MENTOR MemoryGel Breast Implant 3544375Recalls & reported problems
Mentor Texas L.P. · SILTEX Round High Profile Gel-Filled Breast Implant, 375cc |Textured|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 Siltex breast implant has 93 reports, 88 of them injuries, and no deaths. Common reports describe implants rupturing, scar tissue tightening around the implant (capsular contracture), breast deformity, and fluid or lump formation near the implant. Reports fell from 11 in the prior 12 months to 4 in the latest 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
- 92
- Deaths reported
- 0
- Injuries reported
- 87
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 92 adverse event reports that list this exact device (DI 00081317001072), received between Mar 6, 2018 and Sep 17, 2026 — classified as 87 injuries, 5 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (55 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 Rupture55
- Adverse Event Without Identified Device or Use Problem38
- Migration2
- Gel Leak1
- Material Discolored1
- Volume Accuracy Problem1
Patient problems
- Capsular Contracture34
- Deformity/ Disfigurement29
- No Code Available20
- Granuloma10
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available6
- No Clinical Signs, Symptoms or Conditions6
- Cyst(s)4
- Pain4
Recent adverse event reports
The 25 most recent of 92 reports, in the reporter's own words as published by the FDA.
InjurySep 17, 2026Material Rupture
Patient problems: Swollen Lymph Nodes/Glands
MAUDE report 50809470 ↗InjuryAug 27, 2026Material Rupture
It was reported that a patient with MENTOR MemoryGel Breast Implants experienced rupture 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.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50480064 ↗InjuryMay 13, 2026Material Rupture
IT WAS REPORTED THAT A 30-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 375CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED A RUPTURE 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: Deformity/ Disfigurement
MAUDE report 25164983 ↗InjuryJul 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 375CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT EXPERIENCED A LEFT BREAST SEROMA WITH ASSOCIATED PAIN AND SWELLING SHORTLY AFTER SURGERY. THE SEROMA DRAINED SPONTANEOUSLY THROUGH THE LEFT BREAST INCISION SITE; NO SURGICAL INTERVENTION WAS REQUIRED. AT A LATER TIME, THE PATIENT WAS DIAGNOSED WITH BAKER GRADE III (LEFT BREAST) AND II (RIGHT BREAST) CAPSULAR CONTRACTURE BY A MEDICAL PROFESSIONAL USING THE PATIENT'S SYMPTOMS. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXCHANGE WITH MENTOR GEL IMPLANTS ON (B)(6) 2025. THIS REPORT IS FOR THE RIGHT BREAST PROSTHESIS.
Patient problems: Capsular Contracture
MAUDE report 22460931 ↗InjuryJul 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 375CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT EXPERIENCED A LEFT BREAST SEROMA WITH ASSOCIATED PAIN AND SWELLING SHORTLY AFTER SURGERY. THE SEROMA DRAINED SPONTANEOUSLY THROUGH THE LEFT BREAST INCISION SITE; NO SURGICAL INTERVENTION WAS REQUIRED. AT A LATER TIME, THE PATIENT WAS DIAGNOSED WITH BAKER GRADE III (LEFT BREAST) AND II (RIGHT BREAST) CAPSULAR CONTRACTURE BY A MEDICAL PROFESSIONAL USING THE PATIENT'S SYMPTOMS. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXCHANGE WITH MENTOR GEL IMPLANTS ON (B)(6) 2025. THIS REPORT IS FOR THE LEFT BREAST PROSTHESIS.
Patient problems: Capsular Contracture; Impaired Healing; Seroma
MAUDE report 22460929 ↗InjuryMay 30, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH A 375CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED SPONTANEOUS BILATERAL RUPTURE, LEFT SIDED GRANULOMA, AND LEFT SIDED CALCIFICATION POST PROCEDURE. THIS WAS DIAGNOSED THROUGH MAMMOGRAPHY AND ULTRASOUND. AS A RESULT, REPLACEMENT WAS PERFORMED ON (B)(6) 2025. THE LEFT SIDED RUPTURE WAS REPORTED INITIALLY UNDER 1645337-2025-02283 ON (B)(6) 2025. ON MAY 2, 2025, MENTOR RECEIVED ADDITIONAL INFORMATION AND INITIAL AWARENESS OF BILATERAL ISSUES. THIS REPORT RELATES TO THE RIGHT PROSTHESIS.
