MENTOR MemoryGel Breast Implant 3547001Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00081317000952), received between Jun 28, 2018 and Aug 17, 2022 — classified as 18 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjuryAug 17, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 61-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION WITH A 700CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED A RUPTURE ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED VIA CT SCAN. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2022.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 15243035 ↗
• InjuryJan 17, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT WHO UNDERWENT BREAST AUGMENTATION REVISION SURGERY WITH TWO 700CC MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED BILATERAL CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN, LYMPHADENOPATHY, LEFT SIDED LOCAL REACTION AND RIGHT SIDED RUPTURE POST PROCEDURE. AS A RESULT, PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH TWO MENTOR MEMORYGEL BREAST IMPLANTS ON (B)(6) 2021. THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture; Swollen Lymph Nodes/Glands

  MAUDE report 13264318 ↗
• InjuryJan 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT WHO UNDERWENT BREAST AUGMENTATION REVISION SURGERY WITH TWO 700CC MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED BILATERAL CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN, LYMPHADENOPATHY, LEFT SIDED LOCAL REACTION AND RIGHT SIDED RUPTURE POST PROCEDURE. AS A RESULT, PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH TWO MENTOR MEMORYGEL BREAST IMPLANTS ON (B)(6) 2021. THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture; Local Reaction; Swollen Lymph Nodes/Glands

  MAUDE report 13264306 ↗
• InjuryJun 7, 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 FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION WITH A MENTOR MEMORYGEL BREAST IMPLANT 700CC AND SUFFERED FROM A LATE ONSET SEROMA AND CAPSULAR CONTRACTURE AND RUPTURE ON THE LEFT BREAST IMPLANT AND CUTANEOUS CONTOUR DEFORMITY ON THE RIGHT SIDE. AS A RESULT, THE PATIENT HAD UNDERGONE REMOVAL AND REPLACEMENT WITH NON-MENTOR DEVICES ON (B)(6) 2021. THIS MEDWATCH IS FOR THE RIGHT SIDE.

  Patient problems: Wrinkling

  MAUDE report 11953338 ↗
• InjuryJun 7, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD ASIAN FEMALE WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH A MENTOR MEMORYGEL, 700CC SILICONE PROSTHESIS EXPERIENCED LEFT SIDED CUTANEOUS CONTOUR DEFORMITY AND RIGHT SIDED RUPTURE, AND BREAST PAIN POST PROCEDURE. A MAMMOGRAM, AND ULTRASOUND EXAMINATION CONFIRMED THE ISSUES. THE PATIENT STATED THAT THE LEFT SIDE LOOKS PUSHED IN AND DEFORMED LOOKS LIKE THERE'S DENTS; RIGHT SIDE IS RUPTURE SINCE IT'S DROOPY ; SHARP PAIN ; SLANTED AND NOT FULL AND DROOPY . AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT RELATES TO THE RIGHT PROSTHESIS.

  Patient problems: Pain

  MAUDE report 11952507 ↗
• InjuryJun 7, 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 ASIAN FEMALE WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH A MENTOR MEMORYGEL, 700CC SILICONE PROSTHESIS EXPERIENCED LEFT SIDED CUTANEOUS CONTOUR DEFORMITY AND RIGHT SIDED RUPTURE, AND BREAST PAIN POST PROCEDURE. A MAMMOGRAM, AND ULTRASOUND EXAMINATION CONFIRMED THE ISSUES. THE PATIENT STATED THAT THE LEFT SIDE LOOKS PUSHED IN AND DEFORMED LOOKS LIKE THERE'S DENTS; RIGHT SIDE IS RUPTURE SINCE IT'S DROOPY ; SHARP PAIN ; SLANTED AND NOT FULL AND DROOPY . AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT RELATES TO THE LEFT PROSTHESIS.

  Patient problems: Wrinkling

  MAUDE report 11952464 ↗
• InjuryMay 17, 2021Material Rupture; Adverse Event Without Identified Device or Use Problem; Material Rupture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6)-YEAR-OLD FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION WITH A MENTOR MEMORYGEL BREAST IMPLANT 700CC AND SUFFERED FROM A BREAST PAIN AND RUPTURE ON THE LEFT BREAST IMPLANT. AS A RESULT, THE PATIENT HAD UNDERGONE REMOVAL AND REPLACEMENT WITH NON-MENTOR DEVICES ON (B)(6) 2021.

