MENTOR MemoryGel Breast Implant 3507600BCRecalls & reported problems

Summary

The FDA's MAUDE database contains 114 adverse event reports that list this exact device (DI 00081317000174), received between Apr 4, 2018 and Mar 17, 2026 — classified as 114 injuries.

The most frequently reported specific device problem is “Material Rupture” (91 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 114 reports, in the reporter's own words as published by the FDA.

• InjuryMar 17, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 600CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED CAPSULAR CONTRACTURE AND A RUPTURE ON THE LEFT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2026.

  Patient problems: Capsular Contracture

  MAUDE report 24620194 ↗
• InjuryJul 30, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH TWO 600 CC MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED BILATERAL RUPTURES AND BREAST PAIN POST-OPERATIVELY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Breast Discomfort/Pain

  MAUDE report 22669180 ↗
• InjuryJul 30, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH TWO 600CC MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED BILATERAL RUPTURES AND BREAST PAIN POST-OPERATIVELY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Breast Discomfort/Pain

  MAUDE report 22669164 ↗
• InjuryJun 24, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT WITH MENTOR MEMORYGEL BREAST IMPLANTS AND EXPERIENCED BILATERAL RUPTURE 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. THE REPORTED IMPLANTATION DATE IS PRIOR TO THE DEVICE MANUFACTURE DATE. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THE CORRECT DATE OF IMPLANTATION OR DEVICE LOT NUMBER, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 22322224 ↗
• InjuryJun 24, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT WITH MENTOR MEMORYGEL BREAST IMPLANTS AND EXPERIENCED BILATERAL RUPTURE 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 RIGHT BREAST PROSTHESIS. THE REPORTED IMPLANTATION DATE IS PRIOR TO THE DEVICE MANUFACTURE DATE. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THE CORRECT DATE OF IMPLANTATION OR DEVICE LOT NUMBER, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 22322223 ↗
• InjuryMay 20, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 52-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 600CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED CAPSULAR CONTRACTURE (BAKER GRADE 4) AND A RUPTURE ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS DIAGNOSED WITH AN MRI. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025.

  Patient problems: Capsular Contracture

  MAUDE report 22057718 ↗
• InjuryMar 28, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH TWO 600CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT DEVELOPED RIGHT BREAST PAIN AND WAS DIAGNOSED, VIA MRI, WITH POSSIBLE BILATERAL BREAST IMPLANT RUPTURES. AS A RESULT, THE PATIENT UNDERWENT BILATERAL BREAST IMPLANT REMOVAL AND REPLACEMENT SURGERY ON (B)(6) 2025. DURING THE SURGERY, THE PATIENT WAS DIAGNOSED WITH DEFORMITY BUT ONLY THE RIGHT BREAST IMPLANT WAS FOUND TO BE RUPTURED. THE LEFT IMPLANT WAS REMOVED INTACT. SUBSEQUENTLY, THEY WERE BOTH REPLACED WITH THE FOLLOWING: (LEFT) 600CC MENTOR MEMORYGEL BREAST IMPLANT CATALOG: 3506001BC LOT: 9997828 SN: (B)(6) AND (RIGHT) 600CC MENTOR MEMORYGEL BREAST IMPLANT CATALOG: 3506001BC LOT: 9997828 SN: (B)(6). THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Breast Discomfort/Pain

