MENTOR MemoryGel Breast Implant 3504254BCRecalls & reported problems

Summary

The FDA's MAUDE database contains 1,300 adverse event reports that list this exact device (DI 00081317000518), received between May 4, 2018 and Sep 30, 2026 — classified as 1,294 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (513 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 1,300 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient implanted with a 425cc MENTOR MemoryGel Breast Implant experienced ptosis on the left side post-operatively. At the time of this report, Mentor has received no information regarding explantation or an expected explantation date.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 50947605 ↗
• InjurySep 29, 2026Material Rupture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50938805 ↗
• InjurySep 22, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient with MENTOR MemoryGel Breast Implants 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 50858158 ↗
• InjurySep 21, 2026Material Rupture

  It was reported that a patient underwent a primary breast augmentation procedure with a MENTOR MemoryGel Breast Implant gel breast prosthesis that ruptured post implantation. Rupture of the patient¿s left breast prosthesis was diagnosed via ultrasound. As a result, the patient is scheduled to undergo explantation.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50845727 ↗
• InjurySep 17, 2026Adverse Event Without Identified Device or Use Problem

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

  MAUDE report 50811169 ↗
• InjurySep 16, 2026Material Rupture

  It was reported that a patient with MENTOR MemoryGel Breast Implants experienced rupture on the right side post-operatively, which was confirmed during a physical exam. As a result, the patient underwent device removal and replacement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50791089 ↗
• InjurySep 10, 2026Gel Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50722455 ↗
• InjurySep 10, 2026Material Rupture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50722453 ↗
• InjurySep 9, 2026Material Rupture

  It was reported that a patient implanted with a 425cc MENTOR MemoryGel Breast Implant experienced capsular contracture Baker Grade 4 and a rupture on the right side post-operatively. As a result, the patient underwent explantation on (b)(6)2026.

  Patient problems: Capsular Contracture

  MAUDE report 50696087 ↗
• InjurySep 9, 2026Migration

  It was reported that a patient underwent a Primary Breast Augmentation Surgery with implantation of a 425cc MENTOR MemoryGel Breast Implant prosthesis. Post-operatively, the patient was diagnosed with a ruptured left implant using Magnetic Resonance Imaging after noticing an abnormal shape to the left breast. During a physical exam, the implants were noted to have dropped and bottomed out. As a result, the patient underwent bilateral exchange with Mentor gel implants on (b)(6) 2026.This report is for the right breast prosthesis.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 50693766 ↗
• InjuryAug 6, 2026Material Rupture

  A female patient who underwent Breast Augmentation Revisionwith MENTOR MemoryGel 423cc Silicone prosthesis experienced bilateral silent ruptures post implantation. The issue was confirmed through MRI examination. At the time of this report, Mentor received no information regarding explantation or an expected explantation date. This report related to the right side.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50161289 ↗
• InjuryAug 6, 2026Material Rupture

  A female patient who underwent Breast Augmentation Revisionwith MENTOR MemoryGel 423cc Silicone prosthesis experienced bilateral silent ruptures post implantation. The issue was confirmed through MRI examination. At the time of this report, Mentor received no information regarding explantation or an expected explantation date. This report related to the left side.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50161251 ↗
• InjuryJul 29, 2026Material Rupture

  It was reported that a 41-year-old female patient underwent a primary breast augmentation with a 425cc MENTOR MemoryGel Breast Implant and experienced a rupture on the left side post-operatively, which was diagnosed during surgery. The patient underwent explantation on (b)(6) 2026.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50073221 ↗
• InjuryJul 28, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient with MENTOR MemoryGel Xtra Breast Implants experienced capsular contracture Baker Grade III on the right side post-operatively, which was confirmed during a physical exam. As a result, the patient is scheduled for removal on (b)(6) 2026.

