MENTOR MemoryGel Breast Implant 3544500Recalls & reported problems

Summary

The FDA's MAUDE database contains 96 adverse event reports that list this exact device (DI 00081317001119), received between Jan 30, 2018 and Feb 4, 2026 — classified as 95 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Rupture” (47 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 96 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 4, 2026Material Rupture

  IT WAS REPORTED THAT A 41-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A 500CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED A RUPTURE ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS DIAGNOSED WITH AN MRI. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 24259266 ↗
• MalfunctionJun 4, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT DURING A SCHEDULED PRIMARY BREAST AUGMENTATION PROCEDURE, A MENTOR MEMORYGEL BREAST IMPLANT 500CC GEL BREAST PROSTHESIS WAS NOTICED TO BE RUPTURED. AS A RESULT, THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE, A MENTOR MEMORYGEL BREAST IMPLANT 535CC GEL BREAST PROSTHESIS. THERE WAS NO REPORTED PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22144960 ↗
• InjuryMay 30, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH MENTOR MEMORYGEL BREAST IMPLANT 500CC GEL BREAST PROSTHESES WAS DISSATISFIED WITH THE SIZE OF HER BREASTS POST IMPLANTATION. THE PATIENT GAINED 30 POUNDS SINCE HER SURGERY AND THOUGHT HER BREASTS HAD BECOME TOO LARGE. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION WITH NO REPLACEMENT BREAST PROSTHESES. DURING EXPLANT SURGERY, RUPTURE OF THE PATIENT¿S RIGHT BREAST PROSTHESIS WAS OBSERVED. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 22118245 ↗
• InjuryMay 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH MENTOR MEMORYGEL BREAST IMPLANT 500CC GEL BREAST PROSTHESES WAS DISSATISFIED WITH THE SIZE OF HER BREASTS POST IMPLANTATION. THE PATIENT GAINED 30 POUNDS SINCE HER SURGERY AND THOUGHT HER BREASTS HAD BECOME TOO LARGE. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION WITH NO REPLACEMENT BREAST PROSTHESES. DURING EXPLANT SURGERY, RUPTURE OF THE PATIENT¿S RIGHT BREAST PROSTHESIS WAS OBSERVED. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 22118242 ↗
• InjuryDec 31, 2024Material Rupture; Material Rupture

  IT WAS REPORTED (VIA MW5162816 & MW5162817) THAT A PATIENT WHO HAD 500CC MENTOR MEMORYGEL BREAST IMPLANTS PLACED EXPERIENCED BILATERAL RUPTURE, GRANULOMA FORMATION AND SEVERAL UNEXPLAINED SYSTEMIC SYMPTOMS POST PROCEDURE. THE GRANULOMAS WERE NOTED IN THE FORM OF A LUMP AND THE STERNUM AND SILICONE NOTED WITHING THE LYMPH NODES. X-RAY, MAGNETIC RESONANCE IMAGING, AND MAMMOGRAPHY WERE USED TO IDENTIFY DEVICE RUPTURE. PAIN, BRAIN FOG, LOW WHITE BLOOD CELLS, ABNORMAL RED BLOOD CELLS, ELEVATED ESTROGEN, HEADACHES, CONSTIPATION, AND ANXIETY WERE THE UNEXPLAINED SYSTEMIC SYMPTOMS NOTED. 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.

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

  MAUDE report 21048969 ↗
• InjuryDec 31, 2024Material Rupture; Adverse Event Without Identified Device or Use Problem; Material Rupture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED (VIA MW5162816 & MW5162817) THAT A PATIENT WHO HAD 500CC MENTOR MEMORYGEL BREAST IMPLANTS PLACED EXPERIENCED BILATERAL RUPTURE, GRANULOMA FORMATION AND SEVERAL UNEXPLAINED SYSTEMIC SYMPTOMS POST PROCEDURE. THE GRANULOMAS WERE NOTED IN THE FORM OF A LUMP AND THE STERNUM AND SILICONE NOTED WITHING THE LYMPH NODES. X-RAY, MAGNETIC RESONANCE IMAGING, AND MAMMOGRAPHY WERE USED TO IDENTIFY DEVICE RUPTURE. PAIN, BRAIN FOG, LOW WHITE BLOOD CELLS, ABNORMAL RED BLOOD CELLS, ELEVATED ESTROGEN, HEADACHES, CONSTIPATION, AND ANXIETY WERE THE UNEXPLAINED SYSTEMIC SYMPTOMS NOTED. 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.

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

  MAUDE report 21048967 ↗
• InjuryDec 4, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH A 500CC MENTOR MEMORYGEL BREAST IMPLANT (LEFT) AND A 550CC MENTOR MEMORYGEL BREAST IMPLANT (RIGHT) EXPERIENCED SPONTANEOUS BILATERAL RUPTURE AND BILATERAL BAKER GRADE III CAPSULAR CONTRACTURE POST PROCEDURE. AS A RESULT, REPLACEMENT WITH MENTOR GEL BOOST WAS PERFORMED ON (B)(6) 2024.

