MENTOR MemoryGel Breast Implant 3544251Recalls & reported problems
Mentor Texas L.P. · SILTEX Round Moderate Plus Profile Gel-Filled Breast Implant, 425cc |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 is a Mentor MemoryGel silicone gel-filled breast implant, round and textured. The 28 reports mostly describe implants that ruptured or broke after placement, along with hardening of the surrounding scar tissue (capsular contracture), breast pain, fluid collections, and contour changes; 28 reports involved injuries and no deaths. Reports span 2019 to 2026, with 2 in the past 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
- 28
- Deaths reported
- 0
- Injuries reported
- 28
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 00081317003885), received between May 10, 2019 and May 29, 2026 — classified as 28 injuries.
The most frequently reported specific device problem is “Material Rupture” (16 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 Rupture16
- Adverse Event Without Identified Device or Use Problem13
- Appropriate Device Problem Term/Code Not Available1
Patient problems
- Deformity/ Disfigurement11
- Capsular Contracture9
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available4
- No Code Available4
- Breast Discomfort/Pain3
- Granuloma3
- Seroma3
- Hematoma1
Recent adverse event reports
The 25 most recent of 28 reports, in the reporter's own words as published by the FDA.
InjuryMay 29, 2026Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH TWO 425CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA PHYSICAL EXAMINATION AND MRI, WITH POSSIBLE BILATERAL BREAST IMPLANT RUPTURES. 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 25340627 ↗InjuryMay 29, 2026Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH TWO 425CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA PHYSICAL EXAMINATION AND MRI, WITH POSSIBLE BILATERAL BREAST IMPLANT RUPTURES. 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
MAUDE report 25340624 ↗InjuryMar 14, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 425CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA PHYSICAL EXAMINATION AND ULTRASOUND, WITH LEFT BREAST IMPLANT RUPTURE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.
Patient problems: Deformity/ Disfigurement
MAUDE report 21611310 ↗InjuryOct 29, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH A MENTOR MEMORYGEL BREAST IMPLANT 425CC GEL BREAST PROSTHESIS THAT RUPTURED POST IMPLANTATION. RUPTURE OF THE PATIENT¿S LEFT BREAST PROSTHESIS WAS OBSERVED DURING AN IMPLANT EXCHANGE SURGERY ON (B)(6) 2024. THE PATIENT HAD BOTH BREAST PROSTHESES REMOVED AND THEY WERE REPLACED WITH A MENTOR MEMORYGEL BOOST BREAST IMPLANT 400CC GEL BREAST PROSTHESIS AND A MENTOR MEMORYGEL BOOST BREAST IMPLANT 435CC GEL BREAST PROSTHESIS.
Patient problems: Deformity/ Disfigurement
MAUDE report 20560593 ↗InjuryOct 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH IMPLANTATION OF A 425CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT REPORTED EXPERIENCING BILATERAL BREAST PAIN. AS A RESULT, THE PATIENT IS SCHEDULED FOR BILATERAL BREAST IMPLANT REMOVAL ON (B)(6) 2024. THE DATE OF EVENT WAS PROVIDED TO MENTOR AS A BEST ESTIMATE. SEVERAL 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: Breast Discomfort/Pain
MAUDE report 20545509 ↗InjuryJul 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH MENTOR MEMORYGEL BREAST IMPLANTS 350CC AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE BAKER GRADE III POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH SIMILAR DEVICES ON (B)(6), 2024. THIS REPORT IS FOR THE RIGHT BREAST PROSTHESIS.