  Patient problems: Capsular Contracture

  MAUDE report 50058556 ↗
• InjuryJul 27, 2026Migration

  It was reported that a patient underwent a primary breast augmentation procedure with MENTOR MemoryGel Breast Implant gel breast prostheses developed Baker Grade III capsular contracture in her left breast post implantation. Additionally, the patient suffered from lateral drift of the right breast prosthesis. As a result, the patient underwent bilateral explantation and replacement with MENTOR MemoryGel Breast Implant gel breast prostheses.This MedWatch report is for the patient¿s right breast prosthesis.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 50028103 ↗
• InjuryMay 28, 2026Material Rupture

  IT WAS REPORTED THAT A 35-YEAR-OLD ASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 425CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED A RUPTURE 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: Deformity/ Disfigurement

  MAUDE report 25317693 ↗
• InjuryMay 22, 2026Adverse Event Without Identified Device or Use Problem

  A FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH A MENTOR MEMORYGEL, 425CC SILICONE PROSTHESIS DEVELOPED RIGHT SIDED SKIN REACTION POSTOPERATIVE. THE PATIENT REPORTED ITCHING WITHOUT A RASH IN THE NIPPLE AREA OF HER RIGHT BREAST ONLY. MRI AND NUMEROUS MAMMOGRAMS AND ULTRASOUND HAVE SHOWN NO ISSUES. SHE HAS SEEN A BREAST SPECIALIST, DERMATOLOGIST (MULTIPLE TIMES), PRIMARY CARE PHYSICIAN, OBGYN AND A NEUROLOGIST CHIROPRACTOR AND NO ONE CAN DETERMINE THE CAUSE AND THE ONLY THING THAT HELPS IS APPLYING CAPSAICIN AND THAT IS ONLY TEMPORARY RELIEF. AT THE TIME OF THIS REPORT, MENTOR RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 25260497 ↗
• InjuryMay 13, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 425CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED A RUPTURE ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2026.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 25161765 ↗
• InjuryMay 6, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT WITH MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED BILATERAL RUPTURE, BREAST PAIN ON THE LEFT SIDE AND CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN 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. THIS REPORT IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 25093397 ↗
• InjuryApr 16, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST RECONSTRUCTION REVISION WITH TWO 425CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT DEVELOPED LEFT BREAST CAPSULAR CONTRACTURE (BAKER GRADE IV) AND RIGHT BREAST CONTOUR DEFORMITY. THERE WAS INDENTATION OF THE MEDIAL ASPECT OF THE RIGHT BREAST. AS A RESULT, THE PATIENT UNDERWENT RIGHT BREAST CAPSULORRHAPHY, LEFT BREAST CAPSULECTOMY, BREAST IMPLANT REMOVAL AND REPLACEMENT SURGERY ON (B)(6) 2026. THE REPLACEMENT DEVICES WERE TWO MENTOR GEL IMPLANTS. THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Wrinkling

  MAUDE report 24902487 ↗
• InjuryApr 16, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST RECONSTRUCTION REVISION WITH TWO 425CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT DEVELOPED LEFT BREAST CAPSULAR CONTRACTURE (BAKER GRADE IV) AND RIGHT BREAST CONTOUR DEFORMITY. THERE WAS INDENTATION OF THE MEDIAL ASPECT OF THE RIGHT BREAST. AS A RESULT, THE PATIENT UNDERWENT RIGHT BREAST CAPSULORRHAPHY, LEFT BREAST CAPSULECTOMY, BREAST IMPLANT REMOVAL AND REPLACEMENT SURGERY ON (B)(6) 2026. THE REPLACEMENT DEVICES WERE TWO MENTOR GEL IMPLANTS. THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 24902483 ↗
• InjuryApr 14, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH IMPLANTATION OF A 425CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT INQUIRED ON THE RECALL STATUS OF THE IMPLANTS AND REPORTED RIPPLING OF THE BREASTS, BILATERALLY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. 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: Wrinkling

  MAUDE report 24877773 ↗
• InjuryApr 7, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH A 425CC MENTOR MEMORYGEL BREAST IMPLANT ON THE RIGHT BREAST. POST-OPERATIVELY, THE PATIENT EXPERIENCED FALLS AND DEVELOPED RIGHT BREAST DENT WHEN BENDING CERTAIN WAYS. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Crushing Injury; Wrinkling

  MAUDE report 24811200 ↗
• InjuryApr 1, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 33-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 425CC (LEFT) MENTOR MEMORYGEL BREAST IMPLANT AND A 450CC (RIGHT) MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE (BAKER GRADE 4) POST-OPERATIVELY, WHICH WAS DIAGNOSED WITH AN EXAM. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT IS FOR THE LEFT SIDE DEVICE.

  Patient problems: Capsular Contracture

  MAUDE report 24758915 ↗
• InjuryMar 31, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH TWO 425CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED BILATERAL RUPTURES POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2026.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 24748529 ↗