MENTOR MemoryGel Breast Implant 3543407MCRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00081317004417), received between May 7, 2019 and Apr 21, 2025 — classified as 11 injuries.

The most frequently reported specific device problem is “Material Rupture” (9 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryApr 21, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH TWO 340CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED BILATERAL RUPTURES POST-OPERATIVELY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Capsular Contracture; Deformity/ Disfigurement; Seroma

  MAUDE report 21874003 ↗
• InjuryApr 21, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH TWO 340CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED BILATERAL RUPTURES POST-OPERATIVELY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Capsular Contracture; Deformity/ Disfigurement

  MAUDE report 21873999 ↗
• InjuryOct 22, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE WHO UNDERWENT A BREAST AUGMENTATION REVISION WITH A MENTOR MEMORYGEL, 340CC SILICONE PROSTHESIS EXPERIENCED BILATERAL SYMPTOMATIC RUPTURES, AND UNEXPLAINED SYMPTOMATIC RUPTURES INCLUDING BREAST PAIN, ANXIETY/DEPRESSION, MEMORY LOSS AND BRAIN FOG POSTOPERATIVE. THE RUPTURES WERE DISCOVERED DURING THE SURGERY. AS A RESULT, PATIENT UNDERWENT BILATERAL CAPSULOTOMY, AND BILATERAL REMOVAL OF IMPLANTS WITHOUT REPLACEMENTS ON (B)(6) 2024 . THIS REPORT RELATES TO THE RIGHT SIDE.

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

  MAUDE report 20509578 ↗
• InjuryOct 22, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE WHO UNDERWENT A BREAST AUGMENTATION REVISION WITH A MENTOR MEMORYGEL, 340CC SILICONE PROSTHESIS EXPERIENCED BILATERAL SYMPTOMATIC RUPTURES, AND UNEXPLAINED SYMPTOMATIC RUPTURES INCLUDING BREAST PAIN, ANXIETY/DEPRESSION, MEMORY LOSS AND BRAIN FOG POSTOPERATIVE. THE RUPTURES WERE DISCOVERED DURING THE SURGERY. AS A RESULT, PATIENT UNDERWENT BILATERAL CAPSULOTOMY, AND BILATERAL REMOVAL OF IMPLANTS WITHOUT REPLACEMENTS ON (B)(6) 2024. THIS REPORT RELATES TO THE LEFT SIDE.

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

  MAUDE report 20509533 ↗
• InjuryJun 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 340CC (LEFT), 360CC (RIGHT), MENTOR MEMORYGEL BREAST IMPLANT WAS DIAGNOSED WITH LEFT-SIDED BREAST IMPLANT ASSOCIATED ANAPLASTIC LARGE-CELL LYMPHOMA AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE BAKER GRADE 2 POST-OPERATIVELY. IN ADDITION, A SEROMA FORMED ON THE LEFT SIDE WHICH REQUIRED SURGICAL INTERVENTION VIA NEEDLE ASPIRATION. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2024.

  Patient problems: Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA ALCL); Capsular Contracture; Seroma

  MAUDE report 19470354 ↗
• InjuryMar 29, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH A 340CC MENTOR MEMORYGEL BREAST IMPLANT ON THE RIGHT BREAST. POST-OPERATIVELY, THE PATIENT SUFFERED RIGHT BREAST IMPLANT RUPTURE. AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL AND REPLACEMENT ON SURGERY MARCH 7, 2024. THE REPLACEMENT DEVICES WERE: (RIGHT) 320CC MENTOR MEMORYGEL BREAST IMPLANT CATALOG: 3507320MC LOT: 9921762 SN: (B)(6) AND (LEFT) 320CC MENTOR MEMORYGEL BREAST IMPLANT CATALOG: 3507320MC LOT: 9742792 SN: (B)(6).

  Patient problems: Deformity/ Disfigurement

  MAUDE report 19004641 ↗
• InjuryMar 22, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 35-YEAR-OLD CAUCASIAN HISPANIC/LATINO FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 340CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT EXPERIENCED BILATERAL BURNING SENSATIONS IN HER BREASTS. THE FEELING OF HER MUSCLES BEING PULLED WITH NEEDLE PINCH SENSATIONS WAS ALSO REPORTED. SHE WAS SUBSEQUENTLY DIAGNOSED WITH BILATERALLY RUPTURED BREAST IMPLANTS USING COMPUTERIZED TOMOGRAPHY, ULTRASOUND, AND MAMMOGRAM IMAGING. 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 BREAST PROSTHESIS. REFER TO MANUFACTURING REPORT NUMBER 1645337-2023-03171 FOR THE CONTRALATERAL EVENT.

  Patient problems: Paresthesia

  MAUDE report 16591273 ↗
• InjuryMar 22, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 35-YEAR-OLD CAUCASIAN HISPANIC/LATINO FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 340CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT EXPERIENCED BILATERAL BURNING SENSATIONS IN HER BREASTS. THE FEELING OF HER MUSCLES BEING PULLED WITH NEEDLE PINCH SENSATIONS WAS ALSO REPORTED. SHE WAS SUBSEQUENTLY DIAGNOSED WITH BILATERALLY RUPTURED BREAST IMPLANTS USING COMPUTERIZED TOMOGRAPHY, ULTRASOUND, AND MAMMOGRAM IMAGING. 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 LEFT BREAST PROSTHESIS. REFER TO MANUFACTURING REPORT NUMBER 1645337-2023-03172 FOR THE CONTRALATERAL EVENT.

  Patient problems: Paresthesia

  MAUDE report 16591271 ↗
• InjurySep 22, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT WHO UNDERWENT A BREAST AUGMENTATION WITH TWO TEXTURED MENTOR MEMORYGEL BREAST IMPLANTS (A REVISION PROCEDURE WITH 340CC ON THE LEFT AND A PRIMARY PROCEDURE WITH 350CC ON THE RIGHT) HAS EXPERIENCED BILATERAL RUPTURE OF IMPLANTS AND BILATERAL BREAST PAIN POSTOPERATIVELY. AS A RESULT, THE PATIENT IS SCHEDULED TO UNDERGO EXPLANTATION AND REPLACEMENT WITH UNSPECIFIED MENTOR BREAST IMPLANTS ON (B)(6) 2020. THIS MEDWATCH REPORT IS FOR THE LEFT-SIDED IMPLANT.

  Patient problems: Capsular Contracture; No Code Available; Pain

  MAUDE report 10570704 ↗
• InjuryJun 11, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(64) CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A MENTOR MEMORYGEL BREAST IMPLANT 340CC AND EXPERIENCED BREAST PAIN AND DEVICE RUPTURE ON THE RIGHT SIDE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Capsular Contracture; Pain; Swollen Lymph Nodes/Glands

  MAUDE report 8689274 ↗
• InjuryMay 7, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS EVENT IS ASSOCIATED WITH THE GLOW CLINICAL TRIAL. IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT AUGMENTATION REVISION SURGERY WITH MENTOR GLOW STUDY GEL DEVICES ON (B)(6) 2016. ADVERSE EVENT # 1. INFECTION, (LEFT SIDE, IMPLANT SERIAL NUMBER: (B)(6). DOI:(B)(6) 2016, DOE: (B)(6) 2016). ON (B)(6) 2016, SHE PRESENTED WITH THE LEFT BREAST INFECTION, WHICH REQUIRED BILATERAL EXPLANTATION. SHOULD MORE INFORMATION BECOME AVAILABLE, THIS NOTE WILL BE UPDATED AND CASE REASSESSED, AND SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: No Code Available; Post Operative Wound Infection; Unspecified Infection

  MAUDE report 8588189 ↗