MENTOR MemoryGel Breast Implant 3545251Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00081317003908), received between Jun 5, 2019 and Mar 22, 2024 — classified as 11 injuries.

The most frequently reported specific device problem is “Material Rupture” (3 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryMar 22, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 39-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A 525CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED A BREAST MASS AND A RUPTURE ON THE RIGHT SIDE POST-OPERATIVELY. THE PATIENT MENTIONING HAVING A LUMP ON THE TOP RIGHT SIDE AND FEARED WHAT IT COULD BE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Breast Mass

  MAUDE report 18961784 ↗
• InjuryApr 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 36-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT REVISION BREAST RECONSTRUCTION SURGERY WITH 525CC MENTOR MEMORYGEL BREAST IMPLANT ON BOTH SIDES AND EXPERIENCED RIGHT SIDE CAPSULAR CONTRACTURE; BAKER GRADE IV, AND LEFT SIDE BREAST MASS, BREAST PAIN, CUTANEOUS CONTOUR DEFORMITY, CHANGED SHAPE AND PTOSIS 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; Hematoma

  MAUDE report 16678389 ↗
• InjuryApr 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 36-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT REVISION BREAST RECONSTRUCTION SURGERY WITH 525CC MENTOR MEMORYGEL BREAST IMPLANT ON BOTH SIDES AND EXPERIENCED RIGHT SIDE CAPSULAR CONTRACTURE; BAKER GRADE IV, AND LEFT SIDE BREAST MASS, BREAST PAIN, CUTANEOUS CONTOUR DEFORMITY, CHANGED SHAPE AND PTOSIS 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: Breast Discomfort/Pain; Breast Mass; Deformity/ Disfigurement; Wrinkling

  MAUDE report 16678388 ↗
• InjurySep 23, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 45-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH TWO 525CC MENTOR MEMORYGEL BREAST IMPLANTS AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE (BAKER GRADE 4) AND A RUPTURE AND SEROMA ON THE RIGHT SIDE 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; Seroma

  MAUDE report 15470442 ↗
• InjurySep 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 45-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH TWO 525CC MENTOR MEMORYGEL BREAST IMPLANTS AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE (BAKER GRADE 4) AND A RUPTURE AND SEROMA ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6), 2022. THIS REPORT IS FOR THE LEFT SIDE DEVICE.

  Patient problems: Capsular Contracture

  MAUDE report 15470234 ↗
• InjuryJan 4, 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 UNDERWENT AN UNSPECIFIED BREAST SURGERY WITH MENTOR MEMORYGEL BREAST IMPLANT 525CC GEL BREAST PROSTHESES AND SUFFERED SEVERAL UNEXPLAINED SYSTEMIC SYMPTOMS, INCLUDING PAIN, LEFT BREAST IS SWOLLEN AND HARDER THAN RIGHT BREAST, A STABBING & BURNING PAIN IN LEFT BREAST, PAINFUL SWOLLEN LYMPH NODES, NECK AND BACK PAIN ON HER LEFT SIDE, AND SKIN RASH ON LEFT BREAST. NO DEVICE ISSUE SUCH AS RUPTURE WAS REPORTED. 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. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT BREAST PROSTHESIS.

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

  MAUDE report 13161234 ↗
• InjuryJan 4, 2022Adverse 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 AN UNSPECIFIED BREAST SURGERY WITH MENTOR MEMORYGEL BREAST IMPLANT 525CC GEL BREAST PROSTHESES AND SUFFERED SEVERAL UNEXPLAINED SYSTEMIC SYMPTOMS, INCLUDING PAIN, LEFT BREAST IS SWOLLEN AND HARDER THAN RIGHT BREAST, A STABBING & BURNING PAIN IN LEFT BREAST, PAINFUL SWOLLEN LYMPH NODES, NECK AND BACK PAIN ON HER LEFT SIDE, AND SKIN RASH ON LEFT BREAST.. NO DEVICE ISSUE SUCH AS RUPTURE WAS REPORTED. 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. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT BREAST PROSTHESIS.

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

  MAUDE report 13161233 ↗
• InjurySep 22, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED (VIA FDA MEDWATCH MW5088610) THAT A PATIENT OF UNKNOWN AGE WHO UNDERWENT BREAST PROSTHESES IMPLANTATION WITH UNKNOWN SALINE IMPLANTS DURING THE 1980S IS EXPERIENCING HEALTH ISSUES THAT SHE BELIEVES ARE A RESULT OF THE DISINTEGRATION OF HER IMPLANTS IMPLANTED IN THE 1980S. THE PATIENT REPORTED RHEUMATOID ARTHRITIS AND FIBROMYALGIA. THE PATIENT ALSO REPORTED A COMPLETE MASTECTOMY OF HER RIGHT BREAST (PRESUMED TO BE DUE TO A MALIGNANT NEOPLASM) AND UNDERWENT EXPLANTATION OF THESE DEVICES ON AN UNKNOWN DATE. MEDWATCH REPORTS FOR THESE SALINE DEVICES WERE SUBMITTED TO THE FDA UNDER MANUFACTURER REPORT NUMBERS 1645337-2019-19837 AND 1645337-2019-19838. THE PATIENT REPORTED THAT SHE SAW ABOUT A 50% DECREASE IN HER HEALTH ISSUES POST MASTECTOMY. THE PATIENT REPORTED SHE FELT BETTER THAN SHE HAD IN YEARS AND HAD STOPPED PAIN MEDICATION WITHIN 3 DAYS OF MASTECTOMY. THE PATIENT THEN UNDERWENT EXPANSION AND "SILICONE FILLS" WITH UNKNOWN BRAND TISSUE EXPANDERS, AND FOLLOWING THAT, IMPLANTATION WITH A MENTOR MEMORYGEL BREAST IMPLANT 525CC GEL BREAST PROSTHESIS AND A MENTOR MEMORYGEL BREAST IMPLANT 600CC GEL BREAST PROSTHESIS ON (B)(6) 2017. THE PATIENT REPORTED THAT WITHIN WEEKS

