MENTOR MemoryGel Breast Implant 3505295BCRecalls & reported problems

Summary

The FDA's MAUDE database contains 50 adverse event reports that list this exact device (DI 00081317006909), received between Aug 26, 2019 and Sep 21, 2026 — classified as 47 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (19 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 50 reports, in the reporter's own words as published by the FDA.

• InjurySep 21, 2026Migration

  It was reported that a patient involved in a clinical study underwent a Breast Augmentation Surgery with implantation of a 295cc MENTOR MemoryGel Breast Implant prosthesis. Post-operatively, the patient presented with Implant Malposition/Displacement. She underwent revision surgery for bilateral pocket adjustment without removal/replacement of the implants. The principal investigator assessed this event as mild in severity, non-serious, definitely related to the device.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 50845834 ↗
• InjurySep 21, 2026Migration

  Patient problems: Deformity/ Disfigurement

  MAUDE report 50845831 ↗
• InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient underwent breast augmentation with a 295cc MENTOR MemoryGel Breast Implant on the left breast. Post-operatively, the patient developed left breast capsular contracture (baker grade unspecified). At the time of this report, Mentor has received no information regarding explantation or an expected explantation date.

  Patient problems: Capsular Contracture

  MAUDE report 50046130 ↗
• InjuryMay 22, 2026Adverse Event Without Identified Device or Use Problem

  A FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A MENTOR MEMORYGEL, 295CC SILICONE PROSTHESIS DEVELOPED BILATERAL CAPSULAR CONTRACTURE GRADE IV POSTOPERATIVE. THE ISSUE WAS DIAGNOSED THROUGH PHYSICAL EXAMINATION. AT THE TIME OF THIS REPORT, MENTOR RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT RELATES TO THE RIGHT SIDE.

  Patient problems: Capsular Contracture

  MAUDE report 25260214 ↗
• InjuryMay 22, 2026Adverse Event Without Identified Device or Use Problem

  A FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A MENTOR MEMORYGEL, 295CC SILICONE PROSTHESIS DEVELOPED BILATERAL CAPSULAR CONTRACTURE GRADE IV POSTOPERATIVE. THE ISSUE WAS DIAGNOSED THROUGH PHYSICAL EXAMINATION. AT THE TIME OF THIS REPORT, MENTOR RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT RELATES TO THE LEFT SIDE.

  Patient problems: Capsular Contracture

  MAUDE report 25260183 ↗
• InjuryMay 21, 2026Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH A 295CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED A RUPTURE AND CAPSULAR CONTRACTURE (BAKER GRADE UNKNOWN) ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON AN UNDISCLOSED DATE.

  Patient problems: Capsular Contracture

  MAUDE report 25250005 ↗
• InjuryMar 6, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 295CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT DEVELOPED LEFT BREAST PAIN AND WAS DIAGNOSED, VIA ULTRASOUND, WITH LEFT BREAST IMPLANT RUPTURE. 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 24536899 ↗
• InjuryMar 4, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 295CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED A RUPTURE ON THE RIGHT SIDE POST-OPERATIVELY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 24507245 ↗
• InjuryFeb 13, 2026Adverse Event Without Identified Device or Use Problem

  A FEMALE PATIENT WHO UNDERWENT A BREAST SURGERY WITH MENTOR MEMORYGEL, 295CC SILICONE PROSTHESIS EXPERIENCED RIGHT SIDED CAPSULAR CONTRACTURE GRADE IV POST OPERATION. AS A RESULT, THE PATIENT UNDERWENT REMOVAL SURGERY ON (B)(6) 2026.

  Patient problems: Capsular Contracture

  MAUDE report 24335166 ↗
• InjuryNov 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH TWO MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED BILATERAL CAPSULAR CONTRACTURE (BAKER GRADE 3) AND SKIN REACTIONS POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025.

