MENTOR MemoryGel Xtra Breast Implant SHPX560Recalls & reported problems

Summary

The FDA's MAUDE database contains 112 adverse event reports that list this exact device (DI 00081317025320), received between Jun 24, 2019 and Sep 30, 2026 — classified as 111 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Rupture” (23 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 112 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Material Rupture

  It was reported that a patient implanted with a 560cc MENTOR MemoryGel Xtra Breast Implant experienced a rupture, breast pain, and a burning sensation 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: Breast Discomfort/Pain; Paresthesia

  MAUDE report 50947403 ↗
• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient implanted with a 560cc MENTOR MemoryGel Xtra Breast Implant experienced capsular contracture Baker Grade 3 on the right side post-operatively. As a result, the patient underwent explantation on (b)(6) 2026.

  Patient problems: Capsular Contracture

  MAUDE report 50935268 ↗
• InjurySep 16, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient underwent a Primary Breast Augmentation Surgery with implantation of a 560cc MENTOR MemoryGel Xtra Breast Implant prosthesis. Post-operatively, the patient was diagnosed with right breast Baker Grade IV Capsular Contracture 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 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 50794085 ↗
• InjuryAug 23, 2026Adverse Event Without Identified Device or Use Problem

  A female patient who underwent Breast Augmentation Revision with MENTOR MemoryGel, 560cc Silicone prosthesis experienced bilateral capsular contracture grade III postoperative. The ultrasound and MRI examination confirmed the issue. As a result, the patient underwent removal surgery on (b)(6) 2026. This report relates to the right side.

  Patient problems: Capsular Contracture

  MAUDE report 50394902 ↗
• InjuryAug 19, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient implanted with a 560cc MENTOR MemoryGel Xtra 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 50326807 ↗
• InjuryMar 16, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT WITH MENTOR MEMORYGEL XTRA BREAST IMPLANTS EXPERIENCED RUPTURE 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) 2026.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 24604415 ↗
• InjuryMar 5, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 560CC MENTOR MEMORYGEL XTRA BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT SUFFERED LEFT BREAST IMPLANT RUPTURE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 24527734 ↗
• InjuryFeb 11, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 560CC MENTOR MEMORYGEL XTRA BREAST IMPLANT EXPERIENCED BILATERAL RUPTURES AND CAPSULAR CONTRACTURE 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 24315100 ↗
• InjuryFeb 11, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 560CC MENTOR MEMORYGEL XTRA BREAST IMPLANT EXPERIENCED BILATERAL RUPTURES AND CAPSULAR CONTRACTURE 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 24315086 ↗
• InjuryFeb 5, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 560CC MENTOR MEMORYGEL XTRA BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT REPORTED EXPERIENCING A RUPTURED LEFT IMPLANT. A CONSULTATION WITH A MEDICAL PROFESSIONAL HAS YET TO BE CONDUCTED. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THE DATE OF EVENT WAS PROVIDED TO MENTOR AS A BEST ESTIMATE. 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: Deformity/ Disfigurement

  MAUDE report 24274637 ↗
• InjuryFeb 4, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 560CC MENTOR MEMORYGEL XTRA BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA PHYSICAL EXAMINATION AND ULTRASOUND, WITH LEFT BREAST IMPLANT RUPTURE. AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL AND REPLACEMENT SURGERY ON (B)(6) 2026. THE REPLACEMENT DEVICES WERE TWO MENTOR SALINE IMPLANTS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 24260270 ↗
• InjuryJan 9, 2026Material Rupture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH IMPLANTATION OF A 560CC MENTOR MEMORYGEL XTRA BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH POSSIBLY RUPTURED IMPLANTS (BILATERAL) DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT BILATERAL IMPLANT REMOVAL ON (B)(6) 2025. THIS REPORT IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 24027975 ↗
• InjuryJul 14, 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 560CC MENTOR MEMORYGEL XTRA BREAST IMPLANT EXPERIENCED BILATERAL CAPSULAR CONTRACTURE BAKER GRADE 3 POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025.

  Patient problems: Capsular Contracture

  MAUDE report 22500515 ↗
• InjuryJul 14, 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 560CC MENTOR MEMORYGEL XTRA BREAST IMPLANT EXPERIENCED BILATERAL CAPSULAR CONTRACTURE BAKER GRADE 3 POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025.

  Patient problems: Capsular Contracture

  MAUDE report 22500504 ↗
• InjuryJul 9, 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 XTRA BREAST IMPLANTS AND EXPERIENCED CAPSULAR CONTRACTURE BAKER GRADE III ON THE LEFT SIDE AND RUPTURE ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED VIA MAMMOGRAM. 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 22458418 ↗
• InjuryJul 9, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT WITH MENTOR MEMORYGEL XTRA BREAST IMPLANTS AND EXPERIENCED CAPSULAR CONTRACTURE BAKER GRADE III ON THE LEFT SIDE AND RUPTURE ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED VIA MAMMOGRAM. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 22458182 ↗
• InjuryJun 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH TWO 560CC MENTOR MEMORYGEL XTRA BREAST IMPLANTS AND EXPERIENCED ¿MANY ISSUES¿ POST-OPERATIVELY. NO FURTHER INFORMATION REGARDING THE PATIENT¿S EVENT WAS PROVIDED. AT THE TIME OF THIS REPORT, MENTOR RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. MENTOR HAS ATTEMPTED MULTIPLE FOLLOW-UPS TO CLARIFY THE PATIENT¿S EVENT WITHOUT SUCCESS. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, MENTOR WILL SUBMIT A SUPPLEMENTAL REPORT ACCORDINGLY. THIS REPORT IS FOR THE RIGHT SIDE DEVICE.

