MENTOR MemoryGel BOOST Breast Implant SHPB440Recalls & reported problems

Summary

The FDA's MAUDE database contains 44 adverse event reports that list this exact device (DI 00081317027072), received between Oct 27, 2022 and Sep 16, 2026 — classified as 44 injuries.

The most frequently reported specific device problem is “Migration” (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 25 most recent of 44 reports, in the reporter's own words as published by the FDA.

• InjurySep 16, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient implanted with a 440cc 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 50791494 ↗
• InjurySep 9, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient implanted with a 440cc MENTOR MemoryGel BOOST Breast Implant experienced a wound infection on the right side post-operatively. As a result, the patient underwent explantation on (b)(6) 2026.

  Patient problems: Post Operative Wound Infection

  MAUDE report 50694368 ↗
• InjuryMar 17, 2026Adverse Event Without Identified Device or Use Problem; Migration

  IT WAS REPORTED THAT A 25-YEAR-OLD HISPANIC FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 440CC MENTOR MEMORYGEL BOOST BREAST IMPLANT AND EXPERIENCED CAPSULAR CONTRACTURE (BAKER GRADE 3) ON THE LEFT SIDE POST-OPERATIVELY. THE BREAST IS NOTABLY FIRMER WITH TENDERNESS IN THE UPPER POLE AND SOMEWHAT TO THE AXILLA ON THE LEFT AT ABOUT 3 O¿ CLOCK. THE PATIENT EXPERIENCED PERSISTENT PAIN AND A MILD DEFORMITY JUST LATERAL TO THE AREOLA. AS A RESULT, THE PATIENT IS TO UNDERGO DEVICE EXPLANTATION ON (B)(6) 2026.

  Patient problems: Capsular Contracture

  MAUDE report 24620795 ↗
• InjuryMar 11, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 440CC MENTOR MEMORYGEL BOOST BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS NOTED TO HAVE A PAINFUL, TIGHT, FIRM, ELEVATED, AND NARROW RIGHT BREAST WITH ASSOCIATED ASYMMETRY DURING A PHYSICAL EXAM. SHE WAS DIAGNOSED WITH RIGHT BREAST BAKER GRADE III CAPSULAR CONTRACTURE. IN ADDITION, SHE WAS OBSERVED TO HAVE BILATERALLY PTOSIS AND REDUCED NIPPLE SENSATION BILATERALLY. AS A RESULT, THE PATIENT UNDERWENT RIGHT-SIDED EXCHANGE WITH A MENTOR GEL IMPLANT ON (B)(6) 2026. THERE WAS NO INTERVENTION PERFORMED ON THE LEFT SIDE. THIS REPORT IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement; Nipple Sensation Changes

  MAUDE report 24574056 ↗
• InjuryFeb 26, 2026Adverse 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 II (L) AND BAKER GRADE III (R) POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT DEVICE REMOVAL AND REPLACEMENT. THIS REPORT IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 24457305 ↗
• InjuryFeb 26, 2026Adverse 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 II (L) AND BAKER GRADE III (R) POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT DEVICE REMOVAL AND REPLACEMENT. THIS REPORT IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 24457304 ↗
• InjuryFeb 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 20-YEAR-OLD FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 440CC 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. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6), 2026.

  Patient problems: Capsular Contracture

  MAUDE report 24457189 ↗
• InjuryJan 2, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH MENTOR GEL BREAST PROSTHESES DEVELOPED BAKER GRADE IV CAPSULAR CONTRACTURE IN BOTH BREASTS POST IMPLANTATION. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH MENTOR GEL BREAST PROSTHESES. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 23946447 ↗
• InjuryJan 2, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH MENTOR GEL BREAST PROSTHESES DEVELOPED BAKER GRADE IV CAPSULAR CONTRACTURE IN BOTH BREASTS POST IMPLANTATION. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH MENTOR GEL BREAST PROSTHESES. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 23946446 ↗
• InjuryNov 11, 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 SURGERY WITH IMPLANTATION OF A 440CC MENTOR MEMORYGEL BOOST BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT REPORTED EXPERIENCING PAIN ON THE SIDES OF HER BREASTS, NECK, BACK, AND SHOULDERS. 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: Pain

