B)(6) 2023.
Patient problems: Deformity/ Disfigurement
MAUDE report 24847718 ↗InjuryApr 3, 2026Material Rupture; Migration
IT WAS REPORTED THAT A PATIENT WITH MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED RUPTURE AND MIGRATION ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED 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 24778549 ↗InjuryMar 30, 2026Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH IMPLANTATION OF A 375CC 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 BILATERAL EXCHANGE WITH MENTOR GEL IMPLANTS ON (B)(6) 2026.
Patient problems: Deformity/ Disfigurement
MAUDE report 24721450 ↗MalfunctionMar 25, 2026Material Rupture; Material Deformation
IT WAS REPORTED THAT A 375CC MENTOR MEMORYGEL BREAST IMPLANT BEING USED IN A BREAST AUGMENTATION PROCEDURE WAS FOUND TO BE RUPTURED DURING THE OPERATION. THE IMPLANT ALSO FELT VERY SOFT DURING INSERTION. NO ADVERSE EVENT WAS EXPERIENCED BY THE PATIENT. THE SURGEON USED BACKUP DEVICES, AND THERE WERE NO REPORTED PATIENT CONSEQUENCES OR PROCEDURAL DELAYS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24693045 ↗InjuryMar 25, 2026Material Rupture
IT WAS REPORTED THAT A PATIENT IMPLANTED WITH TWO 425CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED BILATERAL RUPTURES AND CAPSULAR CONTRACTURE (BAKER GRADE 4) POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2026.
Patient problems: Capsular Contracture
MAUDE report 24690690 ↗InjuryMar 19, 2026Material Rupture
IT WAS REPORTED THAT A 42-YEAR-OLD FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH 375CC MENTOR MEMORYGEL BREAST IMPLANTS AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE (BAKER GRADE 3) AND BILATERAL RUPTURE POST-OPERATIVELY, WHICH WAS DIAGNOSED WITH A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2026 AND REPLACED WITH TWO 425CC MENTOR MEMORYGEL BREAST IMPLANTS. THIS REPORT IS FOR THE LEFT SIDE DEVICE.
Patient problems: Capsular Contracture
MAUDE report 24640737 ↗InjuryMar 19, 2026Material Rupture
IT WAS REPORTED THAT A 42-YEAR-OLD FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH 375CC MENTOR MEMORYGEL BREAST IMPLANTS AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE (BAKER GRADE 3) AND BILATERAL RUPTURE POST-OPERATIVELY, WHICH WAS DIAGNOSED WITH A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2026 AND REPLACED WITH TWO 425CC MENTOR MEMORYGEL BREAST IMPLANTS. THIS REPORT IS FOR THE RIGHT-SIDE DEVICE.
Patient problems: Capsular Contracture
MAUDE report 24640732 ↗
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