MENTOR MemoryGel Xtra Breast Implant SMPX295Recalls & reported problems

Summary

The FDA's MAUDE database contains 299 adverse event reports that list this exact device (DI 00081317025023), received between May 10, 2019 and Sep 23, 2026 — classified as 273 injuries, 26 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (54 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 299 reports, in the reporter's own words as published by the FDA.

• InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a female patient underwent a primary breast augmentation with a 295cc MENTOR MemoryGel Xtra Breast Implant and experienced capsular contracture (baker grade 3) on the left side post-operatively. As a result, the patient underwent explantation on (b)(6) 2026, and replaced with a 270cc MENTOR MemoryGel Xtra Breast Implant.

  Patient problems: Capsular Contracture

  MAUDE report 50870486 ↗
• InjurySep 22, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient implanted with two 295cc MENTOR MemoryGel Xtra Breast Implant experienced bilateral capsular contracture Baker Grade 3 post-operatively. As a result, the patient underwent explantation on (b)(6) 2026.

  Patient problems: Capsular Contracture

  MAUDE report 50854797 ↗
• InjurySep 22, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient implanted with two 295cc MENTOR MemoryGel Xtra Breast Implant experienced bilateral capsular contracture Baker Grade 3 post-operatively. As a result, the patient underwent explantation on (b)(6) 2026.

  Patient problems: Capsular Contracture

  MAUDE report 50854793 ↗
• MalfunctionSep 21, 2026Material Rupture

  It was reported that an intra-operative rupture of a 295cc MENTOR MemoryGel Xtra Breast Implant prosthesis occurred during a Breast Augmentation Surgery prior to being implanted into the patient. However, the surgery commenced without any reported delays and a new implant was used to complete the implantation. There were no reported patient consequences/harms.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50842560 ↗
• InjurySep 16, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a female patient underwent a breast implantation procedure with MENTOR MemoryGel Xtra Breast Implants and suffered several unexplained systemic symptoms, including fatigue, brain fog, joint discomfort, physical distortion, and asymmetry. No device issue such as rupture was reported. The root cause of the patient¿s symptoms is unclear. 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 50785947 ↗
• InjurySep 11, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Capsular Contracture

  MAUDE report 50738526 ↗
• InjurySep 11, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient underwent breast augmentation revision with a 295cc MENTOR MemoryGel Xtra Breast Implant on the left breast. Post-operatively, the patient developed left breast capsular contracture (baker grade III). As a result, the patient underwent breast implant removal and replacement surgery on July 9, 2026. The replacement device was a Mentor gel implant.

  Patient problems: Capsular Contracture

  MAUDE report 50736632 ↗
• InjuryAug 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 295cc MENTOR MemoryGel Xtra Breast Implant prosthesis. Post-operatively, the patient was diagnosed with a right breast seroma. As a result, the patient underwent right-sided exchange with a Mentor gel implant on (b)(6) 2026.

  Patient problems: Seroma

  MAUDE report 50160685 ↗
• InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a female patient underwent a breast augmentation revision with a 295cc MENTOR MemoryGel Xtra Breast Implant and experienced capsular contracture (baker grade 3) on the left side post-operatively. As a result, the patient underwent explantation on (b)(6) 2026, and replaced with a Mentor breast prosthesis.

  Patient problems: Capsular Contracture

  MAUDE report 50000450 ↗
• MalfunctionApr 8, 2026Material Rupture

  IT WAS REPORTED THAT A 295CC MENTOR MEMORYGEL XTRA BREAST IMPLANT BEING USED IN A BREAST AUGMENTATION PROCEDURE WAS FOUND TO BE RUPTURED DURING THE OPERATION. NO ADVERSE EVENT WAS EXPERIENCED BY THE PATIENT. THE SURGEON USED BACKUP DEVICES, AND THERE WERE NO REPORTED PATIENT CONSEQUENCES OR PROCEDURAL DELAYS. ANOTHER MENTOR GEL DEVICE WAS IMPLANTED INSTEAD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24823769 ↗
• InjuryApr 8, 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 UNKNOWN ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING 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 24815795 ↗
• InjuryMar 25, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST PROSTHESIS IMPLANTATION SURGERY WITH A 295CC MENTOR MEMORYGEL XTRA BREAST IMPLANT ON THE RIGHT BREAST. POST-OPERATIVELY, THE PATIENT DEVELOPED RIGHT BREAST CAPSULAR CONTRACTURE (BAKER GRADE IV). AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL SURGERY ON AN UNSPECIFIED DATE.