  Patient problems: Insufficient Information

  MAUDE report 22333608 ↗
• InjuryJun 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH TWO 560CC MENTOR MEMORYGEL XTRA BREAST IMPLANTS AND EXPERIENCED ¿MANY ISSUES¿ POST-OPERATIVELY. NO FURTHER INFORMATION REGARDING THE PATIENT¿S EVENT WAS PROVIDED. AT THE TIME OF THIS REPORT, MENTOR RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. MENTOR HAS ATTEMPTED MULTIPLE FOLLOW-UPS TO CLARIFY THE PATIENT¿S EVENT WITHOUT SUCCESS. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, MENTOR WILL SUBMIT A SUPPLEMENTAL REPORT ACCORDINGLY. THIS REPORT IS FOR THE LEFT SIDE DEVICE.

  Patient problems: Insufficient Information

  MAUDE report 22333605 ↗
• InjuryMay 28, 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 PRIMARY WITH MENTOR MEMORYGEL XTRA BREAST IMPLANTS AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE BAKER GRADE IV (L) AND BAKER GRADE III (R) POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT REMOVAL ON (B)(6) 2025. THIS REPORT IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 22095542 ↗
• InjuryMay 28, 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 PRIMARY WITH MENTOR MEMORYGEL XTRA BREAST IMPLANTS AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE BAKER GRADE IV (L) AND BAKER GRADE III (R) POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT REMOVAL ON (B)(6) 2025. THIS REPORT IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 22095540 ↗
• InjuryFeb 21, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 33-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH 560CC MENTOR MEMORYGEL XTRA BREAST IMPLANT ON THE LEFT SIDE AND WITH 535CC MENTOR MEMORYGEL XTRA BREAST IMPLANT ON THE RIGHT SIDE AND EXPERIENCED BILATERAL BREAST IMPLANT RUPTURES, BILATERAL RIPPLING, AND BILATERAL BREAST SHAPE CHANGING POSTOPERATIVELY. THE ISSUE WAS 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. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT-SIDED DEVICE.

  Patient problems: Deformity/ Disfigurement; Wrinkling

  MAUDE report 21434548 ↗
• InjuryFeb 5, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH A 560CC MENTOR MEMORYGEL XTRA BREAST IMPLANT ON THE LEFT BREAST. POST-OPERATIVELY, THE PATIENT SUFFERED LEFT BREAST IMPLANT RUPTURE. AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2024.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 21318832 ↗
• InjuryNov 21, 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 560CC MENTOR MEMORYGEL XTRA BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH RIGHT BREAST BAKER GRADE IV CAPSULAR CONTRACTURE BY A MEDICAL PROFESSIONAL DURING A VISUAL EXAM WITH THE PATIENT. AS A RESULT, THE PATIENT UNDERWENT UNILATERAL REMOVAL AND REPLACEMENT WITH A RIGHT-SIDED 560CC MENTOR MEMORYGEL XTRA BREAST IMPLANT ON (B)(6) 2024.

  Patient problems: Capsular Contracture

  MAUDE report 20744823 ↗
• InjuryOct 18, 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 560CC MENTOR MEMORYGEL XTRA BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT EXPERIENCED A NON-HEALING WOUND OF THE LEFT BREAST OBSERVED TO BE A FAINT BRUISE ON THE LATER ASPECT OF THE LEFT BREAST AREOLA. THIS AREA DEVELOPED A SMALL WHITE CENTER WHICH PROGRESSED INTO A ESCHAR COVERED ULCERATION AND WAS NOTED DURING AN IN-OFFICE VISIT WITH A MEDICAL PROFESSIONAL. SOME SEROUS DRAINAGE WITHOUT ODOR WAS PRESENT WITH PERI-WOUND SKIN ERYTHEMA AND WOUND PAIN. A DEBRIDEMENT PROCEDURE WAS CONDUCTED TO REMOVE THE PROBLEMATIC TISSUE OF THE LEFT BREAST WITHOUT BREAST IMPLANT REMOVAL. AFTER THE PROCEDURE, THE LEFT BREAST IMPLANT WAS EXPOSED AT THE ULCERATION SITE; HOWEVER, ESCHAR WAS NO LONGER PRESENT AND THE WOUND WAS DETERIORATING. MAGNETIC RESONANCE IMAGING WAS CONDUCTED WHICH IDENTIFIED A MASS IN THE UPPER OUTER RIGHT BREAST AND BORDERLINE LEFT AXILLARY ADENOPATHY. THERE WAS NO REPORTED INTERVENTION OF THE RIGHT BREAST. THIS REPORT IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Breast Mass

  MAUDE report 20486865 ↗
• InjuryOct 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 64-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A 560CC MENTOR MEMORYGEL XTRA 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 20465139 ↗