MENTOR MemoryGel Xtra Breast Implant SMPX370Recalls & reported problems

Summary

The FDA's MAUDE database contains 213 adverse event reports that list this exact device (DI 00081317025054), received between Jun 6, 2019 and Sep 29, 2026 — classified as 203 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (31 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 213 reports, in the reporter's own words as published by the FDA.

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

  Patient problems: Capsular Contracture

  MAUDE report 50937638 ↗
• InjurySep 29, 2026Material Rupture

  On initial evaluation, the patient had previously undergone breast augmentation with a MENTOR Smooth Round Moderate Profile 350 cc saline prosthesis. She subsequently developed symptoms consistent with implant rupture, including a local inflammatory reaction and impaired wound healing; mammography confirmed the suspected rupture. On (b)(6) 2026, the patient underwent bilateral breast augmentation revision with implant replacement (left implant: (b)(6), catalog/lot 2181500-026). During postoperative follow-up, the inferior aspect of the left breast demonstrated erythema, swelling, and delayed wound healing. On (b)(6) 2026, MD performed revision wound repair of the left breast and identified a suspected rupture of the originally implanted device; the ruptured implant was removed and replaced at that time.

  Patient problems: Impaired Healing; Local Reaction

  MAUDE report 50934798 ↗
• InjurySep 28, 2026Migration

  Patient problems: Deformity/ Disfigurement

  MAUDE report 50926064 ↗
• InjurySep 28, 2026Migration

  Patient problems: Deformity/ Disfigurement

  MAUDE report 50926063 ↗
• InjurySep 16, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a 66-year-old Caucasian female patient underwent a breast reconstruction revision with a 370cc MENTOR MemoryGel Xtra Breast Implant and experienced a seroma on the right side post-operatively. As a result, the patient underwent explantation on (b)(6)2026, and replaced with a 325cc MENTOR MemoryGel Xtra Breast Implant.

  Patient problems: Seroma

  MAUDE report 50791643 ↗
• InjuryAug 7, 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 left 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 50174979 ↗
• InjuryMay 18, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 370CC MENTOR MEMORYGEL XTRA BREAST IMPLANT EXPERIENCED CAPSULAR CONTRACTURE 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: Capsular Contracture

  MAUDE report 25206339 ↗
• InjuryMay 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 41-YEAR-OLD FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH 370CC MENTOR MEMORYGEL XTRA BREAST IMPLANT AND EXPERIENCED CAPSULAR CONTRACTURE (BAKER GRADE 4) ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS DIAGNOSED WITH AN 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 25163164 ↗
• InjuryMar 25, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST PROSTHESIS IMPLANTATION SURGERY WITH A 370CC MENTOR MEMORYGEL XTRA BREAST IMPLANT ON THE LEFT BREAST. POST-OPERATIVELY, THE PATIENT DEVELOPED LEFT 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 24683753 ↗
• InjuryMar 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH A 370CC 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 AN UNSPECIFIED DATE.

  Patient problems: Capsular Contracture

  MAUDE report 24664354 ↗
• InjuryMar 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH TWO 370CC MENTOR MEMORYGEL XTRA BREAST IMPLANTS AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE (BAKER GRADE 3 ON THE LEFT AND BAKER GRADE 4 ON THE RIGHT) POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT BILATERAL DEVICE EXPLANTATION ON AN UNDISCLOSED DATE. THIS REPORT IS FOR THE LEFT SIDE DEVICE.

  Patient problems: Capsular Contracture

  MAUDE report 24664134 ↗
• InjuryMar 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH TWO 370CC MENTOR MEMORYGEL XTRA BREAST IMPLANTS AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE (BAKER GRADE 3 ON THE LEFT AND BAKER GRADE 4 ON THE RIGHT) POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT BILATERAL DEVICE EXPLANTATION ON AN UNDISCLOSED DATE. THIS REPORT IS FOR THE RIGHT SIDE DEVICE.

  Patient problems: Capsular Contracture

  MAUDE report 24664133 ↗
• InjuryMar 20, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT AN UNSPECIFIED BREAST SURGERY WITH A MENTOR MEMORYGEL XTRA BREAST IMPLANT GEL BREAST PROSTHESIS AND AN UNSPECIFIED MENTOR GEL BREAST PROSTHESIS DEVELOPED BAKER GRADE III CAPSULAR CONTRACTURE IN BOTH BREASTS POST IMPLANTATION. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION. THIS MEDWATCH REPORT IS FOR THE 1ST OF THE PATIENT¿S TWO BREAST PROSTHESES.

