MENTOR MemoryGel Breast Implant 3504251BCRecalls & reported problems

Summary

The FDA's MAUDE database contains 805 adverse event reports that list this exact device (DI 00081317003809), received between Jan 14, 2019 and Sep 29, 2026 — classified as 797 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (375 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 805 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2026Material Rupture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50935426 ↗
• InjurySep 25, 2026Adverse 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 gel breast prosthesis developed Baker Grade III capsular contracture in her right breast post implantation. At the time of this report, Mentor has received no information regarding explantation or an expected explantation date.

  Patient problems: Capsular Contracture

  MAUDE report 50892865 ↗
• InjurySep 23, 2026Material Rupture

  It was reported that a female patient underwent Breast Surgery with MENTOR MemoryGel, 425cc Silicone prosthesis. subsequently the patient experienced right sided silent rupture postoperatively. As a result, the patient underwent bilateral replacements as follows: Left Serial Number: SN (b)(6), Right Serial Number: SN (b)(6)on (b)(6)2026.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50873651 ↗
• InjurySep 23, 2026Material Rupture

  It was reported that a patient with MENTOR MemoryGel Breast Implants experienced rupture on the left 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50867946 ↗
• InjurySep 21, 2026Adverse Event Without Identified Device or Use Problem

  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 reported having woken up with right breast pain. Subsequently, Mammogram Imaging was performed which identified a possibly ruptured right implant. She now thinks she may have an encapsulated left breast. Additionally, she states having had bad anxiety that may have resulted due to the implants. At the time of this report, Mentor has received no information regarding explantation or an expected explantation date.This report is for the left breast prosthesis.

  Patient problems: Capsular Contracture; Emotional Changes

  MAUDE report 50846417 ↗
• InjurySep 21, 2026Material Rupture

  Patient problems: Breast Discomfort/Pain; Emotional Changes

  MAUDE report 50846414 ↗
• InjurySep 15, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a 50-year-old Caucasian female patient underwent a breast augmentation revision with a 425cc MENTOR MemoryGel Breast Implant and experienced capsular contracture (baker grade 3) on the right side post-operatively, which was diagnosed with a physical exam. As a result, the patient underwent explantation on (b)(6) 2026.

  Patient problems: Capsular Contracture

  MAUDE report 50778078 ↗
• InjurySep 15, 2026Adverse Event Without Identified Device or Use Problem

  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 reported experiencing bilateral Capsular Contracture. 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.This report is for the right breast prosthesis.

  Patient problems: Capsular Contracture

  MAUDE report 50776945 ↗
• InjurySep 15, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Capsular Contracture

  MAUDE report 50775900 ↗
• InjurySep 15, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Capsular Contracture

  MAUDE report 50775897 ↗
• InjurySep 11, 2026Material Rupture

  This complaint reports bilateral rupture of the breast implants diagnosed by ultrasound. At the time of this report, Mentor has received no information regarding explantation or an expected explantation date.This report is for the patient¿s left breast prosthesis.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50727357 ↗
• InjurySep 11, 2026Material Rupture

  This complaint reports bilateral rupture of the breast implants diagnosed by ultrasound. At the time of this report, Mentor has received no information regarding explantation or an expected explantation date.This report is for the patient¿s right breast prosthesis.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50727356 ↗
• InjurySep 10, 2026Material Rupture; Adverse Event Without Identified Device or Use Problem

  Patient problems: Deformity/ Disfigurement

  MAUDE report 50723007 ↗
• InjurySep 9, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Capsular Contracture

  MAUDE report 50698721 ↗
• InjurySep 8, 2026Material Rupture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50676445 ↗
• InjuryJun 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH A 425CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED CAPSULAR CONTRACTURE (BAKER GRADE UNKNOWN) ON AN UNKNOWN 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 25487958 ↗
• InjuryMay 27, 2026Material Rupture

  IT WAS REPORTED THAT A 64-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH TWO 425CC MENTOR MEMORYGEL BREAST IMPLANTS AND EXPERIENCED BILATERAL RUPTURES POST-OPERATIVELY, WHICH WAS DIAGNOSED WITH A MAMMOGRAM AND MRI. 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: Deformity/ Disfigurement

  MAUDE report 25308065 ↗
• InjuryMay 27, 2026Material Rupture

  IT WAS REPORTED THAT A 64-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH TWO 425CC MENTOR MEMORYGEL BREAST IMPLANTS AND EXPERIENCED BILATERAL RUPTURES POST-OPERATIVELY, WHICH WAS DIAGNOSED WITH A MAMMOGRAM AND MRI. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT IS FOR THE RIGHT SIDE DEVICE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 25308042 ↗
• InjuryMay 21, 2026Adverse Event Without Identified Device or Use Problem

  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'S LEFT BREAST INFRAMAMMARY INCISION OPENED WITH FLUID DRAINAGE AND THE IMPLANT BECAME EXPOSED. AS A RESULT, THE PATIENT UNDERWENT LEFT-SIDED EXCHANGE WITH A MENTOR GEL IMPLANT ON (B)(6) 2026.

  Patient problems: Pocket Erosion

  MAUDE report 25247921 ↗
• InjuryMay 13, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 425CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED A RUPTURE 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 25161799 ↗
• InjuryMay 7, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION WITH TWO MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA MRI, WITH BILATERAL BREAST IMPLANT RUPTURES AND LEFT SIDE CALCIFICATION. AS A RESULT, THE PATIENT UNDERWENT 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: Calcium Deposits/Calcification

  MAUDE report 25114260 ↗
• InjuryApr 15, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 425CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED CAPSULAR CONTRACTURE 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 24886370 ↗
• InjuryMar 30, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT WITH MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED RUPTURE ON THE LEFT 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 24730399 ↗
• InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WITH MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN, RUPTURE, A BREAST CYST AND IMPLANT SITE FLUID COLLECTION ON THE LEFT SIDE ALONG WITH A BREAST MASS ON THE RIGHT SIDE. AS A RESULT, THE PATIENT UNDERWENT DEVICE REMOVAL. THIS REPORT IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Breast Mass

  MAUDE report 24729605 ↗
• InjuryMar 20, 2026Adverse Event Without Identified Device or Use Problem

  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. ADDITIONALLY, SHE WAS NOTED TO HAVE SOME BILATERAL BREAST PTOSIS AND WATERFALL DEFORMITY. 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 24654396 ↗