MENTOR MemoryGel BOOST Breast Implant SMPB340Recalls & reported problems

Summary

The FDA's MAUDE database contains 46 adverse event reports that list this exact device (DI 00081317026877), received between May 31, 2022 and Sep 16, 2026 — classified as 40 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (11 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 46 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 340cc 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 50791093 ↗
• InjurySep 14, 2026Migration

  It was reported that a patient implanted with a 340cc MENTOR MemoryGel BOOST Breast Implant experienced a device migration on the left side post-operatively which required surgical intervention to treat. At the time of this report, Mentor has received no information regarding explantation or an expected explantation date.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 50755487 ↗
• InjuryJul 1, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 340CC MENTOR MEMORYGEL BOOST BREAST IMPLANT EXPERIENCED CAPSULAR CONTRACTURE (BAKER GRADE 4) ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2026.

  Patient problems: Capsular Contracture

  MAUDE report 25679357 ↗
• InjuryMay 28, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 340CC MENTOR MEMORYGEL BOOST BREAST IMPLANT 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 25318919 ↗
• MalfunctionApr 29, 2026Material Rupture

  IT WAS REPORTED THAT DURING A SCHEDULED BREAST SURGERY, A MENTOR MEMORYGEL BOOST BREAST IMPLANT GEL BREAST PROSTHESIS WAS NOTED TO BE RUPTURED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT MENTOR MEMORYGEL BOOST BREAST IMPLANT GEL BREAST PROSTHESIS. THERE WAS NO REPORTED PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25035626 ↗
• InjuryApr 24, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH IMPLANTATION OF A 340CC MENTOR MEMORYGEL BOOST BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH RIGHT BREAST BAKER GRADE IV CAPSULAR CONTRACTURE DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXCHANGE WITH MENTOR GEL IMPLANTS ON (B)(6) 2026.

  Patient problems: Capsular Contracture

  MAUDE report 24988459 ↗
• InjuryMar 7, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH TWO 340CC MENTOR MEMORYGEL BOOST BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA PHYSICAL EXAMINATION, WITH RIGHT BREAST CAPSULAR CONTRACTURE (BAKER GRADE III). AS A RESULT, THE PATIENT HAS BEEN SCHEDULED FOR BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2026.

  Patient problems: Capsular Contracture

  MAUDE report 24541075 ↗
• InjuryDec 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 39-YEAR-OLD HISPANIC FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 340CC MENTOR MEMORYGEL BOOST BREAST IMPLANT AND EXPERIENCED CAPSULAR CONTRACTURE (BAKER GRADE 3) ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS DIAGNOSED WITH A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025.

  Patient problems: Capsular Contracture

  MAUDE report 23938642 ↗
• InjuryDec 30, 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 340CC MENTOR MEMORYGEL BOOST BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH RIGHT BREAST BAKER GRADE III CAPSULAR CONTRACTURE DURING A PHYSICAL EXAM. 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 23930590 ↗
• InjuryDec 19, 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 IV ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING 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 23851869 ↗
• InjuryNov 13, 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 WITH A 340CC (LEFT) MENTOR MEMORYGEL BOOST BREAST IMPLANT AND A 320CC (RIGHT) MENTOR MEMORYGEL BOOST BREAST IMPLANT AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE (BAKER GRADE 3) POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025 AND REPLACED WITH A 310CC MENTOR MEMORYGEL BOOST BREAST IMPLANT ON THE LEFT SIDE AND A 330CC MENTOR MEMORYGEL BOOST BREAST IMPLANT ON THE RIGHT SIDE. THIS REPORT IS FOR THE LEFT SIDE DEVICE.

