MENTOR MemoryGel BOOST Breast Implant SMPB530Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00081317026921), received between Jul 12, 2023 and Feb 18, 2026 — classified as 14 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (3 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.

• InjuryFeb 18, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 530CC MENTOR MEMORYGEL BOOST BREAST IMPLANT EXPERIENCED CAPSULAR CONTRACTURE (BAKER GRADE 2-3) 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 24378253 ↗
• InjuryDec 5, 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 RECONSTRUCTION SURGERY WITH IMPLANTATION OF A 530CC MENTOR MEMORYGEL BOOST BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH BILATERAL BAKER GRADE IV (LEFT-SIDED) AND III (RIGHT-SIDED) CAPSULAR CONTRACTURE BY A MEDICAL PROFESSIONAL. 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.

  Patient problems: Capsular Contracture

  MAUDE report 23735349 ↗
• InjuryNov 6, 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 A MENTOR MEMORYGEL BOOST BREAST IMPLANT 530CC GEL BREAST PROSTHESIS DEVELOPED BAKER GRADE IV CAPSULAR CONTRACTURE IN HER RIGHT BREAST POST IMPLANTATION. THE CAPSULAR CONTRACTURE WAS DIAGNOSED VIA A PHYSICAL EXAM. AS A RESULT, THE PATIENT IS SCHEDULED TO UNDERGO EXPLANTATION ON (B)(6) 2025.

  Patient problems: Capsular Contracture

  MAUDE report 23490828 ↗
• InjuryOct 15, 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 530CC MENTOR MEMORYGEL BOOST BREAST IMPLANTS EXPERIENCED CAPSULAR CONTRACTURE BAKER GRADE 3 ON THE LEFT SIDE AND RIPPLING ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025.

  Patient problems: Wrinkling

  MAUDE report 23302407 ↗
• InjuryOct 15, 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 530CC MENTOR MEMORYGEL BOOST BREAST IMPLANTS EXPERIENCED CAPSULAR CONTRACTURE BAKER GRADE 3 ON THE LEFT SIDE AND RIPPLING ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025.

  Patient problems: Capsular Contracture

  MAUDE report 23302349 ↗
• InjuryAug 21, 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 PRIMARY BREAST AUGMENTATION PROCEDURE WITH A MENTOR MEMORYGEL BOOST BREAST IMPLANT 530CC GEL BREAST PROSTHESIS DEVELOPED BAKER GRADE III CAPSULAR CONTRACTURE IN HER RIGHT BREAST POST IMPLANTATION. THE CAPSULAR CONTRACTURE WAS DIAGNOSED DURING AN OFFICE VISIT. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025.

  Patient problems: Capsular Contracture

  MAUDE report 22868818 ↗
• MalfunctionJun 4, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THREE 530CC MENTOR MEMORYGEL BOOST BREAST IMPLANTS HAD FOREIGN MATERIAL ON THEM PRIOR TO A PROCEDURE. ONLY ONE OF THE DEVICES WAS OPENED COMPLETELY, HOWEVER, THE SAME ISSUE WAS STATED TO BE VISIBLE THROUGH THE PACKAGING OF THE OTHER TWO. THERE WAS FILM NOTED ON THE DEVICE. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22143174 ↗
• MalfunctionJun 4, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THREE 530CC MENTOR MEMORYGEL BOOST BREAST IMPLANTS HAD FOREIGN MATERIAL ON THEM PRIOR TO A PROCEDURE. ONLY ONE OF THE DEVICES WAS OPENED COMPLETELY, HOWEVER, THE SAME ISSUE WAS STATED TO BE VISIBLE THROUGH THE PACKAGING OF THE OTHER TWO. THERE WAS FILM NOTED ON THE DEVICE. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22143172 ↗
• MalfunctionJun 4, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THREE 530CC MENTOR MEMORYGEL BOOST BREAST IMPLANTS HAD FOREIGN MATERIAL ON THEM PRIOR TO A PROCEDURE. ONLY ONE OF THE DEVICES WAS OPENED COMPLETELY, HOWEVER, THE SAME ISSUE WAS STATED TO BE VISIBLE THROUGH THE PACKAGING OF THE OTHER TWO. THERE WAS FILM NOTED ON THE DEVICE. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22143168 ↗
• InjuryMay 6, 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 PRIMARY BREAST AUGMENTATION PROCEDURE WITH MENTOR MEMORYGEL BOOST BREAST IMPLANT 530 CC GEL BREAST PROSTHESES DEVELOPED BAKER GRADE III CAPSULAR CONTRACTURE IN BOTH BREASTS POST IMPLANTATION. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH MENTOR MEMORYGEL BOOST BREAST IMPLANT 390 CC GEL BREAST PROSTHESES ON (B)(6) 2025. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT BREAST PROSTHESIS. REFER TO MANUFACTURER REPORT NUMBER 1645337-2024-12341 FOR THE REPORT FOR THE PATIENT'S LEFT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 21970660 ↗
• InjuryApr 28, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT BREAST AUGMENTATION WITH A 530CC MENTOR MEMORYGEL BOOST BREAST IMPLANT EXPERIENCED RIGHT SIDED RUPTURE POST PROCEDURE. REPLACEMENT WITH MENTOR GEL WAS PERFORMED.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 21921426 ↗
• InjuryOct 22, 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 530 CC 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 20507702 ↗
• InjuryAug 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 530CC 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 20091234 ↗
• InjuryApr 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 31-YEAR-OLD FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A 530CC MENTOR MEMORYGEL BOOST BREAST IMPLANT AND EXPERIENCED EXTRUSION OF THE RIGHT IMPLANT THROUGH THE SKIN POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2024, AND REPLACED WITH A 530CC MENTOR MEMORYGEL BOOST BREAST IMPLANT.

