MENTOR MemoryGel Breast Implant 3505320BCRecalls & reported problems

Summary

The FDA's MAUDE database contains 101 adverse event reports that list this exact device (DI 00081317006916), received between May 14, 2019 and Sep 29, 2026 — classified as 90 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (50 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 101 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2026Material Rupture

  It was reported that a 38-year-old female patient underwent primary breast augmentation with 320cc MENTOR MemoryGel Breast Implant and experienced breast implant rupture on her right side postoperatively; diagnosed via MRI and virtual visit. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50937461 ↗
• InjurySep 25, 2026Material Discolored; Adverse Event Without Identified Device or Use Problem

  Patient problems: Breast Discomfort/Pain

  MAUDE report 50902722 ↗
• InjurySep 18, 2026Migration

  Patient problems: Deformity/ Disfigurement

  MAUDE report 50829637 ↗
• InjurySep 18, 2026Migration

  Patient problems: Deformity/ Disfigurement

  MAUDE report 50829471 ↗
• InjuryOct 29, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 42-YEAR-OLD FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 320CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED A RUPTURE ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS DIAGNOSED WITH A PHYSICAL EXAM AND MRI. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 23415988 ↗
• MalfunctionOct 16, 2025Material Rupture; Material Rupture

  A FEMALE PATIENT WHO UNDERWENT A BREAST AUGMENTATION PRIMARY WITH A MENTOR MEMORYGEL, 320CC SILICONE PROSTHESIS EXPERIENCE LEFT SIDED RUPTURE INTRAOPERATIVE. DURING THE INSERTION OF THE IMPLANT, THE GEL IS EVIDENT COMING OUT. NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23312501 ↗
• InjuryAug 27, 2025Material Rupture; Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Material Rupture; Use of Device Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 39-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A 320CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED A RUPTURE ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS DIAGNOSED WITH AN MRI. AS A RESULT, THE PATIENT IS TO UNDERGO DEVICE EXPLANTATION ON (B)(6) 2025.

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

  MAUDE report 22903762 ↗
• InjuryAug 22, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 320CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA PHYSICAL EXAMINATION, WITH BILATERAL BREAST CAPSULAR CONTRACTURES (BAKER GRADE III), RIGHT BREAST PTOSIS, PALPABLE LYMPH NODE AND BREAST PAIN. THERE IS ALSO A SUSPECTED INFECTION. AS A RESULT, THE PATIENT UNDERWENT BILATERAL BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2025. DURING THE SURGERY, IT WAS DISCOVERED THAT THE PATIENT'S IMPLANTS WERE RUPTURED BILATERALLY AND THAT THEY ALSO HAD BILATERAL PERI-PROSTHETIC SEROMA. THE IMPLANTS WERE NOT REPLACED. THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS.

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

  MAUDE report 22876483 ↗
• InjuryAug 22, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 320CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA PHYSICAL EXAMINATION, WITH BILATERAL BREAST CAPSULAR CONTRACTURES (BAKER GRADE III), RIGHT BREAST PTOSIS, PALPABLE LYMPH NODE AND BREAST PAIN. THERE IS ALSO A SUSPECTED INFECTION. AS A RESULT, THE PATIENT UNDERWENT BILATERAL BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2025. DURING THE SURGERY, IT WAS DISCOVERED THAT THE PATIENT'S IMPLANTS WERE RUPTURED BILATERALLY AND THAT THEY ALSO HAD BILATERAL PERI-PROSTHETIC SEROMA. THE IMPLANTS WERE NOT REPLACED. THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS.

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

  MAUDE report 22876459 ↗
• InjuryAug 11, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 320CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED A RUPTURE ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 22772367 ↗
• InjuryAug 7, 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 BREAST AUGMENTATION REVISION PROCEDURE WITH A MENTOR MEMORYGEL BREAST IMPLANT 320CC GEL BREAST PROSTHESIS DEVELOPED BAKER GRADE III CAPSULAR CONTRACTURE IN HER RIGHT BREAST POST IMPLANTATION. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH MENTOR MEMORYGEL BREAST IMPLANT 350CC GEL BREAST PROSTHESES ON (B)(6) 2025.

