MENTOR MemoryGel Breast Implant 3505004BCRecalls & reported problems

Summary

The FDA's MAUDE database contains 1,540 adverse event reports that list this exact device (DI 00081317000532), received between Mar 6, 2018 and Sep 23, 2026 — classified as 1,522 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (678 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 1,540 reports, in the reporter's own words as published by the FDA.

• InjurySep 23, 2026Material Rupture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50874730 ↗
• InjurySep 17, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Capsular Contracture

  MAUDE report 50808887 ↗
• InjurySep 17, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Capsular Contracture

  MAUDE report 50797019 ↗
• InjurySep 17, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Capsular Contracture

  MAUDE report 50797018 ↗
• InjurySep 14, 2026Material Rupture

  It was reported that a patient underwent a Breast Augmentation Surgery with implantation of a 500cc MENTOR MemoryGel Breast Implant prosthesis. Post-operatively, the patient was diagnosed with a ruptured right implant by a medical professional using the patient's symptoms. As a result, the patient underwent bilateral exchange with Mentor gel implants on(b)(6) 2026.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50757060 ↗
• InjurySep 3, 2026Material Rupture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50598315 ↗
• InjuryAug 26, 2026Material Rupture

  It was reported that a patient who underwent a primary breast augmentation procedure with a MENTOR MemoryGel Breast Implant gel breast prosthesis developed a wound on her left breast post implantation. The wound had a pimple-like appearance. She subsequently developed a full thickness wound with exposed implant. Additionally, imaging indicated left breast prosthesis rupture. The patient also developed Baker Grade III capsular contracture in her left breast. As a result, the patient underwent explantation of the left breast prosthesis. There was a small amount of serous appearing fluid in the breast pocket. A sample was sent to pathology. The implant was not replaced as the patient needs time to heal before another surgery.

  Patient problems: Capsular Contracture; Fluid Discharge; Impaired Healing; Seroma

  MAUDE report 50459818 ↗
• InjuryAug 20, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient who underwent a breast augmentation revision procedure with MENTOR MemoryGel Breast Implant gel breast prostheses developed Baker Grade IV capsular contracture in both breasts post implantation. As a result, the patient underwent unilateral explantation of the left breast prosthesis and it was replaced with a MENTOR MemoryGel Breast Implant gel breast prosthesis. The removed left breast prosthesis was noted to be ruptured during explant surgery. At the time of this report, Mentor has received no information regarding explantation or an expected explantation date for the patient¿s right breast prosthesis. The patient underwent a right breast capsulotomy on the same date as the left breast prosthesis explant surgery.This MedWatch report is for the patient¿s right breast prosthesis.

  Patient problems: Capsular Contracture

  MAUDE report 50359579 ↗
• InjuryAug 20, 2026Material Rupture

  It was reported that a patient who underwent a breast augmentation revision procedure with MENTOR MemoryGel Breast Implant gel breast prostheses developed Baker Grade IV capsular contracture in both breasts post implantation. As a result, the patient underwent unilateral explantation of the left breast prosthesis and it was replaced with a MENTOR MemoryGel Breast Implant gel breast prosthesis. The removed left breast prosthesis was noted to be ruptured during explant surgery. At the time of this report, Mentor has received no information regarding explantation or an expected explantation date for the patient¿s right breast prosthesis. The patient underwent a right breast capsulotomy on the same date as the left breast prosthesis explant surgery.This MedWatch report is for the patient¿s left breast prosthesis.

  Patient problems: Capsular Contracture

  MAUDE report 50359575 ↗
• InjuryAug 17, 2026Material Rupture

  It was reported that a patient underwent a Primary Breast Augmentation Surgery with implantation of a 500cc MENTOR MemoryGel Breast Implant prosthesis. Post-operatively, the patient reported experiencing left breast pain and bilaterally ruptured implants after consulting with a medical professional and Ultrasound Imaging. As a result, the patient was scheduled for bilateral implant removal on (b)(6) 2026.This report is for the left breast prosthesis.

  Patient problems: Breast Discomfort/Pain

  MAUDE report 50281648 ↗
• InjuryAug 6, 2026Material Rupture

  A female patient who underwent Breast Augmentation Revision with MENTOR MemoryGel 500cc Silicone prosthesis experienced right sided capsular contracture grade III-IV post implantation. As a result, the patient underwent removal surgery on (b)(6) 2026.

  Patient problems: Capsular Contracture

  MAUDE report 50167522 ↗
• InjuryAug 4, 2026Migration

  It was reported that a 33-year-old Black female patient underwent a breast augmentation revision with two 500cc MENTOR MemoryGel Breast Implants and experienced bilateral device migration post-operatively. It was reported that in (b)(6)2024, the patient had a breast revision to address the issue. As a result, the patient underwent explantation on (b)(6) 2024, and replaced with two 400cc MENTOR MemoryGel Breast Implants.This report is for the right side device.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 50130685 ↗
• InjuryJun 8, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 500CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED A SKIN REACTION 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: Skin Inflammation/ Irritation

  MAUDE report 25436953 ↗
• InjuryJun 3, 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. AS A RESULT, THE PATIENT UNDERWENT DEVICE REMOVAL AND REPLACEMENT.

  Patient problems: Capsular Contracture

  MAUDE report 25375272 ↗
• InjuryJun 3, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT WITH MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED RUPTURE ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED VIA MRI. AS A RESULT, THE PATIENT UNDERWENT DEVICE REMOVAL.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 25375118 ↗
• InjuryMay 11, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION 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 MAMMOGRAM. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 25145681 ↗
• InjuryApr 29, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 500CC 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 25033328 ↗
• InjuryApr 6, 2026Material Rupture

  IT WAS REPORTED THAT A 43-YEAR-OLD FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 500CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED A RUPTURE ON THE RIGHT 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: Deformity/ Disfigurement

  MAUDE report 24795948 ↗
• InjuryApr 3, 2026Material Rupture; Migration

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 500CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED A RUPTURE AND A DEVICE MIGRATION ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2026.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 24774707 ↗
• InjuryApr 2, 2026Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH AN UNSPECIFIED SMOOTH GEL BREAST PROSTHESIS AND EXPERIENCED A RUPTURE ON THE LEFT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2026.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 24767090 ↗
• InjuryMar 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH IMPLANTATION OF A 500 CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH RIGHT BREAST BAKER GRADE III CAPSULAR CONTRACTURE BY A MEDICAL PROFESSIONAL USING THE PATIENT'S SYMPTOMS. 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: Capsular Contracture

  MAUDE report 24705384 ↗
• InjuryMar 24, 2026Use of Device Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH A MENTOR MEMORYGEL BREAST IMPLANT GEL BREAST PROSTHESIS DEVELOPED BAKER GRADE IV CAPSULAR CONTRACTURE IN HER RIGHT BREAST POST IMPLANTATION. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION.

  Patient problems: Capsular Contracture

  MAUDE report 24676435 ↗
• InjuryMar 19, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WITH MENTOR MEMORYGEL XTRA BREAST IMPLANTS EXPERIENCED CAPSULAR CONTRACTURE BAKER GADE IV ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT DEVICE REMOVAL ON AN UNSPECIFIED DATE.

  Patient problems: Capsular Contracture

  MAUDE report 24640454 ↗
• InjuryMar 18, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WITH MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED BILATERAL CAPSULAR CONTRACTURE BAKER GRADE III POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT DEVICE REMOVAL AND REPLACEMENT. THIS REPORT IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 24633957 ↗
• InjuryMar 13, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 500CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED 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 24590885 ↗