MENTOR MemoryGel Breast Implant 3545480Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00081317007173), received between Jun 11, 2019 and Oct 26, 2023 — classified as 13 injuries.

The most frequently reported specific device problem is “Material Rupture” (4 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.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryOct 26, 2023Migration; Migration

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH A MENTOR MEMORYGEL, 480CC SILICONE BREAST IMPLANT, EXPERIENCED LEFT SIDED SYMPTOMATIC RUPTURE, BREAST PAIN, LYMPHADENOPATHY, BREAST CYST, AND RIGHT SIDED DEVICE MIGRATION POST-OPERATIVELY. THE PATIENT REPORTED RUPTURE - POSSIBLE CYST, LYMPH NODES, DEVICE MIGRATING, BREAST HAS CHANGED, PAINFUL AT TIMES, BREASTS ARE SOFTER, AND SHOOTING PAIN AT CERTAIN AREAS. AS A RESULT, PATIENT SCHEDULED FOR BILATERAL REMOVAL ON (B)(6) 2023. THIS REPORT RELATES TO THE RIGHT-SIDE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18017050 ↗
• InjuryOct 26, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH A MENTOR MEMORYGEL, 480CC SILICONE BREAST IMPLANT, EXPERIENCED LEFT SIDED SYMPTOMATIC RUPTURE, BREAST PAIN, LYMPHADENOPATHY, BREAST CYST, AND RIGHT SIDED DEVICE MIGRATION POST-OPERATIVELY. THE PATIENT REPORTED RUPTURE - POSSIBLE CYST , LYMPH NODES, DEVICE MIGRATING, BREAST HAS CHANGED, PAINFUL AT TIMES, BREASTS ARE SOFTER, AND SHOOTING PAIN AT CERTAIN AREAS. AS A RESULT, PATIENT SCHEDULED FOR BILATERAL REMOVAL ON (B)(6) 2023. THIS REPORT RELATES TO THE LEFT-SIDE.

  Patient problems: Breast Discomfort/Pain; Cyst(s); Swollen Lymph Nodes/Glands

  MAUDE report 18017043 ↗
• InjuryJun 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST IMPLANTATION PROCEDURE WITH A MENTOR MEMORYGEL BREAST IMPLANT 480CC AND EXPERIENCED CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN POST-OPERATIVELY. THE IMPACTED PRODUCT SIDE WAS NOT SPECIFIED. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Capsular Contracture

  MAUDE report 17079386 ↗
• InjuryNov 22, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 57-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST IMPLANTATION PROCEDURE WITH MENTOR MEMORYGEL BREAST IMPLANTS 480CC AND EXPERIENCED RUPTURE ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED VIA MAMMOGRAM/ULTRASOUND. AS A RESULT, THE PATIENT IS SCHEDULED FOR REMOVAL ON (B)(6) 2022.

  Patient problems: Deformity/ Disfigurement; Granuloma

  MAUDE report 15847739 ↗
• InjuryNov 19, 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 WHO UNDERWENT A PRIMARY BREAST RECONSTRUCTION PROCEDURE WITH A MENTOR MEMORYGEL BREAST IMPLANT 480CC GEL BREAST PROSTHESIS DEVELOPED BAKER GRADE IV CAPSULAR CONTRACTURE IN HER LEFT BREAST POST IMPLANTATION. THE CAPSULAR CONTRACTURE WAS DIAGNOSED DURING AN OFFICE VISIT. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Capsular Contracture

  MAUDE report 12849184 ↗
• InjurySep 9, 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 WHO UNDERWENT BREAST AUGMENTATION REVISION 480CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED LEFT SIDED BAKER GRADE III CAPSULAR CONTRACTURE POST PROCEDURE. THE CAPSULAR CONTRACTURE WAS DIAGNOSED THROUGH A PHYSICAL EXAMINATION. AS A RESULT, AN EXPLANT WAS PERFORMED ON (B)(6) 2021.

  Patient problems: Capsular Contracture

  MAUDE report 12448978 ↗
• InjuryMay 13, 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 PRIMARY BREAST AUGMENTATION WITH 480CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED RIGHT SIDE CAPSULAR CONTRACTURE; BAKER GRADE IV CONFIRMED VIA MAMMOGRAM. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Capsular Contracture

