MENTOR MemoryGel Breast Implant 3507275BCRecalls & reported problems
Mentor Texas L.P. · Smooth Round Moderate Profile Gel-Filled Breast Implant, 275cc · 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 breast implant. Its 375 reports mostly describe the implant shell rupturing, and some describe deformity or hardening of scar tissue around the implant. The reports include 374 injuries and no deaths. Reports fell from 37 in the previous 12 months to 16 in the last 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
- 377
- Deaths reported
- 0
- Injuries reported
- 376
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 377 adverse event reports that list this exact device (DI 00081317000082), received between Feb 9, 2018 and Sep 22, 2026 — classified as 376 injuries, 1 malfunction.
The most frequently reported specific device problem is “Material Rupture” (317 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 Rupture317
- Adverse Event Without Identified Device or Use Problem67
- Appropriate Device Problem Term/Code Not Available4
- Gel Leak4
- Material Discolored4
- Migration3
- Material Integrity Problem1
Patient problems
- Deformity/ Disfigurement163
- Capsular Contracture127
- No Code Available102
- Breast Discomfort/Pain14
- Pain13
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available8
- No Clinical Signs, Symptoms or Conditions8
- Local Reaction5
Recent adverse event reports
The 25 most recent of 377 reports, in the reporter's own words as published by the FDA.
InjurySep 22, 2026Material Rupture
It was reported that a 67-year-old female patient underwent a primary breast augmentation with two 275cc MENTOR MemoryGel Breast Implants and experienced bilateral rupture post-operatively, which was diagnosed with a physical exam. As a result, the patient underwent explantation on (b)(6). This report is for the left side device.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50857105 ↗InjurySep 22, 2026Material Rupture
It was reported that a 67-year-old female patient underwent a primary breast augmentation with two 275cc MENTOR MemoryGel Breast Implants and experienced bilateral rupture post-operatively, which was diagnosed with a physical exam. As a result, the patient underwent explantation on (b)(6)2026. This report is for the right side device.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50857094 ↗InjurySep 15, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50776316 ↗InjurySep 15, 2026Material Rupture
It was reported that a patient implanted with two 275cc MENTOR MemoryGel Breast Implant experienced bilateral ruptures 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 50776315 ↗InjurySep 11, 2026Material Rupture
It was reported that a patient implanted with a 275cc MENTOR MemoryGel Breast Implant experienced a rupture 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 50736571 ↗InjurySep 3, 2026Material Rupture
It was reported that a patient underwent breast augmentation with two unknown Mentor gel implants. Post-operatively, the patient was diagnosed with right breast capsular contracture, right breast implant leak, and left breast lipoma. As a result, the patient underwent breast implant removal and replacement surgery on (b)(6) 2026. The replacement devices were two Mentor gel implants.This Medwatch form is for the right breast prosthesis.
Patient problems: Capsular Contracture
MAUDE report 50590392 ↗InjuryMay 12, 2026Material Rupture
IT WAS REPORTED THAT A 69-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH TWO 275CC MENTOR MEMORYGEL BREAST IMPLANTS AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE (BAKER GRADE UNKNOWN), BILATERAL BREAST PAIN, AND BILATERAL RUPTURE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2026. THIS REPORT IS FOR THE LEFT SIDE DEVICE.
Patient problems: Capsular Contracture
MAUDE report 25156368 ↗InjuryMay 12, 2026Material Rupture
IT WAS REPORTED THAT A 69-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH TWO 275CC MENTOR MEMORYGEL BREAST IMPLANTS AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE (BAKER GRADE UNKNOWN), BILATERAL BREAST PAIN, AND BILATERAL RUPTURE 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 25156367 ↗InjuryMar 4, 2026Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 275CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA MRI, 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: Deformity/ Disfigurement
MAUDE report 24513610 ↗InjuryJan 23, 2026Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH TWO 275CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA PHYSICAL EXAMINATION AND MRI, WITH BILATERAL BREAST IMPLANT RUPTURES. AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL AND REPLACEMENT SURGERY ON (B)(6) 2026. THE REPLACEMENT DEVICES WERE TWO MENTOR GEL IMPLANTS. THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS.
