MENTOR MemoryGel Breast Implant 3505350BCRecalls & reported problems

Summary

The FDA's MAUDE database contains 155 adverse event reports that list this exact device (DI 00081317006923), received between Oct 3, 2019 and Sep 17, 2026 — classified as 132 injuries, 23 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (56 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 155 reports, in the reporter's own words as published by the FDA.

• InjurySep 17, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Deformity/ Disfigurement

  MAUDE report 50811270 ↗
• InjuryAug 19, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient underwent a Primary Breast Augmentation Surgery with implantation of a 350cc MENTOR MemoryGel Breast Implant prosthesis. Post-operatively, the patient reported experiencing a hard right breast with intermittent pain/discomfort and red skin around the breast. A consultation with a medical professional and Mammogram Imaging were conducted. At the time of this report, Mentor has received no information regarding explantation or an expected explantation date.The date of event was provided to Mentor as a best estimate.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; Skin Inflammation/ Irritation

  MAUDE report 50329314 ↗
• InjuryApr 16, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 33-YEAR-OLD FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 350CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED CAPSULAR CONTRACTURE (BAKER GRADE 4) ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS DIAGNOSED WITH A PHYSICAL EXAM. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Capsular Contracture

  MAUDE report 24899547 ↗
• InjuryApr 7, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 48-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A 350CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED BREAST PAIN AND EXCESSIVE SCAR FORMATION ON THE LEFT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2026, AND REPLACED WITH A 430CC MENTOR MEMORYGEL XTRA BREAST IMPLANT.

  Patient problems: Breast Discomfort/Pain; Scar Tissue

  MAUDE report 24811016 ↗
• InjuryMar 25, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH TWO 350CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED BILATERAL CAPSULAR CONTRACTURE (BAKER GRADE 3) POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2026.

  Patient problems: Capsular Contracture

  MAUDE report 24690706 ↗
• InjuryDec 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 48-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A 350CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED CAPSULAR CONTRACTURE (BAKER GRADE 3) ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS DIAGNOSED WITH AN EXAM. AS A RESULT, THE PATIENT IS TO UNDERGO DEVICE EXPLANTATION ON (B)(6) 2026.

  Patient problems: Capsular Contracture

  MAUDE report 23720883 ↗
• MalfunctionSep 10, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 350CC MENTOR MEMORYGEL BREAST IMPLANT WAS FOUND TO BE RUPTURED DURING AN OPERATION. NO ADVERSE EVENT WAS EXPERIENCED BY THE PATIENT. THE SURGEON USED BACKUP DEVICES, AND THERE WERE NO REPORTED PATIENT CONSEQUENCES OR PROCEDURAL DELAYS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23020603 ↗
• InjuryJul 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH TWO 350CC MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED BILATERAL BREAST PAIN POST-OPERATIVELY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Breast Discomfort/Pain

  MAUDE report 22555871 ↗
• InjuryJul 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH TWO 350CC MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED BILATERAL BREAST PAIN POST-OPERATIVELY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Breast Discomfort/Pain

  MAUDE report 22555869 ↗
• InjuryMay 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 PRIMARY BREAST AUGMENTATION WITH 350CC MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED BILATERAL CAPSULAR CONTRACTURE AND RIGHT SIDED RUPTURE POST PROCEDURE. THE RIGHT SIDED CAPSULAR CONTRACTURE WAS BAKER GRADE III. THE LEFT SIDED CAPSULAR CONTRACTURE WAS BAKER GRADE II. AS A RESULT, BILATERAL PROSTHESIS REPLACEMENT WITH MENTOR GEL WAS PERFORMED.

  Patient problems: Capsular Contracture

  MAUDE report 21978263 ↗
• InjuryMar 28, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNSPECIFIED BREAST SURGERY WITH A MENTOR MEMORYGEL BREAST IMPLANT 350CC GEL BREAST PROSTHESIS (LEFT DEVICE) AND A MENTOR MEMORYGEL BREAST IMPLANT 375CC GEL BREAST PROSTHESIS (RIGHT DEVICE) THAT BOTH RUPTURED POST IMPLANTATION. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH A MENTOR MEMORYGEL BREAST IMPLANT 320CC GEL BREAST PROSTHESIS AND A MENTOR MEMORYGEL BREAST IMPLANT 400CC GEL BREAST PROSTHESIS ON (B)(6) 2025. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 21722342 ↗
• 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 PRIMARY BREAST AUGMENTATION WITH A 350CC MENTOR MEMORYGEL BREAST IMPLANT ON THE LEFT BREAST. POST-OPERATIVELY, THE PATIENT SUFFERED LEFT BREAST CAPSULAR CONTRACTURE (BAKER GRADE UNKNOWN). AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Capsular Contracture

  MAUDE report 21715507 ↗
• InjuryMar 4, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH MENTOR MEMORYGEL BREAST IMPLANTS 350CC AND EXPERIENCED BREAST PAIN AND RUPTURE ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH A SIMILAR DEVICE ON (B)(6) 2024.

