MENTOR MemoryGel Breast Implant 3507550BCRecalls & reported problems

Summary

The FDA's MAUDE database contains 125 adverse event reports that list this exact device (DI 00081317000167), received between Feb 12, 2018 and Apr 14, 2026 — classified as 124 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Rupture” (99 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 125 reports, in the reporter's own words as published by the FDA.

• InjuryApr 14, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT AN UNSPECIFIED BREAST SURGERY WITH MENTOR MEMORYGEL BREAST IMPLANT GEL BREAST PROSTHESES DEVELOPED BAKER GRADE III CAPSULAR CONTRACTURE IN BOTH BREASTS POST IMPLANTATION. ADDITIONALLY, THE PATIENT¿S RIGHT BREAST PROSTHESIS RUPTURED. 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: Capsular Contracture

  MAUDE report 24877882 ↗
• MalfunctionMar 18, 2026Appropriate Device Problem Term/Code Not Available

  A 550CC MENTOR MEMORYGEL BREAST IMPLANT WAS RECEIVED BY THE MENTOR ANALYSIS LAB WITHOUT A COMPLAINT IN REGARD TO THE PRODUCT QUALITY OR PATIENT ISSUES. AS A RESULT, THE DEVICE WAS TESTED AND DETERMINED TO HAVE A REPORTABLE FAILURE MODE.

  Patient problems: Insufficient Information

  MAUDE report 24634131 ↗
• InjuryFeb 13, 2026Material Rupture

  IT WAS REPORTED THAT A 48-YEAR-OLD FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH 500CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED A RUPTURE ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS DIAGNOSED WITH AN MRI. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2026.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 24339369 ↗
• InjuryFeb 6, 2026Material Rupture

  IT WAS REPORTED THAT A 56-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A 500CC MENTOR MEMORYGEL BREAST IMPLANT AND 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 24280397 ↗
• InjuryJan 30, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH TWO 550CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA IMAGING, WITH LEFT BREAST IMPLANT RUPTURE. AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2026.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 24223629 ↗
• InjuryJan 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH TWO 550CC MENTOR MEMORYGEL BREAST IMPLANTS AND EXPERIENCED BREAST CANCER POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025 AND REPLACED WITH TWO 585CC MENTOR MEMORYGEL BOOST BREAST IMPLANTS. THE EVENT INFORMATION AVAILABLE IS NONSPECIFIC AND VERY LIMITED. AT THE TIME OF THIS REPORT, MENTOR HAS NOT RECEIVED PATHOLOGY/CYTOLOGY RESULTS OR OPERATIVE REPORT. IF ADDITIONAL INFORMATION IS RECEIVED, MENTOR WILL SUBMIT A SUPPLEMENTAL REPORT ACCORDINGLY. THIS REPORT IS FOR THE A SIDE DEVICE.

  Patient problems: Breast Cancer

  MAUDE report 24059172 ↗
• InjuryJan 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH TWO 550CC MENTOR MEMORYGEL BREAST IMPLANTS AND EXPERIENCED BREAST CANCER POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025 AND REPLACED WITH TWO 585CC MENTOR MEMORYGEL BOOST BREAST IMPLANTS. THE EVENT INFORMATION AVAILABLE IS NONSPECIFIC AND VERY LIMITED. AT THE TIME OF THIS REPORT, MENTOR HAS NOT RECEIVED PATHOLOGY/CYTOLOGY RESULTS OR OPERATIVE REPORT. IF ADDITIONAL INFORMATION IS RECEIVED, MENTOR WILL SUBMIT A SUPPLEMENTAL REPORT ACCORDINGLY. THIS REPORT IS FOR THE B SIDE DEVICE.

  Patient problems: Breast Cancer

  MAUDE report 24059151 ↗
• InjuryDec 26, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 550CC 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; Deformity/ Disfigurement