  Patient problems: Capsular Contracture

  MAUDE report 20846463 ↗
• InjuryOct 18, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 45-YEAR-OLD FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH A 500CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED A RUPTURE ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS DIAGNOSED WITH AN ULTRASOUND. THE BREAST PROSTHESIS SHOWED A "LINGUINI SIGN". AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 20482321 ↗
• InjurySep 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST RECONSTRUCTION REVISION WITH TWO 500CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA PHYSICAL EXAMINATION, WITH BILATERAL BREAST CAPSULAR CONTRACTURES (BAKER GRADES III). 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: Capsular Contracture

  MAUDE report 20328588 ↗
• InjurySep 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST RECONSTRUCTION REVISION WITH TWO 500CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA PHYSICAL EXAMINATION, WITH BILATERAL BREAST CAPSULAR CONTRACTURES (BAKER GRADES III). 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: Capsular Contracture

  MAUDE report 20327956 ↗
• InjurySep 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 500CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED CAPSULAR CONTRACTURE BAKER GRADE 3 ON THE LEFT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2024.

  Patient problems: Capsular Contracture

  MAUDE report 20138200 ↗
• InjuryJun 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE WHO UNDERWENT A BREAST AUGMENTATION PRIMARY WITH A MENTOR MEMORYGEL, 500CC SILICONE PROSTHESIS EXPERIENCED LEFT-SIDED SYMPTOMATIC RUPTURE, AND UNEXPLAINED SYMPTOMATIC SYMPTOMS POSTOPERATIVE, INCLUDING PROBLEMS BREATHING, AND FEVER. THE CT-SCAN EXAMINATION CONFIRMED THE LEFT SIDE RUPTURE AND ACUTE CHEST WALL LESION WAS NOTED. AS A RESULT, PATIENT UNDERWENT BILATERAL REMOVAL ON (B)(6) 2024. THIS REPORT RELATES TO THE RIGHT SIDE.

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

  MAUDE report 19608814 ↗
• InjuryJun 25, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE WHO UNDERWENT A BREAST AUGMENTATION PRIMARY WITH A MENTOR MEMORYGEL, 500CC SILICONE PROSTHESIS EXPERIENCED LEFT-SIDED SYMPTOMATIC RUPTURE, AND UNEXPLAINED SYMPTOMATIC SYMPTOMS POSTOPERATIVE, INCLUDING PROBLEMS BREATHING, AND FEVER. THE CT-SCAN EXAMINATION CONFIRMED THE LEFT SIDE RUPTURE AND ACUTE CHEST WALL LESION WAS NOTED. AS A RESULT, PATIENT UNDERWENT BILATERAL REMOVAL ON (B)(6) 2024. THIS REPORT RELATES TO THE LEFT SIDE.

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

  MAUDE report 19608468 ↗
• InjuryJun 14, 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 PATIENT WHO UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE WITH AN UNSPECIFIED MENTOR GEL BREAST PROSTHESIS DEVELOPED BAKER GRADE IV CAPSULAR CONTRACTURE IN HER RIGHT BREAST POST IMPLANTATION. THE CAPSULAR CONTRACTURE WAS DIAGNOSED VIA A HEALTHCARE PROFESSIONAL¿S EXAM. AS A RESULT, THE PATIENT IS SCHEDULED TO UNDERGO EXPLANTATION ON (B)(6) 2024.

  Patient problems: Capsular Contracture

  MAUDE report 19538897 ↗
• InjuryApr 24, 2024Material Rupture; Material Rupture

  ON MARCH 14, 2024, MENTOR RECEIVED TWO 550CC MENTOR MEMORYGEL BREAST IMPLANTS THAT COULD NOT ASSOCIATED WITH ANY WITH ANY EXISTING COMPLAINT FILE. ON APRIL 10, 2024, ANALYSIS OF THESE DEVICES REVEALED EVIDENCE OF POSSIBLE DEVICE RUPTURE. THESE DEVICES WERE EXPLANTED ON FEBRUARY 22, 2024. SEE 1645337-2024-04853 FOR CONTRALATERAL PROSTHESIS REPORT.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 19174127 ↗
• InjuryJan 8, 2024Migration; Migration