  Patient problems: Capsular Contracture

  MAUDE report 24683975 ↗
• InjuryMar 25, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST PROSTHESIS IMPLANTATION SURGERY WITH TWO 295CC MENTOR MEMORYGEL XTRA BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT DEVELOPED BILATERAL BREAST CAPSULAR CONTRACTURES (BAKER GRADE UNSPECIFIED). AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL SURGERY ON AN UNSPECIFIED DATE. THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 24683629 ↗
• InjuryMar 24, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST PROSTHESIS IMPLANTATION SURGERY WITH TWO 295CC MENTOR MEMORYGEL XTRA BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT DEVELOPED BILATERAL BREAST CAPSULAR CONTRACTURES (BAKER GRADE UNSPECIFIED). AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL SURGERY ON AN UNSPECIFIED DATE. THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 24677991 ↗
• InjuryMar 19, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST SURGERY WITH IMPLANTATION OF A 295CC MENTOR MEMORYGEL XTRA BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED RIGHT BREAST BAKER GRADE III CAPSULAR CONTRACTURE BY A MEDICAL PROFESSIONAL. AS A RESULT, THE PATIENT UNDERWENT IMPLANT REMOVAL ON AN UNDISCLOSED DATE. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: Capsular Contracture

  MAUDE report 24643187 ↗
• InjuryMar 17, 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 BAKER GRADE 4 POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON AN UNSPECIFIED DATE.

  Patient problems: Capsular Contracture

  MAUDE report 24621554 ↗
• InjuryMar 17, 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 BAKER GRADE 4 POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON AN UNSPECIFIED DATE.

  Patient problems: Capsular Contracture

  MAUDE report 24621539 ↗
• InjuryMar 17, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE WITH MENTOR MEMORYGEL XTRA BREAST IMPLANT GEL BREAST PROSTHESES THAT BOTH RUPTURED POST IMPLANTATION. BILATERAL RUPTURE WAS OBSERVED DURING AN IMPLANT EXCHANGE SURGERY. THE PATIENT¿S EXPLANTED BREAST PROSTHESES WERE REPLACED WITH MENTOR MEMORYGEL BREAST IMPLANT GEL BREAST PROSTHESES. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 24619938 ↗
• InjuryMar 17, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE WITH MENTOR MEMORYGEL XTRA BREAST IMPLANT GEL BREAST PROSTHESES THAT BOTH RUPTURED POST IMPLANTATION. BILATERAL RUPTURE WAS OBSERVED DURING AN IMPLANT EXCHANGE SURGERY. THE PATIENT¿S EXPLANTED BREAST PROSTHESES WERE REPLACED WITH MENTOR MEMORYGEL BREAST IMPLANT GEL BREAST PROSTHESES. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 24619936 ↗
• InjuryFeb 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH IMPLANTATION OF A 295CC MENTOR MEMORYGEL XTRA BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH A HEMATOMA OF THE RIGHT BREAST DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT RIGHT-SIDED EXCHANGE WITH A MENTOR GEL IMPLANT ON (B)(6) 2025.

