MENTOR MemoryGel Xtra Breast Implant SMHX630Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 10081317027918), received between Oct 13, 2021 and May 15, 2026 — classified as 21 injuries.

The most frequently reported specific device problem is “Material Rupture” (7 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.

• InjuryMay 15, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE WITH A MENTOR MEMORYGEL XTRA BREAST IMPLANT GEL BREAST PROSTHESIS DEVELOPED CAPSULAR CONTRACTURE (BAKER GRADE UNKNOWN) IN HER RIGHT BREAST POST IMPLANTATION. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Capsular Contracture

  MAUDE report 25189156 ↗
• InjuryFeb 4, 2026Adverse Event Without Identified Device or Use Problem

  A FEMALE PATIENT WHO UNDERWENT A BREAST RECONSTRUCTION REVISION WITH A MENTOR MEMORYGEL XTRA 630CC SILICONE PROSTHESIS EXPERIENCED LEFT SIDED CAPSULAR CONTRACTURE GRADE III, AND RIGHT SIDED NIPPLE SENSATION POST OPERATION. THE ISSUE WAS DIAGNOSED THROUGH PATIENT SYMPTOMS. AS A RESULT, THE PATIENT SCHEDULED FOR UNILATERAL REPLACEMENT ON (B)(6) 2026. THIS REPORT RELATES TO THE RIGHT SIDE.

  Patient problems: Deformity/ Disfigurement; Nipple Sensation Changes

  MAUDE report 24261763 ↗
• InjuryFeb 4, 2026Material Rupture; Adverse Event Without Identified Device or Use Problem

  A FEMALE PATIENT WHO UNDERWENT A BREAST RECONSTRUCTION REVISION WITH A MENTOR MEMORYGEL XTRA 630CC SILICONE PROSTHESIS EXPERIENCED LEFT SIDED CAPSULAR CONTRACTURE GRADE III, AND RIGHT SIDED NIPPLE SENSATION POST OPERATION. THE ISSUE WAS DIAGNOSED THROUGH PATIENT SYMPTOMS. AS A RESULT, THE PATIENT SCHEDULED FOR UNILATERAL REPLACEMENT ON (B)(6) 2026. THIS REPORT RELATES TO THE LEFT SIDE.

  Patient problems: Capsular Contracture

  MAUDE report 24261721 ↗
• InjuryJul 15, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 630CC MENTOR MEMORYGEL XTRA BREAST IMPLANT EXPERIENCED A RUPTURE AND AN IMPLANT SITE HEMATOMA ON THE RIGHT SIDE POST-OPERATIVELY. THE PATIENT REQUIRED SURGICAL INTERVENTION TO TREAT THE SEROMA VIA ASPIRATION. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025.

  Patient problems: Hematoma

  MAUDE report 22509789 ↗
• InjuryJul 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 49-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT REVISION BREAST AUGMENTATION WITH 630CC MENTOR MEMORYGEL XTRA BREAST IMPLANT ON BOTH SIDES AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE; BAKER GRADE IV POSTOPERATIVELY. 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: Capsular Contracture

  MAUDE report 22395033 ↗
• InjuryJul 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 49-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT REVISION BREAST AUGMENTATION WITH 630CC MENTOR MEMORYGEL XTRA BREAST IMPLANT ON BOTH SIDES AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE; BAKER GRADE IV POSTOPERATIVELY. 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: Capsular Contracture

  MAUDE report 22395032 ↗
• InjuryMar 14, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT PRIMARY BREAST RECONSTRUCTION WITH A 630CC MENTOR MEMORYGEL XTRA BREAST IMPLANT EXPERIENCED LEFT SIDED RUPTURE POST PROCEDURE. THE RUPTURE WAS DISCOVERED DURING EXPLANT. UNILATERAL REPLACEMENT WITH MENTOR GEL WAS PERFORMED.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 21610339 ↗
• InjuryNov 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 50-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT REVISION BREAST AUGMENTATION WITH 630CC MENTOR MEMORYGEL XTRA BREAST IMPLANT AND EXPERIENCED CAPSULAR CONTRACTURE; BAKER GRADE III ON HER RIGHT SIDE POSTOPERATIVELY; DIAGNOSED IN THE OFFICE. THE PATIENT HAS CONSULTED WITH THE HEALTHCARE PROFESSIONAL. AS A RESULT, THE PATIENT UNDERWENT REPLACEMENT SURGERY ON (B)(6) 2024.

  Patient problems: Capsular Contracture

  MAUDE report 20673900 ↗
• InjuryNov 8, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 37-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 700CC (LEFT) AND A 630CC (RIGHT) MENTOR MEMORYGEL XTRA BREAST IMPLANT AND EXPERIENCED BILATERAL RUPTURES POST-OPERATIVELY. IT WAS ALSO REPORTED THAT THE PATIENT HAD CAPSULAR CONTRACTURE (BAKER GRADE 3) ON THE RIGHT SIDE AND MALPOSITION ON THE LEFT SIDE. AS A RESULT, THE PATIENT UNDERWENT BILATERAL DEVICE EXPLANTATION ON (B)(6) 2024. THIS REPORT IS FOR THE RIGHT SIDE DEVICE.

  Patient problems: Capsular Contracture

  MAUDE report 20642856 ↗
• InjuryOct 16, 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 630CC 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 UNDERWENT REMOVAL ON (B)(6) 2024.

