MENTOR MemoryGel Breast Implant 3501251BCRecalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 00081317000211), received between Dec 4, 2019 and Sep 15, 2026 — classified as 28 injuries.

The most frequently reported specific device problem is “Material Rupture” (9 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 28 reports, in the reporter's own words as published by the FDA.

• InjurySep 15, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient underwent primary breast augmentation with two 125cc MENTOR MemoryGel Breast Implants. Post-operatively, the patient developed bilateral breast capsular contractures (baker grades IV). As a result, the patient has been scheduled for breast implant removal surgery on (b)(6)2026.This Medwatch form is for the right breast prosthesis.

  Patient problems: Capsular Contracture

  MAUDE report 50776743 ↗
• InjurySep 15, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient underwent primary breast augmentation with two 125cc MENTOR MemoryGel Breast Implants. Post-operatively, the patient developed bilateral breast capsular contractures (baker grades IV). As a result, the patient has been scheduled for breast implant removal surgery on (b)(6)2026.This Medwatch form is for the left breast prosthesis.

  Patient problems: Capsular Contracture

  MAUDE report 50776742 ↗
• InjuryJul 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH TWO 125CC MENTOR MEMORYGEL BREAST IMPLANTS AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE (BAKER GRADE 3) POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) , 2024, AND REPLACED WITH TWO 225CC MENTOR MEMORYGEL BREAST IMPLANT (CATALOG NUMBER 3502251BC). THIS REPORT IS FOR THE LEFT SIDE DEVICE.

  Patient problems: Capsular Contracture

  MAUDE report 22682215 ↗
• InjuryJul 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH TWO 125CC MENTOR MEMORYGEL BREAST IMPLANTS AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE (BAKER GRADE 3) POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2024 AND REPLACED WITH TWO 225CC MENTOR MEMORYGEL BREAST IMPLANT (CATALOG NUMBER 3502251BC). THIS REPORT IS FOR THE RIGHT-SIDE DEVICE.

  Patient problems: Capsular Contracture

  MAUDE report 22682214 ↗
• InjuryMay 16, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 54-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH UNKNOWN SIZE UNKNOWN GEL IMPLANTS AND EXPERIENCED BREAST IMPLANT RUPTURE, AND CAPSULAR CONTRACTURE; BAKER GRADE UNKNOWN ON HER LEFT SIDE POSTOPERATIVELY; DIAGNOSED VIA MRI AND ULTRASOUND RESULTS. 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.

  Patient problems: Capsular Contracture

  MAUDE report 22040363 ↗
• InjuryApr 22, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH TWO MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED BILATERAL RUPTURES POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 21883500 ↗
• InjuryApr 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 62-YEAR-OLD FEMALE PATIENT UNDERWENT REVISION BREAST AUGMENTATION WITH UNKNOWN SIZE UNKNOWN GEL IMPLANTS AND EXPERIENCED CAPSULAR CONTRACTURE; BAKER GRADE; BAKER GRADE IV ON THE RIGHT SIDE (DATE OF IMPLANT: (B)(6) 2006), AND GRADE III ON THE LEFT SIDE (DATE OF IMPLANT: (B)(6) 2007) POSTOPERATIVELY; DIAGNOSED IN THE OFFICE. THE PATIENT HAS CONSULTED WITH THE HEALTHCARE PROFESSIONAL. AS A RESULT, THE PATIENT IS SCHEDULED FOR SURGERY ON (B)(6) 2025. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT-SIDED DEVICE.

  Patient problems: Capsular Contracture

  MAUDE report 21827660 ↗
• InjuryMar 21, 2025Material Rupture; Material Rupture

  A FEMALE PATIENT WHO UNDERWENT A BREAST AUGMENTATION PRIMARY WITH MENTOR MEMORYGEL,125CC SILICONE PROSTHESIS EXPERIENCED LEFT SIDED CAPSULAR CONTRACTURE GRADE III, AND SYMPTOMATIC RUPTURE POST OPERATION. LEFT CAPSULAR CONTRACTURE WITH RUPTURE FOUND DURING REVISION, SUDDEN ONSET OF ENCAPSULATION, PAIN. AS A RESULT, PATIENT UNDERWENT BILATERAL CAPSULECTOMY REPLACEMENT WITH L) (B)(6), R) (B)(6) ON (B)(6) 2025.

  Patient problems: Capsular Contracture

  MAUDE report 21665687 ↗
• InjuryMar 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 125CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH BILATERAL BAKER GRADE III CAPSULAR CONTRACTURE OF THE BREASTS USING ULTRASOUND IMAGING. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT WITH 275CC MENTOR MEMORYGEL BREAST IMPLANTS ON (B)(6) 2024.

