MENTOR MemoryGel Breast Implant 3504004BCRecalls & reported problems
Mentor Texas L.P. · Smooth Round High Profile Gel-Filled Breast Implant, 400cc |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 MemoryGel breast implant from Mentor is a silicone gel-filled implant. Its 2,011 adverse event reports, 1,983 of them injuries, mostly describe implants rupturing and scar tissue tightening around them, and some mention deformity, pain or the implant moving. The reports include no deaths. Reports in the last 12 months number 110, down from 268 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
- 2,012
- Deaths reported
- 0
- Injuries reported
- 1,985
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2,012 adverse event reports that list this exact device (DI 00081317000501), received between Mar 20, 2018 and Sep 30, 2026 — classified as 1,985 injuries, 27 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (849 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 Problem1,162
- Material Rupture849
- Migration73
- Appropriate Device Problem Term/Code Not Available35
- Material Deformation11
- Use of Device Problem7
- Gel Leak6
- Material Discolored4
Patient problems
- Capsular Contracture1,071
- Deformity/ Disfigurement550
- No Code Available350
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available96
- Breast Discomfort/Pain79
- Pain60
- No Clinical Signs, Symptoms or Conditions47
- Wrinkling30
Recent adverse event reports
The 25 most recent of 2,012 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Migration
It was reported that a patient underwent breast augmentation revision with two 400cc MENTOR MemoryGel Breast Implants. Post-operatively, the patient was diagnosed with bilateral breast implant malposition and displacement. As a result, the patient underwent breast implant removal and replacement surgery on (b)(6)2020. The replacement devices were two Mentor gel implants.This Medwatch form is for the right breast prosthesis.
Patient problems: Deformity/ Disfigurement
MAUDE report 50949863 ↗InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Capsular Contracture
MAUDE report 50923541 ↗InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Capsular Contracture
MAUDE report 50923538 ↗InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem
It was reported that a patient implanted with a 400cc MENTOR MemoryGel Breast Implant experienced capsular contracture Baker Grade 2 on the left side post-operatively. As a result, the patient underwent explantation on (b)(6)2026.
Patient problems: Capsular Contracture
MAUDE report 50898563 ↗InjurySep 23, 2026Material Rupture
It was reported that a patient implanted with a 400cc 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: No Clinical Signs, Symptoms or Conditions
MAUDE report 50870328 ↗InjurySep 23, 2026Material Rupture
It was reported that a patient implanted with a 400cc 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: No Clinical Signs, Symptoms or Conditions
MAUDE report 50869681 ↗InjurySep 22, 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 reported. At the time of this report, Mentor has received no information regarding explanation or an expected explanation date.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50858192 ↗InjurySep 21, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50848015 ↗InjurySep 16, 2026Adverse Event Without Identified Device or Use Problem
It was reported that a patient underwent a Breast Augmentation Revision Surgery with implantation of a 400cc MENTOR MemoryGel Breast Implant prosthesis. Post-operatively, the patient was diagnosed with right breast Baker Grade IV Capsular Contracture during a physical exam as the right implant was riding high and medial. As a result, the patient was scheduled for right-sided exchange with a Mentor gel implant on (b)(6)2026.
Patient problems: Capsular Contracture
MAUDE report 50793195 ↗InjurySep 15, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50781598 ↗InjurySep 15, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50781595 ↗InjurySep 10, 2026Material Rupture
It was reported that a patient underwent a Breast Augmentation Revision Surgery with implantation of a 400cc MENTOR MemoryGel Breast Implant prosthesis. Post-operatively, the patient was diagnosed with a ruptured left implant during a screening Magnetic Resonance Imaging as per previous rupture history. As a result, the patient was scheduled for left-sided exchange with a Mentor gel implants on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50715696 ↗InjurySep 9, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Autoimmune Disorder
MAUDE report 50695408 ↗InjurySep 9, 2026Adverse Event Without Identified Device or Use Problem
It was reported that a patient implanted with two 400cc MENTOR MemoryGel Breast Implants presented with multiple sclerosis and rheumatological disease post-operatively. At the time of this report, Mentor has received no information regarding explantation or an expected explantation date.
Patient problems: Autoimmune Disorder
MAUDE report 50695406 ↗InjurySep 8, 2026Adverse Event Without Identified Device or Use Problem
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: Necrosis
MAUDE report 50672062 ↗InjurySep 2, 2026Material Rupture
Patient problems: Capsular Contracture; No Clinical Signs, Symptoms or Conditions
MAUDE report 50566645 ↗InjuryAug 24, 2026Material Rupture
It was reported that a patient implanted with two 400cc MENTOR MemoryGel Breast Implant experienced bilateral ruptures post-operatively. As a result, the patient underwent explantation on (b)(6), 2026.
Patient problems: Deformity/ Disfigurement
MAUDE report 50416271 ↗InjuryAug 24, 2026Material Rupture
It was reported that a patient implanted with two 400cc MENTOR MemoryGel Breast Implant experienced bilateral ruptures post-operatively. As a result, the patient underwent explantation on (b)(6) 2026.
Patient problems: Deformity/ Disfigurement
MAUDE report 50416266 ↗InjuryAug 19, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50331017 ↗InjuryAug 7, 2026Material Rupture
It was reported that a patient underwent a Breast Augmentation Revision Surgery with implantation of a 400cc MENTOR MemoryGel Breast Implant prosthesis. Post-operatively, the patient was diagnosed with a ruptured right implant complicated by silicone migration to the bilateral axillary lymph nodes using Magnetic Resonance Imaging. As a result, the patient underwent bilateral exchange with Mentor gel implants on (b)(6) 2026.
Patient problems: Granuloma
MAUDE report 50177871 ↗InjuryAug 5, 2026Adverse Event Without Identified Device or Use Problem
It was reported that a patient underwent primary breast augmentation with two 400cc MENTOR MemoryGel Breast Implants. Post-operatively, the patient developed bilateral breasts that did not go down and have breast pain. 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: Capsular Contracture
MAUDE report 50147514 ↗InjuryJun 9, 2026Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH A 400CC MENTOR MEMORYGEL BREAST IMPLANT ON THE RIGHT BREAST. POST-OPERATIVELY, THE PATIENT DEVELOPED A HARD RIGHT BREAST AND SUFFERED POSSIBLE RIGHT BREAST IMPLANT LEAK. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.
Patient problems: Capsular Contracture
MAUDE report 25451503 ↗InjuryJun 1, 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 25347796 ↗InjuryMay 28, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT WHO UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH A MENTOR MEMORYGEL BREAST IMPLANT GEL BREAST PROSTHESIS DEVELOPED BAKER GRADE IV CAPSULAR CONTRACTURE IN HER RIGHT BREAST POST IMPLANTATION. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH MENTOR MEMORYGEL BREAST IMPLANT GEL BREAST PROSTHESES.
Patient problems: Capsular Contracture
MAUDE report 25323670 ↗InjuryMay 27, 2026Material Rupture
IT WAS REPORTED THAT A 35-YEAR-OLD HISPANIC FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH TWO 400CC MENTOR MEMORYGEL BREAST IMPLANTS AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE (BAKER GRADE UNKNOWN) AND BILATERAL RUPTURES POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2026. THIS REPORT IS FOR THE RIGHT SIDE DEVICE.
Patient problems: Capsular Contracture
MAUDE report 25304488 ↗
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 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
- 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