  MAUDE report 23526524 ↗
• InjuryNov 11, 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 SURGERY WITH IMPLANTATION OF A 440CC MENTOR MEMORYGEL BOOST BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT REPORTED EXPERIENCING PAIN ON THE SIDES OF HER BREASTS, NECK, BACK, AND SHOULDERS. 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: Pain

  MAUDE report 23526475 ↗
• InjurySep 23, 2025Adverse 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 405CC MENTOR MEMORYGEL BOOST BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH RIGHT BREAST BAKER GRADE IV CAPSULAR CONTRACTURE BY A MEDICAL PROFESSIONAL. AS A RESULT, THE PATIENT UNDERWENT RIGHT-SIDED EXCHANGE WITH A MENTOR GEL IMPLANT ON (B)(6) 2025.

  Patient problems: Capsular Contracture

  MAUDE report 23125348 ↗
• InjuryJun 23, 2025Defective Device; Defective Device

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST IMPLANTATION SURGERY WITH A 440CC MENTOR MEMORYGEL BOOST BREAST IMPLANT ON AN UNSPECIFIED BREAST. INTRA-OPERATIVELY, AN UNSPECIFIED ISSUE WITH THE BREAST POCKET WAS NOTED AND THE IMPLANT WAS PULLED OUT. UPON REMOVAL, THE IMPLANT WAS IDENTIFIED TO HAVE AN UNSPECIFIED DEFECT. NO INFORMATION WAS PROVIDED IN REGARDS TO THE OUTCOME OF THE PROCEDURE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE CLARIFICATION IS MADE AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 22309066 ↗
• InjuryApr 23, 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 SURGERY WITH IMPLANTATION OF A 440CC MENTOR MEMORYGEL BOOST BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH LEFT BREAST BAKER GRADE III CAPSULAR CONTRACTURE DURING A PHYSICAL EXAM WITH A MEDICAL PROFESSIONAL. AS A RESULT, THE PATIENT UNDERWENT LEFT-SIDED REMOVAL AND REPLACEMENT WITH A 440CC MENTOR MEMORYGEL BOOST BREAST IMPLANT ON (B)(6) 2025 .

  Patient problems: Capsular Contracture

  MAUDE report 21896359 ↗
• InjuryApr 23, 2025Material Rupture; Adverse Event Without Identified Device or Use Problem; Material Rupture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT A BREAST RECONSTRUCTION PROCEDURE WITH A MENTOR MEMORYGEL BOOST BREAST IMPLANT 440CC GEL BREAST PROSTHESIS DEVELOPED BAKER GRADE III CAPSULAR CONTRACTURE IN HER LEFT 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 21892757 ↗
• InjuryApr 4, 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 440CC MENTOR MEMORYGEL BOOST BREAST IMPLANTS EXPERIENCED BILATERAL CAPSULAR CONTRACTURE ACCOMPANIED BY IMPLANT MALPOSITION POST PROCEDURE. THE RIGHT SIDED CAPSULAR CONTRACTURE WAS BAKER GRADE II/III. THE LEFT SIDED CAPSULAR CONTRACTURE WAS BAKER GRADE III. AS A RESULT, REPLACEMENT WITH MENTOR GEL WAS PERFORMED.

  Patient problems: Capsular Contracture

  MAUDE report 21775560 ↗
• InjuryApr 4, 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 440CC MENTOR MEMORYGEL BOOST BREAST IMPLANTS EXPERIENCED BILATERAL CAPSULAR CONTRACTURE ACCOMPANIED BY IMPLANT MALPOSITION POST PROCEDURE. THE RIGHT SIDED CAPSULAR CONTRACTURE WAS BAKER GRADE II/III. THE LEFT SIDED CAPSULAR CONTRACTURE WAS BAKER GRADE III. AS A RESULT, REPLACEMENT WITH MENTOR GEL WAS PERFORMED.