  Patient problems: Capsular Contracture; Skin Inflammation/ Irritation

  MAUDE report 23479771 ↗
• InjuryJul 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 295CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED CAPSULAR CONTRACTURE BAKER GRADE 4 ON THE RIGHT SIDE POST-OPERATIVELY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Capsular Contracture

  MAUDE report 22669037 ↗
• InjuryMar 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 295 CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED CAPSULAR CONTRACTURE BAKER GRADE 3 ON THE RIGHT SIDE POST-OPERATIVELY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Capsular Contracture

  MAUDE report 21586702 ↗
• InjuryMar 5, 2025Adverse 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 295CC GEL BREAST PROSTHESIS DEVELOPED BAKER GRADE III CAPSULAR CONTRACTURE IN HER LEFT BREAST POST IMPLANTATION. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION AND REPLACEMENT WITH A MENTOR MEMORYGEL BREAST IMPLANT 295CC GEL BREAST PROSTHESIS ON (B)(6) 2025.

  Patient problems: Capsular Contracture

  MAUDE report 21529347 ↗
• InjuryDec 10, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE WITH A MENTOR MEMORYGEL BREAST IMPLANT 295CC GEL BREAST PROSTHESIS THAT RUPTURED POST IMPLANTATION. RUPTURE OF THE PATIENT¿S LEFT BREAST PROSTHESIS WAS DIAGNOSED VIA MRI. ADDITIONALLY, THE PATIENT DEVELOPED BAKER GRADE III CAPSULAR CONTRACTURE POST IMPLANTATION. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Capsular Contracture

  MAUDE report 20894915 ↗
• InjuryDec 6, 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 IMPLANTATION OF A 295CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED BY A MEDICAL PROFESSIONAL WITH BILATERAL MILD BREAST PTOSIS IN WHICH THE RIGHT BREAST NIPPLE AREOLAR COMPLEX WAS LOW AND THE LEFT WAS EVEN LOWER. AS A RESULT, THE PATIENT UNDERWENT BILATERAL MASTOPEXY AND BILATERAL BREAST IMPLANT REMOVAL WITHOUT REPLACEMENTS ON (B)(6) 2024. HOWEVER, DURING THE SURGERY, THE RIGHT BREAST IMPLANT WAS FOUND TO BE RUPTURED. A 60-MIUNUTE PROCEDURAL DELAY WAS REPORTED WITHOUT ANY PATIENT CONSEQUENCES OR ADDITIONAL PROCEDURES. THIS REPORT IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 20867484 ↗
• InjuryDec 6, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 295CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED BY A MEDICAL PROFESSIONAL WITH BILATERAL MILD BREAST PTOSIS IN WHICH THE RIGHT BREAST NIPPLE AREOLAR COMPLEX WAS LOW AND THE LEFT WAS EVEN LOWER. AS A RESULT, THE PATIENT UNDERWENT BILATERAL MASTOPEXY AND BILATERAL BREAST IMPLANT REMOVAL WITHOUT REPLACEMENTS ON (B)(6) 2024. HOWEVER, DURING THE SURGERY, THE RIGHT BREAST IMPLANT WAS FOUND TO BE RUPTURED. A 60-MIUNUTE PROCEDURAL DELAY WAS REPORTED WITHOUT ANY PATIENT CONSEQUENCES OR ADDITIONAL PROCEDURES. THIS REPORT IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 20867080 ↗
• MalfunctionNov 8, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A GEL LEAKAGE ON A MENTOR MEMORYGEL BREAST IMPLANT 295CC GEL BREAST PROSTHESIS WAS OBSERVED DURING A SCHEDULED PRIMARY BREAST AUGMENTATION PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT MENTOR MEMORYGEL BREAST IMPLANT 295CC GEL BREAST PROSTHESIS. THERE WAS NO REPORTED PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20643222 ↗
• InjurySep 11, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 295CC 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 20191348 ↗
• InjuryAug 22, 2024Adverse Event Without Identified Device or Use Problem; Migration; Adverse Event Without Identified Device or Use Problem; Migration

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH A 295CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED RIGHT SIDED BAKER GRADE IV CAPSULAR CONTRACTURE POST PROCEDURE. THE CAPSULAR CONTRACTURE WAS DIAGNOSED THROUGH A PHYSICAL 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 20032228 ↗
• InjuryMar 13, 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 REVISION WITH A 295CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED CAPSULAR CONTRACTURE (BAKER GRADE 3) ON THE LEFT SIDE POST-OPERATIVELY. THE PATIENT HAD INTENSE BREAST PAIN AND REPORTED MORPHOLOGY AND HARDNESS WITH DISCOMFORT AND POOR POSITION. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2024, AND REPLACED WITH A 240CC MENTOR MEMORYGEL BREAST IMPLANT WITH SERIAL NUMBER (B)(6).

