MENTOR MemoryGel Breast Implant 3541501Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00081317000808), received between Dec 4, 2019 and Jan 7, 2026 — classified as 14 injuries.

The most frequently reported specific device problem is “Material Rupture” (7 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryJan 7, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Capsular Contracture

  MAUDE report 23990575 ↗
• InjuryMar 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT REVISION BREAST AUGMENTATION WITH 175CC MENTOR MEMORYGEL BREAST IMPLANT ON THE LEFT SIDE, AND WITH 150CC MENTOR MEMORYGEL BREAST IMPLANT ON THE RIGHT SIDE AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE; BAKER GRADE II. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REPLACEMENT SURGERY WITH CATALOG NUMBER 3503004BC; SERIAL NUMBER (B)(6), ON THE LEFT SIDE, AND WITH CATALOG NUMBER 3502504BC; SERIAL NUMBER (B)(6), ON THE RIGHT SIDE ON (B)(6) 2025. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT-SIDED DEVICE.

  Patient problems: Capsular Contracture

  MAUDE report 21536668 ↗
• InjuryJul 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNSPECIFIED BREAST SURGERY WITH A MENTOR MEMORYGEL BREAST IMPLANT 250CC GEL BREAST PROSTHESIS (LEFT DEVICE) AND A MENTOR MEMORYGEL BREAST IMPLANT 150CC GEL BREAST PROSTHESIS (RIGHT DEVICE) WHEN THE LEFT DEVICE RUPTURED POST IMPLANTATION. ADDITIONALLY, THE PATIENT DEVELOPED BAKER GRADE IV CAPSULAR CONTRACTURE IN BOTH BREASTS POST IMPLANTATION. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION WITH NO REPLACEMENT BREAST PROSTHESES ON (B)(6) 2024. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 19694397 ↗
• InjuryFeb 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION WITH MENTOR MEMORYSHAPE BREAST IMPLANTS 150CC (L) AND 350CC (R) AND EXPERIENCED BREAST CANCER WHICH METASTASIZED TO THE RIGHT LUNG POST-OPERATIVELY ALONG WITH ASYMMETRY ON THE LEFT SIDE. THE LEFT BREAST PROSTHESIS WAS REMOVED AND REPLACED WITH A SIMILAR DEVICE ON (B)(6) 2019. THE PATIENT UNDERWENT A RIGHT-SIDED THORACOTOMY AND LUNG RESECTION ON (B)(6) 2022. THIS REPORT IS FOR THE LEFT BREAST PROSTHESIS. SEE MANUFACTURER REPORT NUMBER 1645337-2023-02740 FOR CONTRALATERAL SIDE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18669973 ↗
• InjuryJan 22, 2024Adverse 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 WITH A 225CC (LEFT) AND A 150CC (RIGHT) MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE (BAKER GRADE 3) POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION ON AN UNDISCLOSED DATE. THIS REPORT IS FOR THE RIGHT SIDE DEVICE.

  Patient problems: Capsular Contracture

  MAUDE report 18559331 ↗
• InjuryOct 13, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 59-YEAR-OLD FEMALE PATIENT WHO UNDERWENT BREAST IMPLANT SURGERY WITH MENTOR MEDICAL DEVICES (- SX MPP GEL 150CC, DATE OF IMPLANT (B)(6) 2011) DEVELOPED LYMPHADENOPATHY IN BOTH AXILLA REGIONS, IT WAS REPORTED THAT LYMPH NODES CONTAIN SILICONE. IT WAS ALSO REPORTED BY THE PATIENT UNEXPLAINED SYSTEMIC SYMPTOMS WHICH INCLUDED: PAIN, JOINT PAIN, CHEST PAIN, FATIGUE, EXHAUST, INFLAMMATION, SWELLING. PER THE INFORMATION PROVIDED IT IS REASONABLE TO ASSUME THAT THE PATIENT HAS EXPERIENCED BREAST IMPLANTS RUPTURE BILATERALLY. AT THIS TIME, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS CASE WILL BE RE-ASSESSED AND NOTES WILL BE UPDATED. THIS REPORT RELATES TO THE RIGHT PROSTHESIS.

