MENTOR MemoryGel Breast Implant 3503004BCRecalls & reported problems
Mentor Texas L.P. · Smooth Round High Profile Gel-Filled Breast Implant, 300cc |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 placed inside the breast. The 1,004 reports often describe hardening of the scar tissue around the implant, implant ruptures, and breast distortion, with some patients reporting pain. There are 957 injury reports, 47 malfunction reports and no deaths. Reports fell from 131 in the prior 12 months to 48 in the last 12. 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
- 1,018
- Deaths reported
- 0
- Injuries reported
- 970
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1,018 adverse event reports that list this exact device (DI 00081317000464), received between Oct 31, 2018 and Sep 30, 2026 — classified as 970 injuries, 48 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (377 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 Problem622
- Material Rupture377
- Migration36
- Appropriate Device Problem Term/Code Not Available20
- Off-Label Use8
- Microbial Contamination of Device3
- No Apparent Adverse Event3
- Gel Leak2
Patient problems
- Capsular Contracture572
- Deformity/ Disfigurement229
- No Code Available155
- No Clinical Signs, Symptoms or Conditions47
- Breast Discomfort/Pain40
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available34
- Hematoma22
- Pain18
Recent adverse event reports
The 25 most recent of 1,018 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Capsular Contracture
MAUDE report 50952391 ↗InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Capsular Contracture
MAUDE report 50952369 ↗InjurySep 30, 2026Migration
Patient problems: Deformity/ Disfigurement
MAUDE report 50952138 ↗MalfunctionSep 29, 2026Material Deformation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50937307 ↗InjurySep 28, 2026Material Rupture; Migration
It was reported that a 68-year-old Caucasian female patient underwent primary breast augmentation with 300cc MENTOR MemoryGel Breast Implant on both sides and experienced bilateral breast implant ruptures postoperatively; diagnosed after physical exam. It was further reported that the left Implant is mishappened, elongated, extending superior into the axilla along the posterior edge. The patient has consulted with the healthcare professional. As a result, the patient is scheduled for surgery on (b)(6) 2026.This MedWatch report is for the patient¿s left-sided device.
Patient problems: Deformity/ Disfigurement
MAUDE report 50918447 ↗InjurySep 28, 2026Material Rupture
It was reported that a 68-year-old Caucasian female patient underwent primary breast augmentation with 300cc MENTOR MemoryGel Breast Implant on both sides and experienced bilateral breast implant ruptures postoperatively; diagnosed after physical exam. It was further reported that the left Implant is mishappened, elongated, extending superior into the axilla along the posterior edge. The patient has consulted with the healthcare professional. As a result, the patient is scheduled for surgery on (b)(6) 2026.This MedWatch report is for the patient¿s right-sided device.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50918420 ↗InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Capsular Contracture
MAUDE report 50892431 ↗InjurySep 24, 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 III/IV 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.This report is for the right breast prosthesis.
Patient problems: Capsular Contracture
MAUDE report 50885244 ↗InjurySep 24, 2026Material Rupture; Migration
It was reported that a 27-year-old Hispanic female patient underwent primary breast augmentation with 300cc MENTOR MemoryGel Breast Implant on both sides and right side breast implant rupture was found during bilateral replacement surgery with catalog number SMHX400; serial number (b)(6) on the left side, and with catalog number SMHX400; serial number (b)(6) on the right side on (b)(6)2026. It was further reported that both sides were bottoming out.This MedWatch report is for the patient¿s right-sided device.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50885174 ↗InjurySep 24, 2026Migration
It was reported that a 27-year-old Hispanic female patient underwent primary breast augmentation with 300cc MENTOR MemoryGel Breast Implant on both sides and right side breast implant rupture was found during bilateral replacement surgery with catalog number SMHX400; serial number (b)(6) on the left side, and with catalog number SMHX400; serial number (b)(6) on the right side on (b)(6)2026. It was further reported that both sides were bottoming out.This MedWatch report is for the patient¿s left-sided device.
Patient problems: Deformity/ Disfigurement
MAUDE report 50885171 ↗InjurySep 15, 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 300cc MENTOR MemoryGel Breast Implant and experienced breast asymmetry and ptosis on the right side post-operatively. As a result, the patient underwent explantation on (b)(6)2026.
Patient problems: Deformity/ Disfigurement; Pain
MAUDE report 50779053 ↗InjurySep 14, 2026Insufficient Device Problem Information
It was reported that a patient implanted with a MENTOR CPX 4 Breast Tissue Expander with Suture Tabs experienced a defective device on the left side post-operatively. As a result, the patient underwent explantation on (b)(6), 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50756697 ↗InjurySep 14, 2026Material Rupture
It was reported that a patient implanted with a 300cc MENTOR MemoryGel Breast Implant experienced capsular contracture and a rupture on the left side post-operatively. As a result, the patient underwent explantation on an unspecified date.
Patient problems: Capsular Contracture
MAUDE report 50756626 ↗InjuryAug 24, 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 diagnosed via a physical exam. Additionally, the patient developed Baker Grade III capsular contracture in her left breast. As a result, the patient underwent bilateral explantation and replacement with MENTOR MemoryGel BOOST Breast Implant gel breast prostheses.