  Patient problems: Capsular Contracture

  MAUDE report 21574625 ↗
• InjuryMar 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 125CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH BILATERAL BAKER GRADE III CAPSULAR CONTRACTURE OF THE BREASTS USING ULTRASOUND IMAGING. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT WITH 275CC MENTOR MEMORYGEL BREAST IMPLANTS ON (B)(6) 2024.

  Patient problems: Capsular Contracture

  MAUDE report 21574623 ↗
• InjuryMar 4, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE WITH A MENTOR MEMORYGEL BREAST IMPLANT 125CC GEL BREAST PROSTHESIS THAT RUPTURED POST IMPLANTATION. RUPTURE OF THE PATIENT¿S RIGHT BREAST PROSTHESIS WAS DIAGNOSED VIA ULTRASONOGRAPHY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION AND REPLACEMENT WITH A MENTOR MEMORYGEL BREAST IMPLANT 300CC GEL BREAST PROSTHESIS ON (B)(6) 2024.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 21516353 ↗
• InjuryAug 22, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 125CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED A RUPTURE ON THE LEFT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2024.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 20033884 ↗
• InjuryApr 22, 2024Material Rupture; Adverse Event Without Identified Device or Use Problem; Material Rupture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 50-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH TWO 125CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED A RUPTURE ON THE LEFT SIDE POST-OPERATIVELY. IT WAS ALSO REPORTED THAT THE PATIENT EXPERIENCED GENERALIZED ILLNESS SYMPTOMS INCLUDING BEING TIRED, LETHARGIC, HAVING UNSPECIFIED SICKNESS, AND HAVING UNSPECIFIED AUTOIMMUNE ISSUES. AS A RESULT, THE PATIENT IS TO UNDERGO BILATERAL DEVICE EXPLANTATION ON (B)(6) 2024. THIS REPORT IS FOR THE LEFT SIDE DEVICE.

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

  MAUDE report 19160500 ↗
• InjuryApr 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 50-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH TWO 125CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED A RUPTURE ON THE LEFT SIDE POST-OPERATIVELY. IT WAS ALSO REPORTED THAT THE PATIENT EXPERIENCED GENERALIZED ILLNESS SYMPTOMS INCLUDING BEING TIRED, LETHARGIC, HAVING UNSPECIFIED SICKNESS, AND HAVING UNSPECIFIED AUTOIMMUNE ISSUES. AS A RESULT, THE PATIENT IS TO UNDERGO BILATERAL DEVICE EXPLANTATION ON (B)(6) 2024. THIS REPORT IS FOR THE RIGHT SIDE DEVICE.

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

  MAUDE report 19160386 ↗
• InjuryApr 10, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION WITH A 125CC 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) 2024.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 19081173 ↗
• InjuryApr 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH A 125CC MENTOR MEMORYGEL BREAST IMPLANT. POST-OPERATIVELY, THE PATIENT EXPERIENCED BAKER GRADE III CAPSULAR CONTRACTURE OF THE LEFT BREAST, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AT THE TIME OF THIS REPORT, MENTOR HAS NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THE INITIAL REPORTER REQUESTED THAT NO FOLLOW-UPS BE PERFORMED AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: Capsular Contracture

  MAUDE report 19038146 ↗
• InjuryApr 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 69-YEAR OLD CAUCASIAN FEMALE PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH A (RIGHT) 125CC MENTOR MEMORYGEL BREAST IMPLANT AND A (LEFT) 225CC MENTOR MEMORYGEL BREAST IMPLANT. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA PHYSICAL EXAMINATION, WITH BILATERAL BREAST CAPSULAR CONTRACTURES (BAKER GRADE IV). 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: Capsular Contracture

  MAUDE report 16788345 ↗
• InjuryApr 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 58-YEAR-OLD FEMALE WHO UNDERWENT BREAST AUGMENTATION REVISION WITH A 125CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED LEFT SIDED BAKER GRADE III CAPSULAR CONTRACTURE POST PROCEDURE. AS A RESULT, REPLACEMENT WITH SILICONE IMPLANTS IS PLANNED FOR (B)(6) 2023. THE PATIENT'S PREVIOUS SET OF IMPLANTS WAS REPORTED IN A DIFFERENT EVENT UNDER 1645337-2022-14148 AND 1645337-2022-14151.

  Patient problems: Capsular Contracture

  MAUDE report 16679203 ↗
• InjuryMar 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 125CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT EXPERIENCED INFLAMMATION, IRRITATION, AND SWELLING OF THE BREASTS, BILATERALLY. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL ON AN UNDISCLOSED DATE. THE DATE OF IMPLANTATION WAS NOT PROVIDED TO MENTOR. SEVERAL FOLLOW-UPS HAVE BEEN CONDUCTED, AND NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. IF MORE INFORMATION BECOMES AVAILABLE, MENTOR WILL SUBMIT A SUPPLEMENTAL REPORT ACCORDINGLY. REFER TO MANUFACTURING REPORT NUMBER 1645337-2023-03542 FOR THE CONTRALATERAL EVENT.

