MENTOR MemoryGel Breast Implant 3504501BCRecalls & reported problems

Summary

The FDA's MAUDE database contains 1,690 adverse event reports that list this exact device (DI 00081317000334), received between Mar 28, 2018 and Sep 28, 2026 — classified as 1,679 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (933 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 1,690 reports, in the reporter's own words as published by the FDA.

• InjurySep 28, 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 and replacement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50917330 ↗
• InjurySep 28, 2026Material Rupture

  It was reported that a patient with MENTOR MemoryGel Breast Implants experienced rupture on the right side post-operatively, which was confirmed via MRI. 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 50917004 ↗
• InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient implanted with a 400cc 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: Capsular Contracture

  MAUDE report 50870483 ↗
• InjurySep 17, 2026Material Rupture

  It was reported that a patient underwent breast augmentation revision with two 450cc MENTOR MemoryGel Breast Implants. Post-operatively, the patient was diagnosed, via MRI, with right breast implant rupture. As a result, the patient underwent breast implant removal and replacement surgery on (b)(6) 2026. The replacement device was a non-Mentor implant.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50805717 ↗
• InjurySep 16, 2026Material Rupture

  It was reported that a patient underwent primary breast augmentation with two 450cc MENTOR MemoryGel Breast Implants. Post-operatively, the patient was diagnosed, via ultrasound, with bilateral breast implant ruptures. As a result, the patient underwent breast implant removal surgery on (b)(6)2026.This Medwatch form is for the right breast prosthesis.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50793783 ↗
• InjurySep 16, 2026Material Rupture

  It was reported that a patient underwent primary breast augmentation with two 450cc MENTOR MemoryGel Breast Implants. Post-operatively, the patient was diagnosed, via ultrasound, with bilateral breast implant ruptures. As a result, the patient underwent breast implant removal surgery on (b)(6)2026.This Medwatch form is for the left breast prosthesis.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50793782 ↗
• InjurySep 15, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Capsular Contracture

  MAUDE report 50782053 ↗
• InjurySep 15, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient underwent primary breast augmentation with two 450cc MENTOR MemoryGel Breast Implants. Post-operatively, the patient developed left breast capsular contracture (baker grade III). At the time of this report, Mentor has received no information regarding explantation or an expected explantation date.

  Patient problems: Capsular Contracture

  MAUDE report 50777141 ↗
• InjurySep 15, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient implanted with two 450cc MENTOR MemoryGel Breast Implant experienced a rupture on the left side and unspecified breast implant illness symptoms post-operatively. As a result, the patient underwent explantation on (b)(6) 2026.

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

  MAUDE report 50775719 ↗
• InjurySep 15, 2026Material Rupture

  It was reported that a patient implanted with two 450cc MENTOR MemoryGel Breast Implant experienced a rupture on the left side and unspecified breast implant illness symptoms post-operatively. As a result, the patient underwent explantation on (b)(6) 2026.

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

  MAUDE report 50775718 ↗
• InjurySep 9, 2026Material Rupture

  It was reported that a patient implanted with two 450cc MENTOR MemoryGel Breast Implant experienced bilateral ruptures post-operatively. As a result, the patient underwent explantation on (b)(6) 2026.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50695074 ↗
• InjurySep 9, 2026Material Rupture

  It was reported that a patient implanted with two 450cc MENTOR MemoryGel Breast Implant experienced bilateral ruptures post-operatively. As a result, the patient underwent explantation on (b)(6)2026.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50695071 ↗
• InjurySep 3, 2026Material Rupture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50596897 ↗
• InjuryJul 27, 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 MRI. 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 50024535 ↗
• InjuryMay 27, 2026Material Rupture

  A FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A MENTOR MEMORYGEL, 450CC PROSTHESIS DEVELOPED LEFT SIDED SILENT RUPTURE POSTOPERATIVE. THE CAT SCAN AND ULTRASOUND EXAMINATION CONFIRMED THE RUPTURE. AT THE TIME OF THIS REPORT, MENTOR RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 25306072 ↗
• InjuryMay 12, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 450CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT EXPERIENCED LEFT BREAST DISCOMFORT. DURING A CONSULTATION WITH A MEDICAL PROFESSIONAL, SHE WAS DIAGNOSED WITH LEFT BREAST CAPSULAR CONTRACTURE (A BAKER GRADE WAS NOT PROVIDED) AND A RUPTURED LEFT IMPLANT USING MAGNETIC RESONANCE IMAGING. AS A RESULT, THE PATIENT WAS SCHEDULED FOR IMPLANT EXCHANGE ON (B)(6) 2026. 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 25156815 ↗
• InjuryMay 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST SURGERY WITH IMPLANTATION OF A 450CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT REPORTED THE LEFT BREAST HAS BEGUN TO CHANGE. NO FURTHER INFORMATION WAS PROVIDED. 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: Deformity/ Disfigurement

  MAUDE report 25156676 ↗
• InjuryMay 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH TWO 450CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA PHYSICAL EXAMINATION, WITH LEFT BREAST CAPSULAR CONTRACTURE (BAKER GRADE III). AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Capsular Contracture

  MAUDE report 25133171 ↗
• InjuryMay 7, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH IMPLANTATION OF A 450CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH A RUPTURED LEFT IMPLANT USING MAGNETIC RESONANCE IMAGING. 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: Deformity/ Disfigurement

  MAUDE report 25117164 ↗
• InjuryMay 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 450CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH BILATERAL BAKER GRADE III CAPSULAR CONTRACTURE DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT WAS SCHEDULED FOR BILATERAL IMPLANT REMOVAL ON (B)(6) 2026.

  Patient problems: Capsular Contracture

  MAUDE report 25087389 ↗
• InjuryMay 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 450CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH BILATERAL BAKER GRADE III CAPSULAR CONTRACTURE DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT WAS SCHEDULED FOR BILATERAL IMPLANT REMOVAL ON (B)(6) 2026.

  Patient problems: Capsular Contracture

  MAUDE report 25087367 ↗
• InjuryApr 22, 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. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 24954044 ↗
• InjuryApr 15, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 450CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA CT SCAN, WITH RIGHT BREAST IMPLANT LEAK. AS A RESULT, THE PATIENT HAS BEEN SCHEDULED FOR BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2026.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 24880934 ↗
• InjuryApr 14, 2026Adverse 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 III CAPSULAR CONTRACTURE IN HER RIGHT BREAST POST IMPLANTATION. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION AND REPLACEMENT WITH A MENTOR MEMORYGEL BREAST IMPLANT GEL BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 24874897 ↗
• InjuryApr 3, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE WITH MENTOR MEMORYGEL BREAST IMPLANT GEL BREAST PROSTHESES AND SUFFERED SEVERAL UNEXPLAINED SYSTEMIC SYMPTOMS, INCLUDING ACHES, PAIN, NUMBNESS IN EXTREMITIES, AND UNSPECIFIED AUTOIMMUNE DISEASE. ADDITIONALLY, THE PATIENT DEVELOPED ¿SLIGHT¿ CAPSULAR CONTRACTURE (BAKER GRADE UNKNOWN). THE SIDE OF CAPSULAR CONTRACTURE (LEFT BREAST, RIGHT BREAST, OR BILATERAL) WAS NOT SPECIFIED. 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; Capsular Contracture

  MAUDE report 24779560 ↗