MENTOR MemoryGel Breast Implant 3544250Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 00081317001027), received between Aug 29, 2018 and Sep 21, 2026 — classified as 31 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Rupture” (14 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 32 reports, in the reporter's own words as published by the FDA.

• InjurySep 21, 2026Material Rupture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50847358 ↗
• InjuryFeb 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH IMPLANTATION OF A 250CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT EXPERIENCED AN INFECTION OF AN UNDISCLOSED BREAST. AS A RESULT, THE PATIENT UNDERWENT DRAIN PLACEMENT WITHOUT IMPLANT REMOVAL/REPLACEMENT. NO FURTHER INFORMATION WAS PROVIDED. 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: Post Operative Wound Infection

  MAUDE report 24272845 ↗
• InjuryMay 20, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH A 200CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED LEFT SIDED RUPTURE WITH BREAST PAIN POST PROCEDURE. THIS WAS THOUGHT TO HAVE BEEN CAUSED BY A FALL. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Breast Discomfort/Pain; Crushing Injury

  MAUDE report 22057099 ↗
• InjuryJul 11, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE WITH A MENTOR MEMORYGEL BREAST IMPLANT 250CC GEL BREAST PROSTHESIS DEVELOPED PAIN WITH INFLAMMATION AND ERYTHEMA IN HER RIGHT BREAST POST IMPLANTATION. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION AND REPLACEMENT WITH A MENTOR MEMORYGEL BREAST IMPLANT 250CC GEL BREAST PROSTHESIS ON (B)(6) 2024. DURING EXPLANT SURGERY, IT WAS OBSERVED THAT THE REMOVED BREAST PROSTHESIS WAS RUPTURED.

  Patient problems: Local Reaction

  MAUDE report 19726826 ↗
• InjuryOct 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 66-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT REVISION BREAST AUGMENTATION WITH A 250CC MENTOR MEMORYGEL BREAST IMPLANT ON BOTH SIDES AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE; BAKER GRADE IV, AND FLUID AROUND THE IMPLANTS POSTOPERATIVELY. THE PATIENT HAS CONSULTED WITH THE MEDICAL PROFESSIONAL. AS A RESULT, THE DEVICES WERE EXPLANTED (B)(6) 2023. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT-SIDED DEVICE.

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

  MAUDE report 17981145 ↗
• InjuryOct 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 66-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT REVISION BREAST AUGMENTATION WITH A 250CC MENTOR MEMORYGEL BREAST IMPLANT ON BOTH SIDES AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE; BAKER GRADE IV, AND FLUID AROUND THE IMPLANTS POSTOPERATIVELY. THE PATIENT HAS CONSULTED WITH THE MEDICAL PROFESSIONAL. AS A RESULT, THE DEVICES WERE EXPLANTED (B)(6) 2023. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT-SIDED DEVICE.

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

  MAUDE report 17981144 ↗
• InjurySep 28, 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 AUGMENTATION REVISION SURGERY WITH IMPLANTATION OF A 250CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DISSATISFIED WITH HER SILICONE IMPLANTS. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL WITHOUT REPLACEMENTS ON (B)(6) 2023. DURING THE SURGERY, A RUPTURED RIGHT BREAST IMPLANT WAS DISCOVERED. THERE WERE NO REPORTED PROCEDURAL DELAYS OR PATIENT CONSEQUENCES DUE TO THE DISCOVERY. THE DATE OF IMPLANTATION 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 LEFT BREAST PROSTHESIS. REFER TO MANUFACTURING REPORT NUMBER 1645337-2023-09757 FOR THE CONTRALATERAL EVENT.

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

  MAUDE report 17839865 ↗
• InjurySep 20, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION WITH A 250CC MENTOR MEMORYGEL BREAST IMPLANT ON THE LEFT BREAST. POST-OPERATIVELY, THE PATIENT SUFFERED LEFT BREAST IMPLANT RUPTURE. AS A RESULT, THE PATIENT UNDERWENT BILATERAL BREAST IMPLANT REMOVAL AND REPLACEMENT SURGERY ON (B)(6) 2023. THE REPLACEMENT DEVICES WERE: (LEFT) 450CC MENTOR MEMORYGEL BREAST IMPLANT CATALOG: 3504504BC LOT: 9884237 SN: (B)(6), AND (RIGHT) 450CC MENTOR MEMORYGEL BREAST IMPLANT CATALOG: 3504504BC LOT: 9884237 SN: (B)(6).