Patient problems: Deformity/ Disfigurement
MAUDE report 22113923 ↗InjuryApr 4, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 375CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA ULTRASOUND, WITH LEFT BREAST SWELLING AND LEFT BREAST IMPLANT RUPTURE. AS A RESULT, THE PATIENT HAS BEEN SCHEDULED FOR BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2025.
Patient problems: Local Reaction; Seroma; Swollen Lymph Nodes/Glands
MAUDE report 21778828 ↗InjuryMar 4, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH A 375CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED SPONTANEOUS LEFT SIDED RUPTURE POST PROCEDURE. THIS WAS DIAGNOSED THROUGH MAMMOGRAPHY AND ULTRASOUND. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.
Patient problems: Calcium Deposits/Calcification; Deformity/ Disfigurement; Granuloma
MAUDE report 21516442 ↗InjuryFeb 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT IMPLANTED WITH TWO 375CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED BILATERAL CAPSULAR CONTRACTURE BAKER GRADE 3 POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025.
Patient problems: Capsular Contracture
MAUDE report 21315114 ↗InjuryFeb 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT IMPLANTED WITH TWO 375CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED BILATERAL CAPSULAR CONTRACTURE BAKER GRADE 3 POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025.
Patient problems: Capsular Contracture
MAUDE report 21315106 ↗InjuryJan 7, 2025Material Rupture; Migration; Material Rupture; Migration
IT WAS REPORTED THAT A 62-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH TWO 375CC MENTOR MEMORYGEL BREAST IMPLANTS AND EXPERIENCED SLIGHT MALPOSITION BILATERALLY AND BILATERAL RUPTURES WITH GRANULOMA FORMATION ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS DIAGNOSED WITH A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2024. THIS REPORT IS FOR THE LEFT SIDE DEVICE.
Patient problems: Granuloma
MAUDE report 21093815 ↗InjuryJan 7, 2025Material Rupture; Migration; Material Rupture; Migration
IT WAS REPORTED THAT A 62-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH TWO 375CC MENTOR MEMORYGEL BREAST IMPLANTS AND EXPERIENCED SLIGHT MALPOSITION BILATERALLY AND BILATERAL RUPTURES WITH GRANULOMA FORMATION ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS DIAGNOSED WITH A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2024. THIS REPORT IS FOR THE RIGHT SIDE DEVICE.
Patient problems: Deformity/ Disfigurement
MAUDE report 21093806 ↗InjuryDec 4, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 375CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED A RUPTURE ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2024.
Patient problems: Deformity/ Disfigurement
MAUDE report 20843979 ↗InjuryNov 27, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT A 71-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 375CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED A RUPTURE ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS DIAGNOSED WITH AN OFFICE VISIT. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025.
Patient problems: Deformity/ Disfigurement
MAUDE report 20799815 ↗InjuryOct 9, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 375CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED A RUPTURE ON THE LEFT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2024.
Patient problems: Deformity/ Disfigurement
MAUDE report 20410290 ↗InjuryAug 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT IMPLANTED WITH TWO 375CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED BILATERAL CAPSULAR CONTRACTURE BAKER GRADE 3 POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2024.
Patient problems: Capsular Contracture
MAUDE report 19983604 ↗InjuryAug 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT IMPLANTED WITH TWO 375CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED BILATERAL CAPSULAR CONTRACTURE BAKER GRADE 3 POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2024.
Patient problems: Capsular Contracture
MAUDE report 19983592 ↗InjuryMay 16, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT A 49-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH TWO 375CC MENTOR MEMORYGEL BREAST IMPLANTS AND EXPERIENCED BILATERAL RUPTURE POST-OPERATIVELY, WHICH WAS DIAGNOSED WITH AN OFFICE VISIT AND ULTRASOUND. IT WAS ALSO REPORTED THAT THE PATIENT EXPERIENCED LYMPHADENOPATHY ON THE RIGHT SIDE; THE PATIENT HAD A LARGE LYMPH NODE. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2024. THIS REPORT IS FOR THE RIGHT SIDE DEVICE.
