MENTOR MemoryShape Breast Implant 3341507Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00081317004998), received between Jan 18, 2022 and Nov 6, 2025 — classified as 5 injuries.

The most frequently reported specific device problem is “Material Rupture” (1 report).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryNov 6, 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 RECONSTRUCTION REVISION SURGERY WITH IMPLANTATION OF A 570CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT REPORTED EXPERIENCING DECLINING HEALTH, CHANGES TO THE LEFT BREAST, PAIN, ACHING MUSCLES, BRAIN FOG, FATIGUE, CRAMPS, AND WALKING DIFFICULTY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. FOLLOW-UPS ARE BEING CONDUCTED. IF MORE INFORMATION BECOMES AVAILABLE, MENTOR WILL SUBMIT A SUPPLEMENTAL REPORT ACCORDINGLY. THIS REPORT IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 23490265 ↗
• InjurySep 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT A BREAST RECONSTRUCTION REVISION PROCEDURE WITH A MENTOR MEMORYSHAPE BREAST IMPLANT 570CC GEL BREAST PROSTHESIS DEVELOPED PAIN 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: Breast Discomfort/Pain

  MAUDE report 17789938 ↗
• InjuryMay 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 65-YEAR-OLD AFRICAN AMERICAN FEMALE WHO UNDERWENT A BREAST RECONSTRUCTION PRIMARY WITH A MENTOR MEMORYSHAPE, 570CC SILICONE PROSTHESIS EXPERIENCED LEFT-SIDED CAPSULAR CONTRACTURE GRADE UNKNOWN, AND NEOPLASM MALIGNANT POST PROCEDURE. THE PATIENT STATED THAT SHE HAS CANCER. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Cancer; Capsular Contracture

  MAUDE report 16946333 ↗
• InjuryJan 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE WHO UNDERWENT BREAST RECONSTRUCTION REVISION WITH A MENTOR MEMORYSHAPE, 570CC SILICONE BREAST IMPLANT EXPERIENCED RIGHT-SIDED CAPSULAR CONTRACTURE (UNKNOWN GRADE), IMPLANT RUPTURE, AND UNEXPLAINED SYSTEMIC SYMPTOMS POSTOPERATIVELY, INCLUDING SENSATIONS, HEADACHES, AND LETHARGIC. THE PATIENT REPORTED THAT ON HER RIGHT SIDE SHE WAS LIFTING SOMETHING AND FELT A PULL ON HER RIGHT IMPLANT. IT'S MUCH SMALLER AND IT'S LIKE WATER IS RUNNING, PAIN AND PULLING FROM THE STERNUM TO THE RIGHT ARMPIT. THE PATIENT INDICATED THAT SHE HAS HEADACHES AND FEELS LETHARGIC, AND IT'S BEEN GETTING PROGRESSIVELY WORSE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT RELATES TO THE LEFT PROSTHESIS.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 13282591 ↗
• InjuryJan 18, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE WHO UNDERWENT BREAST RECONSTRUCTION REVISION WITH A MENTOR MEMORYSHAPE, 570CC SILICONE BREAST IMPLANT EXPERIENCED RIGHT-SIDED CAPSULAR CONTRACTURE (UNKNOWN GRADE), IMPLANT RUPTURE, AND UNEXPLAINED SYSTEMIC SYMPTOMS POSTOPERATIVELY, INCLUDING SENSATIONS, HEADACHES, AND LETHARGIC. THE PATIENT REPORTED THAT ON HER RIGHT SIDE SHE WAS LIFTING SOMETHING AND FELT A PULL ON HER RIGHT IMPLANT. IT'S MUCH SMALLER AND IT'S LIKE WATER IS RUNNING, PAIN AND PULLING FROM THE STERNUM TO THE RIGHT ARMPIT. THE PATIENT INDICATED THAT SHE HAS HEADACHES AND FEELS LETHARGIC, AND IT'S BEEN GETTING PROGRESSIVELY WORSE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT RELATES TO THE RIGHT PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 13282504 ↗