MENTOR MemoryGel Breast Implant 3507100BCRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00081317000013), received between May 10, 2019 and Mar 11, 2024 — classified as 4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMar 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 58-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT REVISION BREAST RECONSTRUCTION SURGERY WITH A 500CC MENTOR MEMORYGEL BREAST IMPLANT ON THE RIGHT SIDE AND WITH 100CC MENTOR MEMORYGEL BREAST IMPLANT ON THE LEFT SIDE, AND EXPERIENCED RIGHT SIDE RUPTURE AND PAIN POSTOPERATIVELY. RUPTURE WAS CONFIRMED VIA MRI AND ULTRASOUND SCANS. ON FEBRUARY 21, 2024, MENTOR BECAME AWARE THAT PATIENT EXPERIENCED BILATERAL PAIN. AS A RESULT, THE PATIENT IS SCHEDULED FOR BILATERAL REPLACEMENT SURGERY ON (B)(6) 2024. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT-SIDED DEVICE.

  Patient problems: Breast Discomfort/Pain

  MAUDE report 18873745 ↗
• InjuryAug 28, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 78-YEAR OLD CAUCASIAN FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO UNSPECIFIED MENTOR GEL IMPLANTS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA MRI, WITH LEFT BREAST IMPLANT RUPTURE. AS A RESULT, THE PATIENT HAS BEEN SCHEDULED FOR BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2023.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 17636523 ↗
• InjuryOct 27, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6)-YEAR-OLD CAUCASIAN FEMALE WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH A MENTOR MEMORYGEL 100CC SILICONE PROSTHESIS EXPERIENCED RIGHT SIDED RUPTURE POST PROCEDURE. MRI, AND PHYSICAL EXAMINATION WAS PERFORMED BY A PHYSICIAN AND RUPTURE WAS DIAGNOSED. AS A RESULT, AN EXPLANT WAS PERFORMED ON (B)(6) 2020.

  Patient problems: No Code Available

  MAUDE report 10741703 ↗
• InjuryMay 10, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH MENTOR MEMORYGEL BREAST IMPLANTS 200CC (L) AND 100CC (R) AND EXPERIENCED BILATERAL RUPTURE AND CAPSULAR CONTRACTURE BAKER GRADE II ON THE RIGHT SIDE. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL ON (B)(6) 2019. THIS REPORT IS FOR THE RIGHT SIDE.

  Patient problems: Capsular Contracture; No Code Available

  MAUDE report 8601315 ↗