  Patient problems: Capsular Contracture

  MAUDE report 22745675 ↗
• InjuryJul 29, 2025Material Rupture; Material Rupture

  A FEMALE PATIENT WHO UNDERWENT BREAST RECONSTRUCTION REVISION WITH MENTOR MEMORYGEL ,320CC SILICONE PROSTHESIS EXPERIENCE LEFT SIDED SILENT RUPTURE POST PROCEDURE. AS A RESULT. PATIENT UNDERWENT UNILATERAL REPLACEMENT WITH L) CN 350-5320, SN (B)(6) ON (B)(6) 2025.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 22650642 ↗
• InjuryApr 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 32-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH 320CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED CAPSULAR CONTRACTURE; BAKER GRADE III ON HER RIGHT SIDE POSTOPERATIVELY; DIAGNOSED IN THE OFFICE. THE PATIENT HAS CONSULTED WITH THE HEALTHCARE PROFESSIONAL. AS A RESULT, THE PATIENT IS SCHEDULED FOR SURGERY ON (B)(6) 2025.

  Patient problems: Capsular Contracture

  MAUDE report 21749157 ↗
• InjuryFeb 18, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 320CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA MRI, WITH BILATERAL BREAST IMPLANT RUPTURES. 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: Deformity/ Disfigurement

  MAUDE report 21405228 ↗
• InjuryFeb 7, 2025Device Damaged Prior to Receipt by User; Device Damaged Prior to Receipt by User

  A FEMALE PATIENT WHO UNDERWENT AN UNSPECIFIED BREAST SURGERY INVOLVING A MENTOR MEMORYGEL, 320 CC SILICONE PROSTHESIS ENCOUNTERED A DELIVERY SERVICE ISSUE RELATED TO THE PROSTHETIC DEVICE. HEALTHCARE PROVIDER (HCP) REPORTED A SITUATION WHERE AN ORDER FOR OVERNIGHT SHIPPING WAS PLACED, BUT THE DELIVERY DID NOT ARRIVE WITHIN THE REQUESTED TIMEFRAME, SPECIFICALLY AFTER THE 10:30 AM WINDOW. CONSEQUENTLY, THE SURGERY HAD TO BE POSTPONED DUE TO THE LATE DELIVERY BY FEDEX. AT THIS TIME, NO FURTHER INFORMATION IS AVAILABLE REGARDING THE INCIDENT. THIS REPORT SPECIFICALLY PERTAINS TO ONE OF THE TWO SIDES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21335942 ↗
• InjuryFeb 7, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT PRIMARY BREAST RECONSTRUCTION WITH A 320CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED RIGHT SIDED RUPTURE POST PROCEDURE. AS A RESULT, EXPLANT WAS PERFORMED ON (B)(6) 2025.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 21332410 ↗
• InjuryDec 6, 2024Adverse 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 TWO 320CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT SUFFERED RIGHT BREAST CAPSULAR CONTRACTURE (BAKER GRADE III) AND LEFT BREAST SLIGHT LOOSENING, LATERALIZATION, AND ASYMMETRY. AS A RESULT, THE PATIENT UNDERWENT BILATERAL BREAST IMPLANT REMOVAL AND REPLACEMENT SURGERY ON (B)(6) 2024. THE REPLACEMENT DEVICES WERE: (RIGHT) 335CC MENTOR MEMORYGEL XTRA BREAST IMPLANT CATALOG: SHPX335 LOT: 9933765, SN: (B)(6) AND (LEFT) 335CC MENTOR MEMORYGEL XTRA BREAST IMPLANT CATALOG: SHPX335 LOT: 9933765 SN: (B)(6). THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 20861705 ↗
• InjuryDec 6, 2024Adverse 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 TWO 320CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT SUFFERED RIGHT BREAST CAPSULAR CONTRACTURE (BAKER GRADE III) AND LEFT BREAST SLIGHT LOOSENING, LATERALIZATION, AND ASYMMETRY. AS A RESULT, THE PATIENT UNDERWENT BILATERAL BREAST IMPLANT REMOVAL AND REPLACEMENT SURGERY ON OCTOBER 24, 2024. THE REPLACEMENT DEVICES WERE: (RIGHT) 335CC MENTOR MEMORYGEL XTRA BREAST IMPLANT CATALOG: SHPX335 LOT: 9933765 SN: (B)(6) AND (LEFT) 335CC MENTOR MEMORYGEL XTRA BREAST IMPLANT CATALOG: SHPX335 LOT: 9933765 SN: (B)(6) THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 20861587 ↗
• InjuryDec 5, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 320CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT REPORTED SHE WAS DIAGNOSED WITH A RUPTURED RIGHT BREAST IMPLANT USING MAGNETIC RESONANCE IMAGING. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT WITH A LEFT-SIDED 355CC MENTOR MEMORYGEL XTRA BREAST IMPLANT AND A RIGHT-SIDED 350CC MENTOR MEMORYGEL BREAST IMPLANT ON  (B)(6) 2024.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 20859631 ↗
• InjuryDec 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 320CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH BILATERAL BAKER GRADE III CAPSULAR CONTRACTURE OF THE BREASTS DURING A PHYSICAL EXAM WITH A MEDICAL PROFESSIONAL. 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: Cancer; Capsular Contracture