  Patient problems: Capsular Contracture

  MAUDE report 21775557 ↗
• InjuryMar 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 62-YEAR-OLD FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH 440CC 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 21532758 ↗
• InjuryJan 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 66-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT REVISION BREAST AUGMENTATION WITH 440CC MENTOR MEMORYGEL BOOST BREAST IMPLANT AND EXPERIENCED RIGHT SIDE CAPSULAR CONTRACTURE; BAKER GRADE III POSTOPERATIVELY; DIAGNOSED IN THE OFFICE. 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 21230095 ↗
• InjuryJan 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 440CC MENTOR MEMORYGEL BOOST BREAST IMPLANTS. POST-OPERATIVELY, PATIENT INITIALLY EXPERIENCED HARDENING, PAIN AND DISPLACEMENT IN THE RIGHT BREAST. THE PATIENT WAS PUT ON SINGULAIR AND OTHER MEDICATION BUT THE CAPSULAR CONTRACTURE STILL PROGRESSED TO BAKER GRADE IV. EVENTUALLY THE PATIENT DEVELOPED A LARGE SCAB ON THE LOWER POWER OF THE RIGHT BREAST AND WHEN THE SCAB CAME OFF, THE RIGHT BREAST IMPLANT BECAME EXPOSED. FURTHER EXAMINATION DIAGNOSED THE PATIENT WITH BILATERAL CAPSULAR CONTRACTURES (BAKER GRADE IV). AS A RESULT, ON (B)(6) 2024, THE PATIENT UNDERWENT BILATERAL MESH PLACEMENT, VERTICAL MASTOPEXY, FAT GRAFTING, AND EXCHANGE TO THE FOLLOWING DEVICES: (RIGHT) 325CC MENTOR MEMORYGEL BOOST BREAST IMPLANT CATALOG: SHPB325 LOT: 9717083 SN: (B)(6) AND (LEFT) 325CC MENTOR MEMORYGEL BOOST BREAST IMPLANT CATALOG: SHPB325 LOT: 9984567 SN: (B)(6). THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 21222873 ↗
• InjuryJan 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 440CC MENTOR MEMORYGEL BOOST BREAST IMPLANTS. POST-OPERATIVELY, THE WAS DIAGNOSED, VIA PHYSICAL EXAMINATION, WITH RIGHT BREAST CAPSULAR CONTRACTURE (BAKER GRADE IV) AND DEVICE EXTRUSION. AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2024.

  Patient problems: Capsular Contracture; Pocket Erosion

  MAUDE report 21059796 ↗
• InjuryDec 27, 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 400CC MENTOR MEMORYGEL BOOST BREAST IMPLANT EXPERIENCED CAPSULAR CONTRACTURE BAKER GRADE 3 ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2024.

  Patient problems: Capsular Contracture; Seroma

  MAUDE report 21028005 ↗
• InjuryOct 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST PROSTHESIS IMPLANTATION SURGERY WITH TWO 440CC MENTOR MEMORYGEL BOOST BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT SUFFERED RIGHT BREAST CAPSULAR CONTRACTURE (BAKER GRADE III). AS A RESULT, THE PATIENT HAS BEEN SCHEDULED FOR BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2024.

  Patient problems: Capsular Contracture

  MAUDE report 20349248 ↗
• InjurySep 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  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: Capsular Contracture

  MAUDE report 20334407 ↗
• InjurySep 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  [SAFETY_NOTE_UPDATE1]IMPACTED PRODUCT NUMBER: IP-02162153 - SMO RO HIGH PRO BOOST GEL440CC IT WAS REPORTED THAT A 46-YEAR-OLD FEMALE PATIENT WHO UNDERWENT BREAST IMPLANT SURGERY WITH MENTOR MEDICAL DEVICES (SMO RO HIGH PRO BOOST GEL440CC, DATE OF IMPLANT (B)(6) 2024) HAS EXPERIENCED EXPOSITION OF THE LEFT IMPLANT COMPLICATED BY BREAST INFECTION AND SEROMA FORMATION IN THE LEFT BREAST. AS A RESULT, THE PATIENT UNDERWENT THE LEFT IMPLANT EXPLANTATION ON (B)(6) 2024.

  Patient problems: Pocket Erosion; Post Operative Wound Infection; Seroma

  MAUDE report 20316923 ↗