Patient problems: Deformity/ Disfigurement
MAUDE report 24167258 ↗InjuryJan 23, 2026Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH TWO 275CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA PHYSICAL EXAMINATION AND MRI, WITH BILATERAL BREAST IMPLANT RUPTURES. AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL AND REPLACEMENT SURGERY ON (B)(6) 2026. THE REPLACEMENT DEVICES WERE TWO MENTOR GEL IMPLANTS. THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS.
Patient problems: Deformity/ Disfigurement
MAUDE report 24167244 ↗InjuryDec 23, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT WHO UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH MENTOR MEMORYGEL BREAST IMPLANT 275CC GEL BREAST PROSTHESES DEVELOPED CAPSULAR CONTRACTURE (BAKER GRADE UNKNOWN) IN BOTH BREASTS POST IMPLANTATION. ADDITIONALLY, RUPTURE OF THE PATIENT¿S LEFT BREAST PROSTHESIS WAS DIAGNOSED VIA A CT SCAN. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH MENTOR MEMORYGEL BREAST IMPLANT 255CC GEL BREAST PROSTHESES ON (B)(6) 2025. DURING EXPLANTATION SURGERY, BILATERAL RUPTURE OF THE BREAST PROSTHESES WAS OBSERVED. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT BREAST PROSTHESIS. REFER TO MANUFACTURER REPORT NUMBER 1645337-2025-12461 FOR THE REPORT FOR THE PATIENT¿S LEFT BREAST PROSTHESIS.
Patient problems: Capsular Contracture
MAUDE report 23885370 ↗InjuryDec 9, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT BREAST AUGMENTATION PROCEDURE WITH 275CC MENTOR MEMORYGEL BREAST IMPLANT ON BOTH SIDES AND EXPERIENCED BILATERAL BREAST IMPLANT RUPTURES. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REPLACEMENT SURGERY WITH SERIAL NUMBERS (B)(6) ON ONE SIDE, AND WITH (B)(6) ON THE OTHER SIDE ON (B)(6) 2025. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT-SIDED DEVICE.
Patient problems: Deformity/ Disfigurement
MAUDE report 23760546 ↗InjuryDec 9, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT BREAST AUGMENTATION PROCEDURE WITH 275CC MENTOR MEMORYGEL BREAST IMPLANT ON BOTH SIDES AND EXPERIENCED BILATERAL BREAST IMPLANT RUPTURES. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REPLACEMENT SURGERY WITH SERIAL NUMBERS (B)(6) ON ONE SIDE, AND WITH (B)(6) ON THE OTHER SIDE ON (B)(6) 2025. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT-SIDED DEVICE.
Patient problems: Deformity/ Disfigurement
MAUDE report 23760545 ↗InjuryNov 24, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH A MENTOR MEMORYGEL BREAST IMPLANT 275CC GEL BREAST PROSTHESIS THAT RUPTURED POST IMPLANTATION. RUPTURE OF THE PATIENT¿S LEFT BREAST PROSTHESIS WAS CONFIRMED VIA MRI. AS A RESULT, THE PATIENT IS SCHEDULED TO UNDERGO EXPLANTATION ON (B)(6) 2025.
Patient problems: Capsular Contracture; Deformity/ Disfigurement
MAUDE report 23635375 ↗InjuryNov 20, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH IMPLANTATION OF A 275CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH BILATERALLY RUPTURED IMPLANTS USING ULTRASOUND IMAGING. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXCHANGE WITH MENTOR GEL IMPLANTS ON (B)(6) 2025.
Patient problems: Deformity/ Disfigurement
MAUDE report 23607236 ↗InjuryNov 20, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH IMPLANTATION OF A 275CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH BILATERALLY RUPTURED IMPLANTS USING ULTRASOUND IMAGING. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXCHANGE WITH MENTOR GEL IMPLANTS ON (B)(6) 2025.
