MENTOR MemoryGel Xtra Breast Implant SHPX150Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00081317025184), received between Jan 25, 2023 and Sep 22, 2026 — classified as 7 injuries.

The most frequently reported specific device problem is “Material Rupture” (2 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjurySep 22, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient underwent a Primary Breast Augmentation Surgery with implantation of a 150cc MENTOR MemoryGel Xtra Breast Implant prosthesis. Post-operatively, the patient was diagnosed with right breast Baker Grade III Capsular Contracture during a physical exam. Soon thereafter, the left side also contracted. A left-sided Baker Grade was not provided. As a result, the patient underwent bilateral exchange with Mentor gel implants on (b)(6)This report is for the left breast prosthesis.

  Patient problems: Capsular Contracture

  MAUDE report 50854758 ↗
• InjuryMar 3, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH A MENTOR MEMORYGEL XTRA BREAST IMPLANT GEL BREAST PROSTHESIS DEVELOPED BAKER GRADE III CAPSULAR CONTRACTURE IN HER RIGHT BREAST POST IMPLANTATION. THE CAPSULAR CONTRACTURE WAS DIAGNOSED DURING AN OFFICE VISIT. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION AND REPLACEMENT WITH A MENTOR MEMORYGEL XTRA BREAST IMPLANT GEL BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 24498096 ↗
• InjurySep 13, 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 PRIMARY WITH MENTOR MEMORYGEL XTRA, 150CC SILICONE PROSTHESIS EXPERIENCED RIGHT SIDED CAPSULAR CONTRACTURE GRADE III, UNSATISFIED WITH THE APPEARANCES OF THE IMPLANTS, AND BILATERAL PTOSIS POSTOPERATIVE. AS A RESULT, PATIENT UNDERWENT BILATERAL MASTOPEXIES, AND BILATERAL REPLACEMENTS AS FOLLOW: L/ CAT: SMHB-500, SN: (B)(6) R/ CAT: SMHB-500, SN: (B)(6) ON (B)(6) 2024. THIS REPORT RELATES TO THE LEFT SIDE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 20214014 ↗
• InjurySep 10, 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 PRIMARY WITH MENTOR MEMORYGEL XTRA, 150CC SILICONE PROSTHESIS EXPERIENCED RIGHT SIDED CAPSULAR CONTRACTURE GRADE III POSTOPERATIVE. AS A RESULT, PATIENT UNDERWENT REMOVAL ON (B)(6) 2024.

  Patient problems: Capsular Contracture

  MAUDE report 20182317 ↗
• InjuryNov 9, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH A 150CC MENTOR MEMORYGEL XTRA BREAST IMPLANT. POST-OPERATIVELY, THE PATIENT PRESENTED WITH SWELLING OF HER LEFT BREAST. SHE WAS DIAGNOSED WITH A RUPTURE OF HER LEFT PROSTHESIS. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH A 200CC MENTOR MEMORYGEL XTRA BREAST IMPLANT ON (B)(6) 2023. FOLLOW-UPS ARE BEING CONDUCTED. IF MORE INFORMATION BECOMES AVAILABLE, MENTOR WILL SUBMIT A SUPPLEMENTAL REPORT ACCORDINGLY.

  Patient problems: Local Reaction

  MAUDE report 18108207 ↗
• InjuryJan 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 37-YEAR-OLD CAUCASIAN FEMALE WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH 150CC MENTOR MEMORYGEL XTRA BREAST IMPLANTS EXPERIENCED RIGHT SIDED RUPTURE, RIGHT SIDED DELAYED WOUND HEALING, RIGHT SIDED BREAST PAIN, RIGHT SIDED LYMPHADENOPATHY, BILATERAL PTOSIS, AND A LEFT SIDED BREAST MASS POST PROCEDURE. THESE ISSUES WERE DEMONSTRATED THROUGH MAGNETIC RESONANCE IMAGING AND ULTRASOUND. THERE IS AS ENLARGED RIGHT AXILLARY LYMPH NODE ON THE RIGHT AND 10MM LOBULATED MASS LIKE AREA OF ENHANCEMENT ON THE RIGHT SIDE. AS A RESULT, BILATERAL CAPSULOTOMY, BILATERAL BREAST LIFT, AND PLACEMENT OF 200CC MENTOR SMOOTH ROUND MODERATE PROFILE SALINE PROSTHESES WAS PERFORMED ON (B)(6) 2023. SEE 3006942524-2023-00002 FOR CONTRALATERAL PROSTHESIS REPORT.

  Patient problems: Breast Mass; Deformity/ Disfigurement

  MAUDE report 16243452 ↗
• InjuryJan 25, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 37-YEAR-OLD CAUCASIAN FEMALE WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH 150CC MENTOR MEMORYGEL XTRA BREAST IMPLANTS EXPERIENCED RIGHT SIDED RUPTURE, RIGHT SIDED DELAYED WOUND HEALING, RIGHT SIDED BREAST PAIN, RIGHT SIDED LYMPHADENOPATHY, BILATERAL PTOSIS, AND A LEFT SIDED BREAST MASS POST PROCEDURE. THESE ISSUES WERE DEMONSTRATED THROUGH MAGNETIC RESONANCE IMAGING AND ULTRASOUND. THERE IS AS ENLARGED RIGHT AXILLARY LYMPH NODE ON THE RIGHT AND 10MM LOBULATED MASS LIKE AREA OF ENHANCEMENT ON THE RIGHT SIDE. AS A RESULT, BILATERAL CAPSULOTOMY, BILATERAL BREAST LIFT, AND PLACEMENT OF 200CC MENTOR SMOOTH ROUND MODERATE PROFILE SALINE PROSTHESES WAS PERFORMED ON (B)(6) 2023.

  Patient problems: Breast Discomfort/Pain; Impaired Healing; Swollen Lymph Nodes/Glands

  MAUDE report 16243447 ↗