MENTOR MemoryGel Xtra Breast Implant SMPX190Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00081317024989), received between Oct 3, 2019 and Sep 16, 2026 — classified as 21 injuries.

The most frequently reported specific device problem is “Material Rupture” (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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• InjurySep 16, 2026Material Rupture

  It was reported that a patient underwent a Breast Augmentation Revision Surgery with implantation of a 190cc MENTOR MemoryGel Xtra Breast Implant prosthesis. Post-operatively, the patient underwent left-sided exchange on(b)(6)2026, for an undisclosed reason. After the surgery, the left implant was reported ruptured.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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50793991 ↗
• InjurySep 11, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient who underwent a primary breast augmentation procedure with a MENTOR MemoryGel Xtra Breast Implant gel breast prosthesis developed Baker Grade IV capsular contracture in her left breast post implantation. The capsular contracture was diagnosed via 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 50725471 ↗
• InjurySep 6, 2026Material Rupture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50641567 ↗
• InjuryJun 4, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH IMPLANTATION OF A 190CC MENTOR MEMORYGEL XTRA BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT REPORTED EXPERIENCING A RUPTURED RIGHT IMPLANT. A CONSULTATION WITH A MEDICAL PROFESSIONAL AND UNSPECIFIED IMAGING WAS PERFORMED. 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25396397 ↗
• InjuryMar 19, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH TWO 190CC MENTOR MEMORYGEL XTRA BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA PHYSICAL EXAMINATION, WITH BILATERAL BREAST CAPSULAR CONTRACTURES (BAKER GRADE III). AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL AND REPLACEMENT SURGERY ON (B)(6) 2026. THE REPLACEMENT DEVICES WERE TWO MENTOR GEL IMPLANTS. THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 24644112 ↗
• InjuryMar 19, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH TWO 190CC MENTOR MEMORYGEL XTRA BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA PHYSICAL EXAMINATION, WITH BILATERAL BREAST CAPSULAR CONTRACTURES (BAKER GRADE III). AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL AND REPLACEMENT SURGERY ON (B)(6) 2026. THE REPLACEMENT DEVICES WERE TWO MENTOR GEL IMPLANTS. THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 24644111 ↗
• InjuryDec 31, 2025Migration; Migration

  IT WAS REPORTED THAT A 31-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 190CC MENTOR MEMORYGEL XTRA BREAST IMPLANT AND EXPERIENCED DEVICE MIGRATION (FLIPPED) ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 23936542 ↗
• InjuryNov 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 31-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 190CC MENTOR MEMORYGEL XTRA BREAST IMPLANT AND EXPERIENCED CAPSULAR CONTRACTURE (BAKER GRADE 4) AND PARESTHESIA ON THE LEFT SIDE POST-OPERATIVELY. THE PATIENT MENTIONED HAVING A PULLING NUMBING SENSATION TO MOTION LIKE REACHING AND BENDING. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025.

  Patient problems: Capsular Contracture; Paresthesia

  MAUDE report 23662632 ↗
• InjuryOct 22, 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 SURGERY WITH IMPLANTATION OF A 190CC MENTOR MEMORYGEL XTRA BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH LEFT BREAST CAPSULAR CONTRACTURE (BAKER GRADE RATING UNKNOWN) BY A MEDICAL PROFESSIONAL USING THE PATIENT'S SYMPTOMS. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. FOLLOW-UPS ARE BEING CONDUCTED. IF MORE INFORMATION BECOMES AVAILABLE, MENTOR WILL SUBMIT A SUPPLEMENTAL REPORT ACCORDINGLY.

  Patient problems: Capsular Contracture

  MAUDE report 20506660 ↗
• InjuryFeb 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT WHO UNDERWENT A BREAST AUGMENTATION PRIMARY WITH A MENTOR MEMORYGEL XTRA, 190CC SILICONE, BREAST IMPLANT EXPERIENCED BILATERAL CAPSULAR CONTRACTURE GRADE III POSTOPERATIVE. THE ISSUE DIAGNOSED THROUGH PATIENT SYMPTOMS. AS A RESULT, PATIENT SCHEDULED FOR REMOVAL ON (B)(6) 2024. THIS REPORT RELATES TO THE LEFT SIDE.

  Patient problems: Capsular Contracture

  MAUDE report 18661767 ↗
• InjuryFeb 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT WHO UNDERWENT A BREAST AUGMENTATION PRIMARY WITH A MENTOR MEMORYGEL XTRA, 190CC SILICONE, BREAST IMPLANT EXPERIENCED BILATERAL CAPSULAR CONTRACTURE GRADE III POSTOPERATIVE. THE ISSUE DIAGNOSED THROUGH PATIENT SYMPTOMS. AS A RESULT, PATIENT SCHEDULED FOR REMOVAL ON (B)(6) 2024. THIS REPORT RELATES TO THE RIGHT SIDE.

