MENTOR MemoryGel Breast Implant 3544751Recalls & reported problems
Mentor Texas L.P. · SILTEX Round Moderate Plus Profile Gel-Filled Breast Implant, 475cc |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 used for breast augmentation. The 28 adverse event reports mostly describe implants rupturing after surgery, sometimes with fluid collecting around the implant, along with tightening of the scar tissue around the implant and the implant shifting position. All 28 reports involve injuries and no deaths. 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 00081317003892), received between Jun 13, 2019 and Aug 6, 2026 — classified as 28 injuries.
The most frequently reported specific device problem is “Material Rupture” (20 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 Rupture20
- Adverse Event Without Identified Device or Use Problem10
- Migration2
- Migration or Expulsion of Device1
Patient problems
- Capsular Contracture16
- No Code Available9
- Deformity/ Disfigurement4
- No Clinical Signs, Symptoms or Conditions4
- Autoimmune Reaction2
- Breast Discomfort/Pain1
- Local Reaction1
- Paresthesia1
Recent adverse event reports
The 25 most recent of 28 reports, in the reporter's own words as published by the FDA.
InjuryAug 6, 2026Material Rupture
It was reported that a patient with MENTOR MemoryGel Breast Implants experienced bilateral rupture post-operatively, which was confirmed during a physical exam. As a result, the patient underwent device removal.This report is for the right breast prosthesis.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50160904 ↗InjuryAug 6, 2026Material Rupture
It was reported that a patient with MENTOR MemoryGel Breast Implants experienced bilateral rupture post-operatively, which was confirmed during a physical exam. As a result, the patient underwent device removal.This report is for the left breast prosthesis.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50160899 ↗InjuryMay 13, 2026Material Rupture
A FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH MENTOR MEMORYGEL, 475 CC SILICONE IMPLANTS DEVELOPED RIGHT SIDED SILENT RUPTURE AFTER THE PROCEDURE. AT THE TIME OF THIS REPORT, MENTOR RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.
Patient problems: Deformity/ Disfigurement
MAUDE report 25161970 ↗InjuryFeb 25, 2026Material Rupture
IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 475CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED A RUPTURE AND FLUID COLLECTION AROUND THE IMPLANT SITE ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2026.
Patient problems: Capsular Contracture; No Clinical Signs, Symptoms or Conditions
MAUDE report 24446348 ↗InjuryMar 18, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT A 43-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH TWO 475CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE (BAKER GRADE 3 ON THE LEFT AND BAKER GRADE 2 ON THE RIGHT) POST-OPERATIVELY. DISPLACEMENT OF THE RIGHT MAMMARY IMPLANT INFERIORLY WAS REPORTED. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025, AND REPLACED WITH MENTOR MEMORYGEL BREAST IMPLANT (SERIAL NUMBER (B)(6) ON THE RIGHT AND SERIAL NUMBER (B)(6) ON THE LEFT). THIS REPORT IS FOR THE LEFT SIDE DEVICE.
Patient problems: Capsular Contracture
MAUDE report 21635070 ↗InjuryMar 18, 2025Material Rupture; Migration; Material Rupture; Migration
IT WAS REPORTED THAT A 43-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH TWO 475CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE (BAKER GRADE 3 ON THE LEFT AND BAKER GRADE 2 ON THE RIGHT) POST-OPERATIVELY. DISPLACEMENT OF THE RIGHT MAMMARY IMPLANT INFERIORLY WAS REPORTED. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025, AND REPLACED WITH MENTOR MEMORYGEL BREAST IMPLANT (SERIAL NUMBER (B)(6) ON THE RIGHT AND SERIAL NUMBER (B)(6) ON THE LEFT). THIS REPORT IS FOR THE RIGHT SIDE DEVICE.
Patient problems: Capsular Contracture
MAUDE report 21635069 ↗InjuryJan 30, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT A 41-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH 475CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED BILATERAL BREAST IMPLANT RUPTURES, AND BILATERAL CAPSULAR CONTRACTURE; BAKER GRADE III ON THE RIGHT AND GRADE II ON THE LEFT SIDE POSTOPERATIVELY. 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: Capsular Contracture
MAUDE report 21273619 ↗InjuryJan 30, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT A 41-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH 475CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED BILATERAL BREAST IMPLANT RUPTURES, AND BILATERAL CAPSULAR CONTRACTURE; BAKER GRADE III ON THE RIGHT AND GRADE II ON THE LEFT SIDE POSTOPERATIVELY. 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 RIGHT-SIDED DEVICE.