  Patient problems: Breast Discomfort/Pain

  MAUDE report 21515654 ↗
• 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, 320CC 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 21336137 ↗
• MalfunctionNov 27, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 350CC MENTOR MEMORYGEL BREAST IMPLANT RUPTURED INTRA-OPERATIVELY, DURING A PRIMARY BREAST AUGMENTATION. THERE WAS NO REPORT OF ADVERSE EVENT OR PATIENT CONSEQUENCE. ANOTHER UNSPECIFIED IMPLANT WAS PLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20799559 ↗
• InjuryNov 20, 2024Migration; Migration

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH A MENTOR MEMORYGEL BREAST IMPLANT 350CC GEL BREAST PROSTHESES DEVELOPED CAPSULAR CONTRACTURE IN BOTH BREASTS POST IMPLANTATION (BAKER GRADE II IN LEFT BREAST, BAKER GRADE III IN RIGHT BREAST). ADDITIONALLY, THE BREAST PROSTHESES BOTH MIGRATED. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION ON AN UNKNOWN DATE. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 20738805 ↗
• InjuryNov 20, 2024Migration; Migration

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH A MENTOR MEMORYGEL BREAST IMPLANT 350CC GEL BREAST PROSTHESES DEVELOPED CAPSULAR CONTRACTURE IN BOTH BREASTS POST IMPLANTATION (BAKER GRADE II IN LEFT BREAST, BAKER GRADE III IN RIGHT BREAST). ADDITIONALLY, THE BREAST PROSTHESES BOTH MIGRATED. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION ON AN UNKNOWN DATE. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 20738257 ↗
• InjuryNov 8, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH A MENTOR MEMORYGEL BREAST IMPLANT 350CC GEL BREAST PROSTHESIS DEVELOPED CAPSULAR CONTRACTURE (BAKER GRADE UNKNOWN) IN HER RIGHT BREAST POST IMPLANTATION. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION WITH NO REPLACEMENT BREAST PROSTHESES ON (B)(6) 2024. DURING EXPLANT SURGERY, IT WAS OBSERVED THAT THE REMOVED RIGHT BREAST PROSTHESIS WAS RUPTURED.

  Patient problems: Capsular Contracture

  MAUDE report 20642435 ↗
• MalfunctionOct 29, 2024Gel Leak; Gel Leak

  IT WAS REPORTED THAT A 350CC MENTOR MEMORYGEL BREAST IMPLANT HAD GEL BLEED INTRAOPERATIVELY. A STICKY, OILY, SILICONE RESIDUE WAS FELT ON THE OUTSIDE OF THE DEVICE OUT OF THE BOX. THE DEVICE DID NOT CONTACT THE PATIENT. THE PROCEDURE WAS CONTINUED USING A BACKUP WITHOUT PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20561680 ↗
• InjuryOct 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH MENTOR MEMORYGEL BREAST IMPLANTS 350CC AND EXPERIENCED CAPSULAR CONTRACTURE BAKER GRADE III ON THE RIGHT SIDE POST-OPERATIVELY, 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.

  Patient problems: Capsular Contracture

  MAUDE report 20384486 ↗
• InjurySep 30, 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 350CC MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED GENERALIZED ILLNESS SYMPTOMS. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2024.

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

  MAUDE report 20335909 ↗
• InjurySep 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 350C MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT EXPERIENCED A PAINFUL, TENSE, AND HARD LEFT BREAST. SHE WAS DIAGNOSED WITH LEFT BREAST BAKER GRADE IV CAPSULAR CONTRACTURE BY A MEDICAL PROFESSIONAL. AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL ON (B)(6) 2024.

  Patient problems: Capsular Contracture

  MAUDE report 20295452 ↗
• InjurySep 18, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH MENTOR MEMORYGEL BREAST IMPLANTS 350CC AND EXPERIENCED RUPTURE ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED VIA ULTRASOUND/MRI. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH SIMILAR DEVICES ON (B)(6) 2024.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 20251500 ↗
• InjurySep 17, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH A 350CC MENTOR MEMORYGEL BREAST IMPLANT ON THE RIGHT BREAST. POST-OPERATIVELY, THE PATIENT SUFFERED RIGHT BREAST IMPLANT RUPTURE. AS A RESULT, THE PATIENT UNDERWENT BILATERAL BREAST IMPLANT REMOVAL AND REPLACEMENT SURGERY ON (B)(6) 2024. THE REPLACEMENT DEVICES WERE: (RIGHT) 350CC MENTOR MEMORYGEL BREAST IMPLANT CATALOG: 3545350, LOT: 9950200, SN: (B)(6) AND (LEFT) 350CC MENTOR MEMORYGEL BREAST IMPLANT CATALOG: 3545350, LOT: 9950200, SN: (B)(6).

  Patient problems: Deformity/ Disfigurement

  MAUDE report 20240387 ↗
• InjuryJul 23, 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 350CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT REPORTED EXPERIENCING MIGRAINES AND BACK ACHES DUE THE IMPLANTS BEING TOO BIG FOR HER BODY AND HER BREASTS ARE DROPPING. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THE DATE OF EVENT 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; Pain

  MAUDE report 19810435 ↗