MENTOR MemoryGel Breast Implant 3546501Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00081317003922), received between Dec 23, 2020 and Jan 26, 2023 — classified as 5 injuries.

The most frequently reported specific device problem is “Material Rupture” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJan 26, 2023Migration; Migration

  IT WAS REPORTED THAT A 42-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH TWO 650CC MENTOR MEMORYGEL BREAST IMPLANTS AND EXPERIENCED BILATERAL DEVICE MIGRATION AND CUTANEOUS CONTOUR DEFORMITY POST-OPERATIVELY. THE PATIENT MENTIONS SHE CAN FEEL THEM FOLDING AND COLLAPSING ALONG WITH FEELING A BUBBLE ON THE TOP. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT IS FOR THE RIGHT SIDE DEVICE.

  Patient problems: Wrinkling

  MAUDE report 16247788 ↗
• InjuryJan 26, 2023Migration; Migration

  IT WAS REPORTED THAT A 42-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH TWO 650CC MENTOR MEMORYGEL BREAST IMPLANTS AND EXPERIENCED BILATERAL DEVICE MIGRATION AND CUTANEOUS CONTOUR DEFORMITY POST-OPERATIVELY. THE PATIENT MENTIONS SHE CAN FEEL THEM FOLDING AND COLLAPSING ALONG WITH FEELING A BUBBLE ON THE TOP. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT IS FOR THE LEFT SIDE DEVICE.

  Patient problems: Wrinkling

  MAUDE report 16247786 ↗
• InjuryNov 2, 2022Material Rupture; Material Rupture

  THIS REPORT CONTAINS SUPPLEMENTAL INFORMATION FOR MENTOR PSR REFERENCE NUMBER (B)(4). IT WAS REPORTED THAT A BLACK OR AFRICAN AMERICAN PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH 650CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED BREAST IMPLANT RUPTURE ON HER LEFT SIDE POSTOPERATIVELY. ON OCTOBER 27, 2022, MENTOR BECAME AWARE TAHT THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH CATALOG NUMBER 3505504BC; SERIAL NUMBER (B)(4) ON THE LEFT SIDE, AND WITH CATALOG 3505504BC; SERIAL NUMBER (B)(4) ON THE RIGHT SIDE ON (B)(6) 2022.

  Patient problems: Capsular Contracture; Deformity/ Disfigurement; Granuloma

  MAUDE report 15715305 ↗
• InjurySep 14, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH AN UNSPECIFIED GEL IMPLANT. POST-OPERATIVELY, THE PATIENT EXPERIENCED A RUPTURE ON AN UNDISCLOSED SIDE. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH A 550CC MENTOR MEMORYGEL IMPLANT ON (B)(6) 2022. FOLLOW-UPS ARE BEING CONDUCTED. IF MORE INFORMATION BECOMES AVAILABLE, MENTOR WILL SUBMIT A SUPPLEMENTAL REPORT ACCORDINGLY.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 15422215 ↗
• InjuryDec 23, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR OLD CAUCASIAN FEMALE PATIENT, WHO'S UNDERGONE BREAST AUGMENTATION REVISION WITH A (LEFT) 650CC MENTOR MEMORYGEL BREAST IMPLANT AND A (RIGHT) 750CC MENTOR MEMORYGEL BREAST IMPLANT, SUFFERED BILATERAL BREAST IMPLANT RUPTURES, POST-PROCEDURE. AS A RESULT, THE PATIENT UNDERWENT BILATERAL IMPLANT EXPLANTATION ON (B)(6) 2020. THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture; Deformity/ Disfigurement; Granuloma

  MAUDE report 11070032 ↗