Patient problems: Capsular Contracture
MAUDE report 21273616 ↗InjuryNov 18, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT A 50-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A 475CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED A RUPTURE 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: Deformity/ Disfigurement
MAUDE report 20708318 ↗InjuryMar 14, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH A MENTOR MEMORYGEL BREAST IMPLANT 475CC GEL BREAST PROSTHESIS THAT RUPTURED POST IMPLANTATION. RUPTURE OF THE PATIENT¿S RIGHT BREAST PROSTHESIS WAS REPORTED. ADDITIONALLY, IT WAS REPORTED THAT THE RIGHT BREAST ¿FELT WEIRD¿, WAS ¿DISCONFIGURED¿, AND PAINFUL. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.
Patient problems: Breast Discomfort/Pain; Paresthesia; Wrinkling
MAUDE report 18909070 ↗InjurySep 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A 41-YEAR-OLD CAUCASIAN FEMALE PATIENT WHO UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH A MENTOR MEMORYGEL BREAST IMPLANT 475CC GEL BREAST PROSTHESIS (LEFT DEVICE) AND A MENTOR MEMORYGEL BREAST IMPLANT 450CC GEL BREAST PROSTHESIS (RIGHT DEVICE) DEVELOPED A SEROMA IN HER RIGHT BREAST POST IMPLANTATION. NEEDLE ASPIRATION WAS PERFORMED ON THE RIGHT BREAST SEROMA FLUID AND A SAMPLE WAS SENT TO PATHOLOGY. THE RESULTS WERE NEGATIVE FOR MALIGNANT CELLS. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION WITH NO REPLACEMENT BREAST PROSTHESES ON (B)(6) 2022. THE REMOVED BREAST PROSTHESES WERE DISCARDED FOLLOWING EXPLANT SURGERY. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT BREAST PROSTHESIS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15476843 ↗InjuryJun 7, 2022Material Rupture; Adverse Event Without Identified Device or Use Problem; Material Rupture; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE WHO UNDERWENT A REVISION BREAST PRIMARY WITH TWO 475CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED LEFT-SIDE-SIDED SILENT RUPTURE, AND RIGHT-SIDED ASYMMETRY ISSUE POST PROCEDURE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT RELATES TO THE RIGHT PROSTHESIS.
Patient problems: Deformity/ Disfigurement
MAUDE report 14626539 ↗InjuryJun 7, 2022Material Rupture; Material Rupture
IT WAS REPORTED THAT A 71-YEAR-OLD CAUCASIAN FEMALE WHO UNDERWENT A REVISION BREAST PRIMARY WITH TWO 475CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED LEFT-SIDE-SIDED SILENT RUPTURE, AND RIGHT-SIDED ASYMMETRY ISSUE POST PROCEDURE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT RELATES TO THE LEFT PROSTHESIS.
Patient problems: Deformity/ Disfigurement
MAUDE report 14626261 ↗InjuryMay 18, 2022Material Rupture; Material Rupture
IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT WHO UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE WITH MENTOR MEMORYGEL BREAST IMPLANT 475CC GEL BREAST PROSTHESES DEVELOPED CAPSULAR CONTRACTURE (BAKER GRADE UNKNOWN) IN BOTH OF HER BREASTS POST IMPLANTATION. ADDITIONALLY, IT WAS REPORTED THAT THERE IS POSSIBLE BILATERAL RUPTURE. THE ISSUES WERE DIAGNOSED DURING AN IN OFFICE EXAM. AS A RESULT, THE PATIENT IS SCHEDULED TO UNDERGO BILATERAL EXPLANTATION AND REPLACEMENT WITH UNSPECIFIED MENTOR GEL BREAST PROSTHESES ON (B)(6) 2022. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT BREAST PROSTHESIS.
Patient problems: Capsular Contracture
MAUDE report 14432270 ↗InjuryMay 18, 2022Material Rupture; Material Rupture
IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT WHO UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE WITH MENTOR MEMORYGEL BREAST IMPLANT 475CC GEL BREAST PROSTHESES DEVELOPED CAPSULAR CONTRACTURE (BAKER GRADE UNKNOWN) IN BOTH OF HER BREASTS POST IMPLANTATION. ADDITIONALLY, IT WAS REPORTED THAT THERE IS POSSIBLE BILATERAL RUPTURE. THE ISSUES WERE DIAGNOSED DURING AN IN OFFICE EXAM. AS A RESULT, THE PATIENT IS SCHEDULED TO UNDERGO BILATERAL EXPLANTATION AND REPLACEMENT WITH UNSPECIFIED MENTOR GEL BREAST PROSTHESES ON (B)(6) 2022. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT BREAST PROSTHESIS.