  Patient problems: Capsular Contracture

  MAUDE report 18897537 ↗
• MalfunctionFeb 16, 2024Material Rupture; Appropriate Device Problem Term/Code Not Available; Material Rupture; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A 295CC MENTOR MEMORYGEL BREAST IMPLANT WAS FOUND TO BE RUPTURED DURING AN OPERATION. NO ADVERSE EVENT WAS EXPERIENCED BY THE PATIENT. THE SURGEON USED BACKUP DEVICES, AND THERE WERE NO REPORTED PATIENT CONSEQUENCES OR PROCEDURAL DELAYS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18723367 ↗
• InjuryFeb 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH MENTOR MEMORYGEL BREAST IMPLANTS 295CC (R) AND EXPERIENCED CAPSULAR CONTRACTURE BAKER GRADE IV ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT REMOVAL ON (B)(6) 2024.

  Patient problems: Capsular Contracture

  MAUDE report 18627481 ↗
• MalfunctionNov 15, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 295CC MENTOR MEMORYGEL BREAST IMPLANT RUPTURED DURING A PRIMARY BREAST AUGMENTATION 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 REPORTED ADVERSE EVENTS OR PATIENT OUTCOMES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18144865 ↗
• InjuryOct 11, 2023Material Rupture; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Material Rupture; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH A (LEFT) 185CC MENTOR MEMORYGEL BREAST IMPLANT AND A (RIGHT) 295CC MENTOR MEMORYGEL BREAST IMPLANT. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA PHYSICAL EXAMINATION, WITH LEFT BREAST CAPSULAR CONTRACTURE (BAKER GRADE III) AND POSSIBLE LEFT BREAST IMPLANT RUPTURE. AS A RESULT, THE PATIENT UNDERWENT BILATERAL BREAST IMPLANT REMOVAL AND REPLACEMENT SURGERY ON (B)(6) 2023. DURING THE SURGERY, THE LEFT IMPLANT WAS IDENTIFIED TO BE INTACT, HOWEVER, THE RIGHT BREAST IMPLANT HAD AN EARLY DISC SEPARATION. SUBSEQUENTLY, BOTH THE IMPLANTS WERE REMOVED AND REPLACED WITH THE FOLLOWING: (LEFT) 350CC MENTOR MEMORYGEL BREAST IMPLANT CATALOG: 3505350BC LOT: 9816420 SN: (B)(6) AND (RIGHT) 350CC MENTOR MEMORYGEL BREAST IMPLANT CATALOG: 3505350BC LOT: 9880760 SN: (B)(6). THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS. COMPLICATIONS ON THE LEFT BREAST/IMPLANT HAVE BEEN REPORTED UNDER MRN: 1645337-2023-05505.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 17914717 ↗
• InjuryAug 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  [SAFETY_NOTE_UPDATE1]IMPACTED PRODUCT NUMBER:IP-00329043/PRODUCT NAME: (B)(6)295CC/NOTES: THIS IS ASSOCIATED WITH THE MEN-15-003 STUDY, PARTICIPANT 931-008 . IT WAS REPORTED THAT A 32 YEAR OLD CAUCASIAN FEMALE PATIENT WHO UNDERWENT AUGMENTATION WITH MENTOR GLOW STUDY GEL DEVICES ON (B)(6) 2018 DEVELOPED POST OPERATIVE HEMATOMA IN THE LEFT SIDE THAT WAS EVACUATED IN A SECONDARY PROCEDURE AND RESOLVED ON THE SAME DAY. THIS WAS ASSESSED BY THE PRINCIPAL INVESTIGATOR AS UNRELATED TO THE DEVICE. SINCE THIS ADVERSE EVENT REQUIRED MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE, IT IS CONSIDERED SERIOUS AND REPORTABLE. THIS REPORT PART OF PSR-Q3-10-31-2018, IP-00329043.

  Patient problems: Hematoma

  MAUDE report 17616532 ↗