MENTOR MemoryGel Breast Implant 3545375Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00081317007135), received between Oct 31, 2019 and Oct 16, 2025 — classified as 14 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (10 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 16, 2025Material Rupture; Material Rupture

  A FEMALE PATIENT WHO UNDERWENT A BREAST SURGERY WITH A MENTOR MEMORYGEL 375CC, SILICONE PROSTHESIS EXPERIENCE LEFT SIDED RUPTURE INTRAOPERATION. THE SURGEON USED ANOTHER IMPLANT AND COMPLETED THE PROCEDURE. NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23318895 ↗
• InjuryNov 6, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 375CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA ULTRASOUND, WITH BILATERAL BREAST IMPLANT RUPTURES. 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: Deformity/ Disfigurement

  MAUDE report 20623158 ↗
• InjuryNov 6, 2024Material Rupture; Migration; Material Rupture; Migration

  IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 375CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA ULTRASOUND, WITH BILATERAL BREAST IMPLANT RUPTURES. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture; Deformity/ Disfigurement

  MAUDE report 20623085 ↗
• MalfunctionAug 21, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 375CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS RUPTURED DURING A BREAST SURGERY PRIOR TO BEING IMPLANTED INTO THE PATIENT. HOWEVER, THE SURGERY COMMENCED WITHOUT ANY REPORTED DELAYS AND A NEW IMPLANT WAS USED TO COMPLETE THE IMPLANTATION. NO ADVERSE EVENTS OR PATIENT CONSEQUENCES WERE REPORTED. AS THE AFFECTED DEVICE WAS NOT PROVIDED, THE LOT/SERIAL NUMBERS FOR BOTH PRODUCTS ARE BEING PROVIDED AS DEVICE A - LOT NUMBER: 9950540 / SERIAL NUMBER: (B)(6) AND DEVICE B - LOT NUMBER: 9984734 / SERIAL NUMBER: (B)(6). FOLLOW-UPS HAVE BEEN CONDUCTED, AND NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. IF MORE INFORMATION BECOMES AVAILABLE, MENTOR WILL SUBMIT A SUPPLEMENTAL REPORT ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20018838 ↗
• InjuryNov 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 61-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH TWO 375CC MENTOR MEMORYGEL BREAST IMPLANTS AND EXPERIENCED A RUPTURE ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS DIAGNOSED DURING SURGERY. IT WAS ALSO REPORTED THAT THE PATIENT EXPERIENCED BILATERAL CAPSULAR CONTRACTURE (BAKER GRADE 4 ON THE RIGHT AND 3 ON THE LEFT); THE PATIENT HAD BREASTS PTOSIS AND MALPOSITION. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2023. THIS REPORT IS FOR THE LEFT SIDE DEVICE.

  Patient problems: Capsular Contracture

  MAUDE report 18130936 ↗
• InjuryNov 14, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 61-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH TWO 375CC MENTOR MEMORYGEL BREAST IMPLANTS AND EXPERIENCED A RUPTURE ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS DIAGNOSED DURING SURGERY. IT WAS ALSO REPORTED THAT THE PATIENT EXPERIENCED BILATERAL CAPSULAR CONTRACTURE (BAKER GRADE 4 ON THE RIGHT AND 3 ON THE LEFT); THE PATIENT HAD BREASTS PTOSIS AND MALPOSITION. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2023. THIS REPORT IS FOR THE RIGHT SIDE DEVICE.

  Patient problems: Capsular Contracture

  MAUDE report 18130933 ↗
• InjuryMar 13, 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 PRIMARY BREAST AUGMENTATION SURGERY WITH A LEFT-SIDED 400CC MENTOR MEMORYGEL BREAST IMPLANT AND A RIGHT-SIDED 375CC MENTOR MEMORYGEL BREAST IMPLANT. POST-OPERATIVELY, THE PATIENT EXPERIENCED BILATERAL BAKER GRADE IV CAPSULAR CONTRACTURE, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH A LEFT-SIDED 365CC MENTOR MEMORYGEL XTRA BREAST IMPLANT AND A RIGHT-SIDED 405CC MENTOR MEMORYGEL XTRA BREAST IMPLANT ON (B)(6) 2023. THIS REPORT IS FOR THE RIGHT IMPLANT. REFER TO MANUFACTURING REPORT NUMBER 1645337-2023-02848 FOR THE CONTRALATERAL EVENT.