Patient problems: Capsular Contracture
MAUDE report 14432209 ↗InjuryAug 6, 2021Material Rupture; Material Rupture
IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH A 475CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED RIGHT SIDED RUPTURE, CAPSULAR CONTRACTURE, AND LOCAL REACTION POST PROCEDURE. THERE IS TENDERNESS, PAIN, A LOSS OF SHAPE, A RASH ON HER ARM, RIPPLING, HARDENING, DIMPLES NEAR THE AREOLA, AND LUMPS. SHE BELIEVES ITS POSSIBLE THE RUPTURE TO BE CAUSING A PALPABLE AREA TOWARDS THE BOTTOM OF THE IMPLANT. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.
Patient problems: Capsular Contracture; Local Reaction
MAUDE report 12291997 ↗InjuryApr 29, 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 FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 475CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED CAPSULAR CONTRACTURE, BAKER GRADE 3 AND A SUSPECTED INFECTION ON THE RIGHT SIDE POST-OPERATIVELY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.
Patient problems: Capsular Contracture; Post Operative Wound Infection
MAUDE report 11748139 ↗InjuryOct 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A (B)(6) YEAR-OLD FEMALE UNDERWENT BREAST AUGMENTATION REVISION WITH 475CC MENTOR MEMORYGEL BREAST IMPLANTS AND EXPERIENCED RUPTURE ON THE LEFT, BAKER GRADE III CAPSULAR CONTRACTURE ON THE LEFT SIDE AND BAKER GRADE II CAPSULAR CONTRACTURE ON THE RIGHT SIDE POSTOPERATIVELY. THE RUPTURE AND CAPSULAR CONTRACTURES WERE CONFIRMED WITH AN MRI. AS A RESULT, THE PATIENT UNDERWENT BILATERAL DEVICE REMOVAL AND REPLACEMENT WITH MENTOR MEMORYGEL BREAST IMPLANTS, SERIAL NUMBERS (B)(4) ON THE LEFT SIDE AND (B)(4) ON THE RIGHT SIDE ON (B)(6) 2020. THIS REPORT IS FOR THE PATIENT'S RIGHT-SIDED DEVICE.
Patient problems: Capsular Contracture; No Code Available
MAUDE report 10708838 ↗InjuryOct 20, 2020Material Rupture; Material Rupture
IT WAS REPORTED THAT A (B)(6) YEAR-OLD FEMALE UNDERWENT BREAST AUGMENTATION REVISION WITH 475CC MENTOR MEMORYGEL BREAST IMPLANTS AND EXPERIENCED RUPTURE ON THE LEFT, BAKER GRADE III CAPSULAR CONTRACTURE ON THE LEFT SIDE AND BAKER GRADE II CAPSULAR CONTRACTURE ON THE RIGHT SIDE POSTOPERATIVELY. THE RUPTURE AND CAPSULAR CONTRACTURES WERE CONFIRMED WITH AN MRI. AS A RESULT, THE PATIENT UNDERWENT BILATERAL DEVICE REMOVAL AND REPLACEMENT WITH MENTOR MEMORYGEL BREAST IMPLANTS, SERIAL NUMBERS (B)(4) ON THE LEFT SIDE AND (B)(4) ON THE RIGHT SIDE ON (B)(6) 2020. THIS REPORT IS FOR THE PATIENT'S LEFT-SIDED DEVICE.
Patient problems: Capsular Contracture; No Code Available
MAUDE report 10708834 ↗InjuryOct 5, 2020Migration; Migration
IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE WITH A MENTOR MEMORYGEL BREAST IMPLANT 475CC GEL BREAST PROSTHESIS (LEFT DEVICE) AND A MENTOR MEMORYGEL BREAST IMPLANT 375CC GEL BREAST PROSTHESIS (RIGHT DEVICE) THAT BOTH DROPPED LOWER IN THE BREAST POCKET AFTER IMPLANTATION. BILATERAL BREAST PROSTHESIS MIGRATION WAS DIAGNOSED BY A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH A MENTOR MEMORYGEL BREAST IMPLANT 475CC GEL BREAST PROSTHESIS AND A MENTOR MEMORYGEL BREAST IMPLANT 375CC GEL BREAST PROSTHESIS ON (B)(6) 2020. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT BREAST PROSTHESIS.
