MENTOR MemoryGel BOOST Breast Implant SHPB370Recalls & reported problems

Summary

The FDA's MAUDE database contains 43 adverse event reports that list this exact device (DI 00081317027058), received between Jan 19, 2023 and Sep 21, 2026 — classified as 39 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Migration” (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 25 most recent of 43 reports, in the reporter's own words as published by the FDA.

• InjurySep 21, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Capsular Contracture

  MAUDE report 50844330 ↗
• InjurySep 21, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Capsular Contracture

  MAUDE report 50844329 ↗
• InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient with MENTOR MemoryGel BOOST Breast Implants experienced capsular contracture Baker Grade IV on the left side post-operatively, which was confirmed during a physical exam. As a result, the patient is scheduled for removal on (b)(6) 2026.

  Patient problems: Capsular Contracture

  MAUDE report 50822330 ↗
• InjuryMay 11, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT AN UNSPECIFIED BREAST SURGERY WITH MENTOR MEMORYGEL BOOST BREAST IMPLANT GEL BREAST PROSTHESES DEVELOPED UNSPECIFIED HEALTH ISSUES POST IMPLANTATION. THE PATIENT IS NOW SEEING AN ONCOLOGIST. 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 25142933 ↗
• InjuryMay 11, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 370CC MENTOR MEMORYGEL BOOST BREAST IMPLANT EXPERIENCED PTOSIS ON THE LEFT 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 25137506 ↗
• InjuryApr 3, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 370CC MENTOR MEMORYGEL BOOST BREAST IMPLANT EXPERIENCED CAPSULAR CONTRACTURE BAKER GRADE 3 ON THE LEFT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2026.

  Patient problems: Capsular Contracture

  MAUDE report 24774740 ↗
• InjuryMar 19, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST RECONSTRUCTION REVISION PROCEDURE WITH MENTOR MEMORYGEL BOOST BREAST IMPLANT GEL BREAST PROSTHESES DEVELOPED CAPSULAR CONTRACTURE (BAKER GRADE UNKNOWN) IN HER LEFT BREAST POST IMPLANTATION. ADDITIONALLY, THE PATIENT DEVELOPED LEFT BREAST ANIMATION DEFORMITY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION OF THE LEFT BREAST PROSTHESIS AND IT WAS REPLACED WITH A MENTOR MEMORYGEL BOOST BREAST IMPLANT GEL BREAST PROSTHESIS. DURING THE PROCEDURE, IT WAS NOTED THAT PARTS OF THE PATIENT¿S RIGHT BREAST CAPSULE WERE FIRM. NO EXPLANTATION WAS PERFORMED ON THE RIGHT BREAST PROSTHESIS AND IT REMAINS IMPLANTED. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture; Deformity/ Disfigurement

  MAUDE report 24644177 ↗
• InjuryDec 11, 2025Migration; Migration

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 370CC MENTOR MEMORYGEL BOOST BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH RIGHT BREAST BAKER GRADE IV CAPSULAR CONTRACTURE WITH DEFORMITY, FIRMNESS, AND PAIN IN ADDITION TO DISPLACEMENT OF THE IMPLANTS DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL ON (B)(6) 2025. THIS REPORT IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 23785282 ↗
• InjuryDec 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 41-YEAR-OLD ASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A 370CC MENTOR MEMORYGEL BOOST BREAST IMPLANT AND EXPERIENCED CAPSULAR CONTRACTURE (BAKER GRADE 4) ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS DIAGNOSED WITH A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025, AND REPLACED WITH A 370CC MENTOR MEMORYGEL BOOST BREAST IMPLANT.

  Patient problems: Capsular Contracture

  MAUDE report 23708263 ↗
• InjuryAug 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WITH MENTOR MEMORYGEL BOOST BREAST IMPLANTS EXPERIENCED CAPSULAR CONTRACTURE BAKER GRADE III ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT IS SCHEDULED FOR REMOVAL ON (B)(6) 2025.

  Patient problems: Capsular Contracture

  MAUDE report 22914354 ↗
• InjuryAug 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT AN UNSPECIFIED BREAST SURGERY WITH A MENTOR MEMORYGEL BOOST BREAST IMPLANT 370CC GEL BREAST PROSTHESIS DEVELOPED AN INFECTION IN HER LEFT BREAST POST IMPLANTATION. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025.

  Patient problems: Post Operative Wound Infection

  MAUDE report 22787777 ↗
• InjuryJul 3, 2025Adverse 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 REVISION PROCEDURE WITH A MENTOR MEMORYGEL BOOST BREAST IMPLANT 370CC GEL BREAST PROSTHESIS DEVELOPED CAPSULAR CONTRACTURE (BAKER GRADE UNKNOWN) IN HER RIGHT BREAST 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 22401356 ↗
• InjuryJun 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH A 370CC MENTOR MEMORYGEL BOOST BREAST IMPLANT EXPERIENCED RIGHT SIDED BAKER GRADE III CAPSULAR CONTRACTURE POST PROCEDURE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Capsular Contracture

  MAUDE report 22124143 ↗
• InjuryApr 28, 2025Adverse 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 REVISION WITH MENTOR MEMORYGEL BOOST BREAST IMPLANTS 370CC AND EXPERIENCED HEMATOMA ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT REMOVAL ON (B)(6) 2025.

