MENTOR MemoryGel Breast Implant 3504001BCRecalls & reported problems
Mentor Texas L.P. · Smooth Round Moderate Plus 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 Mentor MemoryGel silicone breast implant has 2,130 reports, with 2,118 listed as injuries and no deaths. Many describe the implant rupturing, and others describe hardening scar tissue around the implant, known as capsular contracture, or a deformed breast. 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
- 2,130
- Deaths reported
- 0
- Injuries reported
- 2,119
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2,130 adverse event reports that list this exact device (DI 00081317000327), received between May 18, 2018 and Sep 29, 2026 — classified as 2,119 injuries, 11 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (1,130 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
- Material Rupture1,130
- Adverse Event Without Identified Device or Use Problem1,047
- Migration69
- Appropriate Device Problem Term/Code Not Available36
- Off-Label Use8
- Gel Leak6
- Material Discolored5
- Air/Gas in Device3
Patient problems
- Capsular Contracture1,054
- Deformity/ Disfigurement655
- No Code Available402
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available115
- Breast Discomfort/Pain77
- Pain76
- No Clinical Signs, Symptoms or Conditions42
- Cyst(s)30
Recent adverse event reports
The 25 most recent of 2,130 reports, in the reporter's own words as published by the FDA.
InjurySep 29, 2026Material Rupture
It was reported that a patient underwent a Primary Breast Augmentation Surgery with implantation of a 400cc MENTOR MemoryGel Breast Implant prosthesis. Post-operatively, the patient experienced a ruptured right implant. As a result, the patient underwent bilateral exchange with Mentor gel implants on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50932799 ↗InjurySep 25, 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 imaging. Additionally, the patient developed Baker Grade IV capsular contracture in her right breast. As a result, the patient is scheduled to undergo explantation.
Patient problems: Capsular Contracture
MAUDE report 50892831 ↗InjurySep 24, 2026Material Rupture
It was reported that a patient underwent a breast augmentation revision procedure with a MENTOR MemoryGel Breast Implant gel breast prosthesis that ruptured post implantation. Rupture of the patient¿s left breast prosthesis was diagnosed via a physical exam and via MRI. 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 50876757 ↗InjurySep 21, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50846496 ↗InjurySep 17, 2026Material Rupture
Patient problems: Capsular Contracture
MAUDE report 50809886 ↗InjurySep 17, 2026Migration
Patient problems: Deformity/ Disfigurement
MAUDE report 50809873 ↗InjurySep 17, 2026Material Rupture
It was reported that a patient with MENTOR MemoryGel Breast Implants experienced lumps under left armpit. As a result, the patient underwent removal and replacement with non Mentor breast implants. Upon explantation, the right breast prosthesis was found to be ruptured. This report is for the right breast prosthesis.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50804567 ↗InjurySep 16, 2026Adverse Event Without Identified Device or Use Problem
It was reported that a patient implanted with a 400cc MENTOR MemoryGel Breast Implant experienced a breast mass and breast pain 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: Breast Discomfort/Pain; Breast Mass
MAUDE report 50791221 ↗InjurySep 16, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Capsular Contracture
MAUDE report 50782402 ↗InjurySep 16, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Capsular Contracture
MAUDE report 50782400 ↗InjurySep 15, 2026Adverse Event Without Identified Device or Use Problem
It was reported that a patient underwent a Primary Breast Augmentation Surgery with implantation of a 400cc MENTOR MemoryGel Breast Implant prosthesis. Post-operatively, the patient reported experiencing bilateral Capsular Contracture. No further information was provided. 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 left breast prosthesis.
Patient problems: Capsular Contracture
MAUDE report 50776949 ↗InjurySep 8, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50676443 ↗InjurySep 8, 2026Material Rupture
It was reported that a patient with MENTOR MemoryGel Breast Implantz experienced capsular contracture Baker Grade IV along with rupture on the right side post-operatively, which was confirmed during a physical exam. The patient experienced a fall which may have caused or contributed to the event. As a result, the patient underwent device removal and replacement.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Capsular Contracture
MAUDE report 50674155 ↗InjurySep 7, 2026Material Rupture
Patient problems: Capsular Contracture
MAUDE report 50656623 ↗InjurySep 7, 2026Material Rupture
Patient problems: Capsular Contracture
MAUDE report 50656622 ↗InjuryAug 31, 2026Material Rupture
It was reported that a patient involved in an adjunct study underwent a Primary Breast Augmentation Surgery with implantation of a 400cc MENTOR MemoryGel Breast Implant prosthesis. Post-operatively, the patient was diagnosed with a ruptured right implant using Magnetic Resonance Imaging and during a physical exam. As a result, the patient underwent bilateral exchange with Mentor gel implants on (b)(6), 2026. Furthermore, during the surgery, the left implant was also found to be ruptured. There were no reported procedural delay or patient consequence/harm due to the finding. This report is for the left breast prosthesis.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50533834 ↗InjuryAug 25, 2026Material Rupture
It was reported that a patient underwent a breast reconstruction procedure with an unspecified Mentor gel breast prosthesis that ruptured post implantation. The side of rupture (left breast, right breast, or bilateral) was not specified. The patient underwent explant surgery on an unknown date.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50441288 ↗InjuryAug 21, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50381729 ↗InjuryAug 13, 2026Material Rupture
It was reported that a 33-year-old female patient underwent a breast augmentation revision with a 400cc 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 50244476 ↗InjuryAug 13, 2026Material Rupture; Adverse Event Without Identified Device or Use Problem
It was reported that a patient underwent a Primary Breast Augmentation Surgery with implantation of a 400cc prosthesis. Post-operatively, the patient was diagnosed with bilateral Baker Grade III Capsular Contracture during a physical exam. As a result, the patient underwent bilateral implant removal without replacements on (b)(6), 2023. However, during the surgery, it was noted that the implants were ruptured. There were no reported procedural delays or patient consequences/harms due to the finding. This report is for the left breast prosthesis.
Patient problems: Capsular Contracture
MAUDE report 50243887 ↗InjuryAug 6, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50164791 ↗InjuryAug 6, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50164790 ↗InjuryAug 3, 2026Material Rupture; Migration
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 using Magnetic Resonance Imaging, and she believes it may have been caused by a Mammogram which was performed earlier this year. At the time of this report, Mentor has received no information regarding explantation or an expected explantation date.Follow-ups are being conducted. If more information becomes available, Mentor will submit a supplemental report accordingly.
Patient problems: Breast Discomfort/Pain; Deformity/ Disfigurement; No Clinical Signs, Symptoms or Conditions
MAUDE report 50117854 ↗InjuryJul 31, 2026Material Rupture
It was reported that a patient underwent primary breast augmentation with two 400cc MENTOR MemoryGel Breast Implants. Post-operatively, the patient experienced right breast implant rupture and left breast implant device migration. 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: No Clinical Signs, Symptoms or Conditions
MAUDE report 50107868 ↗InjuryJul 31, 2026Migration
It was reported that a patient underwent primary breast augmentation with two 400cc MENTOR MemoryGel Breast Implants. Post-operatively, the patient experienced right breast implant rupture and left breast implant device migration. 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 50107867 ↗
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 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
- 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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