  Patient problems: Capsular Contracture; Pain; Seroma

  MAUDE report 11832359 ↗
• InjuryApr 20, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT REVISION BREAST AUGMENTATION WITH A 700CC MENTOR MEMORYGEL BREAST IMPLANT ON BOTH SIDES AND EXPERIENCED BILATERAL WOUND INFECTION, BILATERAL SKIN REACTION, AND RIGHT SIDE BUBBLES AND BREAST IMPLANT RUPTURE. CAT SCAN ON (B)(6) 2018 CAPTURED THE RUPTURE OF THE RIGHT BREAST. AS A RESULT, THE DEVICES WILL BE EXPLANTED ON (B)(6) 2021. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT-SIDED DEVICE.

  Patient problems: Capsular Contracture; Local Reaction; Post Operative Wound Infection

  MAUDE report 11693037 ↗
• InjuryApr 20, 2021Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT REVISION BREAST AUGMENTATION WITH A 700CC MENTOR MEMORYGEL BREAST IMPLANT ON BOTH SIDES AND EXPERIENCED BILATERAL WOUND INFECTION, BILATERAL SKIN REACTION, AND RIGHT SIDE BUBBLES AND BREAST IMPLANT RUPTURE. CAT SCAN ON (B)(6) 2018 CAPTURED THE RUPTURE OF THE RIGHT BREAST. AS A RESULT, THE DEVICES WILL BE EXPLANTED ON (B)(6) 2021. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT-SIDED DEVICE.

  Patient problems: Capsular Contracture; Local Reaction; Post Operative Wound Infection

  MAUDE report 11693036 ↗
• InjuryMar 2, 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 HISPANIC FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION WITH TWO MENTOR MEMORYGEL BREAST IMPLANT 700CC AND EXPERIENCED A RUPTURE ON THE RIGHT SIDE, AND WINKING AND A WOUND INFECTION ON THE LEFT POST-OPERATIVELY, WHICH REQUIRED SURGICAL INTERVENTION. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2020. THIS REPORT IS FOR THE LEFT SIDE DEVICE.

  Patient problems: Post Operative Wound Infection; Wrinkling

  MAUDE report 11401969 ↗
• InjuryFeb 4, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE WHO UNDERWENT BREAST RECONSTRUCTION REVISION WITH A MENTOR MEMORYGEL 700CC SILICONE PROSTHESIS EXPERIENCED LEFT SIDED RUPTURE POST PROCEDURE. THE ULTRASOUND EXAMINATION REPORTED RUPTURE & MRI EXAMINATION SCHEDULED TO CONFIRM THE 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 11280548 ↗
• InjuryMay 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED (VIA FDA MW5093336) THAT A (B)(6) YEAR OLD FEMALE PATIENT WHO UNDERWENT BREAST RECONSTRUCTION REVISION WITH A 700CC MENTOR MEMORYGEL BREAST IMPLANTS ON (B)(6) 2015, PRESENTED WITH SWELLING, PAIN, AND REDNESS TO HER LEFT RECONSTRUCTED BREAST ON (B)(6) 2019. THE SWELLING INCREASED IN SIZE OVER THREE WEEKS. AS A RESULT, THE PATIENT UNDERWENT AN ULTRASOUND GUIDED ASPIRATION OF THE SEROMA FLUID PROCEDURE ON (B)(6) 2019. THE SEROMA FLUID WAS TESTED, AND THE FLOW CYTOMETRY RESULTS SHOWED A HYPOCELLULAR SAMPLE WITH A POPULATION OF CD30+ LARGE T-CELLS. THE FINDINGS WERE CONSISTENT WITH ANAPLASTIC LARGE CELL T-CELL LYMPHOMA. AFTER TESTING OF THE SEROMA FLUID, CAPSULE, AND BREAST TISSUE THE PATIENT WAS OFFICIALLY DIAGNOSED WITH BIA-ALCL ON (B)(6) 2019. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL ON (B)(6) 2019. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THE IMPLANTS AND COMPLETE CAPSULES WERE REMOVED. THE PATIENT WAS NOT RECONSTRUCTED AFTER THE TREATMENT OF ALCL. THE IMPLANTS WERE NOT REPLACED. AS OF (B)(6) 2020, THE PATIENT IS ALIVE WITH NO EVIDENCE OF ALCL. THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Anaplastic Large Cell Lymphoma; Necrosis; No Code Available; Seroma

