MENTOR MemoryGel Breast Implant 3503504BCRecalls & reported problems
Mentor Texas L.P. · Smooth Round High Profile Gel-Filled Breast Implant, 350cc |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 1,735 reports, 1,696 involve an injury, and many describe ruptured implants and hardened scar tissue forming around them, while some describe the implant shifting position. Reports fell from 211 in the prior 12 months to 88 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
- 1,749
- Deaths reported
- 0
- Injuries reported
- 1,711
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1,749 adverse event reports that list this exact device (DI 00081317000488), received between Jan 30, 2018 and Sep 30, 2026 — classified as 1,711 injuries, 38 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (696 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 Problem1,023
- Material Rupture696
- Migration59
- Appropriate Device Problem Term/Code Not Available39
- Use of Device Problem12
- Gel Leak10
- Off-Label Use8
- Material Deformation5
Patient problems
- Capsular Contracture899
- Deformity/ Disfigurement461
- No Code Available301
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available79
- Breast Discomfort/Pain67
- Pain57
- No Clinical Signs, Symptoms or Conditions53
- Breast Mass31
Recent adverse event reports
The 25 most recent of 1,749 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem
It was reported that a patient underwent breast augmentation revision with two 350cc MENTOR MemoryGel Breast Implants. Post-operatively, the patient was diagnosed with bilateral breast asymmetry and wrinkling. 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; Wrinkling
MAUDE report 50950086 ↗InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem
It was reported that a patient underwent breast augmentation revision with two 350cc MENTOR MemoryGel Breast Implants. Post-operatively, the patient was diagnosed with bilateral breast asymmetry and wrinkling. 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; Wrinkling
MAUDE report 50950078 ↗InjurySep 29, 2026Material Rupture
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Crushing Injury
MAUDE report 50940637 ↗InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50940634 ↗InjurySep 24, 2026Material Rupture
It was reported that a patient who underwent a primary breast augmentation procedure with a MENTOR MemoryGel Breast Implant gel breast prosthesis developed capsular contracture (Baker Grade unknown) in her left breast post implantation. As a result, the patient underwent bilateral explantation and replacement with Sientra gel breast prostheses. During explant surgery, rupture of the left breast prosthesis was observed.
Patient problems: Capsular Contracture
MAUDE report 50888912 ↗InjurySep 22, 2026Material Rupture
It was reported that a 37-year-old Caucasian female patient underwent a primary breast augmentation with a 350cc MENTOR MemoryGel Breast Implant and experienced a rupture on the right side post-operatively. As a result, the patient underwent explantation on (b)(6) 2026, and replaced with a non-Mentor device (Allergan).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50856120 ↗InjurySep 22, 2026Material Rupture
It was reported that a 28-year-old Caucasian female patient underwent a primary breast augmentation with a 350cc MENTOR MemoryGel Breast Implant and experienced a rupture and capsular contracture (baker grade unknown) on the right side post-operatively, which was diagnosed with an office visit and ultrasound. As a result, the patient is to undergo device explantation on (b)(6), 2026.
Patient problems: Capsular Contracture
MAUDE report 50856002 ↗InjurySep 22, 2026Material Rupture
It was reported that a patient underwent a Primary Breast Augmentation Surgery with implantation of a 350cc MENTOR MemoryGel Breast Implant prosthesis. Post-operatively, the patient was diagnosed with a ruptured right implant using 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: No Clinical Signs, Symptoms or Conditions
MAUDE report 50855609 ↗InjurySep 21, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50848355 ↗InjurySep 21, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50848353 ↗InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Capsular Contracture
MAUDE report 50829528 ↗InjurySep 17, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50810460 ↗InjurySep 17, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50810346 ↗InjurySep 16, 2026Material Rupture
It was reported that a patient underwent a Primary Breast Augmentation Surgery with implantation of a 350cc MENTOR MemoryGel Breast Implant prosthesis. Post-operatively, the patient was diagnosed with a ruptured left implant using 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: No Clinical Signs, Symptoms or Conditions
MAUDE report 50792804 ↗InjurySep 16, 2026Migration
It was reported that a patient implanted with a 350cc MENTOR MemoryGel Breast Implant experienced a device migration on the left side post-operatively. As a result, the patient underwent explantation on (b)(6), 2019.
Patient problems: Deformity/ Disfigurement
MAUDE report 50790560 ↗InjurySep 16, 2026Adverse Event Without Identified Device or Use Problem
It was reported that a patient with MENTOR MemoryGel Breast Implants experienced bilateral capsular contracture Baker Grade II-III post-operatively, which was confirmed via MRI. The patient experienced a fall which may have caused or contributed to the event. The patient has a history of benign imaging guided biopsy right breast. The patient underwent device removal.This report is for the right breast prosthesis.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Capsular Contracture
MAUDE report 50787644 ↗InjurySep 16, 2026Adverse Event Without Identified Device or Use Problem
It was reported that a patient with MENTOR MemoryGel Breast Implants experienced bilateral capsular contracture Baker Grade II-III post-operatively, which was confirmed via MRI. The patient experienced a fall which may have caused or contributed to the event. The patient has a history of benign imaging guided biopsy right breast. The patient underwent device removal.This report is for the left breast prosthesis.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Capsular Contracture
MAUDE report 50787298 ↗InjurySep 15, 2026Material Rupture
It was reported that a patient with MENTOR MemoryGel Breast Implants experienced capsular contracture Baker Grade IV along with rupture on the right side post-operatively, which was confirmed during a physical exam. As a result, the patient underwent device removal.
Patient problems: Capsular Contracture
MAUDE report 50775180 ↗InjurySep 11, 2026Migration
It was reported that a patient underwent primary breast augmentation with two MENTOR MemoryGel Breast Implants. Post-operatively, the patient was diagnosed, via physical examination, with asymmetry of the breasts with ptosis of the lower poles that is worse on the left than the right. As a result, the patient underwent breast implant removal and replacement surgery on (b)(6) 2026. During the surgery, the right breast implant was found to be ruptured. The replacement devices were two Mentor gel implants.This Medwatch form is for the left breast prosthesis.
Patient problems: Deformity/ Disfigurement
MAUDE report 50725315 ↗InjurySep 6, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50640256 ↗InjurySep 3, 2026Material Rupture
It was reported that a patient underwent primary breast augmentation with two 350cc MENTOR MemoryGel Breast Implants. Post-operatively, the patient was diagnosed, via MRI and ultrasound, with right breast implant rupture. 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 50590931 ↗InjuryAug 21, 2026Adverse Event Without Identified Device or Use Problem
It was reported that a patient underwent a Breast Augmentation Revision Surgery with implantation of a 350cc MENTOR MemoryGel Breast Implant prosthesis. Post-operatively, the patient reported her implants are encapsuled and experienced bilaterally hard breasts with ripples. At the time of this report, Mentor has received no information regarding explantation or an expected explantation date.The date of event was provided to Mentor as a best estimate.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 50381332 ↗InjuryAug 21, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50380897 ↗InjuryJul 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. 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 50069764 ↗InjuryJul 28, 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 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 50059236 ↗
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
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- 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 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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