  MAUDE report 21725031 ↗
• InjuryMar 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH TWO 600CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT DEVELOPED RIGHT BREAST PAIN AND WAS DIAGNOSED, VIA MRI, WITH POSSIBLE BILATERAL BREAST IMPLANT RUPTURES. AS A RESULT, THE PATIENT UNDERWENT BILATERAL BREAST IMPLANT REMOVAL AND REPLACEMENT SURGERY ON (B)(6) 2025. DURING THE SURGERY, THE PATIENT WAS DIAGNOSED WITH DEFORMITY BUT ONLY THE RIGHT BREAST IMPLANT WAS FOUND TO BE RUPTURED. THE LEFT IMPLANT WAS REMOVED INTACT. SUBSEQUENTLY, THEY WERE BOTH REPLACED WITH THE FOLLOWING: (LEFT) 600CC MENTOR MEMORYGEL BREAST IMPLANT CATALOG: 3506001BC LOT: 9997828 SN: (B)(6)AND (RIGHT) 600CC MENTOR MEMORYGEL BREAST IMPLANT CATALOG: 3506001BC LOT: 9997828 SN: (B)(6). THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 21724308 ↗
• InjuryMar 17, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 600CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED A RUPTURE ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 21625711 ↗
• InjuryDec 10, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF AN UNDISCLOSED MENTOR SMOOTH GEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH BILATERALLY RUPTURED BREAST IMPLANTS DURING A PHYSICAL EXAM WITH A MEDICAL PROFESSIONAL AND USING ULTRASOUND IMAGING. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT WITH ALLERGAN BREAST IMPLANTS ON (B)(6)2024. THE DATE OF IMPLANTATION WAS PROVIDED TO MENTOR AS A BEST ESTIMATE. FOLLOW-UPS ARE BEING CONDUCTED. IF MORE INFORMATION BECOMES AVAILABLE, MENTOR WILL SUBMIT A SUPPLEMENTAL REPORT ACCORDINGLY.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 20898882 ↗
• InjuryDec 10, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF AN UNDISCLOSED MENTOR SMOOTH GEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH BILATERALLY RUPTURED BREAST IMPLANTS DURING A PHYSICAL EXAM WITH A MEDICAL PROFESSIONAL AND USING ULTRASOUND IMAGING. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT WITH ALLERGAN BREAST IMPLANTS ON (B)(6) 2024. THE DATE OF IMPLANTATION WAS PROVIDED TO MENTOR AS A BEST ESTIMATE. FOLLOW-UPS ARE BEING CONDUCTED. IF MORE INFORMATION BECOMES AVAILABLE, MENTOR WILL SUBMIT A SUPPLEMENTAL REPORT ACCORDINGLY.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 20898880 ↗
• InjuryOct 15, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE WHO UNDERWENT A BREAST AUGMENTATION REVISION WITH AN UNKNOWN MENTOR PROSTHESIS ON THE A SIDE, AND MENTOR MEMORYGEL , 600CC ON THE B SIDE EXPERIENCED BILATERAL SILENT RUPTURE POSTOPERATIVE. THE HEALTH CARE PROFESSIONAL DIAGNOSED THE RUPTURE. AS A RESULT, PATIENT UNDERWENT BILATERAL REPLACEMENTS WITH UNSPECIFIED PROSTHESIS ON (B)(6) 2024. NOTE: ACCORDING TO THE "RECEIVED DEVICE PAPERWORK" BOTH RETURNED PRODUCTS BELONGS TO THIS FILE (600 CC). CUSTOMER STATED THE LOT NUMBERS FOR THIS CLAIM WERE UNKNOWN AND DEVICES WERE NOT DAMAGED DURING EXPLANTATION AS PER PAPERWORK. SINCE BOTH PRODUCTS WERE RETURNED RUPTURED AND IS NOT POSSIBLE TO IDENTIFY THE IMPACTED ONE, THE FOLLOWING UPDATES WERE PERFORMED ACCORDINGLY: 1. IP-02154283: UPDATED AFFECTED SIDE FROM RIGHT TO A. 2. IP-02154283 / RIGHT REPORTED (A): UPDATED PRODUCT CODE FROM UNK_GEL IMPLANTS TO UNK_GEL IMPLANTS SMOOTH AS PER RETURNED DEVICE. 3. IP-02193769 (B) HAS BEEN CREATED TO CAPTURE THE OTHER PRODUCT WITH THE LOT#: 5612602 SHOWN ON THE DEVICE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 20451519 ↗
• InjuryOct 14, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE WHO UNDERWENT A BREAST AUGMENTATION PRIMARY WITH MENTOR MEMORYGEL 600CC, SILICONE PROSTHESIS EXPERIENCED BILATERAL CAPSULAR CONTRACTURE UNKNOWN GRADE, AND SYMPTOMATIC RUPTURE POSTOPERATIVE. THE ISSUE WAS DIAGNOSED IN OFFICE EXAMINATION. AS A RESULT, PATIENT SCHEDULED FOR BILATERAL REMOVAL ON (B)(6) 2024. THIS REPORT RELATES TO THE RIGHT SIDE.

  Patient problems: Capsular Contracture

  MAUDE report 20445737 ↗
• InjuryOct 14, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE WHO UNDERWENT A BREAST AUGMENTATION PRIMARY WITH MENTOR MEMORYGEL 600CC, SILICONE PROSTHESIS EXPERIENCED BILATERAL CAPSULAR CONTRACTURE UNKNOWN GRADE, AND SYMPTOMATIC RUPTURE POSTOPERATIVE. THE ISSUE WAS DIAGNOSED IN OFFICE EXAMINATION. AS A RESULT, PATIENT SCHEDULED FOR BILATERAL REMOVAL ON (B)(6) 2024. THIS REPORT RELATES TO THE LEFT SIDE.

  Patient problems: Capsular Contracture

  MAUDE report 20445113 ↗
• InjuryOct 14, 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 MENTOR MEMORYGEL XTRA 295CC, SILICONE PROSTHESIS EXPERIENCED RIGHT-SIDED CAPSULAR CONTRACTURE GRADE IV GRADE POSTOPERATIVE. THE ISSUE WAS DIAGNOSED IN OFFICE EXAMINATION. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Capsular Contracture

  MAUDE report 20445076 ↗
• InjuryOct 1, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 54-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH 600CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED BREAST IMPLANT RUPTURE, AND CAPSULAR CONTRACTURE; BAKER GRADE III ON HER RIGHT SIDE POSTOPERATIVELY. THE PATIENT UNDERWENT BILATERAL REPLACEMENT SURGERY WITH SERIAL NUMBERS (B)(6) ON THE LEFT SIDE, AND WITH (B)(6) ON THE RIGHT SIDE ON (B)(6) 2024.