Patient problems: No Code Available
MAUDE report 10632099 ↗InjuryNov 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A FEMALE PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION SURGERY WITH A 475CC MENTOR MEMORYGEL LEFT BREAST IMPLANT AND A 405CC MENTOR MEMORYGEL RIGHT BREAST IMPLANT EXPERIENCED SEROMA. THE DATE THAT THE SEROMA OCCURRED IS UNKNOWN AS WELL AS THE SIDE OF THE BREAST IN WHICH THE SEROMA OCCURRED IS UNKNOWN. THIS SEROMA DIAGNOSIS WAS NOT CONFIRMED BY A HEALTH CARE PROFESSIONAL. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.
Patient problems: Capsular Contracture; No Code Available; Seroma
MAUDE report 9341118 ↗InjuryNov 11, 2019Material Rupture; Adverse Event Without Identified Device or Use Problem; Material Rupture; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION REVISION WITH MENTOR MEMORYGEL,475CC SILICONE BREAST IMPLANTS WHICH THE REPORT INDICATES ITCHING FOR THE PAST 2 YEARS, PAIN UNDERNEATH HER BREASTS, BAD ALLERGIES, SHE HAS LOST BALANCE, EYES SEE DOUBLE, SWALLOWING IS BAD, COLON DISEASE, DRY EYE SURGERY TWICE, ARTHRITIS, DISEASE ALL OVER HER BODY, LOOSE BREAST SKIN. NO DIAGNOSIS AS OF THIS REPORT. 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.
Patient problems: No Code Available
MAUDE report 9305693 ↗InjuryNov 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION REVISION WITH MENTOR MEMORYGEL,475CC SILICONE BREAST IMPLANTS WHICH THE REPORT INDICATES ITCHING FOR THE PAST 2 YEARS, PAIN UNDERNEATH HER BREASTS, BAD ALLERGIES, SHE HAS LOST BALANCE, EYES SEE DOUBLE, SWALLOWING IS BAD, COLON DISEASE, DRY EYE SURGERY TWICE, ARTHRITIS, DISEASE ALL OVER HER BODY, LOOSE BREAST SKIN. NO DIAGNOSIS AS OF THIS REPORT. 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.
Patient problems: No Code Available
MAUDE report 9305678 ↗InjuryOct 14, 2019Material Rupture; Material Rupture
IT WAS REPORTED THAT A (B)(6) OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH MENTOR MEMORYGEL BREAST IMPLANT 475CC AND EXPERIENCED CAPSULAR CONTRACTURE, BAKER GRADE 3 ON THE LEFT SIDE, A DEVICE MIGRATION ON THE RIGHT SIDE, AND BILATERAL RUPTURES POST-OPERATIVELY WHICH WERE CONFIRMED BY A PHYSICIAN AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH UNSPECIFIED ALLERGAN IMPLANTS ON (B)(6) 2018. THIS REPORT IS FOR THE LEFT SIDE DEVICE. THIS REPORT CONTAINS SUPPLEMENTAL INFORMATION FOR MENTOR PSR REFERENCE NUMBER IP-00195160
Patient problems: Capsular Contracture; No Code Available
MAUDE report 9186609 ↗InjuryOct 14, 2019Migration or Expulsion of Device; Material Rupture; Migration or Expulsion of Device; Material Rupture
IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH MENTOR MEMORYGEL BREAST IMPLANT 475CC AND EXPERIENCED CAPSULAR CONTRACTURE, BAKER GRADE 3 ON THE LEFT SIDE, A DEVICE MIGRATION ON THE RIGHT SIDE, AND BILATERAL RUPTURES POST-OPERATIVELY WHICH WERE CONFIRMED BY A PHYSICIAN AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH UNSPECIFIED ALLERGAN IMPLANTS ON (B)(6) 2018. THIS REPORT IS FOR THE RIGHT SIDE DEVICE. THIS REPORT CONTAINS SUPPLEMENTAL INFORMATION FOR MENTOR PSR REFERENCE NUMBER (B)(4).
Patient problems: No Code Available
MAUDE report 9186595 ↗
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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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