  Patient problems: Hematoma

  MAUDE report 24458642 ↗
• InjuryFeb 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH A 295CC 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 III). AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Capsular Contracture

  MAUDE report 24266085 ↗
• InjuryJan 12, 2026Use of Device Problem; Migration

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT A PRIMARY BREAST RECONSTRUCTION PROCEDURE WITH MENTOR GEL BREAST PROSTHESES DEVELOPED BAKER GRADE IV CAPSULAR CONTRACTURE IN HER RIGHT BREAST POST IMPLANTATION. THE CAPSULAR CONTRACTURE WAS DIAGNOSED VIA A PHYSICAL EXAM. ADDITIONALLY, THE PATIENT DEVELOPED A DEFORMITY MANIFEST IN THE LOWER POLE, ABOVE THE INFRAMAMMARY FOLD OF THE LEFT BREAST. ULTRASOUND RESULTS INDICATED A SMALL FLUID COLLECTION IN THE RIGHT BREAST. THE PATIENT ALSO HAD DEVELOPED AN INFECTION ON THE LEFT SIDE THAT REQUIRED LATISSIMUS DORSI FLAP RECONSTRUCTION. LASTLY, THERE WAS BILATERAL MIGRATION OF THE BREAST PROSTHESES. AS A RESULT, THE PATIENT UNDERWENT UNILATERAL EXPLANTATION AND REPLACEMENT OF THE RIGHT BREAST PROSTHESIS. THE PATIENT UNDERWENT A SURGICAL INTERVENTION ON THE LEFT BREAST TO TREAT THE LEFT BREAST ISSUES. THE BREAST PROSTHESIS WAS REMOVED FROM THE BREAST AND RE-IMPLANTED. MENTOR BREAST PROSTHESES ARE SINGLE-USE DEVICES AND RE-IMPLANTATION IS CONTRAINDICATED. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement; Post Operative Wound Infection

  MAUDE report 24045599 ↗
• InjuryJan 12, 2026Migration

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT A PRIMARY BREAST RECONSTRUCTION PROCEDURE WITH MENTOR GEL BREAST PROSTHESES DEVELOPED BAKER GRADE IV CAPSULAR CONTRACTURE IN HER RIGHT BREAST POST IMPLANTATION. THE CAPSULAR CONTRACTURE WAS DIAGNOSED VIA A PHYSICAL EXAM. ADDITIONALLY, THE PATIENT DEVELOPED A DEFORMITY MANIFEST IN THE LOWER POLE, ABOVE THE INFRAMAMMARY FOLD OF THE LEFT BREAST. ULTRASOUND RESULTS INDICATED A SMALL FLUID COLLECTION IN THE RIGHT BREAST. THE PATIENT ALSO HAD DEVELOPED AN INFECTION ON THE LEFT SIDE THAT REQUIRED LATISSIMUS DORSI FLAP RECONSTRUCTION. LASTLY, THERE WAS BILATERAL MIGRATION OF THE BREAST PROSTHESES. AS A RESULT, THE PATIENT UNDERWENT UNILATERAL EXPLANTATION AND REPLACEMENT OF THE RIGHT BREAST PROSTHESIS. THE PATIENT UNDERWENT A SURGICAL INTERVENTION ON THE LEFT BREAST TO TREAT THE LEFT BREAST ISSUES. THE BREAST PROSTHESIS WAS REMOVED FROM THE BREAST AND RE-IMPLANTED. MENTOR BREAST PROSTHESES ARE SINGLE-USE DEVICES AND RE-IMPLANTATION IS CONTRAINDICATED. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture; Fluid Discharge

  MAUDE report 24045582 ↗
• InjuryJan 7, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH IMPLANTATION OF A 295CC MENTOR MEMORYGEL XTRA BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH BILATERAL BAKER GRADE III BREAST CAPSULAR CONTRACTURE DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXCHANGE WITH MENTOR GEL IMPLANTS ON (B)(6) 2025.

  Patient problems: Capsular Contracture

  MAUDE report 23995852 ↗
• InjuryJan 7, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH IMPLANTATION OF A 295CC MENTOR MEMORYGEL XTRA BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH BILATERAL BAKER GRADE III BREAST CAPSULAR CONTRACTURE DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXCHANGE WITH MENTOR GEL IMPLANTS ON (B)(6), 2025.

  Patient problems: Capsular Contracture

  MAUDE report 23995845 ↗