  Patient problems: Autoimmune Reaction

  MAUDE report 9101409 ↗
• InjurySep 20, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT WITH A HISTORY OF CHRONIC LYMPHOCYTIC LEUKEMIA DIAGNOSED IN 2003 WHO UNDERWENT BREAST AUGMENTATION REVISION WITH 525CC MENTOR MEMORYGEL BREAST IMPLANT PRESENTED TO PHYSICIAN'S OFFICE STATING THAT SHE BEGAN RUNNING A FEVER, RIGHT BREAST WAS PAINFUL, BREASTS BEGAN HARDENING, AND IT FELT LIKE HER RIGHT BREAST GOT MUCH LARGER. UPON EXAMINATION OF THE RIGHT BREAST, IT WAS NOTED TO BE TENDER, LARGE, SWOLLEN, MILDLY WARMER THAN LEFT WITH SLIGHT ERYTHEMA IN DEPENDENT PORTIONS. THE PATIENT WAS ASSESSED AS HAVING BAKER GRADE IV CAPSULAR CONTRACTURE OF THE RIGHT BREAST AND BAKER GRADE III CAPSULAR CONTRACTURE OF THE LEFT BREAST. THE PATIENT HAD A PET SCAN ON (B)(6) 2019 THAT SHOWED FLUID IN THE RIGHT BREAST. THE PATIENT UNDERWENT BILATERAL REMOVAL OF THE IMPLANTS, BILATERAL REMOVAL OF CAPSULES, AND BILATERAL REPLACEMENT WITH SMOOTH SILICONE UNKNOWN BRAND BREAST IMPLANTS ON (B)(6) 2019. UPON EXPLANTATION, IT WAS NOTED VIA GROSS EXAMINATION THAT THE RIGHT IMPLANT WAS RUPTURED AND THE LEFT IMPLANT WAS INTACT. BOTH THE LEFT AND RIGHT SIDE CAPSULES SHOWED CHRONIC LYMPHOCYTIC LEUKEMIA/SLL, SILICONE GRANULOMA, AND FIBROSIS. THIS MEDWATC

  Patient problems: Cancer; Capsular Contracture; Granuloma; Lymphoma; No Code Available; Seroma

  MAUDE report 9101367 ↗
• InjurySep 20, 2019Gel Leak; Gel Leak

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT WITH A HISTORY OF CHRONIC LYMPHOCYTIC LEUKEMIA DIAGNOSED IN 2003 WHO UNDERWENT BREAST AUGMENTATION REVISION WITH 525CC MENTOR MEMORYGEL BREAST IMPLANT PRESENTED TO PHYSICIAN'S OFFICE STATING THAT SHE BEGAN RUNNING A FEVER, RIGHT BREAST WAS PAINFUL, BREASTS BEGAN HARDENING, AND IT FELT LIKE HER RIGHT BREAST GOT MUCH LARGER. UPON EXAMINATION OF THE RIGHT BREAST, IT WAS NOTED TO BE TENDER, LARGE, SWOLLEN, MILDLY WARMER THAN LEFT WITH SLIGHT ERYTHEMA IN DEPENDENT PORTIONS. THE PATIENT WAS ASSESSED AS HAVING BAKER GRADE IV CAPSULAR CONTRACTURE OF THE RIGHT BREAST AND BAKER GRADE III CAPSULAR CONTRACTURE OF THE LEFT BREAST. THE PATIENT HAD A PET SCAN ON (B)(6) 2019 THAT SHOWED FLUID IN THE RIGHT BREAST. THE PATIENT UNDERWENT BILATERAL REMOVAL OF THE IMPLANTS, BILATERAL REMOVAL OF CAPSULES, AND BILATERAL REPLACEMENT WITH SMOOTH SILICONE UNKNOWN BRAND BREAST IMPLANTS ON (B)(6) 2019. UPON EXPLANTATION, IT WAS NOTED VIA GROSS EXAMINATION THAT THE RIGHT IMPLANT WAS RUPTURED AND THE LEFT IMPLANT WAS INTACT. BOTH THE LEFT AND RIGHT SIDE CAPSULES SHOWED CHRONIC LYMPHOCYTIC LEUKEMIA/SLL, SILICONE GRANULOMA, AND FIBROSIS. THIS MEDWATC

  Patient problems: Cancer; Capsular Contracture; Lymphoma; No Code Available

  MAUDE report 9101357 ↗
• InjuryJun 5, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT REVISION BREAST AUGMENTATION WITH 525CC MENTOR MEMORYGEL BREAST IMPLANT AND WAS PRESENTED WITH RIGHT SIDE CAPSULAR CONTRACTURE; BAKER GRADE III ON (B)(6)2019. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Capsular Contracture

  MAUDE report 8670209 ↗