  Patient problems: Deformity/ Disfigurement

  MAUDE report 17785650 ↗
• InjuryAug 21, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 70-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH IMPLANTATION OF A 250CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH A RUPTURED RIGHT BREAST IMPLANT BY A MEDICAL PROFESSIONAL. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL WITHOUT REPLACEMENTS ON (B)(6) 2023. THE DATE OF IMPLANTATION 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.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 17586443 ↗
• InjuryJan 20, 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 SURGERY WITH IMPLANTATION OF A 250CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH BAKER GRADE III CAPSULAR CONTRACTURE OF THE LEFT BREAST. AS A RESULT, THE PATIENT UNDERWENT UNILATERAL REMOVAL AND REPLACEMENT WITH A LEFT-SIDED 250CC MENTOR MEMORYGEL BREAST IMPLANT ON (B)(6) 2022.

  Patient problems: Capsular Contracture

  MAUDE report 16216603 ↗
• InjuryDec 14, 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 BREAST AUGMENTATION SURGERY WITH A 250CC MENTOR MEMORYGEL BREAST IMPLANT. POST-OPERATIVELY, THE PATIENT EXPERIENCED CAPSULAR CONTRACTURE OF AN UNSPECIFIED BAKER GRADE ON THE LEFT SIDE, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED 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: Capsular Contracture

  MAUDE report 15979019 ↗
• InjuryAug 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 59-YEAR-OLD CAUCASIAN FEMALE WHO UNDERWENT AN UNSPECIFIED BREAST SURGERY WITH A MENTOR MEMORYGEL, 225CC ON THE RIGHT AND 250CC ON THE LEFT, SILICONE BREAST IMPLANT EXPERIENCED RIGHT-SIDED SYMPTOMATIC RUPTURE, AND BILATERAL CAPSULAR CONTRACTURE, GRADE III ON THE RIGHT AND UNKNOWN GRADE ON THE LEFT SIDE POSTOPERATIVE. THE RUPTURE DISCOVERED BY MRI, AND MAMMOGRAM EXAMINATION. AS A RESULT, PATIENT UNDERWENT BILATERAL CAPSULECTOMY, BILATERAL MASTOPEXY AND BILATERAL REMOVAL ON (B)(6), 2022. THIS REPORT RELATES TO THE LEFT PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 15275527 ↗
• InjuryJan 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT, WHO'S UNDERGONE BREAST AUGMENTATION REVISION WITH A 250CC MENTOR MEMORYGEL BREAST IMPLANT ON THE LEFT BREAST, SUFFERED BREAST CAPSULAR CONTRACTURE (BAKER GRADE IV), POST-PROCEDURE. THE BREAST WAS CHARACTERIZED BY STIFFNESS AND PAIN. AS A RESULT, THE PATIENT UNDERWENT IMPLANT REMOVAL AND REPLACEMENT WITH A 250CC MENTOR MEMORYGEL BREAST IMPLANT (CATALOG: 3544250 LOT: 9547985 SN: (B)(4)) ON (B)(6) 2021.

  Patient problems: Capsular Contracture

  MAUDE report 13295666 ↗
• InjuryDec 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT BREAST AUGMENTATION WITH A 250CC MENTOR MEMORYGEL BREAST IMPLANT ON BOTH SIDES AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE; BAKER GRADE III. AS A RESULT, THE DEVICES WERE EXPLANTED ON AN UNKNOWN DATE. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT-SIDED DEVICE.

  Patient problems: Capsular Contracture

  MAUDE report 12955980 ↗
• InjuryDec 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT BREAST AUGMENTATION WITH A 250CC MENTOR MEMORYGEL BREAST IMPLANT ON BOTH SIDES AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE; BAKER GRADE III. AS A RESULT, THE DEVICES WERE EXPLANTED ON AN UNKNOWN DATE. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT-SIDED DEVICE.

  Patient problems: Capsular Contracture

  MAUDE report 12955927 ↗
• InjuryNov 2, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH A 250CC MENTOR MEMORYGEL BREAST IMPLANT (RIGHT) AND A 275CC MENTOR MEMORYGEL BREAST IMPLANT (LEFT) EXPERIENCED RIGHT SIDED RUPTURE AND SEVERAL UNEXPLAINED SYSTEMIC SYMPTOMS POST PROCEDURE. JOINT PAIN, SWELLING, FAINTING, DIFFICULTY CONCENTRATING, AN ABNORMAL GYNECOLOGIST VISIT, AND HAND TREMORS WERE NOTED. THE RUPTURE WAS DIAGNOSED THROUGH MAMMOGRAPHY. THE ROOT CAUSE OF THE PATIENT¿S OTHER SYMPTOMS IS UNCLEAR. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. SEE 1645337-2021-12204 FOR CONTRALATERAL PROSTHESIS REPORT.