  Patient problems: Local Reaction

  MAUDE report 16628494 ↗
• InjuryOct 31, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION PROCEDURE WITH A MENTOR MEMORYGEL BREAST IMPLANT 125CC GEL BREAST PROSTHESIS (LEFT DEVICE) AND A MENTOR MEMORYGEL BREAST IMPLANT 800CC GEL BREAST PROSTHESIS (RIGHT DEVICE) SUFFERED FROM MISSHAPEN BREASTS POST IMPLANTATION. THE PATIENT UNDERWENT OPEN HEART SURGERY AND BELIEVES THAT MAY HAVE CAUSED THE MISSHAPING. ADDITIONALLY, LEFT BREAST PROSTHESIS RUPTURE WAS REPORTED. 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: Deformity/ Disfigurement

  MAUDE report 15704586 ↗
• InjuryOct 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT PARTICIPATING IN A CLINICAL STUDY UNDERWENT A BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 125CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT UNDERWENT SURGICAL INTERVENTION TO BILATERALLY CORRECT HER IMPLANT SITE INCISION SCARRING ON (B)(6) 2019, AND (B)(6) 2020. THIS REPORT IS FOR THE RIGHT BREAST PROSTHESIS. REFER TO MANUFACTURING REPORT NUMBER 1645337-2022-11531 FOR THE CONTRALATERAL EVENT.

  Patient problems: Scar Tissue

  MAUDE report 15567371 ↗
• InjuryOct 5, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 73-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT BREAST SURGERY WITH A 125CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED BREAST LUMP NEOPLASM MALIGNANT AND BREAST IMPLANT RUPTURE ON HER LEFT SIDE POSTOPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION AND REPLACEMENT WITH CATALOG NUMBER SDC135H; SERIAL NUMBER (B)(4) ON (B)(6) 2022.

  Patient problems: Cancer

  MAUDE report 15547119 ↗
• InjuryJul 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 54-YEAR-OLD FEMALE PATIENT UNDERWENT REVISION BREAST AUGMENTATION WITH A 125CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED CAPSULAR CONTRACTURE; BAKER GRADE III ON HER LEFT SIDE POSTOPERATIVELY; DIAGNOSED IN THE OFFICE. AS A RESULT, THE DEVICE WILL BE EXPLANTED ON (B)(6) 2022.

  Patient problems: Capsular Contracture

  MAUDE report 15053271 ↗
• InjuryMay 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH A 450CC MENTOR MEMORYGEL BREAST IMPLANT ON THE RIGHT SIDE AND WITH A 125CC MENTOR MEMORYGEL BREAST IMPLANT ON THE LEFT AND EXPERIENCED BREAST IMPLANT RUPTURE ON HER RIGHT SIDE POSTOPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION AND REPLACEMENT WITH ALLERGAN DEVICE ON (B)(6) 2021. ON MAY 2, 2022, MENTOR BECAME AWARE THAT PATIENT ALSO EXPERIENCED LEFT SIDE PTOSIS THAT REQUIRED LEFT BREAST MASTOPEXY IN ADDITION TO RIGHT RUPTURE. PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH ALLERGAN BRAND DEVICES (605CC ON RIGHT, AND 295CC ON THE LEFT) ON (B)(6) 2021. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT-SIDED DEVICE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 14346056 ↗
• InjuryMay 31, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD AFRICAN AMERICAN FEMALE PATIENT WHO UNDERWENT A BREAST AUGMENTATION REVISION WITH 125CC SMOOTH MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED LEFT-SIDED CAPSULAR CONTRACTURE POSTOPERATIVELY, BAKER GRADE UNKNOWN. THE PATIENT REPORTED THAT THE IMPLANT IS UNCOMFORTABLE AND FEELS LIKE IT IS GOING DOWN THE CHEST. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THE PATIENT EXPERIENCED A PREVIOUS CAPSULAR CONTRACTURE THAT WAS REPORTED UNDER MANUFACTURE REFERENCE NUMBER 1645337-2021-06085, WHERE SURGICAL INTERVENTION WAS PERFORMED AND THE SAME BREAST IMPLANT WAS RE-IMPLANTED IN 2018. THE PATIENT IS CURRENTLY EXPERIENCING A RECURRENCE OF THE CAPSULAR CONTRACTURE ON THE LEFT BREAST.

  Patient problems: Capsular Contracture

  MAUDE report 11911098 ↗