MENTOR MemoryGel BOOST Breast Implant SMPB430Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 00081317026891), received between Oct 3, 2022 and Sep 24, 2026 — classified as 30 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Rupture” (4 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 31 reports, in the reporter's own words as published by the FDA.

• InjurySep 24, 2026Material Discolored

  It was reported that a 53-year-old Caucasian female patient underwent a primary breast augmentation with a 430cc MENTOR MemoryGel BOOST Breast Implant and experienced capsular contracture (baker grade 3) and discoloration on the left side post-operatively. As a result, the patient underwent explantation on (b)(6) 2026, and replaced with a 545cc MENTOR MemoryGel BOOST Breast Implant.

  Patient problems: Capsular Contracture

  MAUDE report 50886272 ↗
• InjurySep 9, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient underwent a Breast Augmentation Revision Surgery with implantation of a 430cc MENTOR MemoryGel BOOST Breast Implant prosthesis. Post-operatively, the patient was diagnosed with right breast Baker Grade IV Capsular Contracture by a medical professional. At the time of this report, Mentor has received no information regarding explantation or an expected explantation date.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 50698097 ↗
• InjuryJul 29, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a 75-year-old female patient underwent a breast augmentation revision with a 430cc MENTOR MemoryGel BOOST Breast Implant and experienced capsular contracture (baker grade 3) on the left side post-operatively, which was diagnosed with a physical exam. At the time of this report, Mentor has received no information regarding explantation or an expected explantation date.

  Patient problems: Capsular Contracture

  MAUDE report 50073146 ↗
• InjuryMay 1, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH IMPLANTATION OF A 430CC MENTOR MEMORYGEL BOOST BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH LEFT BREAST BAKER GRADE III CAPSULAR CONTRACTURE BY A MEDICAL PROFESSIONAL. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. 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 25059799 ↗
• InjuryMar 26, 2026Use of Device Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WITH MENTOR MEMORYGEL BOOST BREAST IMPLANTS EXPERIENCED BILATERAL CAPSULAR CONTRACTURE BAKER GRADE III (L) AND BAKER GRADE IV (R)POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT DEVICE REMOVAL OF THE LEFT BREAST PROSTHESIS. THE RIGHT BREAST PROSTHESIS WAS REPORTEDLY REINSERTED BACK INTO THE PATIENT. THIS REPORT IS FOR THE LEFT BREAST PROSTHESIS,

  Patient problems: Capsular Contracture

  MAUDE report 24700669 ↗
• InjuryMar 25, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE WITH A MENTOR MEMORYGEL BOOST BREAST IMPLANT GEL BREAST PROSTHESIS THAT RUPTURED POST IMPLANTATION. RUPTURE OF THE PATIENT¿S RIGHT BREAST PROSTHESIS WAS OBSERVED DURING AN IMPLANT EXCHANGE PROCEDURE. THE PATIENT¿S EXPLANTED BREAST PROSTHESES WERE REPLACED WITH MENTOR MEMORYGEL BOOST BREAST IMPLANT GEL BREAST PROSTHESES.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 24690965 ↗
• InjuryFeb 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH TWO 430CC MENTOR MEMORYGEL BOOST BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA PHYSICAL EXAMINATION, WITH LEFT BREAST SEROMA. AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL AND REPLACEMENT SURGERY ON (B)(6) 2026. THE REPLACEMENT DEVICE WAS A MENTOR GEL IMPLANT.

  Patient problems: Seroma

  MAUDE report 24339998 ↗
• InjuryJan 29, 2026Use of Device 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 IV ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT DEVICE REMOVAL.

