MENTOR MemoryGel Xtra Breast Implant SMHX350Recalls & reported problems

Summary

The FDA's MAUDE database contains 164 adverse event reports that list this exact device (DI 10081317027833), received between Sep 13, 2022 and Sep 29, 2026 — classified as 158 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (13 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 164 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient with MENTOR MemoryGel Xtra Breast Implants 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 device removal and replacement.

  Patient problems: Capsular Contracture

  MAUDE report 50936639 ↗
• InjurySep 22, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a female patient underwent Breast Augmentation Revision with MENTOR MemoryGel Xtra, 350cc Silicone prosthesis. subsequently the patient experienced right sided implant site hematoma postoperatively. As a result, the patient underwent unilateral replacement with Right: SMHX350 /(b)(6)on (b)(6) 2026.

  Patient problems: Hematoma

  MAUDE report 50856762 ↗
• InjurySep 15, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Capsular Contracture

  MAUDE report 50779283 ↗
• InjurySep 14, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Capsular Contracture

  MAUDE report 50763268 ↗
• InjuryAug 3, 2026Material Rupture

  It was reported that a female patient underwent revision breast augmentation with 350cc MENTOR MemoryGel Xtra Breast Implant and experienced breast implant rupture on her left side postoperatively. As a result, the patient underwent replacement surgery with catalog number SMHX350; serial number (b)(6) on (b)(6) 2026.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50113792 ↗
• InjuryApr 30, 2026Use of Device Problem; Migration

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 350CC MENTOR MEMORYGEL XTRA BREAST IMPLANT EXPERIENCED A DEVICE MIGRATION ON THE LEFT SIDE POST-OPERATIVELY. THE PATIENT UNDERWENT SURGICAL INTERVENTION TO REMOVE AND REINSERT THE IMPLANT, WHICH IS CONSIDERED USE ERROR OF THE DEVICE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 25047127 ↗
• InjuryApr 7, 2026Adverse Event Without Identified Device or Use Problem

  A FEMALE PATIENT WHO UNDERWENT A BREAST AUGMENTATION PRIMARY WITH MENTOR MEMORYGEL XTRA, 350CC SILICONE PROSTHESIS EXPERIENCE RIGHT SIDED CAPSULAR CONTRACTURE GRADE III POST OPERATION. THE ISSUE WAS DIAGNOSED THROUGH PHYSICAL EXAMINATION. AT THE TIME OF THIS REPORT, MENTOR RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Capsular Contracture

  MAUDE report 24808813 ↗
• MalfunctionApr 6, 2026Material Rupture

  IT WAS REPORTED THAT A MENTOR MEMORYGEL XTRA BREAST IMPLANT WAS FOUND TO BE RUPTURED DURING AN OPERATION. NO ADVERSE EVENT WAS EXPERIENCED BY THE PATIENT. THE SURGEON USED BACKUP DEVICES, AND THERE WERE NO REPORTED PATIENT CONSEQUENCES OR PROCEDURAL DELAYS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24791664 ↗
• InjuryApr 3, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH TWO 350CC MENTOR MEMORYGEL XTRA BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA PHYSICAL EXAMINATION, WITH LEFT BREAST CAPSULAR CONTRACTURE (BAKER GRADE III/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 24781703 ↗
• InjuryMar 16, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WITH MENTOR MEMORYGEL XTRA BREAST IMPLANTS EXPERIENCED CAPSULAR CONTRACTURE BAKER GRADE III/IV ON THE RIGHT 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 24604347 ↗
• InjuryMar 11, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT BREAST SURGERY WITH 350CC MENTOR MEMORYGEL XTRA BREAST IMPLANT AND EXPERIENCED CAPSULAR CONTRACTURE; BAKER GRADE III ON HER LEFT SIDE. AS A RESULT, THE DEVICE WAS EXPLANTED ON AN UNKNOWN DATE.

  Patient problems: Capsular Contracture

  MAUDE report 24572085 ↗
• InjuryMar 6, 2026Material Rupture

  A FEMALE PATIENT WHO UNDERWENT A BREAST AUGMENTATION PRIMARY WITH MENTOR MEMORYGEL, XTRA, 350CC SILICONE ON THE LEFT, AND UNKNOWN MENTOR GEL ON THE RIGHT-SIDE PROSTHESIS EXPERIENCED LEFT SIDED SYMPTOMATIC RUPTURE, CAPSULAR CONTRACTURE UNKNOWN GRADE, BREAST PAIN, AND BILATERAL ANISOMASTIA POSTOPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT LEFT SIDE CAPSULECTOMY, REPLACEMENT WITH SERIAL NUMBER (B)(6), AND BILATERAL AREOLAR TIGHTENING ON (B)(6) 2026. THIS REPORT RELATES TO THE LEFT SIDE.

  Patient problems: Breast Discomfort/Pain; Capsular Contracture

  MAUDE report 24535674 ↗
• InjuryMar 3, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 59-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A 350CC MENTOR MEMORYGEL XTRA BREAST IMPLANT AND EXPERIENCED CAPSULAR CONTRACTURE (BAKER GRADE 3) ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS DIAGNOSED WITH AN OFFICE VISIT. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Capsular Contracture

  MAUDE report 24500890 ↗
• InjuryMar 2, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH TWO MENTOR MEMORYGEL XTRA BREAST IMPLANTS EXPERIENCED BILATERAL CAPSULAR CONTRACTURE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2026.