  Patient problems: Pocket Erosion

  MAUDE report 19121892 ↗
• InjuryApr 9, 2024Adverse 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 530CC MENTOR MEMORYGEL BOOST BREAST IMPLANTS EXPERIENCED RIGHT SIDED BAKER GRADE III/IV CAPSULAR CONTRACTURE, RIGHT SIDED RUPTURE, LEFT SIDED BREAST CYST, AND LEFT SIDED BREAST MASS POST PROCEDURE. THE ISSUES WERE CONFIRMED THROUGH ULTRASOUND AND MAMMOGRAPHY. THE BREAST MASS WAS DESCRIBED AS A 6CM CIRCUMSCRIBED SOLID MASS AT THE 7 O¿CLOCK POSITION THAT IS PROBABLY BENIGN. THESE ISSUES WERE ACCOMPANIED BY BREAST PAIN. AS A RESULT, REPLACEMENT WITH MENTOR GEL BOOST WAS PERFORMED ON (B)(6) 2024. SEE 1645337-2024-04242 FOR CONTRALATERAL PROSTHESIS REPORT.

  Patient problems: Breast Mass; Cyst(s)

  MAUDE report 19072401 ↗
• InjuryApr 9, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH 530CC MENTOR MEMORYGEL BOOST BREAST IMPLANTS EXPERIENCED RIGHT SIDED BAKER GRADE III/IV CAPSULAR CONTRACTURE, RIGHT SIDED RUPTURE, LEFT SIDED BREAST CYST, AND LEFT SIDED BREAST MASS POST PROCEDURE. THE ISSUES WERE CONFIRMED THROUGH ULTRASOUND AND MAMMOGRAPHY. THE BREAST MASS WAS DESCRIBED AS A 6CM CIRCUMSCRIBED SOLID MASS AT THE 7 O¿CLOCK POSITION THAT IS PROBABLY BENIGN. THESE ISSUES WERE ACCOMPANIED BY BREAST PAIN. AS A RESULT, REPLACEMENT WITH MENTOR GEL BOOST WAS PERFORMED ON (B)(6) 2024. SEE 1645337-2024-04241 FOR CONTRALATERAL PROSTHESIS REPORT.

  Patient problems: Capsular Contracture

  MAUDE report 19072378 ↗
• InjuryJul 12, 2023Device Damaged Prior to Receipt by User; Device Damaged Prior to Receipt by User

  IT WAS REPORTED THAT A FEMALE PATIENT EXPERIENCED PROLONGED SURGERY DUE TO A DELIVERY SERVICE ISSUE WITH A 530CC AND 545CC MENTOR MEMORYGEL BOOST BREAST IMPLANT. THE PHYSICIAN CONFIRMED THAT THE PROLONGED PROCEDURE INCREASED RISK TO THE PATIENT AS SHE WAS KEPT UNDER ANESTHESIA LONGER THAN INTENDED. THE PROCEDURE WAS COMPLETED WITHOUT ANY PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17309353 ↗