Patient problems: Capsular Contracture
MAUDE report 19691574 ↗InjuryJul 4, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNSPECIFIED BREAST SURGERY WITH A 425CC MENTOR MEMORYGEL BREAST IMPLANT. POST-OPERATIVELY, THE PATIENT DEVELOPED SILICONE LYMPHADENOPATHY IN THE RIGHT-SIDED BREAST AREA, WHICH WAS CONFIRMED VIA MAMMOGRAM. AT THE TIME OF THIS REPORT, MENTOR HAS NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. SEVERAL 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: Granuloma
MAUDE report 19675516 ↗InjuryApr 12, 2024Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED VIA MW5152198 THAT A PATIENT IMPLANTED WITH TWO 400CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED SYMPTOMS INCLUDING BREAST IMPLANT ILLNESS, DEBILITATING HEALTH ISSUES, VISION ISSUES, FATIGUE, BRAIN FOG, HIGH PROLACTIN, LOW THYROID FUNCTION, LOW HORMONES, HIGH RHEUMATOID FACTOR POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2024. THIS REPORT IS FOR THE SECOND OF TWO DEVICES.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 19098085 ↗InjuryMar 12, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNSPECIFIED BREAST SURGERY WITH A 425CC MENTOR MEMORYGEL BREAST IMPLANT. POST-OPERATIVELY, THE PATIENT EXPERIENCED CAPSULAR CONTRACTURE OF AN UNSPECIFIED BAKER GRADE AND A SUSPECTED RUPTURE OF HER RIGHT PROSTHESIS, WHICH WERE IDENTIFIED BY A MEDICAL PROFESSIONAL. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH A 425CC MENTOR MEMORYGEL BREAST IMPLANT ON (B)(6) 2014. SEVERAL 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: Capsular Contracture
MAUDE report 18890758 ↗InjuryOct 6, 2023Adverse 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 425CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT EXPERIENCED BILATERAL CAPSULAR CONTRACTURE OF AN UNSPECIFIED BAKER GRADE AS WELL AS A RUPTURE OF HER RIGHT PROSTHESIS, WHICH WERE CONFIRMED VIA MAMMOGRAM AND ULTRASOUND. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH 425CC MENTOR MEMORYGEL BREAST IMPLANTS ON (B)(6) 2023. THIS REPORT IS FOR THE LEFT IMPLANT. REFER TO MANUFACTURING REPORT NUMBER 1645337-2023-11093 FOR THE CONTRALATERAL EVENT.
Patient problems: Capsular Contracture
MAUDE report 17886718 ↗InjurySep 19, 2023Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH A 425CC MENTOR MEMORYGEL BREAST IMPLANT. POST-OPERATIVELY, THE PATIENT EXPERIENCED A RUPTURE OF HER RIGHT PROSTHESIS, WHICH WAS CONFIRMED VIA MAMMOGRAM AND ULTRASOUND. AS A RESULT, THE PATIENT IS SCHEDULED FOR REMOVAL SURGERY ON (B)(6) 2023.
Patient problems: Capsular Contracture; Deformity/ Disfigurement
MAUDE report 17777077 ↗InjuryAug 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A 61-YEAR-OLD FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH TWO 425CC MENTOR MEMORYGEL BREAST IMPLANTS AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE (BAKER GRADE 3) POST-OPERATIVELY, WHICH WAS DIAGNOSED WITH AN OFFICE VISIT. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THE DEVICE DATE OF IMPLANTATION WAS REPORTED TO BE SOMETIME IN 2012. SECTION D6A. FOR THE EXPLANTATION DATE HAS BEEN DOCUMENTED WITH (B)(6) 2012 SINCE THE EXACT DATE IS UNKNOWN. IF MORE INFORMATION BECOMES AVAILABLE, MENTOR WILL SUBMIT A SUPPLEMENTAL REPORT ACCORDINGLY. THIS REPORT IS FOR THE RIGHT SIDE DEVICE.