  Patient problems: Capsular Contracture

  MAUDE report 24211158 ↗
• MalfunctionDec 12, 2025Material Deformation; Appropriate Device Problem Term/Code Not Available; Material Deformation; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A 430CC MENTOR MEMORYGEL BOOST BREAST IMPLANT BEING USED IN A BREAST SURGERY WAS FOUND TO HAVE BUBBLES AND DESCRIBED AS "DEFECTIVE" BY THE SURGEON. NO ADVERSE EVENT WAS EXPERIENCED BY THE PATIENT. THERE WERE NO REPORTED PATIENT CONSEQUENCES OR PROCEDURAL DELAYS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23791211 ↗
• InjuryNov 14, 2025Adverse 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 A BREAST RECONSTRUCTION REVISION PROCEDURE WITH A MENTOR MEMORYGEL BOOST BREAST IMPLANT 430CC GEL BREAST PROSTHESIS DEVELOPED BAKER GRADE III CAPSULAR CONTRACTURE IN HER RIGHT BREAST POST IMPLANTATION. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH MENTOR ARTOURA PLUS, SMOOTH, HIGH PROFILE 475CC TISSUE EXPANDERS ON (B)(6) 2025.

  Patient problems: Capsular Contracture

  MAUDE report 23556584 ↗
• InjuryOct 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE WITH MENTOR MEMORYGEL BOOST BREAST IMPLANT 430CC GEL BREAST PROSTHESES DEVELOPED CAPSULAR CONTRACTURE (BAKER GRADE UNKNOWN) IN BOTH BREASTS POST IMPLANTATION. AS A RESULT, THE PATIENT IS SCHEDULED TO UNDERGO BILATERAL EXPLANTATION ON (B)(6) 2026. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 23326760 ↗
• InjuryOct 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE WITH MENTOR MEMORYGEL BOOST BREAST IMPLANT 430CC GEL BREAST PROSTHESES DEVELOPED CAPSULAR CONTRACTURE (BAKER GRADE UNKNOWN) IN BOTH BREASTS POST IMPLANTATION. AS A RESULT, THE PATIENT IS SCHEDULED TO UNDERGO BILATERAL EXPLANTATION ON (B)(6) 2026. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 23326752 ↗
• InjurySep 3, 2025Migration; Migration

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH MENTOR MEMORYGEL BOOST BREAST IMPLANT 430CC GEL BREAST PROSTHESES DEVELOPED BAKER GRADE III-IV CAPSULAR CONTRACTURE IN BOTH BREASTS POST IMPLANTATION. ADDITIONALLY, THE PATIENT DEVELOPED BILATERAL BREAST PROSTHESIS MALPOSITION. AS A RESULT, THE PATIENT IS SCHEDULED TO UNDERGO EXPLANTATION ON (B)(6) 2025. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 22959685 ↗
• InjurySep 3, 2025Migration; Migration

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH MENTOR MEMORYGEL BOOST BREAST IMPLANT 430CC GEL BREAST PROSTHESES DEVELOPED BAKER GRADE III-IV CAPSULAR CONTRACTURE IN BOTH BREASTS POST IMPLANTATION. ADDITIONALLY, THE PATIENT DEVELOPED BILATERAL BREAST PROSTHESIS MALPOSITION. AS A RESULT, THE PATIENT IS SCHEDULED TO UNDERGO EXPLANTATION ON (B)(6) 2025. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 22959680 ↗
• InjuryJan 31, 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 IMPLANTATION PROCEDURE WITH MENTOR MEMORYGEL BOOST BREAST IMPLANTS 430CC AND EXPERIENCED BILATERAL PTOSIS ALONG WITH RUPTURE ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH A SIMILAR DEVICE ON (B)(6) 2024. THIS REPORT IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 21283610 ↗
• InjuryJan 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 41-YEAR-OLD FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A 430CC MENTOR MEMORYGEL BOOST BREAST IMPLANT AND EXPERIENCED CAPSULAR CONTRACTURE (BAKER GRADE 3) 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: Capsular Contracture

  MAUDE report 21098149 ↗
• InjuryJan 6, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST IMPLANTATION PROCEDURE WITH MENTOR MEMORYGEL BOOST BREAST IMPLANTS 430CC AND EXPERIENCED RUPTURE ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH A SIMILAR DEVICE ON (B)(6) 2024.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 21080692 ↗
• InjuryDec 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 AUGMENTATION REVISION WITH MENTOR MEMORYGEL BOOST BREAST IMPLANTS 430CC AND 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 20881193 ↗
• InjuryOct 15, 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 430CC MENTOR MEMORYGEL BOOST BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH RIGHT BREAST BAKER GRADE III CAPSULAR CONTRACTURE DURING IN-OFFICE VISIT WITH A MEDICAL PROFESSIONAL. AS A RESULT, THE PATIENT UNDERWENT UNILATERAL REMOVAL AND REPLACEMENT WITH A RIGHT-SIDED 430CC MENTOR MEMORYGEL BOOST BREAST IMPLANT ON (B)(6) 2024.