  MAUDE report 11816221 ↗
• InjuryDec 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED IN THE UNITED STATES THAT A (B)(6) YEAR-OLD FEMALE PATIENT UNDERWENT REVISION BREAST AUGMENTATION WITH MENTOR MEMORYGEL BREAST IMPLANTS 480CC AND WAS DIAGNOSED WITH BREAST IMPLANT ASSOCIATED ANAPLASTIC LARGE CELL LYMPHOMA (BIA-ALCL) ON THE LEFT BREAST. PER RECEIVED ULTRASOUND REPORT, THE PATIENT PRESENTED WITH DEVELOPED FULLNESS, SWELLING IN THE LEFT BREAST (IN SUPERIOR AND INFERIOR REGIONS) AND SEROMA IN A DIAGNOSTIC EXAM ON (B)(6) 2020. ON (B)(6) 2020, THE PATIENT UNDERWENT ULTRASOUND-GUIDED ASPIRATION OF THE LARGE PERI-IMPLANT FLUID IN THE LEFT BREAST (COLLECTION ABOUT 120CC). PER CYTOLOGIC EVALUATION ON (B)(6) 2020, THE MORPHOLOGICAL FINDINGS AND IMMUNOHISTOCHEMICAL STAINING PATTERN ARE CHARACTERISTIC FOR BREAST IMPLANT ASSOCIATED ANAPLASTIC LARGE CELL LYMPHOMA (BIA-ALCL), WITH CD30 EXPRESSED IN ATYPICAL CELLS AND ALK NOT EXPRESSED IN ATYPICAL CELLS. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. FOLLOW-UPS ARE IN PROGRESS. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA ALCL); Seroma

  MAUDE report 11067257 ↗
• InjuryApr 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE WHO UNDERWENT BREAST AUGMENTATION REVISION WITH A 430CC MENTOR MEMORYGEL BREAST IMPLANT (LEFT) AND A 480CC MENTOR MEMORYGEL BREAST IMPLANT (RIGHT) EXPERIENCED SEVERAL HEALTH ISSUES POST PROCEDURE. BILATERAL CAPSULAR CONTRACTURE, BILATERAL SEROMA, INFECTION, AND AUTOIMMUNE DISORDERS WERE ALL NOTED. AFTER A MAMMOGRAM IDENTIFIED AN ISSUE, AN ULTRASOUND WAS RECOMMENDED. THE ULTRASOUND WAS PERFORMED AT THE END OF (B)(6) 2020 AND REVEALED THAT SEROMAS AND EFFUSIONS WERE SURROUNDING THE IMPLANTS. THE CAPSULAR CONTRACTURE WAS IDENTIFIED BY A PHYSICIAN EXAMINATION. THE PHYSICIAN INDICATED THE DEGREE OF CAPSULAR CONTRACTURE WAS LIKELY BAKER GRADE IV BY STATING THAT THE CONTRACTURE WAS THE HIGHEST SEVERITY. THE PATIENT WAS DIAGNOSED WITH RAYNAUD¿S AND WAS EXPERIENCING PINS AND NEEDLE SENSATIONS IN HER HANDS. ADDITIONALLY, THE PATIENT HAD RASHES OVER HER BODY, INSOMNIA, HER LYMPH SYSTEM WAS UNABLE TO DRAIN, CHRONIC FATIGUE, RED EYES, AND SICKLY APPEARANCE. THE PATIENT WAS UNABLE TO WORK DUE TO THESE ISSUES. NO DEVICE ISSUE SUCH AS RUPTURE WAS REPORTED. THE DEVICES WERE EXPLANTED WITHOUT REPLACEMENT AND THE PATIENT REPORTED AN IMPROVEMENT IN HER SY

  Patient problems: Autoimmune Reaction; Capsular Contracture; No Code Available; Seroma; Unspecified Infection

  MAUDE report 9963878 ↗
• InjuryMar 30, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT WHO UNDERWENT A BREAST AUGMENTATION PRIMARY WITH 480CC TEXTURED MENTOR MEMORYGEL BREAST IMPLANT HAS EXPERIENCED POSTOPERATIVE RIGHT-SIDED RUPTURE. RUPTURE WAS CONFIRMED BY MRI. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: No Code Available

  MAUDE report 9901668 ↗
• InjuryDec 10, 2019Adverse 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 PRIMARY BREAST AUGMENTATION WITH A 480CC MENTOR MEMORYGEL BREAST IMPLANT ON BOTH SIDES AND WAS PRESENTED WITH BILATERAL CAPSULAR CONTRACTURE; BAKER GRADE IV POSTOPERATIVELY. AS A RESULT, THE DEVICES WILL BE EXPLANTED ON (B)(6) 2019. THIS REPORT IS FOR THE PATIENT¿S RIGHT-SIDED DEVICE.

  Patient problems: Capsular Contracture; No Code Available

  MAUDE report 9446241 ↗
• InjuryJul 16, 2019Adverse 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 WHO UNDERWENT BREAST SURGERY WITH MENTOR MEMORYGEL BREAST 480CC IMPLANT EXPERIENCED LEFT SIDE CAPSULAR CONTRACTURE BAKER GRADE III POSTOPERATIVELY. AS A RESULT, THE PATIENT HAD AN EXPLANTATION ON (B)(6) 2019.

  Patient problems: Capsular Contracture; No Code Available

  MAUDE report 8796364 ↗
• InjuryJun 11, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6)-YEAR-OLD FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH 535CC MENTOR MEMORYGEL BREAST IMPLANTS AND EXPERIENCED CAPSULAR CONTRACTURE AND RUPTURE ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2019.

  Patient problems: Capsular Contracture; No Code Available

  MAUDE report 8689596 ↗