  MAUDE report 23897629 ↗
• InjuryApr 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH MENTOR MEMORYGEL BREAST IMPLANT 550CC GEL BREAST PROSTHESES DEVELOPED CAPSULAR CONTRACTURE IN BOTH BREASTS POST IMPLANTATION (BAKER GRADE II IN LEFT BREAST, BAKER GRADE IV IN RIGHT BREAST). BILATERAL CAPSULAR CONTRACTURE WAS DIAGNOSED VIA A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION ON (B)(6) 2025. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 21874850 ↗
• InjuryApr 21, 2025Material Rupture; Adverse Event Without Identified Device or Use Problem; Material Rupture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH MENTOR MEMORYGEL BREAST IMPLANT 550CC GEL BREAST PROSTHESES DEVELOPED CAPSULAR CONTRACTURE IN BOTH BREASTS POST IMPLANTATION (BAKER GRADE II IN LEFT BREAST, BAKER GRADE IV IN RIGHT BREAST). BILATERAL CAPSULAR CONTRACTURE WAS DIAGNOSED VIA A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION ON (B)(6) 2025. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 21874849 ↗
• InjuryApr 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH MENTOR MEMORYGEL BREAST IMPLANTS 550CC AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE BAKER GRADE II (L) AND BAKER GRADE III (R) ALONG WITH RUPTURE ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED VIA MRI. AS A RESULT, THE PATIENT UNDERWENT REMOVAL ON (B)(6) 2025. THIS REPORT IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 21755841 ↗
• InjuryApr 2, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH MENTOR MEMORYGEL BREAST IMPLANTS 550CC AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE BAKER GRADE II (L) AND BAKER GRADE III (R) ALONG WITH RUPTURE ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED VIA MRI. AS A RESULT, THE PATIENT UNDERWENT REMOVAL ON (B)(6) 2025. THIS REPORT IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 21755839 ↗
• InjuryMar 12, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION WITH MENTOR MEMORYGEL BREAST IMPLANTS 550 CC AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE BAKER GRADE II/III AND BILATERAL RUPTURE. AS A RESULT, THE PATIENT UNDERWENT REMOVAL ON (B)(6) 2024. THIS REPORT IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 21586398 ↗
• InjuryMar 4, 2025Material Rupture; Material Rupture

  A FEMALE PATIENT WHO UNDERWENT BREAST AUGMENTATION REVISION WITH A MENTOR MEMORYGEL 550 CC SILICONE PROSTHESIS EXPERIENCED BILATERAL SILENT RUPTURES POSTOPERATIVELY. THE PATIENT REPORTED THE PRESENCE OF LUMPS AND HARD KNOTS ON BOTH SIDES, RAISING CONCERNS ABOUT POSSIBLE BILATERAL RUPTURES. A MAMMOGRAM EXAMINATION CONFIRMED THE EXISTENCE OF THESE RUPTURES. AT THE TIME OF THIS REPORT, MENTOR HAS NOT RECEIVED ANY INFORMATION REGARDING THE PATIENT'S EXPLANTATION OR AN EXPECTED DATE FOR THE PROCEDURE. THIS REPORT SPECIFICALLY PERTAINS TO THE FINDINGS RELATED TO THE LEFT SIDE.

  Patient problems: Capsular Contracture; Deformity/ Disfigurement

  MAUDE report 21518592 ↗
• InjuryMar 4, 2025Material Rupture; Material Rupture

  A FEMALE PATIENT WHO UNDERWENT BREAST AUGMENTATION REVISION WITH A MENTOR MEMORYGEL 550 CC SILICONE PROSTHESIS EXPERIENCED BILATERAL SILENT RUPTURES POSTOPERATIVELY. THE PATIENT REPORTED THE PRESENCE OF LUMPS AND HARD KNOTS ON BOTH SIDES, RAISING CONCERNS ABOUT POSSIBLE BILATERAL RUPTURES. A MAMMOGRAM EXAMINATION CONFIRMED THE EXISTENCE OF THESE RUPTURES. AT THE TIME OF THIS REPORT, MENTOR HAS NOT RECEIVED ANY INFORMATION REGARDING THE PATIENT'S EXPLANTATION OR AN EXPECTED DATE FOR THE PROCEDURE. THIS REPORT SPECIFICALLY PERTAINS TO THE FINDINGS RELATED TO THE RIGHT SIDE.

  Patient problems: Capsular Contracture; Deformity/ Disfigurement

  MAUDE report 21518542 ↗
• InjuryJan 6, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION WITH MENTOR MEMORYGEL BREAST IMPLANTS 550CC AND EXPERIENCED RUPTURE ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT REMOVAL ON (B)(6) 2024.