  Patient problems: Hematoma

  MAUDE report 21918745 ↗
• InjuryApr 23, 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 370CC MENTOR MEMORYGEL BOOST 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 21892086 ↗
• InjuryFeb 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 34-YEAR-OLD HISPANIC FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH 370 CC MENTOR MEMORYGEL BOOST BREAST IMPLANT AND EXPERIENCED CAPSULAR CONTRACTURE; BAKER GRADE III ON HER RIGHT SIDE POSTOPERATIVELY; DIAGNOSED AFTER PHYSICAL EXAM. 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 21326533 ↗
• InjuryNov 20, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE WHO UNDERWENT A BREAST AUGMENTATION PRIMARY WITH A MENTOR MEMORYGEL BOOST, 370CC SILICONE PROSTHESIS EXPERIENCED LEFT SIDED SYMPTOMATIC RUPTURE AND SKIN REACTION POSTOPERATIVE. INITIALLY THE PATIENT SAW REDNESS THEN THE REDNESS WAS ALMOST COVERED IN HER LEFT BREAST. AS A RESULT, PATIENT UNDERWENT REMOVAL ON (B)(6) 2024.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 20736839 ↗
• InjurySep 30, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT BREAST RECONSTRUCTION REVISION WITH MENTOR MEMORYGEL BOOST BREAST IMPLANTS EXPERIENCED LEFT SIDED RUPTURE, RIGHT SIDED CAPSULAR CONTRACTURE, AND LEFT SIDED CUTANEOUS CONTOUR DEFORMITY POST PROCEDURE. THIS WAS ACCOMPANIED BY RIGHT SIDED SUPERIOR DISPLACEMENT, RIGHT SIDED TIGHTNESS, RIGHT SIDED PAIN, THE LEFT SIDED IMPLANT STRETCHED OUT LATERALLY, AND BILATERAL CONTOUR IRREGULARITIES. AS A RESULT, BILATERAL FAT INJECTION, BILATERAL IMPLANT EXCHANGE, AND LEFT SIDED MASTOPEXY WAS PERFORMED ON (B)(6) 2024.

  Patient problems: Wrinkling

  MAUDE report 20334404 ↗
• MalfunctionAug 7, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 370CC MENTOR MEMORYGEL BOOST BREAST IMPLANT RUPTURED, INTRA-OPERATIVELY, DURING A PRIMARY BREAST AUGMENTATION. THERE WAS NO REPORT OF ADVERSE EVENT OR PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19933984 ↗
• InjuryJul 9, 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 SURGERY WITH IMPLANTATION OF A 370CC MENTOR MEMORYGEL BOOST BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT REPORTED EXPERIENCING CAPSULAR CONTRACTURE OF ONE OF HER BREASTS. THE AFFECTED SIDE NOR THE BAKER GRADE RATING WERE PROVIDED. A CONSULTATION WITH A MEDICAL PROFESSIONAL HAS BEEN CONDUCTED. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. AS THE AFFECTED SIDE WAS NOT PROVIDED, THE LOT/SERIAL NUMBERS FOR BOTH PRODUCTS ARE BEING PROVIDED AS LEFT IMPLANT - LOT NUMBER: 9959154 / SERIAL NUMBER: (B)(6) AND RIGHT IMPLANT - LOT NUMBER: 9965020 / SERIAL NUMBER: (B)(6). THE CATALOG NUMBERS ARE THE SAME FOR BOTH DEVICES. 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.

  Patient problems: Capsular Contracture

  MAUDE report 19707173 ↗
• InjuryJul 5, 2024Migration; Migration

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH MENTOR MEMORYGEL BOOST BREAST IMPLANT 370CC GEL BREAST PROSTHESES THAT BILATERALLY BOTTOMED OUT POST IMPLANTATION. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH MENTOR MEMORYGEL BOOST BREAST IMPLANT 325CC GEL BREAST PROSTHESES ON (B)(6) 2024. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 19681063 ↗
• InjuryJul 5, 2024Migration; Migration

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH MENTOR MEMORYGEL BOOST BREAST IMPLANT 370CC GEL BREAST PROSTHESES THAT BILATERALLY BOTTOMED OUT POST IMPLANTATION. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH MENTOR MEMORYGEL BOOST BREAST IMPLANT 325CC GEL BREAST PROSTHESES ON (B)(6) 2024. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 19681062 ↗
• MalfunctionJun 26, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 370CC MENTOR MEMORYGEL BOOST BREAST IMPLANT WAS FOUND TO BE RUPTURED PREOPERATIVELY. NO ADVERSE EVENT WAS EXPERIENCED BY THE PATIENT. THERE WERE NO PATIENT CONSEQUENCES OR PROCEDURAL DELAYS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19615949 ↗
• InjuryJun 10, 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 REVISION WITH MENTOR MEMORYGEL BOOST BREAST IMPLANTS 370CC 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; Pocket Erosion

  MAUDE report 19499576 ↗
• MalfunctionMar 21, 2024Material Deformation; Appropriate Device Problem Term/Code Not Available; Material Deformation; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A 370CC MENTOR MEMORYGEL BOOST BREAST IMPLANT WAS FOUND TO CONTAIN SHELL IRREGULARITIES 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 18951258 ↗