MENTOR MemoryGel Breast Implant 3505501BCRecalls & reported problems

Summary

The FDA's MAUDE database contains 683 adverse event reports that list this exact device (DI 00081317000358), received between Feb 15, 2018 and Sep 17, 2026 — classified as 679 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (378 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 683 reports, in the reporter's own words as published by the FDA.

• InjurySep 17, 2026Migration

  Patient problems: Deformity/ Disfigurement

  MAUDE report 50809878 ↗
• InjurySep 17, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Capsular Contracture

  MAUDE report 50809163 ↗
• InjurySep 16, 2026Material Rupture

  It was reported that a patient underwent a breast augmentation procedure with a MENTOR MemoryGel Breast Implant gel breast prosthesis that ruptured post implantation. Rupture of the patient¿s right breast prosthesis was observed during an implant exchange surgery. The patient¿s explanted breast prostheses were replaced with Non-Mentor breast prostheses.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50791916 ↗
• InjurySep 16, 2026Material Rupture

  It was reported that a patient implanted with a 550cc MENTOR MemoryGel Breast Implant experienced a rupture on the left side post-operatively. As a result, the patient underwent explantation on (b)(6) 2026.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50791668 ↗
• InjuryJul 29, 2026Material Rupture

  It was reported that a patient underwent primary breast augmentation with two 550cc MENTOR MemoryGel Breast Implants. Post-operatively, the patient underwent breast implant removal and replacement surgery on (b)(6) 2026, for unspecified reasons. During the surgery, the right breast implant was found to be ruptured. The replacement devices were two Mentor gel implants.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50067983 ↗
• InjuryJul 28, 2026Material Rupture

  It was reported that a 55-year-old Caucasian female patient underwent a breast augmentation revision with two 550cc MENTOR MemoryGel Breast Implants and experienced bilateral rupture post-operatively. 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50060156 ↗
• InjuryJul 28, 2026Material Rupture

  It was reported that a 55-year-old Caucasian female patient underwent a breast augmentation revision with two 550cc MENTOR MemoryGel Breast Implants and experienced bilateral rupture post-operatively. 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50060154 ↗
• InjuryJun 11, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH TWO 550CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT SUFFERED LEFT BREAST IMPLANT RUPTURE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 25481015 ↗
• InjuryJun 5, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT IS A FEMALE WHO UNDERWENT A BREAST AUGMENTATION REVISION WITH A MENTOR MEMORYGEL SILICONE PROSTHESIS (550 CC). POSTOPERATIVELY SHE DEVELOPED A LEFT-SIDED, GRADE IV CAPSULAR CONTRACTURE, SUSTAINED A CHEST INJURY, AND PRESENTED WITH A PALPABLE BREAST MASS. THE FINDINGS WERE ESTABLISHED BY PHYSICAL EXAMINATION. SHE UNDERWENT LUMPECTOMY WITH ADJUVANT RADIATION THERAPY IN 2024 AND SUBSEQUENTLY EXPERIENCED A FALL. AS OF THIS REPORT, MENTOR HAS NOT RECEIVED INFORMATION ABOUT EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Breast Mass; Capsular Contracture

  MAUDE report 25408248 ↗
• InjuryMay 27, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH TWO 550CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED BILATERAL RUPTURES 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 25304265 ↗
• InjuryMay 27, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH TWO 550CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED BILATERAL RUPTURES 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 25304228 ↗
• InjuryMay 27, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH TWO 550CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED BILATERAL CAPSULAR CONTRACTURE 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 25303479 ↗
• InjuryMay 27, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH TWO 550CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED BILATERAL CAPSULAR CONTRACTURE 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 25303476 ↗
• InjuryMay 22, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH MENTOR MEMORYGEL BREAST IMPLANT GEL BREAST PROSTHESES AND SUFFERED SEVERAL UNEXPLAINED SYSTEMIC SYMPTOMS, INCLUDING UNSPECIFIED IMMUNE SYSTEM ISSUES, BODY ACHES, LOW IRON, FEELING TIRED, NO ENERGY, DEPRESSION, ANXIETY, PAIN IN THE BODY, ¿ALWAYS IN BED¿, BRAIN FOG, BLURRY VISION, DIZZINESS, AND INABILITY TO CONCENTRATE. 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 LEFT BREAST PROSTHESIS.