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH 500CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT EXPERIENCED A RUPTURE OF HER RIGHT PROSTHESIS, A CYST IN HER RIGHT BREAST, AND BILATERAL MALPOSITION OF HER IMPLANTS, WHICH WERE CONFIRMED VIA ULTRASOUND AND PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL SURGERY ON (B)(6) 2023. THIS REPORT IS FOR THE LEFT IMPLANT. REFER TO MANUFACTURING REPORT NUMBER 1645337-2023-09471 FOR THE CONTRALATERAL EVENT.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18466736 ↗
• InjuryNov 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 500CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, IN-OFFICE, WITH BILATERAL BREAST CAPSULAR CONTRACTURES (BAKER GRADE IV). AS A RESULT, THE PATIENT UNDERWENT BILATERAL BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2023.THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 18136238 ↗
• InjuryNov 2, 2023Adverse 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 500CC MENTOR MEMORYGEL BREAST IMPLANT ON BOTH SIDES AND EXPERIENCED BREAST IMPLANT RUPTURE ON HER RIGHT SIDE POSTOPERATIVELY; DIAGNOSED VIA MRI SCAN. THE PATIENT HAS CONSULTED WITH THE HEALTHCARE PROFESSIONAL. ON (B)(6) 2023, MENTOR BECAME AWARE THAT THE PATIENT ALSO EXPERIENCED RIGHT SIDE GRANULOMA, AND BILATERAL CUTANEOUS CONTOUR DEFORMITY IN ADDITION TO RIGHT SIDE RUPTURE AND UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT SURGERY WITH CATALOG NUMBER SMHX500; SERIAL NUMBER (B)(6) ON THE LEFT SIDE, AND WITH CATALOG NUMBER SMHX500; SERIAL NUMBER (B)(6) ON THE RIGHT SIDE ON (B)(6) 2023. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT-SIDED DEVICE.

  Patient problems: Wrinkling

  MAUDE report 18062583 ↗
• InjuryOct 17, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT PRIMARY BREAST RECONSTRUCTION WITH A 500CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED RIGHT SIDED RUPTURE POST PROCEDURE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 17954415 ↗
• InjuryOct 6, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT REVISION BREAST AUGMENTATION WITH 500CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED BREAST IMPLANT RUPTURE ON HER RIGHT SIDE POSTOPERATIVELY; DIAGNOSED VIA MRI SCAN. THE PATIENT HAS CONSULTED WITH THE HEALTHCARE PROFESSIONAL. AS A RESULT, THE DEVICE WILL BE EXPLANTED ON (B)(6) 2023.

  Patient problems: Deformity/ Disfigurement; Granuloma; Wrinkling

  MAUDE report 17885786 ↗
• InjurySep 20, 2023Migration; Migration

  IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH A (LEFT) 500CC MENTOR MEMORYGEL BREAST IMPLANT AND A (RIGHT) 450CC MENTOR MEMORYGEL BREAST IMPLANT. POST-OPERATIVELY, THE PATIENT SUFFERED BILATERAL BREAST FOLDING ON THE SIDES AND BOTTOM. THE BREAST FELT LIKE THEY ARE SHIFTING TO THE OUTSIDE. 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 17784886 ↗
• InjurySep 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH A MENTOR MEMORYGEL BREAST IMPLANT 450CC GEL BREAST PROSTHESIS (LEFT DEVICE) AND A MENTOR MEMORYGEL BREAST IMPLANT 500CC GEL BREAST PROSTHESIS (RIGHT DEVICE) DEVELOPED BAKER GRADE III/IV CAPSULAR CONTRACTURE IN BOTH OF HER BREASTS POST IMPLANTATION. BILATERAL CAPSULAR CONTRACTURE WAS DIAGNOSED VIA A PHYSICAL EXAM. 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 BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 17777635 ↗
• InjuryAug 14, 2023Material Rupture; Migration; Material Rupture; Migration

  IT WAS REPORTED THAT A 43-YEAR-OLD BLACK OR AFRICAN AMERICAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH A 500CC MENTOR MEMORYGEL BREAST IMPLANT. POST-OPERATIVELY, THE PATIENT EXPERIENCED A RUPTURE OF HER RIGHT PROSTHESIS, WHICH WAS CONFIRMED VIA ULTRASOUND. AS A RESULT, THE PATIENT UNDERWENT REMOVAL SURGERY ON (B)(6), 2023. 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: Cyst(s); Deformity/ Disfigurement

  MAUDE report 17543731 ↗
• InjuryAug 9, 2023Adverse 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 UNDERWENT A BREAST SURGERY WITH 500CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT EXPERIENCED BILATERAL BAKER GRADE III CAPSULAR CONTRACTURE AND FLUID COLLECTION AROUND HER IMPLANTS, WHICH WERE CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT REMOVAL SURGERY ON B)(6) 2023. THIS REPORT IS FOR THE LEFT IMPLANT. REFER TO MANUFACTURING REPORT NUMBER 1645337-2023-09251 FOR THE CONTRALATERAL EVENT.

  Patient problems: Capsular Contracture; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17487655 ↗
• InjuryAug 9, 2023Adverse 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 UNDERWENT A BREAST SURGERY WITH 500CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT EXPERIENCED BILATERAL BAKER GRADE III CAPSULAR CONTRACTURE AND FLUID COLLECTION AROUND HER IMPLANTS, WHICH WERE CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT REMOVAL SURGERY ON (B)(6), 2023. THIS REPORT IS FOR THE RIGHT IMPLANT. REFER TO MANUFACTURING REPORT NUMBER 1645337-2023-09250 FOR THE CONTRALATERAL EVENT.

  Patient problems: Capsular Contracture; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17487651 ↗