MENTOR MemoryGel Breast Implant 3544150Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00081317000983), received between Apr 3, 2019 and Dec 12, 2023 — classified as 6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryDec 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 150CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT REPORTED SHE EXPERIENCED CAPSULAR CONTRACTURE OF THE LEFT BREAST. MAMMOGRAM AND ULTRASOUND IMAGING WAS CONDUCTED AND RESULTS INDICATED BENIGN CALCIFICATIONS IN THE BREASTS WITH A RIGHT BREAST CYST. AS A RESULT, THE PATIENT IS SCHEDULED FOR BREAST IMPLANT REMOVAL AND REPLACEMENT ON APPROXIMATELY (B)(6) 2024. THE DATE OF EVENT WAS NOT PROVIDED TO MENTOR. AS THE SIDE INDICATIONS FOR THE REPORTED DEVICES WERE NOT PROVIDED, THE SERIAL NUMBERS FOR BOTH PRODUCTS ARE BEING PROVIDED AS DEVICE A - SERIAL NUMBER: (B)(6) AND DEVICE B - SERIAL NUMBER: (B)(6). THE LOT NUMBERS ARE THE SAME FOR BOTH DEVICES. 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 BREAST PROSTHESIS. REFER TO MANUFACTURING REPORT NUMBER 1645337-2023-12948 FOR THE CONTRALATERAL EVENT.

  Patient problems: Calcium Deposits/Calcification; Cyst(s)

  MAUDE report 18312615 ↗
• InjuryNov 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION WITH A 150CC MENTOR MEMORYGEL BREAST IMPLANT ON THE RIGHT BREAST. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH BREAST CAPSULAR CONTRACTURE (BAKER GRADE IV). AS A RESULT, THE PATIENT HAS BEEN SCHEDULED FOR BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2024.

  Patient problems: Capsular Contracture

  MAUDE report 18112362 ↗
• InjuryNov 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 150CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT REPORTED SHE EXPERIENCED CAPSULAR CONTRACTURE OF THE LEFT BREAST. AS A RESULT, THE PATIENT IS SCHEDULED FOR BREAST IMPLANT REMOVAL AND REPLACEMENT ON APPROXIMATELY (B)(6) 2024. THE DATE OF EVENT WAS NOT PROVIDED TO MENTOR. AS THE SIDE INDICATIONS FOR THE REPORTED DEVICES WERE NOT PROVIDED, THE SERIAL NUMBERS FOR BOTH PRODUCTS ARE BEING PROVIDED AS DEVICE A - SERIAL NUMBER: (B)(6) AND DEVICE B - SERIAL NUMBER: (B)(6) . THE LOT NUMBERS ARE THE SAME FOR BOTH DEVICES. 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.

  Patient problems: Capsular Contracture

  MAUDE report 18049663 ↗
• InjuryJun 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A MENTOR MEMORYGEL BREAST IMPLANT 150CC AND SUFFERED FROM GENERALIZED ILLNESS SYMPTOMS: COUGHS, RUPTURE ON THE LEFT SIDE. THE LEFT SIDE CAPSULE WAS THICKENED. AS A RESULT, THE PATIENT HAD UNDERGONE REMOVAL WITHOUT REPLACEMENT ON (B)(6) 2021. THIS MEDWATCH IS FOR THE RIGHT SIDE.

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

  MAUDE report 12046910 ↗
• InjuryJun 22, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A MENTOR MEMORYGEL BREAST IMPLANT 150CC AND SUFFERED FROM GENERALIZED ILLNESS SYMPTOMS: COUGHS, RUPTURE ON THE LEFT SIDE. THE LEFT SIDE CAPSULE WAS THICKENED. AS A RESULT, THE PATIENT HAD UNDERGONE REMOVAL WITHOUT REPLACEMENT ON (B)(6) 2021. THIS MEDWATCH IS FOR THE LEFT SIDE.

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

  MAUDE report 12046909 ↗
• InjuryApr 3, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH MENTOR MEMORYGEL 150CC SILICONE BREAST IMPLANTS WHICH THE LEFT SIDE RUPTURED AFTER IMPLANTATION. THE ISSUE WAS CONFIRMED BY MAMMOGRAM EXAMINATION. AS A RESULT PATIENT HAD THE DEVICE REMOVED ON (B)(6) 2019.

  Patient problems: No Code Available

  MAUDE report 8479283 ↗