MENTOR MemoryGel Breast Implant 3542007Recalls & reported problems

Summary

The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 00081317000631), received between Feb 7, 2018 and Dec 11, 2025 — classified as 36 injuries.

The most frequently reported specific device problem is “Material Rupture” (25 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 25 most recent of 36 reports, in the reporter's own words as published by the FDA.

• InjuryDec 11, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 200CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED A RUPTURE AND LYMPHADENOPATHY ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) , 2009, AND REPLACED WITH A 200CC MENTOR MEMORYGEL BREAST IMPLANT.

  Patient problems: Swollen Lymph Nodes/Glands

  MAUDE report 23785569 ↗
• InjuryMar 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH A 200CC MENTOR MEMORYGEL BREAST IMPLANT ON THE LEFT BREAST. POST-OPERATIVELY, THE PATIENT SUFFERED LEFT BREAST CAPSULAR CONTRACTURE (BAKER GRADE II). AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2025.

  Patient problems: Capsular Contracture

  MAUDE report 21709545 ↗
• InjuryOct 16, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 58-YEAR-OLD FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH 200CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED BREAST IMPLANT RUPTURE ON HER RIGHT SIDE POSTOPERATIVELY; DIAGNOSED VIA ULTRASOUND. THE PATIENT HAS CONSULTED WITH THE HEALTHCARE PROFESSIONAL. AS A RESULT, THE PATIENT IS SCHEDULED FOR SURGERY ON (B)(6) 2024.

  Patient problems: Capsular Contracture; Deformity/ Disfigurement; Seroma

  MAUDE report 20460617 ↗
• InjuryOct 8, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 70-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH 200CC MENTOR MEMORYGEL BREAST IMPLANT ON BOTH SIDES AND EXPERIENCED BILATERAL PAIN, RUPTURE, AND BULGING OUT ON ONE SIDE POSTOPERATIVELY. THE PATIENT HAS CONSULTED WITH THE HEALTHCARE PROFESSIONAL. 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: Breast Discomfort/Pain; Capsular Contracture; Deformity/ Disfigurement

  MAUDE report 20404307 ↗
• InjuryOct 8, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 70-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH 200CC MENTOR MEMORYGEL BREAST IMPLANT ON BOTH SIDES AND EXPERIENCED BILATERAL PAIN, RUPTURE, AND BULGING OUT ON ONE SIDE POSTOPERATIVELY. THE PATIENT HAS CONSULTED WITH THE HEALTHCARE PROFESSIONAL. 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: Breast Discomfort/Pain; Capsular Contracture; Deformity/ Disfigurement

  MAUDE report 20404306 ↗
• InjurySep 26, 2023Material Rupture; Use of Device Problem; Material Rupture; Use of Device Problem

  IT WAS REPORTED THAT A FEMALE WHO UNDERWENT A BREAST RECONSTRUCTION PRIMARY WITH A MENTOR MEMORYGEL, 200CC SILICONE PROSTHESIS EXPERIENCED RIGHT-SIDED SYMPTOMATIC RUPTURE AND BREAST PAIN POST PROCEDURE. AS A RESULT, PATIENT SCHEDULED FOR BILATERAL REMOVAL WITHOUT REPLACEMENTS ON (B)(6) 2023.

  Patient problems: Breast Discomfort/Pain

  MAUDE report 17817292 ↗
• InjuryApr 12, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 44-YEAR-OLD FEMALE WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH A 200CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED RIGHT SIDED RUPTURE POST PROCEDURE. THE RUPTURE WAS DIAGNOSED THROUGH AN OFFICE VISIT. AS A RESULT, EXPLANT IS PLANNED FOR (B)(6) 2023.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 16724693 ↗
• InjuryAug 19, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION WITH 250CC (LEFT) AND A 200CC (RIGHT) MENTOR MEMORYGEL BREAST IMPLANTS AND EXPERIENCED BILATERAL RUPTURE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2022. THIS REPORT IS FOR THE RIGHT SIDE DEVICE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 15259049 ↗
• InjuryMay 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION RECONSTRUCTION REVISION SURGERY WITH A 175CC (LEFT) AND A 200CC (RIGHT) AND MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2022. THIS REPORT IS FOR THE RIGHT SIDE DEVICE.