  Patient problems: Capsular Contracture

  MAUDE report 23543786 ↗
• InjuryOct 23, 2025Migration; Migration

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE WITH MENTOR MEMORYGEL BOOST BREAST IMPLANT 340CC GEL BREAST PROSTHESES DEVELOPED BAKER GRADE IV CAPSULAR CONTRACTURE WITH MALPOSITION AND A DOUBLE BUBBLE DEFORMITY IN HER RIGHT BREAST POST IMPLANTATION. ADDITIONALLY, THE PATIENT DEVELOPED SOME INFERIOR BOTTOMING OUT OF THE LEFT BREAST PROSTHESIS. THE ISSUES WERE DIAGNOSED VIA A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT RIGHT BREAST UNILATERAL EXPLANTATION AND REPLACEMENT OF THE WITH A MENTOR MEMORYGEL BOOST BREAST IMPLANT 340CC GEL BREAST PROSTHESIS ON (B)(6) 2025. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE FOR THE PATIENT¿S LEFT BREAST PROSTHESIS. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT BREAST PROSTHESIS. REFER TO MANUFACTURER REPORT NUMBER 1645337-2025-11110 FOR THE REPORT FOR THE PATIENT¿S RIGHT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 23375245 ↗
• InjuryAug 4, 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 WITH MENTOR MEMORYGEL BOOST BREAST IMPLANTS EXPERIENCED CAPSULAR CONTRACTURE BAKER GRADE III ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT DEVICE REMOVAL AND REPLACEMENT.

  Patient problems: Capsular Contracture

  MAUDE report 22699388 ↗
• InjuryJul 14, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH IMPLANTATION OF A 340CC MENTOR MEMORYGEL BOOST BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH A RUPTURED LEFT BREAST IMPLANT USING MAGNETIC RESONANCE IMAGING. 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; Deformity/ Disfigurement

  MAUDE report 22499680 ↗
• InjuryJun 26, 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 340CC MENTOR MEMORYGEL BOOST BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH BILATERAL BAKER GRADE IV CAPSULAR CONTRACTURE DURING AN IN-OFFICE VISIT WITH A MEDICAL PROFESSIONAL. AS A RESULT, THE PATIENT UNDERWENT BILATERAL BREAST IMPLANT REMOVAL ON (B)(6) 2025.

  Patient problems: Capsular Contracture

  MAUDE report 22341788 ↗
• InjuryJun 26, 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 340CC MENTOR MEMORYGEL BOOST BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH BILATERAL BAKER GRADE IV CAPSULAR CONTRACTURE DURING AN IN-OFFICE VISIT WITH A MEDICAL PROFESSIONAL. AS A RESULT, THE PATIENT UNDERWENT BILATERAL BREAST IMPLANT REMOVAL ON (B)(6) 2025.

  Patient problems: Capsular Contracture

  MAUDE report 22341786 ↗
• InjuryApr 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT BREAST AUGMENTATION REVISION WITH A 340CC MENTOR MEMORYGEL BOOST BREAST IMPLANT EXPERIENCED LEFT SIDED BAKER GRADE IV CAPSULAR CONTRACTURE POST PROCEDURE. THIS WAS ACCOMPANIED BY PAIN, FIRMNESS, AND THE DEVICE SITTING HIGHER. AS A RESULT, EXPLANT IS PLANNED FOR (B)(6) 2025.

  Patient problems: Capsular Contracture

  MAUDE report 21746513 ↗
• InjuryMar 21, 2025Migration; Migration

  A FEMALE PATIENT UNDERWENT BREAST AUGMENTATION REVISION USING MENTOR MEMORYGEL BOOST SILICONE IMPLANTS, SPECIFICALLY 390CC ON THE LEFT, 340CC ON THE RIGHT POST-OPERATION, THE PATIENT EXPERIENCED ACQUIRED DEFORMITY OF BILATERAL BREASTS. BILATERAL BREAST IMPLANT, INFERIOR MALPOSITION, AND RUPTURED LEFT BREAST IMPLANT WHICH WAS DISCOVERED DURING THE EXCHANGE PROCEDURE. CONSEQUENTLY, THE PATIENT UNDERWENT BILATERAL CAPSULORRHAPHIES AND PLACEMENT OF P4HB SCAFFOLD TO THE INFERIOR POLE OF BILATERAL BREAST. INFERIOR MASTOPEXY ON THE LEFT NIPPLE TO INFRAMAMMARY FOLD IS 9.5 CM, AND BILATERAL REPLACEMENT OF THE IMPLANTS ON (B)(6) 2025. THE DETAILS OF THE REPLACEMENTS ARE AS FOLLOWS: THE LEFT IMPLANT WAS REPLACED WITH CATALOG NUMBER SMPB340, SERIAL NUMBER (B)(6), AND THE RIGHT IMPLANT WAS REPLACED WITH CATALOG NUMBER SMPB430, SERIAL NUMBER (B)(6). THIS REPORT RELATES TO THE RIGHT SIDE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 21663093 ↗
• InjuryMar 7, 2025Material Rupture; Material Rupture