  Patient problems: Capsular Contracture

  MAUDE report 20348203 ↗
• InjurySep 27, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH 600CC MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED BILATERAL RUPTURE POST PROCEDURE. AS A RESULT, EXPLANT IS PLANNED FOR (B)(6) 2024.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 20319380 ↗
• InjurySep 27, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH 600CC MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED BILATERAL RUPTURE POST PROCEDURE. AS A RESULT, EXPLANT IS PLANNED FOR (B)(6) 2024.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 20317408 ↗
• InjurySep 4, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 600CC MENTOR MEMORYGEL BREAST IMPLANT SALINE BREAST PROSTHESIS EXPERIENCED A RUPTURE AND A DEVICE EXTRUSION ON THE LEFT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON AUGUST 13, 2024.

  Patient problems: Pocket Erosion

  MAUDE report 20137775 ↗
• InjuryAug 6, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 58-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT BREAST SURGERY WITH UNKNOWN SIZE UNKNOWN GEL IMPLANTS ON BOTH SIDES AND EXPERIENCED BILATERAL BREAST IMPLANT RUPTURES POSTOPERATIVELY; DIAGNOSED IN THE OFFICE VIA MRI. THE PATIENT HAS CONSULTED WITH THE HEALTHCARE PROFESSIONAL. AS A RESULT, THE PATIENT IS SCHEDULED FOR SURGERY ON (B)(6) 2024. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT-SIDED DEVICE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 19917965 ↗
• InjuryJul 1, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION, AS PART OF A CLINICAL STUDY, WITH TWO 600CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT SUFFERED BILATERAL BREAST IMPLANT RUPTURES. AS A RESULT, THE PATIENT UNDERWENT BILATERAL BREAST IMPLANT REMOVAL AND REPLACEMENT SURGERY ON (B)(6) 2024. THE REPLACEMENT DEVICES WERE: (LEFT) 585CC MENTOR MEMORYGEL BOOST BREAST IMPLANT CATALOG: SHPB585 LOT: 9982694 SN: (B)(6) AND (RIGHT) 585CC MENTOR MEMORYGEL BOOST BREAST IMPLANT CATALOG: SHPB585 LOT: 9982694 SN: (B)(6). THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS. THE RUPTURE ON THE LEFT BREAST IMPLANT HAS BEEN REPORTED UNDER MRN: 1645337-2024-06677.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 19651668 ↗
• InjuryJun 13, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 60-YEAR-OLD FEMALE PATIENT UNDERWENT BREAST SURGERY WITH 600CC MENTOR MEMORYGEL BREAST IMPLANT ON THE LEFT SIDE, AND WITH 700CC MENTOR MEMORYGEL BREAST IMPLANT ON THE RIGHT SIDE AND BILATERAL BREAST IMPLANT RUPTURES WERE FOUND DURING BILATERAL REPLACEMENT SURGERY WITH CATALOG NUMBER 3507001BC; SERIAL NUMBER (B)(6) ON THE LEFT SIDE, AND WITH CATALOG NUMBER 3506001BC; SERIAL NUMBER (B)(6) ON THE RIGHT SIDE ON (B)(6) 2024. MENTOR IS AWARE THAT THE DATE OF IMPLANT ((B)(6) 2001) IS PRIOR TO THE MANUFACTURING DATE (5/1/2002) OF LOT 243512. PER RESPONSE RECEIVED, THE PATIENT GUESSED ON THE DATE OF IMPLANT. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT-SIDED DEVICE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 19529338 ↗
• InjuryJun 4, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION WITH TWO UNSPECIFIED MENTOR GEL 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), 2024.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 19463577 ↗
• InjuryApr 29, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 65-YEAR-OLD FEMALE PATIENT UNDERWENT REVISION BREAST AUGMENTATION WITH 600CC MENTOR MEMORYGEL BREAST IMPLANT ON BOTH SIDES AND EXPERIENCED RIGHT SIDE CAPSULAR CONTRACTURE; BAKER GRADE IV, AND LEFT SIDE RUPTURE POSTOPERATIVELY. THE PATIENT HAS CONSULTED WITH THE HEALTHCARE PROFESSIONAL. 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-SIDED DEVICE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 19201309 ↗
• InjuryApr 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 65-YEAR-OLD FEMALE PATIENT UNDERWENT REVISION BREAST AUGMENTATION WITH 600CC MENTOR MEMORYGEL BREAST IMPLANT ON BOTH SIDES AND EXPERIENCED RIGHT SIDE CAPSULAR CONTRACTURE; BAKER GRADE IV, AND LEFT SIDE RUPTURE POSTOPERATIVELY. THE PATIENT HAS CONSULTED WITH THE HEALTHCARE PROFESSIONAL. 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-SIDED DEVICE.

  Patient problems: Capsular Contracture

  MAUDE report 19201308 ↗