  Patient problems: Capsular Contracture

  MAUDE report 20455774 ↗
• InjuryOct 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH A MENTOR MEMORYGEL BOOST BREAST IMPLANT 430CC GEL BREAST PROSTHESIS DEVELOPED BAKER GRADE III CAPSULAR CONTRACTURE IN HER RIGHT BREAST POST IMPLANTATION. THE CAPSULAR CONTRACTURE WAS DIAGNOSED DURING AN OFFICE VISIT. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Capsular Contracture

  MAUDE report 20348974 ↗
• InjurySep 18, 2024Adverse 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 BOOST BREAST IMPLANTS EXPERIENCED SYMPTOMS INCLUDING PAIN, AND A RASH ON THE FACE, NECK, AND CHEST POST-OPERATIVELY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

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

  MAUDE report 20249323 ↗
• InjurySep 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE WHO UNDERWENT A BREAST AUGMENTATION REVISION WITH A MENTOR MEMORYGEL BOOST, 430CC SILICONE PROSTHESIS EXPERIENCED LEFT-SIDED CAPSULAR CONTRACTURE GRADE III-IV POSTOPERATIVE. THE ISSUE WAS DIAGNOSED BY THE HEALTH CARE PROFESSIONAL. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Capsular Contracture; Seroma

  MAUDE report 20136930 ↗
• InjuryAug 26, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT BREAST RECONSTRUCTION REVISION WITH 545CC MENTOR MEMORYGEL BOOST BREAST IMPLANT (RIGHT) AND A 430CC MENTOR MEMORYGEL BOOST BREAST IMPLANT (LEFT) EXPERIENCED BILATERAL RUPTURE AND BILATERAL WOUND INFECTION POST PROCEDURE. THE PATIENT BEGAN EXPERIENCING CELLULITIS SHORTLY AFTER IMPLANT. THIS NECESSITATED MULTIPLE HOSPITAL VISITS. AN ULTRASOUND WAS PERFORMED AND A BREAST MASS ON THE LEFT SIDE WAS IDENTIFIED. A BIOPSY WAS PERFORMED, AND THE RESULTS ARE PENDING. THE RIGHT IMPLANT HAS MOVED TOWARDS THE PATIENT¿S ARMPIT. THE PATIENT IS CURRENTLY BEING TREATED WITH AN UNSPECIFIED ANTIBIOTIC. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Post Operative Wound Infection

  MAUDE report 20066429 ↗
• InjuryJun 1, 2024Appropriate Device Problem Term/Code Not Available; Migration; Appropriate Device Problem Term/Code Not Available; Migration

  IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH A 430CC MENTOR MEMORYGEL BOOST BREAST IMPLANT ON THE LEFT BREAST. POST-OPERATIVELY, THE PATIENT SUFFERED LEFT BREAST IMPLANT MALPOSITION. AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL AND REPLACEMENT SURGERY ON (B)(6) 2024. DURING THE REMOVAL SURGERY, THE IMPLANT WAS IDENTIFIED TO HAVE BUBBLES IN THE PATCH. THE REPLACEMENT DEVICE WAS A 430CC MENTOR MEMORYGEL BOOST BREAST IMPLANT (CATALOG: SMPB430 LOT: 9985914 SN: (B)(6).

  Patient problems: Deformity/ Disfigurement

  MAUDE report 19441940 ↗
• InjuryApr 25, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE WITH A MENTOR MEMORYGEL BOOST BREAST IMPLANT 430CC GEL BREAST PROSTHESIS THAT RUPTURED POST IMPLANTATION. RUPTURE OF THE PATIENT¿S RIGHT BREAST PROSTHESIS WAS DIAGNOSED VIA A HEALTHCARE PROFESSIONAL¿S EXAM. ADDITIONALLY, THE PATIENT 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 19183654 ↗