Patient problems: Capsular Contracture; Swollen Lymph Nodes/Glands
MAUDE report 19335110 ↗InjuryMay 16, 2024Material Rupture; Adverse Event Without Identified Device or Use Problem; Material Rupture; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A 49-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH TWO 375CC MENTOR MEMORYGEL BREAST IMPLANTS AND EXPERIENCED BILATERAL RUPTURE POST-OPERATIVELY, WHICH WAS DIAGNOSED WITH AN OFFICE VISIT AND ULTRASOUND. IT WAS ALSO REPORTED THAT THE PATIENT EXPERIENCED LYMPHADENOPATHY ON THE RIGHT SIDE; THE PATIENT HAD A LARGE LYMPH NODE. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2024. THIS REPORT IS FOR THE LEFT SIDE DEVICE.
Patient problems: Capsular Contracture; Deformity/ Disfigurement
MAUDE report 19335106 ↗InjuryApr 23, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH MENTOR MEMORYGEL BREAST IMPLANTS 375CC AND EXPERIENCED BILATERAL RUPTURE POST-OPERATIVELY, WHICH WAS CONFIRMED VIA ULTRASOUND. AS A RESULT, THE PATIENT UNDERWENT REMOVAL ON (B)(6) 2024. THIS REPORT IS FOR THE RIGHT BREAST PROSTHESIS. SEE MANUFACTURER REPORT NUMBER 1645337-2024-01270 FOR CONTRALATERAL SIDE.
Patient problems: Deformity/ Disfigurement
MAUDE report 19169039 ↗InjuryMar 7, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 375CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH A RUPTURED LEFT BREAST IMPLANT USING MAMMOGRAM IMAGING. AS A RESULT, THE PATIENT IS SCHEDULED FOR FOR BREAST IMPLANT REMOVAL ON (B)(6) 2024.
Patient problems: Deformity/ Disfigurement
MAUDE report 18862609 ↗InjuryMar 6, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH A 375CC MENTOR MEMORYGEL BREAST IMPLANT ON THE LEFT BREAST. POST-OPERATIVELY, THE PATIENT SUFFERED LEFT BREAST IMPLANT RUPTURE. AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2024.
Patient problems: Deformity/ Disfigurement
MAUDE report 18853127 ↗InjuryMar 4, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT A 45-YEAR-OLD FEMALE PATIENT WHO UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH UNSPECIFIED MENTOR SALINE BREAST PROSTHESES DEVELOPED BAKER GRADE III CAPSULAR CONTRACTURE IN HER LEFT BREAST POST IMPLANTATION. THE CAPSULAR CONTRACTURE WAS DIAGNOSED DURING AN OFFICE VISIT. ADDITIONALLY, THE PATIENT¿S RIGHT BREAST PROSTHESIS DEFLATED POST IMPLANTATION. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH A MENTOR MEMORYGEL XTRA BREAST IMPLANT 350CC GEL BREAST PROSTHESIS AND A MENTOR MEMORYGEL BREAST IMPLANT 325CC GEL BREAST PROSTHESIS ON (B)(6) 2024. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT BREAST PROSTHESIS. REFER TO MANUFACTURER REPORT NUMBER 1645337-2022-13405 FOR THE REPORT FOR THE PATIENT¿S LEFT BREAST PROSTHESIS.
Patient problems: Deformity/ Disfigurement
MAUDE report 18832834 ↗InjuryFeb 5, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH MENTOR MEMORYGEL BREAST IMPLANTS 375CC AND EXPERIENCED RUPTURE ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED VIA ULTRASOUND. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.
Patient problems: Deformity/ Disfigurement
MAUDE report 18646430 ↗InjuryDec 15, 2023Material Rupture; Material Rupture
IT WAS REPORTED THAT A FEMALE WHO UNDERWENT A BREAST AUGMENTATION REVISION WITH A MENTOR MEMORYGEL, 375CC SILICONE PROSTHESIS EXPERIENCED LEFT-SIDED SILENT RUPTURE POSTOPERATIVE. THE MAMMOGRAM EXAMINATION CONFIRMED THE ISSUE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.
Patient problems: Deformity/ Disfigurement
MAUDE report 18334994 ↗
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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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