  A FEMALE PATIENT WHO HAD PREVIOUSLY UNDERGONE BREAST AUGMENTATION USING MENTOR MEMORYGEL BOOST 340CC SILICONE PROSTHESES EXPERIENCED A RIGHT-SIDED SILENT RUPTURE POSTOPERATIVELY. DUE TO THE COMPLICATIONS ASSOCIATED WITH THE RUPTURE, THE PATIENT REQUIRED A UNILATERAL REPLACEMENT OF THE DEFECTIVE IMPLANT. THIS SURGICAL INTERVENTION TOOK PLACE ON (B)(6) 2024, DURING WHICH THE RIGHT-SIDED PROSTHESIS WAS REPLACED WITH MODEL NUMBER 9990210-035.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 21549789 ↗
• InjuryFeb 7, 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 BREAST AUGMENTATION REVISION WITH A 340CC 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; Deformity/ Disfigurement

  MAUDE report 21337326 ↗
• InjuryFeb 3, 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 340CC MENTOR MEMORYGEL BOOST BREAST IMPLANT EXPERIENCED LEFT SIDED BAKER GRADE III CAPSULAR CONTRACTURE POST PROCEDURE. AS A RESULT, CAPSULECTOMY, EXPLANT, AND REPLACEMENTIS PLANNED FOR (B)(6) 2025.

  Patient problems: Capsular Contracture

  MAUDE report 21293759 ↗
• InjuryJan 30, 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 340CC MENTOR MEMORYGEL BOOST BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT REPORTED THAT HER IMPLANTS HAVE BEEN BOTHERING HER; DESCRIBING IT AS FEELING LIKE SHE HAS A REALLY BAD BRUISE AND THE IMPLANTS ARE CAUSING HER TO HAVE BILATERAL BREAST PAIN. SHE HAS BEEN SCHEDULED FOR BREAST IMAGING. 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: Breast Discomfort/Pain

  MAUDE report 21279828 ↗
• InjuryJan 30, 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 340CC MENTOR MEMORYGEL BOOST BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT REPORTED THAT HER IMPLANTS HAVE BEEN BOTHERING HER; DESCRIBING IT AS FEELING LIKE SHE HAS A REALLY BAD BRUISE AND THE IMPLANTS ARE CAUSING HER TO HAVE BILATERAL BREAST PAIN. SHE HAS BEEN SCHEDULED FOR BREAST IMAGING. 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: Breast Discomfort/Pain

  MAUDE report 21279826 ↗
• InjuryDec 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 44-YEAR-OLD HISPANIC FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 340CC MENTOR MEMORYGEL BOOST BREAST IMPLANT AND EXPERIENCED BREAST PAIN AND CAPSULAR CONTRACTURE (BAKER GRADE 4) ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS DIAGNOSED WITH A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2024, AND REPLACED WITH A 450CC MENTOR MEMORYGEL BOOST BREAST IMPLANT (CATALOG NUMBER SMPB450).

  Patient problems: Capsular Contracture

  MAUDE report 20894772 ↗
• InjuryNov 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE WHO UNDERWENT AN UNKNOWN BREAST AUGMENTATION WITH MENTOR MEMORYGEL BOOST, 340CC SILICONE PROSTHESIS EXPERIENCED RIGHT SIDED CAPSULAR CONTRACTURE GRADE III POSTOPERATIVE. AS A RESULT, PATIENT UNDERWENT REMOVAL ON (B)(6) 2024 .

  Patient problems: Capsular Contracture

  MAUDE report 20625494 ↗