  Patient problems: Capsular Contracture

  MAUDE report 18661703 ↗
• InjuryJan 2, 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 XTRA BREAST IMPLANT 190CC GEL BREAST PROSTHESIS DEVELOPED BAKER GRADE III CAPSULAR CONTRACTURE IN HER RIGHT BREAST POST IMPLANTATION. THE CAPSULAR CONTRACTURE WAS DIAGNOSED DURING AN IMPLANT EXCHANGE SURGERY ON (B)(6) 2023. THE PATIENT HAD BOTH BREAST PROSTHESES EXPLANTED AND THEY WERE REPLACED WITH A MENTOR MEMORYGEL XTRA BREAST IMPLANT 240CC GEL BREAST PROSTHESIS AND A MENTOR MEMORYGEL XTRA BREAST IMPLANT 465CC GEL BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 18427022 ↗
• InjuryOct 26, 2023Adverse 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 A 190CC MENTOR MEMORYGEL XTRA BREAST IMPLANT ON THE RIGHT BREAST. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA PHYSICAL EXAMINATION, WITH RIGHT BREAST CAPSULAR CONTRACTURE (BAKER GRADE IV). AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Capsular Contracture

  MAUDE report 18016383 ↗
• InjuryFeb 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 41-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH TWO UNSPECIFIED MENTOR SMOOTH GEL BREAST PROSTHESES AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE, BAKER GRADE 3 POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2023. THIS REPORT IS FOR THE RIGHT SIDE DEVICE.

  Patient problems: Capsular Contracture

  MAUDE report 16373560 ↗
• InjuryMay 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6)-YEAR-OLD CAUCASIAN FEMALE WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH A 190CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED LEFT SIDED BAKER GRADE III CAPSULAR CONTRACTURE POST PROCEDURE. THE BREAST WAS SITTING HIGHER AND FLATTENED ON THE SIDE. AS A RESULT, REPLACEMENT WITH 270CC MENTOR MEMORYGEL BREAST IMPLANTS IS PLANNED FOR (B)(6) 2022.

  Patient problems: Capsular Contracture

  MAUDE report 14466385 ↗
• InjuryFeb 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) YEAR OLD FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 190CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA PHYSICAL EXAMINATION, WITH RIGHT BREAST CAPSULAR CONTRACTURE (BAKER GRADE IV). AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT WITH TWO 240CC MENTOR MEMORYGEL XTRA BREAST IMPLANT (CATALOG: TMPX240) ON (B)(6) 2022.

  Patient problems: Capsular Contracture

  MAUDE report 13508148 ↗
• InjuryJan 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A HISPANIC FEMALE PATIENT, WHO'S UNDERGONE BREAST AUGMENTATION REVISION WITH TWO 190CC MENTOR MEMORYGEL BREAST IMPLANTS, SUFFERED BILATERAL BREAST CAPSULAR CONTRACTURES (BAKER GRADE III), POST-PROCEDURE. THE CAPSULAR CONTRACTURES WERE DIAGNOSED VIA PHYSICAL EXAMINATION. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 13198020 ↗
• InjuryJan 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A HISPANIC FEMALE PATIENT, WHO'S UNDERGONE BREAST AUGMENTATION REVISION WITH TWO 190CC MENTOR MEMORYGEL BREAST IMPLANTS, SUFFERED BILATERAL BREAST CAPSULAR CONTRACTURES (BAKER GRADE III), POST-PROCEDURE. THE CAPSULAR CONTRACTURES WERE DIAGNOSED VIA PHYSICAL EXAMINATION. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 13198019 ↗
• InjurySep 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT WHO UNDERWENT AN UNSPECIFIED BREAST SURGERY WITH MENTOR MEMORYGEL, 190CC BREAST IMPLANT EXPERIENCED RIGHT-SIDED CAPSULAR CONTRACTURE GRADE III POSTOPERATIVELY. AS A RESULT, PATIENT UNDERWENT PARTIAL CAPSULECTOMY, AND UNILATERAL REPLACEMENT WITH CAT#: SMPX190, SN#: (B)(4) ON (B)(6) 2021.

  Patient problems: Capsular Contracture

  MAUDE report 12453839 ↗
• InjuryNov 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH A 190CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED RIGHT SIDED BAKER¿S GRADE III CAPSULAR CONTRACTURE POST PROCEDURE. THE PATIENT RECEIVED A MEDICAL DIAGNOSIS FOR THE CAPSULAR CONTRACTURE. AS A RESULT, AN EXPLANT IS PLANNED FOR (B)(6) 2020.

  Patient problems: Capsular Contracture; No Code Available

  MAUDE report 9348536 ↗
• InjuryOct 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6)-YEAR-OLD FEMALE PATIENT WHO UNDERWENT PRIMARY BREAST RECONSTRUCTION SURGERY WITH A 490CC MENTOR SMOOTH HIGH PROFILE MEMORYGEL BREAST IMPLANT (RIGHT) AND A 190CC MENTOR SMOOTH MODERATE PLUS PROFILE MEMORYGEL BREAST IMPLANT (LEFT) EXPERIENCED HAIR LOSS, CHRONIC FATIGUE, GEOGRAPHIC TONGUE, JOINTS ARE ACHING, CHRONIC BRAIN FROG AND CHRONIC INFORMATION, BAD VISION, DIAGNOSED WITH CHILDREN SYNDROME, MUSCLE WEAKNESS, VERTIGO, INSOMNIA, PAIN ON THE SIDE OF NECK, PAIN ON THE SCAPULA, LUPUS DISEASE AND A COUPLE OF LYMPH NODES THE SIZE OF QUARTER UNDER ARMPIT POST PROCEDURE. THE MENTIONED COMPLICATIONS HAVE NOT BEEN CONFIRMED BY A PHYSICIAN. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS. SEE 1645337-2019-20763 FOR CONTRALATERAL PROSTHESIS REPORT.

  Patient problems: Autoimmune Reaction; Swollen Lymph Nodes

  MAUDE report 9151078 ↗