  MAUDE report 20834052 ↗
• InjuryDec 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 320CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH BILATERAL BAKER GRADE III CAPSULAR CONTRACTURE OF THE BREASTS DURING A PHYSICAL EXAM WITH A MEDICAL PROFESSIONAL. 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: Cancer; Capsular Contracture

  MAUDE report 20834028 ↗
• InjuryNov 27, 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 320CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED CAPSULAR CONTRACTURE BAKER GRADE 3 ON THE RIGHT SIDE POST-OPERATIVELY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Capsular Contracture

  MAUDE report 20791474 ↗
• InjuryNov 12, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH A MENTOR MEMORYGEL BREAST IMPLANT 320CC GEL BREAST PROSTHESIS DEVELOPED A POSSIBLE INFECTION IN HER LEFT BREAST POST IMPLANTATION. IT WAS REPORTED THAT THE PATIENT PRESENTED WITH GENERAL MALAISE AND FEVER. A DRAIN WAS REMOVED AND IT CAME OUT WITH SILICONE GEL RESIDUE. RUPTURE OF THE BREAST PROSTHESIS WAS SUSPECTED. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION AND REPLACEMENT WITH A MENTOR MEMORYGEL BREAST IMPLANT 320CC GEL BREAST PROSTHESIS ON (B)(6) 2024. RUPTURE OF THE BREAST PROSTHESIS WAS CONFIRMED DURING EXPLANT SURGERY.

  Patient problems: Post Operative Wound Infection

  MAUDE report 20668402 ↗
• InjuryOct 30, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE WHO UNDERWENT A BREAST RECONSTRUCTION PRIMARY WITH MENTOR MEMORYGEL, 320CC SILICONE PROSTHESIS EXPERIENCED RIGHT-SIDED SYMPTOMATIC RUPTURE, AND DEVICE EXTRUSION POSTOPERATIVE. THE PATIENT COMES TO CONSULTATION WITH AN OPEN WOUND FROM WHICH A GEL APPEARS. AN ULTRASOUND IS PERFORMED, AND A RUPTURE IS OBSERVED. AS A RESULT, PATIENT UNDERWENT REMOVAL ON (B)(6) 2024.

  Patient problems: Pocket Erosion

  MAUDE report 20569707 ↗
• InjuryOct 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 80-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT REVISION BREAST AUGMENTATION WITH 320CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED CAPSULAR CONTRACTURE; BAKER GRADE IV ON HER RIGHT SIDE POSTOPERATIVELY; DIAGNOSED AFTER PHYSICAL EXAM. 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

  MAUDE report 20569409 ↗