MENTOR MemoryGel Breast Implant 3541251Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00081317000792), received between Dec 30, 2020 and Oct 18, 2022 — classified as 2 injuries, 1 malfunction.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryOct 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 63-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH A LEFT-SIDED 375CC MENTOR MEMORYGEL BREAST IMPLANT AND A RIGHT-SIDED 125CC MENTOR MEMORYGEL BREAST IMPLANT . POST-OPERATIVELY, THE PATIENT EXPERIENCED SEVERE PAIN ON THE RIGHT BREAST, BODY RASHES, AND AN INABILITY TO LIFT HER LEFT ARM. THE PATIENT CONSULTED WITH A MEDICAL PROFESSIONAL. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. SEVERAL FOLLOW-UPS HAVE BEEN CONDUCTED, AND NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. IF MORE INFORMATION BECOMES AVAILABLE, MENTOR WILL SUBMIT A SUPPLEMENTAL REPORT ACCORDINGLY. THIS REPORT IS FOR THE RIGHT IMPLANT. REFER TO MANUFACTURING REPORT NUMBER 1645337-2022-12526 FOR THE CONTRALATERAL EVENT.

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

  MAUDE report 15629426 ↗
• MalfunctionJun 16, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 125CC MENTOR MEMORYGEL BREAST IMPLANT RUPTURED INTRA-OPERATIVELY. THERE IS NO REPORT OF ADVERSE EVENT OR PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14716556 ↗
• InjuryDec 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT BREAST AUGMENTATION REVISION SURGERY WITH A 125CC MENTOR MEMORYGEL LEFT BREAST IMPLANT AND A 175CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED BILATERAL CAPSULAR CONTRACTURE BAKER GRADE III POST PROCEDURE. AS A RESULT, PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT WITH TWO UNSPECIFIED MEMORY GEL XTRA BREAST IMPLANTS ON (B)(6) 2019. THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 11098980 ↗