  MAUDE report 10059679 ↗
• InjuryMay 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED (VIA FDA MW5093336) THAT A (B)(6) YEAR OLD FEMALE PATIENT WHO UNDERWENT BREAST RECONSTRUCTION REVISION WITH TWO 700CC MENTOR MEMORYGEL BREAST IMPLANTS IN (B)(6) 2015, SUFFERED EARLY ONSET SEROMA ON THE RIGHT BREAST AND HAD TO UNDERGO UNILATERAL REMOVAL AND REPLACEMENT WITH A NEW 700CC MENTOR MEMORYGEL BREAST IMPLANT SALINE (CATALOG: 3547001, LOT: 6896026, SN: (B)(4) ON (B)(6) 2015. THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: No Code Available; Seroma

  MAUDE report 10059677 ↗
• InjuryAug 28, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION WITH TWO 700CC MENTOR MEMORYGEL BREAST IMPLANTS AND EXPERIENCED POSTOPERATIVE SKIN REACTION (OCCASIONAL ITCHINESS). THE PATIENT ALSO REPORTS THAT SHE WAS DIAGNOSED WITH LARGE B-CELL NON-HODGKIN'S LYMPHOMA IN 2014, BUT THAT HER ONCOLOGIST DOES NOT ATTRIBUTE IT TO HER BREAST IMPLANTS, AND THAT IT IS NOT BIA-ALCL. WITH THE INFORMATION CURRENTLY AVAILABLE, THE PATIENT'S CANCER DIAGNOSIS DOES NOT APPEAR TO BE RELATED TO HER BREAST IMPLANTS. IF ADDITIONAL INFORMATION IS RECEIVED SURROUNDING THE DIAGNOSIS, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT IS FOR RIGHT PROSTHESIS.

  Patient problems: Skin Irritation

  MAUDE report 8941174 ↗
• InjuryAug 28, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION WITH TWO 700CC MENTOR MEMORYGEL BREAST IMPLANTS AND EXPERIENCED POSTOPERATIVE SKIN REACTION (OCCASIONAL ITCHINESS). THE PATIENT ALSO REPORTS THAT SHE WAS DIAGNOSED WITH LARGE B-CELL NON-HODGKIN'S LYMPHOMA IN 2014, BUT THAT HER ONCOLOGIST DOES NOT ATTRIBUTE IT TO HER BREAST IMPLANTS, AND THAT IT IS NOT BIA-ALCL. WITH THE INFORMATION CURRENTLY AVAILABLE, THE PATIENT'S CANCER DIAGNOSIS DOES NOT APPEAR TO BE RELATED TO HER BREAST IMPLANTS. IF ADDITIONAL INFORMATION IS RECEIVED SURROUNDING THE DIAGNOSIS, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT IS FOR THE LEFT PROSTHESIS.

  Patient problems: Skin Irritation

  MAUDE report 8941143 ↗
• InjuryAug 8, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH A MENTOR MEMORYGEL BREAST IMPLANT 700CC AND EXPERIENCED PAINFUL NIPPLE, LOSS OF FEELING IN HER BREAST, AND RUPTURE ON THE RIGHT SIDE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Neurological Deficit/Dysfunction

  MAUDE report 8874109 ↗
• InjuryJun 28, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) FEMALE UNDERWENT BREAST AUGMENTATION REVISION WITH 700CC MENTOR MEMORYGEL BREAST IMPLANTS. ON 5/24/2018 BILATERAL RUPTURE AND BAKER¿S GRADE III CAPSULAR CONTRACTURE WAS OBSERVED ON (B)(6) 2018. AS A RESULT, BILATERAL PROSTHESIS REPLACEMENT WITH 500CC MENTOR MEMORYGEL BREAST IMPLANTS IS SCHEDULED FOR (B)(6) 2018. (SEE 1645337-2018-03951 FOR CONTRALATERAL PROSTHESIS REPORT).

  Patient problems: Capsular Contracture; No Code Available

  MAUDE report 7648527 ↗
• InjuryJun 28, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) FEMALE UNDERWENT BREAST AUGMENTATION REVISION WITH 700CC MENTOR MEMORYGEL BREAST IMPLANTS. ON (B)(6) 2018 BILATERAL RUPTURE AND BAKER¿S GRADE III CAPSULAR CONTRACTURE WAS OBSERVED ON (B)(6) 2018. AS A RESULT, BILATERAL PROSTHESIS REPLACEMENT WITH 500CC MENTOR MEMORYGEL BREAST IMPLANTS IS SCHEDULED FOR (B)(6) 2018. (SEE 1645337-2018-03950 FOR CONTRALATERAL PROSTHESIS REPORT).

  Patient problems: Capsular Contracture; No Code Available

  MAUDE report 7648518 ↗