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

  MAUDE report 15601146 ↗
• InjuryOct 13, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 59-YEAR-OLD FEMALE PATIENT WHO UNDERWENT BREAST IMPLANT SURGERY WITH MENTOR MEDICAL DEVICES (- SX MPP GEL 150CC, DATE OF IMPLANT (B)(6) 2011) DEVELOPED LYMPHADENOPATHY IN BOTH AXILLA REGIONS, IT WAS REPORTED THAT LYMPH NODES CONTAIN SILICONE. IT WAS ALSO REPORTED BY THE PATIENT UNEXPLAINED SYSTEMIC SYMPTOMS WHICH INCLUDED: PAIN, JOINT PAIN, CHEST PAIN, FATIGUE, EXHAUST, INFLAMMATION, SWELLING. PER THE INFORMATION PROVIDED IT IS REASONABLE TO ASSUME THAT THE PATIENT HAS EXPERIENCED BREAST IMPLANTS RUPTURE BILATERALLY. AT THIS TIME, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS CASE WILL BE RE-ASSESSED AND NOTES WILL BE UPDATED. THIS REPORT RELATES TO THE LEFT PROSTHESIS.

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

  MAUDE report 15600956 ↗
• InjuryOct 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 64-YEAR-OLD FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH MENTOR MEMORYGEL BREAST IMPLANTS 150CC AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE BAKER GRADE III 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.

  Patient problems: Capsular Contracture

  MAUDE report 15587812 ↗
• InjuryOct 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 64-YEAR-OLD FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH MENTOR MEMORYGEL BREAST IMPLANTS 150CC AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE BAKER GRADE III 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: Capsular Contracture

  MAUDE report 15587811 ↗
• InjuryApr 11, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION WITH A MENTOR MEMORYGEL BREAST IMPLANT 150CC 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) 2022.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 14078747 ↗
• InjuryAug 2, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A 150CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED A RUPTURE ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2021.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 12264306 ↗
• InjuryMar 24, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT WHO UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 150CC MENTOR MEMORYGEL BREAST IMPLANT (LEFT) AND A 200CC MENTOR MEMORYGEL BREAST IMPLANT (RIGHT) EXPERIENCED POSTOPERATIVE BILATERAL RUPTURE AND GRADE II CAPSULAR CONTRACTURE. THE DIAGNOSIS WAS CONFIRMED BY A HEALTHCARE PROFESSIONAL. THE PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT ON (B)(6) 2020 DUE TO THE BILATERAL CAPSULAR CONTRACTURE. UPON EXPLANTATION, THE BILATERAL RUPTURE WAS OBSERVED. THIS REPORT IS FOR THE LEFT PROSTHESIS.

  Patient problems: Capsular Contracture; No Code Available

  MAUDE report 9875582 ↗
• InjuryDec 4, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH MENTOR MEMORYGEL BREAST IMPLANTS 150CC AND EXPERIENCED BILATERAL RUPTURE POSTOPERATIVELY. RUPTURE WAS CONFIRMED VIA MRI. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH MENTOR MEMORYGEL BREAST IMPLANTS 200CC, CATALOG NUMBER 3502001BC, SERIAL NUMBERS (B)(4) ON (B)(6) 2019. THIS REPORT IS FOR THE RIGHT SIDE.

  Patient problems: No Code Available

  MAUDE report 9411187 ↗
• InjuryDec 4, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH MENTOR MEMORYGEL BREAST IMPLANTS 150CC AND EXPERIENCED BILATERAL RUPTURE POSTOPERATIVELY. RUPTURE WAS CONFIRMED VIA MRI. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH MENTOR MEMORYGEL BREAST IMPLANTS 200CC, CATALOG NUMBER 3502001BC, SERIAL NUMBERS (B)(4) ON (B)(6) 2019. THIS REPORT IS FOR THE LEFT SIDE.

  Patient problems: No Code Available

  MAUDE report 9411173 ↗