  Patient problems: Capsular Contracture

  MAUDE report 14289179 ↗
• InjuryApr 7, 2022Adverse 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 PRIMARY BREAST AUGMENTATION WITH A 325CC MENTOR MEMORYGEL BREAST IMPLANT (RIGHT) AND A 200CC MENTOR MEMORYGEL BREAST IMPLANT (LEFT) EXPERIENCED SPONTANEOUS RIGHT SIDED RUPTURE AND SEVERAL UNEXPLAINED SYSTEMIC SYMPTOMS POST PROCEDURE. SINUS INFECTION, LARYNGITIS, PAIN, A GROWING LUMP, THE IMPLANT MOVING TOWARDS THE ARMPIT, INSOMNIA, DIFFICULTY BREATHING, SWEATING, HOT FLASHES, AND A KNOT IN THE IMPLANT WERE NOTED. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. SEE 1645337-2022-03921 FOR CONTRALATERAL PROSTHESIS REPORT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 14048257 ↗
• InjuryMar 16, 2022Adverse 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 WHO UNDERWENT A BREAST AUGMENTATION PROCEDURE WITH A MENTOR MEMORYGEL BREAST IMPLANT 275CC GEL BREAST PROSTHESIS (LEFT DEVICE) AND A MENTOR MEMORYGEL BREAST IMPLANT 200CC GEL BREAST PROSTHESIS (RIGHT DEVICE) DEVELOPED AN UNSPECIFIED DEFORMITY BILATERALLY POST IMPLANTATION. 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: Deformity/ Disfigurement

  MAUDE report 13778913 ↗
• InjuryFeb 17, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A MENTOR MEMORYGEL BREAST IMPLANT 200CC AND EXPERIENCED GRANULOMA AND RUPTURE ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED VIA ULTRASOUND. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH A MENTOR GEL BREAST IMPLANT ON (B)(6) 2022.

  Patient problems: Granuloma

  MAUDE report 13550962 ↗
• InjuryNov 9, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE WHO UNDERWENT A BREAST AUGMENTATION REVISION WITH MENTOR MEMORYGEL, 200CC BREAST IMPLANT EXPERIENCED RIGHT-SIDED RUPTURE, GRANULOMA, AND WRINKLING POST PROCEDURE. THE MRI EXAMINATION REPORTED SILICONE IN THE LYMPH GLANDS, AND NIPPLE WAS INVERTED. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. NOTE: (B)(6).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Calcium Deposits/Calcification; Capsular Contracture; Granuloma; Local Reaction; Wrinkling

  MAUDE report 12783286 ↗
• InjuryJun 7, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE WITH MENTOR MEMORYGEL BREAST IMPLANT 200CC GEL BREAST PROSTHESES THAT BILATERALLY RUPTURED. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION WITH NO REPLACEMENT BREAST PROSTHESES ON (B)(6) 2019. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 11953269 ↗
• InjuryJun 7, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE WITH MENTOR MEMORYGEL BREAST IMPLANT 200CC GEL BREAST PROSTHESES THAT BILATERALLY RUPTURED. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION WITH NO REPLACEMENT BREAST PROSTHESES ON (B)(6) 2019. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 11953266 ↗
• InjuryJan 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT REVISION BREAST AUGMENTATION WITH A 200CC MENTOR MEMORYGEL BREAST IMPLANT ON BOTH SIDES AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE; BAKER GRADE III POSTOPERATIVELY. AS A RESULT, THE DEVICES WERE EXPLANTED ON (B)(6) 2019. THIS REPORT IS FOR THE PATIENT¿S LEFT-SIDED DEVICE.

  Patient problems: Capsular Contracture

  MAUDE report 11107593 ↗
• InjuryJan 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT REVISION BREAST AUGMENTATION WITH A 200CC MENTOR MEMORYGEL BREAST IMPLANT ON BOTH SIDES AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE; BAKER GRADE III POSTOPERATIVELY. AS A RESULT, THE DEVICES WERE EXPLANTED ON (B)(6) 2019. THIS REPORT IS FOR THE PATIENT¿S RIGHT-SIDED DEVICE.

  Patient problems: Capsular Contracture

  MAUDE report 11107592 ↗
• InjuryDec 16, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT WHO UNDERWENT BREAST AUGMENTATION REVISION WITH A 175CC MENTOR MEMORYGEL BREAST IMPLANT AND A 200CC MENTOR MEMORYGEL BREAST IMPLANT AN UNKNOWN DATE EXPERIENCED BILATERAL RUPTURE POST PROCEDURE. AS A RESULT, AN EXPLANT WAS PERFORMED ON (B)(6) 2020. SEE 1645337-2020-16020 FOR CONTRALATERAL PROSTHESIS REPORT.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 11024537 ↗
• InjuryMay 29, 2020Off-Label Use; Material Rupture; Off-Label Use; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A MENTOR MEMORYGEL BREAST IMPLANT 200CC AND EXPERIENCED DEFLATION ON THE LEFT SIDE POSTOPERATIVELY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THE EXPIRATION DATE FOR THE REPORTED LOT NUMBER IS PRIOR TO THE IMPLANTATION DATE. PER IFU, DEVICES ARE NOT TO BE IMPLANTED AFTER STERILITY EXPIRATION DATE. THIS IS AN OFF-LABEL USE OF THE DEVICE. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THE LOT NUMBER OR IMPLANTATION DATE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: No Code Available