  Patient problems: Capsular Contracture

  MAUDE report 24488884 ↗
• InjuryFeb 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 350CC MENTOR MEMORYGEL XTRA BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH LEFT BREAST BAKER GRADE III CAPSULAR CONTRACTURE BY A MEDICAL PROFESSIONAL USING THE PATIENT'S SYMPTOMS. AS A RESULT, THE PATIENT UNDERWENT LEFT-SIDED EXCHANGE WITH A MENTOR GEL IMPLANT ON (B)(6) 2026.

  Patient problems: Capsular Contracture

  MAUDE report 24278793 ↗
• InjuryJan 27, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH TWO 350CC MENTOR MEMORYGEL XTRA BREAST IMPLANTS AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE (BAKER GRADE 4) POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2026 AND REPLACED WITH TWO 250CC MENTOR MEMORYGEL BREAST IMPLANTS. THIS REPORT IS FOR THE RIGHT-SIDE DEVICE.

  Patient problems: Capsular Contracture

  MAUDE report 24190567 ↗
• InjuryJan 27, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH TWO 350CC MENTOR MEMORYGEL XTRA BREAST IMPLANTS AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE (BAKER GRADE 4) POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2026 AND REPLACED WITH TWO 250CC MENTOR MEMORYGEL BREAST IMPLANTS. THIS REPORT IS FOR THE LEFT SIDE DEVICE.

  Patient problems: Capsular Contracture

  MAUDE report 24190566 ↗
• InjuryJan 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH IMPLANTATION OF A 350CC MENTOR MEMORYGEL XTRA BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH LEFT BREAST BAKER GRADE III CAPSULAR CONTRACTURE DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT LEFT-SIDED EXCHANGE WITH A MENTOR GEL IMPLANT ON (B)(6) 2025.

  Patient problems: Capsular Contracture

  MAUDE report 23981480 ↗
• InjuryDec 30, 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 AUGMENTATION REVISION WITH A 350CC MENTOR MEMORYGEL XTRA BREAST IMPLANT AND EXPERIENCED CAPSULAR CONTRACTURE (BAKER GRADE 3) ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025, AND REPLACED WITH A 350CC MENTOR MEMORYGEL XTRA BREAST IMPLANT.

  Patient problems: Capsular Contracture

  MAUDE report 23924446 ↗
• InjuryNov 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 AUGMENTATION REVISION WITH TWO 350CC MENTOR MEMORYGEL XTRA BREAST IMPLANTS 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 435CC MENTOR MEMORYGEL BOOST BREAST IMPLANTS. THIS REPORT IS FOR THE RIGHT SIDE DEVICE.

  Patient problems: Capsular Contracture

  MAUDE report 23652520 ↗
• InjuryNov 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 AUGMENTATION REVISION WITH TWO 350CC MENTOR MEMORYGEL XTRA BREAST IMPLANTS 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 435CC MENTOR MEMORYGEL BOOST BREAST IMPLANTS. THIS REPORT IS FOR THE LEFT SIDE DEVICE.

  Patient problems: Capsular Contracture

  MAUDE report 23652516 ↗
• InjuryNov 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 50-YEAR-OLD FEMALE PATIENT UNDERWENT REVISION BREAST AUGMENTATION WITH 350CC MENTOR MEMORYGEL XTRA BREAST IMPLANT AND EXPERIENCED CAPSULAR CONTRACTURE; BAKER GRADE IV ON HER LEFT SIDE POSTOPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT REPLACEMENT SURGERY WITH CATALOG NUMBER SMHX350; SERIAL NUMBER (B)(6) ON (B)(6) 2025.

  Patient problems: Capsular Contracture

  MAUDE report 23451857 ↗
• InjurySep 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 40-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 350CC MENTOR MEMORYGEL XTRA BREAST IMPLANT AND EXPERIENCED CAPSULAR CONTRACTURE (BAKER GRADE 3) ON THE LEFT SIDE POST-OPERATIVELY. THE BREAST WAS SITTING HIGH, WAS TIGHT AND FIRM. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025 AND REPLACED WITH A 375CC MENTOR MEMORYGEL XTRA BREAST IMPLANT (CATALOG NUMBER SMHX375) WITH LOT 9988860.

  Patient problems: Capsular Contracture

  MAUDE report 23099408 ↗
• InjuryAug 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 XTRA 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. THE REPORTED IMPLANTATION DATE IS PRIOR TO THE DEVICE MANUFACTURE DATE. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THE CORRECT DATE OF IMPLANTATION OR DEVICE LOT NUMBER, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: Capsular Contracture

  MAUDE report 22842817 ↗
• InjuryAug 7, 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 AUGMENTATION REVISION WITH A 350CC MENTOR MEMORYGEL XTRA BREAST IMPLANT AND EXPERIENCED CAPSULAR CONTRACTURE (BAKER GRADE 4) ON THE LEFT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025 AND REPLACED WITH A 350CC MENTOR MEMORYGEL XTRA BREAST IMPLANT (CATALOG NUMBER SMHX350) WITH SERIAL NUMBER (B)(6).

  Patient problems: Capsular Contracture

  MAUDE report 22741640 ↗