  Patient problems: Capsular Contracture; Deformity/ Disfigurement

  MAUDE report 21085696 ↗
• InjuryDec 30, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH TWO 550CC MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED BILATERAL BREAST PAIN, RUPTURES, AND IMPLANT SITE CALCIFICATION ON THE LEFT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2024.

  Patient problems: Breast Discomfort/Pain; Calcium Deposits/Calcification

  MAUDE report 21038389 ↗
• InjuryDec 30, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH TWO 550CC MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED BILATERAL BREAST PAIN, RUPTURES, AND IMPLANT SITE CALCIFICATION ON THE LEFT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2024.

  Patient problems: Breast Discomfort/Pain

  MAUDE report 21038371 ↗
• InjuryDec 19, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE WHO UNDERWENT A BREAST AUGMENTATION REVISION WITH AN UNKNOWN SILICONE PROSTHESIS EXPERIENCED BILATERAL CHEST INJURY, AND BILATERAL SILENT RUPTURES POSTOPERATIVE. THE PATIENT HAD A SCAN A FEW MONTHS BACK THAT SHOWED RUPTURED IMPLANTS. POSSIBLE TRAUMA DUE BY MAMMOGRAM EXAMINATION. AS A RESULT, PATIENT UNDERWENT BILATERAL REMOVAL ON (B)(6) 2024. THIS REPORT RELATES TO THE LEFT SIDE.

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

  MAUDE report 20984240 ↗
• InjuryDec 19, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE WHO UNDERWENT A BREAST AUGMENTATION REVISION WITH AN UNKNOWN SILICONE PROSTHESIS EXPERIENCED BILATERAL CHEST INJURY, AND BILATERAL SILENT RUPTURES POSTOPERATIVE. THE PATIENT HAD A SCAN A FEW MONTHS BACK THAT SHOWED RUPTURED IMPLANTS. POSSIBLE TRAUMA DUE BY MAMMOGRAM EXAMINATION. AS A RESULT, PATIENT UNDERWENT BILATERAL REMOVAL ON (B)(6) 2024. THIS REPORT RELATES TO THE RIGHT SIDE.

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

  MAUDE report 20984224 ↗
• InjuryOct 21, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH A 550 CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED SPONTANEOUS RIGHT SIDED RUPTURE POST PROCEDURE. THE DIAGNOSIS WAS MADE THROUGH MAGNETIC RESONANCE IMAGING. AS A RESULT, EXPLANT WAS PERFORMED ON (B)(6) 2024.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 20495045 ↗
• InjuryOct 17, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 550CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH A RUPTURED BREAST IMPLANT OF AN UNSPECIFIED SIDE USING MAMMOGRAM IMAGING. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT WITH 550CC MENTOR MEMORYGEL BREAST IMPLANTS ON (B)(6) 2010. HOWEVER, DURING THE SURGERY, BOTH IMPLANTS WERE FOUND TO BE RUPTURED. THERE WERE NO REPORTED PROCEDURAL DELAYS OR PATIENT CONSEQUENCES DUE TO THE DISCOVERY. THIS REPORT IS FOR THE RIGHT BREAST PROSTHESIS.

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

  MAUDE report 20470928 ↗
• InjuryOct 17, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 550CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH A RUPTURED BREAST IMPLANT OF AN UNSPECIFIED SIDE USING MAMMOGRAM IMAGING. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT WITH 550CC MENTOR MEMORYGEL BREAST IMPLANTS ON (B)(6) 2010. HOWEVER, DURING THE SURGERY, BOTH IMPLANTS WERE FOUND TO BE RUPTURED. THERE WERE NO REPORTED PROCEDURAL DELAYS OR PATIENT CONSEQUENCES DUE TO THE DISCOVERY. THIS REPORT IS FOR THE LEFT BREAST PROSTHESIS.

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

  MAUDE report 20470870 ↗
• InjuryOct 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE WHO UNDERWENT A BREAST AUGMENTATION REVISION WITH A MENTOR MEMORYGEL, 550CC SILICONE EXPERIENCED RIGHT-SIDED CAPSULAR CONTRACTURE GRADE IV POST OPERATION. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Capsular Contracture

  MAUDE report 20345075 ↗
• InjuryAug 23, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH MENTOR MEMORYGEL BREAST IMPLANTS 550CC AND EXPERIENCED RUPTURE ON THE LEFT SIDE AND CAPSULAR CONTRACTURE BAKER GRADE II 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 LEFT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 20051304 ↗