MENTOR MemoryGel Xtra Breast Implant SHPX535Recalls & reported problems

Summary

The FDA's MAUDE database contains 125 adverse event reports that list this exact device (DI 00081317025313), received between Sep 17, 2019 and Sep 23, 2026 — classified as 118 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (27 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 125 reports, in the reporter's own words as published by the FDA.

• InjurySep 23, 2026Material Rupture

  It was reported that a patient implanted with a 535cc MENTOR MemoryGel Xtra Breast Implant experienced a rupture 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50871466 ↗
• InjurySep 22, 2026Material Rupture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50856936 ↗
• InjuryMay 22, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 49-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A 535CC MENTOR MEMORYGEL XTRA BREAST IMPLANT AND EXPERIENCED BREAST SCARRING ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT SURGICAL INTERVENTION ON (B)(6) 2026. THE BREAST PROSTHESIS ON THE RIGHT SIDE WAS NOT REPLACED.

  Patient problems: Scar Tissue

  MAUDE report 25260551 ↗
• InjuryMay 21, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH IMPLANTATION OF A 535CC MENTOR MEMORYGEL XTRA BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH LEFT BREAST BAKER GRADE II CAPSULAR CONTRACTURE WITH ASSOCIATED ASYMMETRY DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXCHANGE WITH MENTOR GEL IMPLANTS ON (B)(6) 2026. FURTHERMORE, DURING THE SURGERY, A RUPTURE LEFT WAS DISCOVERED RESULTING IN 1.5 HOUR SURGICAL DELAY. THERE WERE NO REPORTED PATIENT CONSEQUENCES/HARMS DUE TO THE FINDING.

  Patient problems: Capsular Contracture

  MAUDE report 25244153 ↗
• InjuryMar 30, 2026Migration

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH TWO XX. POST-OPERATIVELY, THE PATIENT DEVELOPED LEFT BREAST CAPSULAR CONTRACTURE (BAKER GRADE IV) COMPLICATED WITH BREAST PAIN, WATERFALL DEFORMITY, BILATERAL BREAST PTOSIS AND BILATERAL BREAST IMPLANT DISPLACEMENTS. 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: Deformity/ Disfigurement

  MAUDE report 24722562 ↗
• InjuryMar 30, 2026Migration

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH TWO XX. POST-OPERATIVELY, THE PATIENT DEVELOPED LEFT BREAST CAPSULAR CONTRACTURE (BAKER GRADE IV) COMPLICATED WITH BREAST PAIN, WATERFALL DEFORMITY, BILATERAL BREAST PTOSIS AND BILATERAL BREAST IMPLANT DISPLACEMENTS. 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 24722093 ↗
• InjuryMar 18, 2026Material Rupture; Migration

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 535CC MENTOR MEMORYGEL XTRA BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH A RUPTURED RIGHT IMPLANT WITH LATERAL DISPLACEMENT DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXCHANGE WITH MENTOR GEL IMPLANTS ON (B)(6) 2026. FURTHERMORE, DURING THE SURGERY, THE RIGHT IMPLANT WAS NOTED TO BE FLIPPED.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 24634657 ↗
• InjuryJul 9, 2025Migration; Migration

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH TWO 535CC MENTOR MEMORYGEL XTRA BREAST IMPLANTS EXPERIENCED BILATERAL CAPSULAR CONTRACTURE (BAKER GRADE 3) AND DEVICE MIGRATIONS POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025.

  Patient problems: Capsular Contracture

  MAUDE report 22460414 ↗
• InjuryJul 9, 2025Migration; Migration

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH TWO 535CC MENTOR MEMORYGEL XTRA BREAST IMPLANTS EXPERIENCED BILATERAL CAPSULAR CONTRACTURE (BAKER GRADE 3) AND DEVICE MIGRATIONS POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025.

  Patient problems: Capsular Contracture

  MAUDE report 22460408 ↗
• InjuryJun 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 535CC 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) 2025.

  Patient problems: Capsular Contracture

  MAUDE report 22284862 ↗
• InjuryJun 12, 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 535CC MENTOR MEMORYGEL XTRA BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH BILATERAL CAPSULAR CONTRACTURE BY A MEDICAL PROFESSIONAL (NO BAKER GRADE RATINGS WERE PROVIDED). AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT WITH MENTOR MEMORYGEL BOOST BREAST IMPLANTS ON (B)(6) 2025. 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 22197561 ↗
• InjuryJun 2, 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 MENTOR MEMORYGEL XTRA BREAST IMPLANT 535CC GEL BREAST PROSTHESES DEVELOPED BAKER GRADE IV CAPSULAR CONTRACTURE IN BOTH BREASTS POST IMPLANTATION. BILATERAL CAPSULAR CONTRACTURE WAS DIAGNOSED VIA A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH MENTOR MEMORYGEL BREAST IMPLANT 350CC GEL BREAST PROSTHESES ON (B)(6) 2025. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 22129341 ↗
• InjuryJun 2, 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 MENTOR MEMORYGEL XTRA BREAST IMPLANT 535CC GEL BREAST PROSTHESES DEVELOPED BAKER GRADE IV CAPSULAR CONTRACTURE IN BOTH BREASTS POST IMPLANTATION. BILATERAL CAPSULAR CONTRACTURE WAS DIAGNOSED VIA A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH MENTOR MEMORYGEL BREAST IMPLANT 350CC GEL BREAST PROSTHESES ON (B)(6) 2025. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 22129340 ↗
• InjuryMay 15, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH TWO 535 CC MENTOR MEMORYGEL XTRA BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT SUFFERED LEFT BREAST CAPSULAR CONTRACTURE (BAKER GRADE II-III) AND LEFT BREAST IMPLANT RUPTURE. AS A RESULT, THE PATIENT UNDERWENT BILATERAL BREAST IMPLANT REMOVAL AND REPLACEMENT SURGERY ON (B)(6) 2025. THE REPLACEMENT DEVICES WERE NEW MENTOR GEL IMPLANTS.