Patient problems: Capsular Contracture
MAUDE report 50416983 ↗InjuryJul 31, 2026Adverse Event Without Identified Device or Use Problem
A female patient who underwent a Breast Augmentation Primary with MENTOR MemoryGel, 300cc Silicone prosthesis experienced left sided symptomatic rupture, breast pain, right sided palpable abnormalities and, bilateral ptosis postoperative. The mammogram and ultrasound examinations confirmed the rupture. Ultrasound examinations identified abnormalities corresponding to palpable findings in the right breast. As a result, the patient underwent bilateral partial capsulectomies, mastopexy, placement of GalaFLEX mesh, and bilateral implant removal without replacements on (b)(6) 2026. This report relates to the right side.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50100615 ↗InjuryJul 27, 2026Material Rupture
It was reported that a patient underwent a primary breast augmentation procedure with MENTOR MemoryGel Breast Implant gel breast prostheses that both ruptured post implantation. Bilateral rupture was observed during an implant exchange surgery. The patient¿s explant breast prostheses were replaced with non-Mentor breast prostheses. This MedWatch report is for the patient¿s right breast prosthesis.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50009516 ↗InjuryJul 27, 2026Material Rupture
It was reported that a patient underwent a primary breast augmentation procedure with MENTOR MemoryGel Breast Implant gel breast prostheses that both ruptured post implantation. Bilateral rupture was observed during an implant exchange surgery. The patient¿s explant breast prostheses were replaced with non-Mentor breast prostheses. This MedWatch report is for the patient¿s left breast prosthesis.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50009513 ↗InjuryJun 17, 2026Adverse Event Without Identified Device or Use Problem; Migration
IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION WITH TWO UNSPECIFIED SMOOTH GEL BREAST PROSTHESES AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE (BAKER GRADE UNKNOWN) POST-OPERATIVELY. THE PATIENT HAD PAIN AND HARDNESS. AS A RESULT, THE PATIENT IS TO UNDERGO BILATERAL DEVICE EXPLANTATION ON (B)(6) 2026. THIS REPORT IS FOR THE RIGHT SIDE DEVICE.
Patient problems: Capsular Contracture
MAUDE report 25541708 ↗InjuryJun 17, 2026Adverse Event Without Identified Device or Use Problem; Migration
IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION WITH TWO UNSPECIFIED SMOOTH GEL BREAST PROSTHESES AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE (BAKER GRADE UNKNOWN) POST-OPERATIVELY. THE PATIENT HAD PAIN AND HARDNESS. AS A RESULT, THE PATIENT IS TO UNDERGO BILATERAL DEVICE EXPLANTATION ON (B)(6) 2026. THIS REPORT IS FOR THE LEFT SIDE DEVICE.
Patient problems: Capsular Contracture
MAUDE report 25541707 ↗InjuryJun 17, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT REVISION BREAST AUGMENTATION WITH 300CC MENTOR MEMORYGEL BREAST IMPLANT ON BOTH SIDES AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE; BAKER GRADE III POSTOPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REPLACEMENT SURGERY WITH CATALOG NUMBER 3502754BC; SERIAL NUMBER (B)(6) ON THE LEFT SIDE, AND WITH CATALOG NUMBER 3502754BC; SERIAL NUMBER (B)(6) ON THE RIGHT SIDE ON (B)(6) 2026. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT-SIDED DEVICE.
Patient problems: Capsular Contracture
MAUDE report 25541138 ↗InjuryJun 17, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT REVISION BREAST AUGMENTATION WITH 300CC MENTOR MEMORYGEL BREAST IMPLANT ON BOTH SIDES AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE; BAKER GRADE III POSTOPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REPLACEMENT SURGERY WITH CATALOG NUMBER 3502754BC; SERIAL NUMBER (B)(6) ON THE LEFT SIDE, AND WITH CATALOG NUMBER 3502754BC; SERIAL NUMBER (B)(6) ON THE RIGHT SIDE ON (B)(6) 2026. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT-SIDED DEVICE.
Patient problems: Capsular Contracture
MAUDE report 25541137 ↗InjuryJun 4, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH MENTOR MEMORYGEL 300CC SILICONE PROSTHESIS DEVELOPED RIGHT SIDED CAPSULAR CONTRACTURE GRADE III POST OPERATION. THE PHYSICAL EXAMINATION DIAGNOSED THE ISSUE. AS A RESULT, THE PATIENT SCHEDULED FOR REMOVAL SURGERY ON (B)(6) 2026.
Patient problems: Capsular Contracture
MAUDE report 25393332 ↗InjuryMay 28, 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 MRI. AS A RESULT, THE PATIENT IS SCHEDULED TO UNDERGO EXPLANTATION.
Patient problems: Deformity/ Disfigurement
MAUDE report 25319475 ↗InjuryMay 27, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A 32-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH TWO 300CC MENTOR MEMORYGEL BREAST IMPLANTS AND EXPERIENCED GENERALIZED ILLNESS SYMPTOMS INCLUDING BREAST IMPLANT ILLNESS, FATIGUE, INSOMNIA, MUSCLE PAIN, JOINT PAIN, RASHES, NOT BEING ABLE TO SLEEP, AND IMPLANT REJECTION POST-OPERATIVELY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT IS FOR THE LEFT SIDE DEVICE.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 25303193 ↗InjuryMay 27, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A 32-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH TWO 300CC MENTOR MEMORYGEL BREAST IMPLANTS AND EXPERIENCED GENERALIZED ILLNESS SYMPTOMS INCLUDING BREAST IMPLANT ILLNESS, FATIGUE, INSOMNIA, MUSCLE PAIN, JOINT PAIN, RASHES, NOT BEING ABLE TO SLEEP, AND IMPLANT REJECTION POST-OPERATIVELY. 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 25303171 ↗
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.
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