Patient problems: Capsular Contracture
MAUDE report 17475512 ↗InjuryAug 7, 2023Material Rupture; Adverse Event Without Identified Device or Use Problem; Material Rupture; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A 61-YEAR-OLD FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH TWO 425CC MENTOR MEMORYGEL BREAST IMPLANTS AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE (BAKER GRADE 3) POST-OPERATIVELY, WHICH WAS DIAGNOSED WITH AN OFFICE VISIT. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THE DEVICE DATE OF IMPLANTATION WAS REPORTED TO BE SOMETIME IN 2012. SECTION D6A. FOR THE EXPLANTATION DATE HAS BEEN DOCUMENTED WITH (B)(6) 2012 SINCE THE EXACT DATE IS UNKNOWN. IF MORE INFORMATION BECOMES AVAILABLE, MENTOR WILL SUBMIT A SUPPLEMENTAL REPORT ACCORDINGLY. THIS REPORT IS FOR THE LEFT SIDE DEVICE.
Patient problems: Capsular Contracture
MAUDE report 17471935 ↗InjuryAug 3, 2023Material Rupture; Material Rupture
IT WAS REPORTED THAT A 48-YEAR-OLD CAUCASIAN FEMALE WHO UNDERWENT BREAST AUGMENTATION REVISION WITH A 425CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED RIGHT SIDED RUPTURE POST PROCEDURE. THE RUPTURE WAS DIAGNOSED THROUGH A PHYSICAL EXAMINATION AND ULTRASOUND. AS A RESULT, EXPLANT WAS PERFORMED ON (B)(6) 2023.
Patient problems: Deformity/ Disfigurement; Seroma
MAUDE report 17455772 ↗InjuryJul 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A 48-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 425CC (LEFT), 375CC (RIGHT) MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED PTOSIS ON THE LEFT SIDE AND CAPSULAR CONTRACTURE, BAKER GRADE 2 AND A RUPTURE ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2023.
Patient problems: Deformity/ Disfigurement
MAUDE report 17390395 ↗InjuryNov 16, 2022Material Rupture; Material Rupture
IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH A 425CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED A RUPTURE ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION, BUT A SPECIFIC DATE HAS NOT BEEN PROVIDED.
Patient problems: Breast Discomfort/Pain; Deformity/ Disfigurement; Granuloma
MAUDE report 15807746 ↗InjuryOct 14, 2022Material Rupture; Material Rupture
IT WAS REPORTED THAT A 44-YEAR-OLD FEMALE PATIENT UNDERWENT AN UNSPECIFIED BREAST IMPLANTATION PROCEDURE WITH MENTOR MEMORYGEL BREAST IMPLANTS 425CC AND SUFFERED SEVERAL UNEXPLAINED SYSTEMIC SYMPTOMS, INCLUDING PAIN, ASYMMETRY, NUMBNESS, INFLAMED LYMPH NODE, DRY MOUTH, DRY EYES, DIFFICULTY SWALLOWING, SWOLLEN FEET. THE PATIENT ALSO REPORTEDLY EXPERIENCED BILATERAL RUPTURE AND HEMATOMA ON THE RIGHT SIDE POST-OPERATIVELY. THE ROOT CAUSE OF THE PATIENT¿S SYMPTOMS IS UNCLEAR. 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hematoma
MAUDE report 15608978 ↗InjuryOct 14, 2022Material Rupture; Material Rupture
IT WAS REPORTED THAT A 44-YEAR-OLD FEMALE PATIENT UNDERWENT AN UNSPECIFIED BREAST IMPLANTATION PROCEDURE WITH MENTOR MEMORYGEL BREAST IMPLANTS 425CC AND SUFFERED SEVERAL UNEXPLAINED SYSTEMIC SYMPTOMS, INCLUDING PAIN, ASYMMETRY, NUMBNESS, INFLAMED LYMPH NODE, DRY MOUTH, DRY EYES, DIFFICULTY SWALLOWING, SWOLLEN FEET. THE PATIENT ALSO REPORTEDLY EXPERIENCED BILATERAL RUPTURE AND HEMATOMA ON THE RIGHT SIDE POST-OPERATIVELY. THE ROOT CAUSE OF THE PATIENT¿S SYMPTOMS IS UNCLEAR. 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 15608898 ↗InjuryAug 29, 2022Material Rupture; Material Rupture
IT WAS REPORTED THAT A 30-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 425CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH A RUPTURED RIGHT BREAST IMPLANT DURING AN IN-OFFICE VISIT AS THE MEDICAL PROFESSIONAL NOTED A LOSS OF FULLNESS. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH 485CC NATRELLE INSPIRA COHESIVE BREAST IMPLANTS ON (B)(6), 2022.