  Patient problems: Capsular Contracture

  MAUDE report 22029534 ↗
• InjuryMay 15, 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 WITH MENTOR MEMORYGEL XTRA BREAST IMPLANTS AND EXPERIENCED CAPSULAR CONTRACTURE BAKER GRADE IV ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH SIMILAR DEVICES ON (B)(6) 2025.

  Patient problems: Capsular Contracture

  MAUDE report 22029115 ↗
• InjuryMar 26, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 535 CC MENTOR MEMORYGEL XTRA BREAST IMPLANT EXPERIENCED A RUPTURE ON THE LEFT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 21699914 ↗
• MalfunctionMar 18, 2025Gel Leak; Gel Leak

  IT WAS REPORTED THAT A 535CC MENTOR MEMORYGEL XTRA BREAST IMPLANT WAS IDENTIFIED TO HAVE SILICONE OUTSIDE OF IT, INTRA-OPERATIVELY, DURING A BREAST IMPLANTATION SURGERY. THE SURGEON WAS NOT COMFORTABLE IMPLANTING IT. IT DID NOT MAKE CONTACT WITH THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21634435 ↗
• InjuryMar 12, 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 WITH MENTOR MEMORYGEL XTRA BREAST IMPLANTS 535CC AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE BAKER GRADE III POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH SIMILAR DEVICES ON (B)(6) 2024. THIS REPORT IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 21585640 ↗
• InjuryMar 12, 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 WITH MENTOR MEMORYGEL XTRA BREAST IMPLANTS 535CC AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE BAKER GRADE III POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH SIMILAR DEVICES ON (B)(6) 2024. THIS REPORT IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 21585638 ↗
• 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 RIGHT-SIDED DEVICE.

  Patient problems: Deformity/ Disfigurement; Wrinkling

  MAUDE report 21434547 ↗
• InjuryFeb 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FEMALE PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH A MENTOR MEMORYGEL XTRA 535CC SILICONE PROSTHESIS EXPERIENCED RIGHT-SIDED CAPSULAR CONTRACTURE CLASSIFIED AS GRADE III-IV FOLLOWING IMPLANTATION. SHE REPORTED INTERMITTENT CAPSULAR CONTRACTURE PAIN SPECIFICALLY ON THE RIGHT SIDE, DIAGNOSED BY HER PHYSICIAN ON (B)(6) 2025. AS OF THE TIME OF THIS REPORT, MENTOR HAS NOT RECEIVED ANY INFORMATION REGARDING THE EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Capsular Contracture

  MAUDE report 21424016 ↗
• InjuryFeb 6, 2025Material Rupture; Migration; Material Rupture; Migration

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION WITH A 535CC MENTOR MEMORYGEL XTRA BREAST IMPLANT ON THE RIGHT BREAST. POST-OPERATIVELY, THE PATIENT SUFFERED RIGHT BREAST IMPLANT RUPTURE. AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL SURGERY ON (B)(6), 2025.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 21329201 ↗
• InjuryNov 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 30-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH 535CC MENTOR MEMORYGEL XTRA BREAST IMPLANT AND EXPERIENCED CAPSULAR CONTRACTURE; BAKER GRADE III ON HER RIGHT SIDE POSTOPERATIVELY. 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 20757826 ↗
• InjuryOct 23, 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 WITH MENTOR MEMORYGEL XTRA BREAST IMPLANTS 535CC AND EXPERIENCED CAPSULAR CONTRACTURE BAKER GRADE III 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) 2024.

  Patient problems: Capsular Contracture

  MAUDE report 20517907 ↗
• InjurySep 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE WHO UNDERWENT A BREAST AUGMENTATION REVISION WITH A MENTOR MEMORYGEL XTRA 535CC SILICONE PROSTHESIS EXPERIENCED BILATERAL CAPSULAR CONTRACTURES UNKNOWN GRADE POSTOPERATIVE. THE ISSUE WAS DIAGNOSED THROUGH VISUAL EXAMINATION. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT RELATES TO THE LEFT SIDE.

  Patient problems: Capsular Contracture

  MAUDE report 20322852 ↗