  MAUDE report 10102296 ↗
• InjuryMay 28, 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 CAUCASIAN FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH 200CC MENTOR MEMORYGEL BREAST IMPLANT AND RIGHT SIDE RUPTURE, AND BILATERAL CAPSULAR CONTRACTURE; BAKER GRADE II POSTOPERATIVELY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. AFTER FOLLOWING UP FOR ADDITIONAL INFORMATION, NO RESPONSE WAS RECEIVED AND THE REPORTED DOI CAN¿T BE CONFIRMED, SINCE IT¿S BEFORE THE MANUFACTURING DATE OF THE DEVICES. SHOULD MORE INFORMATION BECOME AVAILABLE, THIS CASE WILL BE RE-ASSESSED, AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THIS REPORT IS FOR THE PATIENT¿S LEFT-SIDED DEVICE.

  Patient problems: Capsular Contracture; No Code Available

  MAUDE report 10094753 ↗
• InjuryMay 28, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH 200CC MENTOR MEMORYGEL BREAST IMPLANT AND RIGHT SIDE RUPTURE, AND BILATERAL CAPSULAR CONTRACTURE; BAKER GRADE II POSTOPERATIVELY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. AFTER FOLLOWING UP FOR ADDITIONAL INFORMATION, NO RESPONSE WAS RECEIVED AND THE REPORTED DOI CAN¿T BE CONFIRMED, SINCE IT¿S BEFORE THE MANUFACTURING DATE OF THE DEVICES. SHOULD MORE INFORMATION BECOME AVAILABLE, THIS CASE WILL BE RE-ASSESSED, AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THIS REPORT IS FOR THE PATIENT¿S RIGHT-SIDED DEVICE.

  Patient problems: Capsular Contracture; No Code Available

  MAUDE report 10094752 ↗
• InjuryMar 31, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION WITH MENTOR MEMORYGEL BREAST IMPLANTS (300CC ON THE LEFT SIDE; 200CC ON THE RIGHT SIDE). THE PATIENT REPORTED THAT SHE WAS DIAGNOSED WITH RIGHT-SIDED BREAST CANCER ON (B)(6) 2020. SHE STATED THAT SHE WOULD HAVE TO GO INTO RADIATION BUT HER PHYSICIAN DOES NOT BELIEVE THAT HER IMPLANTS COULD HANDLE THE TREATMENT. SHE ALSO STATED THAT AN MRI ON (B)(6) 2020 CONFIRMED BILATERAL INTRACAPSULAR RUPTURE. AS A RESULT, THE PATIENT'S DEVICES WERE SCHEDULED FOR REMOVAL ON (B)(6) 2020. THIS REPORT IS FOR THE PATIENT'S RIGHT-SIDED DEVICE.

  Patient problems: Calcium Deposits/Calcification; Cancer; No Code Available

  MAUDE report 9908401 ↗
• InjuryDec 4, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT WHO UNDERWENT BREAST AUGMENTATION REVISION SURGERY WITH 200CC MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED BILATERAL RUPTURE, GRANULOMA AND RIGHT SIDED CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN POST PROCEDURE. PATIENT ALSO EXPERIENCED DISCOMFORT AND PAIN. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT IS FOR RIGHT SIDED DEVICE. SEE 1645337-2019-25128 FOR CONTRALATERAL PROSTHESIS REPORT.

  Patient problems: Capsular Contracture; Granuloma

  MAUDE report 9414507 ↗
• InjuryDec 4, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT WHO UNDERWENT BREAST AUGMENTATION REVISION SURGERY WITH 200CC MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED BILATERAL RUPTURE, GRANULOMA AND RIGHT SIDED CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN POST PROCEDURE. PATIENT ALSO EXPERIENCED DISCOMFORT AND PAIN. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT IS FOR THE LEFT SIDED REPORT. SEE 1645337-2019-25129 FOR CONTRALATERAL PROSTHESIS REPORT.

  Patient problems: Granuloma

  MAUDE report 9414503 ↗
• InjuryNov 1, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT OF UNKNOWN AGE WHO UNDERWENT BREAST AUGMENTATION REVISION WITH TWO 200CC MENTOR MEMORYGEL BREAST IMPLANTS ON (B)(6) 1993, HAD TO UNDERGO BILATERAL EXPLANTATION WITHOUT REPLACEMENTS ON (B)(6) 2019 FOR UNSPECIFIED REASONS. NO DEVICE ISSUE SUCH AS RUPTURE WAS REPORTED. THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: No Code Available

  MAUDE report 9267247 ↗