  Patient problems: Capsular Contracture

  MAUDE report 16529765 ↗
• InjuryNov 29, 2022Material Rupture; Adverse Event Without Identified Device or Use Problem; Material Rupture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 39-YEAR-OLD CAUCASIAN FEMALE WHO UNDERWENT A BREAST AUGMENTATION PRIMARY WITH A 375CC MENTOR MEMORYGEL, SILICONE BREAST IMPLANT EXPERIENCED LEFT SIDED SYMPTOMATIC RUPTURE, GRANULOMA, AND RIGHT-SIDED SILENT RUPTURE POST PROCEDURE. PATIENT FELT LIKE IT WAS FOLDING ON THE EDGES ON BOTH AND IT HIGHER UP FROM THE SAME YEAR SHE HAD THEM PUT IT. PATIENT WAS INFORMED SHE HAD 2 LUMPS OF SILICONE AND THERE IS ONE ON THE ARMPIT AREA AND ONE NEAR THE LEFT BREAST. 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: Deformity/ Disfigurement

  MAUDE report 15879774 ↗
• InjuryNov 29, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 39-YEAR-OLD CAUCASIAN FEMALE WHO UNDERWENT A BREAST AUGMENTATION PRIMARY WITH A 375CC MENTOR MEMORYGEL, SILICONE BREAST IMPLANT EXPERIENCED LEFT SIDED SYMPTOMATIC RUPTURE, GRANULOMA, AND RIGHT-SIDED SILENT RUPTURE POST PROCEDURE. PATIENT FELT LIKE IT WAS FOLDING ON THE EDGES ON BOTH AND IT HIGHER UP FROM THE SAME YEAR SHE HAD THEM PUT IT. PATIENT WAS INFORMED SHE HAD 2 LUMPS OF SILICONE AND THERE IS ONE ON THE ARMPIT AREA AND ONE NEAR THE LEFT BREAST. 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: Granuloma

  MAUDE report 15879743 ↗
• InjuryAug 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 53-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH IMPLANTATION OF A 375CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT OBSERVED A LITTLE BUBBLE ON THE BOTTOM OF THE RIGHT BREAST. THE BREAST IS MALFORMED AND SITS DIFFERENT AT THE BOTTOM. ADDITIONALLY, SHE HAS ALLERGY SYMPTOMS SUCH AS SNEEZING AND A RUNNY NOSE. HER TOES AND FINGERS ARE WHITE AND NUMB. DUE TO THE COMPLICATIONS, SHE CONSULTED WITH A MEDIAL PROFESSIONAL WHO NOTED THE RIGHT BREAST HAD ABNORMAL SIZE AND POSITION. MAMMOGRAM IMAGING WAS PERFORMED. FINDINGS SUGGESTED A POSSIBLE RUPTURE TO THE RIGHT IMPLANT. ALLERGY TESTING WAS PERFORMED AND WAS NEGATIVE FOR ALLERGIES. 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. REFER TO MANUFACTURING REPORT NUMBER 1645337-2022-10067 FOR THE CONTRALATERAL EVENT.