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

  MAUDE report 25260193 ↗
• InjuryMay 20, 2026Material Rupture

  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 IV CAPSULAR CONTRACTURE IN HER LEFT BREAST POST IMPLANTATION. ADDITIONALLY, THE LEFT BREAST PROSTHESIS RUPTURED. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH MENTOR MEMORYGEL BREAST IMPLANT GEL BREAST PROSTHESES.

  Patient problems: Capsular Contracture

  MAUDE report 25233828 ↗
• InjuryMay 18, 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: Deformity/ Disfigurement

  MAUDE report 25206520 ↗
• InjuryApr 22, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH TWO 550CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT DEVELOPED LEFT BREAST PAIN AND SUSPECTED A POSSIBLE LEFT BREAST IMPLANT RUPTURE. MRI CONFIRMED A RIGHT BREAST IMPLANT RUPTURE. 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 24957499 ↗
• InjuryApr 22, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH TWO 550CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT DEVELOPED LEFT BREAST PAIN AND SUSPECTED A POSSIBLE LEFT BREAST IMPLANT RUPTURE. MRI CONFIRMED A RIGHT BREAST IMPLANT RUPTURE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Breast Discomfort/Pain

  MAUDE report 24957498 ↗
• InjuryApr 22, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH TWO 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 24955400 ↗
• InjuryApr 15, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 550CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED CAPSULAR CONTRACTURE ON THE LEFT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2026.

  Patient problems: Capsular Contracture

  MAUDE report 24886055 ↗
• InjuryMar 31, 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 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: Capsular Contracture

  MAUDE report 24743405 ↗
• InjuryMar 16, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 550CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT SUFFERED RIGHT BREAST IMPLANT RUPTURE. AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL AND REPLACEMENT SURGERY ON (B)(6) 2026. THE REPLACEMENT DEVICES WERE TWO MENTOR GEL IMPLANTS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 24603898 ↗
• InjuryMar 11, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 46-YEAR-OLD ASIAN FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION REVISION WITH TWO 550CC MENTOR MEMORYGEL BREAST IMPLANTS AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE (BAKER GRADE 2 ON THE LEFT AND BAKER GRADE 4 ON THE RIGHT) POST-OPERATIVELY. THE PATIENT HAD LOST MOBILITY, FELT STRAINED, AND LOSS STRENGTH IN THE RIGHT ARM. AS A RESULT, THE PATIENT IS TO UNDERGO BILATERAL DEVICE EXPLANTATION ON (B)(6) 2026. THIS REPORT IS FOR THE RIGHT-SIDE DEVICE.

  Patient problems: Capsular Contracture

  MAUDE report 24576217 ↗
• InjuryMar 11, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 46-YEAR-OLD ASIAN FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION REVISION WITH TWO 550CC MENTOR MEMORYGEL BREAST IMPLANTS AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE (BAKER GRADE 2 ON THE LEFT AND BAKER GRADE 4 ON THE RIGHT) POST-OPERATIVELY. THE PATIENT HAD LOST MOBILITY, FELT STRAINED, AND LOSS STRENGTH IN THE RIGHT ARM. AS A RESULT, THE PATIENT IS TO UNDERGO BILATERAL DEVICE EXPLANTATION ON (B)(6) 2026. THIS REPORT IS FOR THE LEFT SIDE DEVICE.

  Patient problems: Capsular Contracture

  MAUDE report 24571351 ↗
• InjuryMar 5, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT A BREAST RECONSTRUCTION REVISION PROCEDURE WITH MENTOR MEMORYGEL BREAST IMPLANT GEL BREAST PROSTHESIS DEVELOPED BAKER GRADE III CAPSULAR CONTRACTURE IN BOTH BREASTS POST IMPLANTATION. ADDITIONALLY, THE PATIENT¿S LEFT BREAST PROSTHESIS RUPTURED AND THERE WAS IMPLANT MALPOSITION. 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 LEFT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 24525279 ↗