  Patient problems: Capsular Contracture

  MAUDE report 20464639 ↗
• InjuryOct 10, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION WITH A 630CC MENTOR MEMORYGEL XTRA BREAST IMPLANT ON THE RIGHT BREAST. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA ULTRASOUND, WITH RIGHT BREAST IMPLANT RUPTURE. AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL AND REPLACEMENT SURGERY ON (B)(6) 2024.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 20422642 ↗
• InjuryJul 9, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST RECONSTRUCTION REVISION WITH MENTOR MEMORYGEL XTRA BREAST IMPLANTS 630CC AND EXPERIENCED CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN ALONG WITH RUPTURE ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH A SIMILAR DEVICE ON (B)(6) 2024. BREAST CANCER WAS OBSERVED PRIOR TO THE ISSUES RELATED TO THIS IMPLANT EXCHANGE. ¿PERSONAL HISTORY OF MALIGNANT NEOPLASM OF BREAST¿.

  Patient problems: Breast Cancer; Capsular Contracture

  MAUDE report 19703371 ↗
• InjuryJun 10, 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 PRIMARY WITH MENTOR MEMORYGEL XTRA BREAST IMPLANTS 630CC AND EXPERIENCED CAPSULAR CONTRACTURE BAKER GRADE III ON THE LEFT 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 19499261 ↗
• InjuryApr 8, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST RECONSTRUCTION WITH MENTOR MEMORYGEL XTRA BREAST IMPLANTS 630CC AND EXPERIENCED RUPTURE ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED VIA MRI. AS A RESULT, THE PATIENT UNDERWENT REMOVAL ON (B)(6) 2024.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 19061164 ↗
• InjuryMar 5, 2024Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 630CC 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) 2024.

  Patient problems: Capsular Contracture

  MAUDE report 18838689 ↗
• InjuryJul 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 37-YEAR-OLD FEMALE PATIENT UNDERWENT REVISION BREAST AUGMENTATION WITH A 630CC MENTOR MEMORYGEL XTRA BREAST IMPLANT AND EXPERIENCED CAPSULAR CONTRACTURE; BAKER GRADE III ON HER RIGHT SIDE. THE PATIENT HAS CONSULTED WITH THE HEALTHCARE PROFESSIONAL. AS A RESULT, THE PATIENT UNDERWENT REPLACEMENT SURGERY WITH CATALOG NUMBER SMHX630; SERIAL NUMBER (B)(6) ON (B)(6) 2023.

  Patient problems: Capsular Contracture

  MAUDE report 17298866 ↗
• InjuryMay 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 55-YEAR-OLD CAUCASIAN FEMALE WHO UNDERWENT A BREAST AUGMENTATION REVISION WITH A MENTOR MEMORYGEL XTRA, 630CC SILICONE PROSTHESIS EXPERIENCED LEFT-SIDED CAPSULAR CONTRACTURE GRADE III POST PROCEDURE. THE ISSUE WAS DIAGNOSED THROUGH OFFICE VISITATION. AS A RESULT, PATIENT UNDERWENT LEFT-SIDED CAPSULECTOMY, AND REMOVAL ON (B)(6) 2023.

  Patient problems: Capsular Contracture

  MAUDE report 16902932 ↗
• InjuryFeb 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 39-YEAR-OLD HISPANIC/LATINO FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH 630CC MENTOR MEMORYGEL XTRA BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT EXPERIENCED BILATERAL BAKER GRADE III CAPSULAR CONTRACTURE, WHICH WAS CONFIRMED BY A MEDICAL PROFESSIONAL. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. SEVERAL FOLLOW-UPS HAVE BEEN CONDUCTED, AND NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. IF MORE INFORMATION BECOMES AVAILABLE, MENTOR WILL SUBMIT A SUPPLEMENTAL REPORT ACCORDINGLY. THIS REPORT IS FOR THE LEFT IMPLANT. REFER TO MANUFACTURING REPORT NUMBER 1645337-2023-01980 FOR THE CONTRALATERAL EVENT.

  Patient problems: Capsular Contracture

  MAUDE report 16420816 ↗
• InjuryFeb 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 39-YEAR-OLD HISPANIC/LATINO FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH 630CC MENTOR MEMORYGEL XTRA BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT EXPERIENCED BILATERAL BAKER GRADE III CAPSULAR CONTRACTURE, WHICH WAS CONFIRMED BY A MEDICAL PROFESSIONAL. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. SEVERAL FOLLOW-UPS HAVE BEEN CONDUCTED, AND NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. IF MORE INFORMATION BECOMES AVAILABLE, MENTOR WILL SUBMIT A SUPPLEMENTAL REPORT ACCORDINGLY. THIS REPORT IS FOR THE RIGHT IMPLANT. REFER TO MANUFACTURING REPORT NUMBER 1645337-2023-01979 FOR THE CONTRALATERAL EVENT.

  Patient problems: Capsular Contracture

  MAUDE report 16420804 ↗
• InjuryMay 19, 2022Migration; Migration

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION REVISION WITH A 630CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED A DEVICE MIGRATION AND BREAST PAIN ON THE LEFT SIDE POST-OPERATIVELY. THE PATIENT REPORTED THAT THE DEVICE HAD FLIPPED, AND SHE WAS EXPERIENCING DISCOMFORT. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Breast Discomfort/Pain

  MAUDE report 14438201 ↗
• InjuryOct 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) YEAR OLD HISPANIC FEMALE PATIENT, WHO'S UNDERGONE BREAST RECONSTRUCTION WITH A 630CC MENTOR MEMORYGEL BREAST IMPLANT ON THE RIGHT BREAST, SUFFERED RIGHT BREAST SKIN CHANGES, BREAST PAIN, AND BREAST INFECTION, POST-PROCEDURE. AS A RESULT, THE PATIENT UNDERWENT SEROMA DRAINING AND IMPLANT REMOVAL ON (B)(6) 2021. THE SEROMA WAS CULTURED TO (B)(6).

  Patient problems: Post Operative Wound Infection; Seroma

  MAUDE report 12627033 ↗