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

  MAUDE report 12741467 ↗
• InjurySep 23, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR OLD FEMALE PATIENT, WHO'S UNDERGONE BREAST PROSTHESIS IMPLANTATION SURGERY WITH TWO 250CC MENTOR MEMORYGEL BREAST IMPLANTS, SUFFERED BILATERAL BREAST IMPLANT RUPTURES AND A RIGHT BREAST THAT HAS A BUBBLE OR WRINKLE THAT PROTRUDES, POST-PROCEDURE. THE RUPTURES WERE DIAGNOSED VIA CT SCAN. 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: Wrinkling

  MAUDE report 12520552 ↗
• InjurySep 23, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR OLD FEMALE PATIENT, WHO'S UNDERGONE BREAST PROSTHESIS IMPLANTATION SURGERY WITH TWO 250CC MENTOR MEMORYGEL BREAST IMPLANTS, SUFFERED BILATERAL BREAST IMPLANT RUPTURES AND A RIGHT BREAST THAT HAS A BUBBLE OR WRINKLE THAT PROTRUDES, POST-PROCEDURE. THE RUPTURES WERE DIAGNOSED VIA CT SCAN. 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 12520516 ↗
• InjuryAug 27, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A MENTOR MEMORYGEL BREAST IMPLANT 250CC AND SUFFERED FROM A BILATERAL RUPTURE. AS A RESULT, THE PATIENT HAD UNDERGONE REMOVAL AND REPLACEMENT WITH MENTOR MEMORYGEL BREAST IMPLANT 440CC ON (B)(6) 2021. THIS MEDWATCH IS FOR THE RIGHT SIDE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 12379764 ↗
• InjuryAug 27, 2021Material Rupture; Appropriate Device Problem Term/Code Not Available; Material Rupture; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A MENTOR MEMORYGEL BREAST IMPLANT 250CC AND SUFFERED FROM A BILATERAL RUPTURE. AS A RESULT, THE PATIENT HAD UNDERGONE REMOVAL AND REPLACEMENT WITH MENTOR MEMORYGEL BREAST IMPLANT 440CC ON (B)(6) 2021. THIS MEDWATCH IS FOR THE LEFT SIDE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 12379679 ↗
• InjuryJul 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) AFRICAN AMERICAN FEMALE PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION SURGERY WITH A 250CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED LEFT SIDED CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN POST PROCEDURE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Capsular Contracture

  MAUDE report 12147902 ↗
• InjuryJun 16, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(4) CAUCASIAN FEMALE PATIENT, WHO'S UNDERGONE PRIMARY BREAST AUGMENTATION WITH A (LEFT) 175CC MENTOR MEMORYGEL BREAST IMPLANT AND A (RIGHT) 250CC MENTOR MEMORYGEL BREAST IMPLANT, SUFFERED POSSIBLE RIGHT BREAST IMPLANT RUPTURE, BILATERAL CAPSULAR CONTRACTURES (BAKER GRADE IV ON THE RIGHT AND BAKER GRADE I ON THE LEFT), BREAST PAINT AND ROTATING IMPLANT, POST-PROCEDURE. THE COMPLICATIONS WERE DIAGNOSED VIA PHYSICAL EXAMINATION. AS A RESULT, THE PATIENT UNDERWENT IMPLANT EXPLANTATION AND POSSIBLE REPLACEMENT WITH MENTOR GEL IMPLANTS ON (B)(4) 2021. THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 12014169 ↗
• InjuryFeb 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE WHO UNDERWENT BREAST AUGMENTATION REVISION WITH A 250CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED BILATERAL BAKER¿S GRADE III CAPSULAR CONTRACTURE POST PROCEDURE. THE CAPSULAR CONTRACTURE WAS DIAGNOSED VIA ULTRASOUND EXAMINATIONS. AS A RESULT, PATIENT UNDERWENT BILATERAL REPLACEMENTS WITH UNKNOWN DEVICES ON (B)(6) 2019. THIS REPORT BELONGS TO ONE OF THE TWO PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 11311013 ↗
• InjuryJan 6, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT AN UNSPECIFIED BREAST SURGERY WITH MENTOR MEMORYGEL BREAST IMPLANT 250CC GEL BREAST PROSTHESES THAT BOTH RUPTURED AFTER IMPLANTATION. IT WAS REPORTED THAT BOTH BREAST PROSTHESES WERE LEAKING. 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 BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 11128753 ↗
• InjuryJan 6, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT AN UNSPECIFIED BREAST SURGERY WITH MENTOR MEMORYGEL BREAST IMPLANT 250CC GEL BREAST PROSTHESES THAT BOTH RUPTURED AFTER IMPLANTATION. IT WAS REPORTED THAT BOTH BREAST PROSTHESES WERE LEAKING. 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: Deformity/ Disfigurement

  MAUDE report 11128752 ↗