  Patient problems: Capsular Contracture

  MAUDE report 24653167 ↗
• InjuryMar 19, 2026Adverse Event Without Identified Device or Use Problem

  A FEMALE PATIENT WHO UNDERWENT AN UNKNOWN BREAST SURGERY WITH MENTOR MEMORYGEL XTRA, 370CC SILICONE BREAST PROSTHESIS EXPERIENCED RIGHT SIDED CAPSULAR CONTRACTURE UNKNOWN GRADE POSTOPERATIVE. AS A RESULT, THE PATIENT UNDERWENT REMOVAL SURGERY ON AN UNSPECIFIED DATE.

  Patient problems: Capsular Contracture

  MAUDE report 24641637 ↗
• InjuryMar 19, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST SURGERY WITH IMPLANTATION OF A 370CC MENTOR MEMORYGEL XTRA BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH BILATERAL BAKER GRADE III CAPSULAR CONTRACTURE BY A MEDICAL PROFESSIONAL. AS A RESULT, THE PATIENT UNDERWENT BILATERAL IMPLANT REMOVAL ON AN UNDISCLOSED DATE. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: Capsular Contracture

  MAUDE report 24641561 ↗
• InjuryMar 19, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST SURGERY WITH IMPLANTATION OF A 370CC MENTOR MEMORYGEL XTRA BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH BILATERAL BAKER GRADE III CAPSULAR CONTRACTURE BY A MEDICAL PROFESSIONAL. AS A RESULT, THE PATIENT UNDERWENT BILATERAL IMPLANT REMOVAL ON AN UNDISCLOSED DATE. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: Capsular Contracture

  MAUDE report 24641560 ↗
• InjuryMar 18, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WITH MENTOR MEMORYGEL XTRA BREAST IMPLANTS EXPERIENCED BILATERAL CAPSULAR CONTRACTURE BAKER GRADE III POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT IS SCHEDULED FOR REMOVAL ON (B)(6) 2026. THIS REPORT IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 24632678 ↗
• InjuryMar 18, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WITH MENTOR MEMORYGEL XTRA BREAST IMPLANTS EXPERIENCED BILATERAL CAPSULAR CONTRACTURE BAKER GRADE III POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT DEVICE REMOVAL ON AN UNSPECIFIED DATE.THIS REPORT IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 24630140 ↗
• InjuryFeb 24, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH IMPLANTATION OF A 370CC MENTOR MEMORYGEL XTRA BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH BILATERAL BAKER GRADE III CAPSULAR CONTRACTURE USING ULTRASOUND IMAGING. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXCHANGE WITH MENTOR GEL IMPLANTS ON (B)(6) 2026.

  Patient problems: Capsular Contracture

  MAUDE report 24430075 ↗
• InjuryDec 11, 2025Adverse Event Without Identified Device or Use Problem; Migration; Adverse Event Without Identified Device or Use Problem; Migration

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE WITH A MENTOR MEMORYGEL XTRA BREAST IMPLANT 370CC GEL BREAST PROSTHESIS DEVELOPED BAKER GRADE IV CAPSULAR CONTRACTURE IN HER RIGHT BREAST POST IMPLANTATION. THE CAPSULAR CONTRACTURE WAS DIAGNOSED VIA A PHYSICAL EXAM. AS A RESULT, THE PATIENT IS SCHEDULED TO UNDERGO EXPLANTATION ON (B)(6) 2026.

  Patient problems: Capsular Contracture

  MAUDE report 23782692 ↗
• InjuryDec 4, 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 WITH MENTOR MEMORYGEL XTRA BREAST IMPLANTS AND EXPERIENCED BILATERAL WRINKLING POST-OPERATIVELY. THE PATIENT UNDERWENT A SKIN ADJUSTMENT TO CORRECT THE ISSUE ON (B)(6) 2022. 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: Wrinkling

  MAUDE report 23717673 ↗
• InjuryNov 13, 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 BILATERAL CAPSULAR CONTRACTURE BAKER GRADE IV POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT DEVICE REMOVAL. THIS REPORT IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Autoimmune Disorder; Capsular Contracture

  MAUDE report 23544817 ↗
• InjuryNov 13, 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 BILATERAL CAPSULAR CONTRACTURE BAKER GRADE IV POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT DEVICE REMOVAL. THIS REPORT IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Autoimmune Disorder; Breast Cancer; Capsular Contracture

  MAUDE report 23544816 ↗
• InjuryNov 6, 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 BILATERAL CAPSULAR CONTRACTURE BAKER GRADE IV POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT DEVICE REMOVAL. THIS REPORT IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 23490779 ↗
• InjuryOct 28, 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. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Capsular Contracture

  MAUDE report 23407472 ↗