Patient problems: Deformity/ Disfigurement
MAUDE report 23607235 ↗InjuryNov 10, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH A MENTOR MEMORYGEL BREAST IMPLANT 275CC GEL BREAST PROSTHESIS THAT RUPTURED POST IMPLANTATION. RUPTURE OF THE PATIENT¿S LEFT BREAST PROSTHESIS WAS DIAGNOSED VIA A CT SCAN. AS A RESULT, THE PATIENT IS SCHEDULED TO UNDERGO EXPLANTATION ON (B)(6) 2025.
Patient problems: Capsular Contracture; Deformity/ Disfigurement
MAUDE report 23513645 ↗InjuryOct 23, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH MENTOR MEMORYGEL BREAST IMPLANT 275CC GEL BREAST PROSTHESES THAT BILATERALLY RUPTURED POST IMPLANTATION. ADDITIONALLY, THE PATIENT DEVELOPED BAKER GRADE III CAPSULAR CONTRACTURE IN HER LEFT BREAST. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION ON (B)(6) 2025. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT BREAST PROSTHESIS. REFER TO MANUFACTURER REPORT NUMBER 1645337-2025-07326 FOR THE REPORT FOR THE PATIENT¿S LEFT BREAST PROSTHESIS.
Patient problems: Deformity/ Disfigurement
MAUDE report 23375675 ↗InjuryOct 15, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT A 53-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH TWO 275CC MENTOR MEMORYGEL BREAST IMPLANTS AND EXPERIENCED BILATERAL RUPTURES POST-OPERATIVELY, WHICH WAS DIAGNOSED WITH AN MRI. 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: Deformity/ Disfigurement
MAUDE report 23280392 ↗InjuryOct 15, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT A 53-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH TWO 275CC MENTOR MEMORYGEL BREAST IMPLANTS AND EXPERIENCED BILATERAL RUPTURES POST-OPERATIVELY, WHICH WAS DIAGNOSED WITH AN MRI. 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: Deformity/ Disfigurement
MAUDE report 23280355 ↗InjurySep 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A 68-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A 275CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED CAPSULAR CONTRACTURE (BAKER GRADE 4) ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS DIAGNOSED WITH 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 22955896 ↗InjuryAug 20, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE WITH A MENTOR MEMORYGEL BREAST IMPLANT 275CC GEL BREAST PROSTHESIS THAT RUPTURED POST IMPLANTATION. RUPTURE OF THE PATIENT¿S RIGHT BREAST PROSTHESIS WAS REPORTED. ADDITIONALLY, THE PATIENT DEVELOPED BAKER GRADE III CAPSULAR CONTRACTURE IN HER RIGHT BREAST. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION AND REPLACEMENT WITH AN UNSPECIFIED MENTOR GEL BREAST PROSTHESIS ON (B)(6) 2025.
Patient problems: Capsular Contracture
MAUDE report 22857321 ↗InjuryAug 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A FEMALE PATIENT WHO UNDERWENT A BREAST RECONSTRUCTION PRIMARY WITH MENTOR MEMORYGEL 275CC SILICONE PROSTHESIS EXPERIENCE RIGHT SIDED WOUND INFECTION POSTOPERATIVE. THE PATHOLOGY RESULTS FROM THE ULTRASOUND-GUIDED BREAST BIOPSY PERFORMED ON (B)(6) 2025, ARE CURRENTLY PENDING. MENTOR WILL COMMUNICATE THE BIOPSY RESULTS AS SOON AS THEY ARE RECEIVED.
Patient problems: Post Operative Wound Infection
MAUDE report 22688208 ↗InjuryJul 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT WITH MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED RUPTURE ON THE LEFT SIDE AND CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN ON THE RIGHT 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. THIS REPORT IS FOR THE LEFT BREAST PROSTHESIS.
Patient problems: Capsular Contracture
MAUDE report 22591345 ↗
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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