Patient problems: Deformity/ Disfigurement
MAUDE report 15316630 ↗InjuryAug 18, 2022Material Rupture; Material Rupture
IT WAS REPORTED THAT A 39-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH IMPLANTATION OF A LEFT-SIDED 425CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT EXPERIENCED PAIN AND A TINGING SENSATION ASSOCIATED WITH HER LEFT BREAST. SHE BELIEVED THE LEFT IMPLANT WAS RUPTURED. UPON CONSULTATION WITH A MEDICAL PROFESSIONAL, SHE WAS SCHEDULED FOR REMOVAL ON (B)(6) 2022.
Patient problems: Breast Discomfort/Pain; Paresthesia
MAUDE report 15254965 ↗InjuryJun 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A 40-YEAR-OLD HISPANIC FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH A 425CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED CAPSULAR CONTRACTURE; BAKER GRADE IV ON HER RIGHT SIDE POSTOPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT RIGHT SIDE UNILATERAL REMOVAL ONLY SURGERY ON (B)(6) 2022.
Patient problems: Capsular Contracture; Post Operative Wound Infection
MAUDE report 14775084 ↗InjuryJan 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A (B)(6)-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH 425CC MENTOR MEMORYGEL BREAST IMPLANT ON THE LEFT SIDE, AND WITH 450CC MENTOR MEMORYGEL BREAST IMPLANT ON THE RIGHT SIDE AND EXPERIENCED BREAST IMPLANT ILLNESS SYMPTOMS. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT-SIDED DEVICE.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 13137994 ↗InjuryMar 31, 2021Material Rupture; Material Rupture
IT WAS REPORTED THAT A (B)(6) YEAR-OLD FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 425CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED POSTOPERATIVE RIGHT-SIDED RUPTURE. THE PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT WITH TWO 765CC MENTOR MEMORYGEL XTRA BREAST IMPLANT PROSTHESES (CATALOG #: THPX765, LEFT SERIAL #: (B)(4), RIGHT SERIAL #: (B)(4)) ON (B)(6) 2021 TO REPLACE THE CURRENT IMPLANTS WITH LARGER SIZE IMPLANTS AND REDUCE THE SIZE OF RIGHT AREOLA. UPON EXPLANTATION, THE RIGHT-SIDED DEVICE WAS FOUND TO BE RUPTURED.
Patient problems: Deformity/ Disfigurement
MAUDE report 11600061 ↗InjuryFeb 25, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH A 425CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED AN UNKNOWN ADVERSE EVENT ON HER LEFT SIDE POSTOPERATIVELY. AS A RESULT, THE DEVICE WILL BE EXPLANTED ON (B)(6) 2021. FOLLOW-UPS ARE IN PROGRESS FOR ADDITIONAL INFORMATION REGARDING THE ADVERSE EVENT. WHEN INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Patient problems: Deformity/ Disfigurement
MAUDE report 11380833 ↗InjuryDec 4, 2019Material Rupture; Material Rupture
IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION PRIMARY WITH MENTOR MEMORYGEL BREAST IMPLANT 425CC AND EXPERIENCED A RECURRING LATE ONSET SEROMA ON THE LEFT SIDE. DURING EXPLORATION, A RUPTURE AND GRANULOMA WERE FOUND ON THE LEFT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH MENTOR MEMORYGEL BREAST IMPLANT, CATALOG# 3504251BC, SERIAL# (B)(4) ON (B)(6) 2019.
Patient problems: Granuloma; No Code Available; Seroma
MAUDE report 9412154 ↗
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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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