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

  MAUDE report 15306711 ↗
• InjuryAug 26, 2022Material Rupture; Migration; Material Rupture; Migration

  IT WAS REPORTED THAT A 53-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH IMPLANTATION OF A 375CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT OBSERVED A LITTLE BUBBLE ON THE BOTTOM OF THE RIGHT BREAST. THE BREAST IS MALFORMED AND SITS DIFFERENT AT THE BOTTOM. ADDITIONALLY, SHE HAS ALLERGY SYMPTOMS SUCH AS SNEEZING AND A RUNNY NOSE. HER TOES AND FINGERS ARE WHITE AND NUMB. DUE TO THE COMPLICATIONS, SHE CONSULTED WITH A MEDIAL PROFESSIONAL WHO NOTED THE RIGHT BREAST HAD ABNORMAL SIZE AND POSITION. MAMMOGRAM IMAGING WAS PERFORMED. FINDINGS SUGGESTED A POSSIBLE RUPTURE TO THE RIGHT IMPLANT. ALLERGY TESTING WAS PERFORMED AND WAS NEGATIVE FOR ALLERGIES. 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. REFER TO MANUFACTURING REPORT NUMBER 1645337-2022-10068 FOR THE CONTRALATERAL EVENT.

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

  MAUDE report 15306675 ↗
• InjuryJan 31, 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 WHO UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH MENTOR MEMORYGEL BREAST IMPLANT 320CC GEL BREAST PROSTHESIS (LEFT DEVICE) AND A MENTOR MEMORYGEL BREAST IMPLANT 375CC GEL BREAST PROSTHESIS (RIGHT DEVICE) DEVELOPED CAPSULAR CONTRACTURE IN BOTH OF HER BREASTS POST IMPLANTATION (BAKER GRADE IV IN LEFT BREAST, BAKER GRADE III IN RIGHT BREAST). BILATERAL CAPSULAR CONTRACTURE WAS DIAGNOSED BY A HEALTHCARE PROFESSIONAL. AS A RESULT, THE PATIENT IS SCHEDULED TO UNDERGO BILATERAL EXPLANTATION ON (B)(6) 2022. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 13401681 ↗
• InjuryDec 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT WHO HAD A 375CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED CAPSULAR CONTRACTURE (BAKER GRADE UNKNOWN) POST PROCEDURE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. NO ADDITIONAL EVENT DETAILS WERE MADE AVAILABLE TO MENTOR. IF ADDITIONAL DETAILS BECOME AVAILABLE IN THE FUTURE, THEN A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: Capsular Contracture

  MAUDE report 13115307 ↗
• MalfunctionOct 29, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT 375CC MENTOR MEMORYGEL BREAST IMPLANTS BEING USED FOR A BREAST AUGMENTATION PROCEDURE RUPTURED INTRAOPERATIVELY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. FOLLOW-UPS ARE IN PROGRESS FOR ADDITIONAL DETAILS. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE ADDITIONAL REPORTABLE INFORMATION IS RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12720379 ↗
• InjuryAug 13, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT WHO UNDERWENT BREAST SURGERY WITH A 375CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED LEFT SIDED RUPTURE POST PROCEDURE. AS A RESULT, PATIENT HAD AN EXPLANTATION ON (B)(6) 2020.

  Patient problems: No Code Available

  MAUDE report 10403557 ↗
• InjuryOct 31, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) HISPANIC FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A MENTOR MEMORYGEL BREAST IMPLANT 375CC AND EXPERIENCED ¿ENERGY IS GONE DOWN COMPLETELY, NOT AS ACTIVE, PAIN IN NECK, HANDS ARE NUMB, CRAMPS IN LEGS, PAIN IN HER BONE LIKE ARTHRITIS¿. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS MEDWATCH IS FOR THE LEFT BREAST IMPLANT.

  Patient problems: No Code Available

  MAUDE report 9260137 ↗
• InjuryOct 31, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) HISPANIC FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A MENTOR MEMORYGEL BREAST IMPLANT 375CC AND EXPERIENCED ¿ENERGY IS GONE DOWN COMPLETELY, NOT AS ACTIVE, PAIN IN NECK, HANDS ARE NUMB, CRAMPS IN LEGS, PAIN IN HER BONE LIKE ARTHRITIS¿. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS MEDWATCH IS FOR THE RIGHT BREAST IMPLANT.

  Patient problems: No Code Available

  MAUDE report 9260134 ↗