MENTOR MemoryGel Breast Implant 3545700Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00081317007210), received between Aug 1, 2019 and Nov 6, 2024 — classified as 18 injuries.

The most frequently reported specific device problem is “Material Rupture” (4 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjuryNov 6, 2024Adverse 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 REVISION SURGERY WITH IMPLANTATION OF A 700CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH LEFT BREAST BAKER GRADE III CAPSULAR CONTRACTURE AND A RUPTURED RIGHT BREAST IMPLANT BY A MEDICAL PROFESSIONAL. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT WITH 700CC MENTOR MEMORYGEL BREAST IMPLANTS ON (B)(6) 2024. THIS REPORT IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 20625156 ↗
• InjuryNov 6, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH IMPLANTATION OF A 700CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH LEFT BREAST BAKER GRADE III CAPSULAR CONTRACTURE AND A RUPTURED RIGHT BREAST IMPLANT BY A MEDICAL PROFESSIONAL. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT WITH 700CC MENTOR MEMORYGEL BREAST IMPLANTS ON (B)(6), 2024. THIS REPORT IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 20624629 ↗
• InjurySep 26, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH 700CC MENTOR MEMORYGEL BREAST IMPLANT ON BOTH SIDES AND EXPERIENCED BILATERAL BREAST IMPLANT RUPTURE POSTOPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REPLACEMENT SURGERY WITH CATALOG NUMBER SMPB430; SERIAL NUMBERS (B)(6) ON THE LEFT SIDE, AND WITH CATALOG NUMBER SMPB430; SERIAL NUMBER (B)(6) ON THE RIGHT SIDE ON (B)(6) 2024. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT-SIDED DEVICE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 20311057 ↗
• InjurySep 26, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH 700CC MENTOR MEMORYGEL BREAST IMPLANT ON BOTH SIDES AND EXPERIENCED BILATERAL BREAST IMPLANT RUPTURE POSTOPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REPLACEMENT SURGERY WITH CATALOG NUMBER SMPB430; SERIAL NUMBERS (B)(6) ON THE LEFT SIDE, AND WITH CATALOG NUMBER SMPB430; SERIAL NUMBER (B)(6) ON THE RIGHT SIDE ON (B)(6) 2024. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT-SIDED DEVICE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 20310977 ↗
• InjuryFeb 28, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 700CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED A RUPTURE ON THE RIGHT SIDE POST-OPERATIVELY. FLUID WAS COLLECTED AT THE IMPLANT SITE. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2024.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18798815 ↗
• InjuryAug 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 36-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH 700CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH BILATERAL BAKER GRADE III CAPSULAR CONTRACTURE. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2022. REFER TO MANUFACTURING REPORT NUMBER 1645337-2022-08983 FOR THE CONTRALATERAL EVENT.

  Patient problems: Capsular Contracture

  MAUDE report 15158791 ↗
• InjuryAug 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 36-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH 700CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH BILATERAL BAKER GRADE III CAPSULAR CONTRACTURE. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2022. REFER TO MANUFACTURING REPORT NUMBER 1645337-2022-08982 FOR THE CONTRALATERAL EVENT.

  Patient problems: Capsular Contracture

  MAUDE report 15158782 ↗
• InjurySep 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) YEAR OLD ASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A MENTOR MEMORYGEL BREAST IMPLANT 700CC AND SUFFERED FROM A CAPSULAR CONTRACTURE BAKER GRADE III ON THE RIGHT BREAST IMPLANT. AS A RESULT, THE PATIENT HAD UNDERGONE REMOVAL ON (B)(6) 2020.

  Patient problems: Capsular Contracture; No Code Available

  MAUDE report 10526158 ↗
• InjuryAug 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH MENTOR MEMORYGEL BREAST IMPLANT 700CC AND EXPERIENCED GENERALIZED ILLNESS SYMPTOMS INCLUDING JOINT PAIN AND MUSCLE PAIN POST-OPERATIVELY. 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: No Code Available

  MAUDE report 10454911 ↗
• InjuryAug 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH MENTOR MEMORYGEL BREAST IMPLANT 700CC AND EXPERIENCED GENERALIZED ILLNESS SYMPTOMS INCLUDING JOINT PAIN AND MUSCLE PAIN POST-OPERATIVELY. 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: No Code Available

  MAUDE report 10454909 ↗
• InjuryMar 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH TWO 700CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESES AND EXPERIENCED POSTOPERATIVE BILATERAL GRADE III CAPSULAR CONTRACTURE. THE PATIENT HAD SLIGHT PAIN IN HER LEFT BREAST AFTER CONTINUED TAKING ANTIBIOTICS. THE PATIENT WENT IN FOR A CONSULTATION, AND THE DIAGNOSIS WAS CONFIRMED BY A HEALTHCARE PROFESSIONAL. ALSO, DURING THE SAME CONSULTATION, A POTENTIAL IMPLANT EXCHANGE SURGERY WAS DISCUSSED, AND THE PATIENT WAS ASKED TO CONTINUE TAKING ANTIBIOTICS. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH TWO 700CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESES (CATALOG #:3505700BC, RIGHT SERIAL #: (B)(4), LEFT SERIAL #: (B)(4)) ON (B)(6) 2020. THIS REPORT IS FOR THE RIGHT PROSTHESIS.

  Patient problems: Capsular Contracture; No Code Available

  MAUDE report 9851079 ↗
• InjuryMar 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH TWO 700CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESES AND EXPERIENCED POSTOPERATIVE BILATERAL GRADE III CAPSULAR CONTRACTURE. THE PATIENT HAD SLIGHT PAIN IN HER LEFT BREAST AFTER CONTINUED TAKING ANTIBIOTICS. THE PATIENT WENT IN FOR A CONSULTATION, AND THE DIAGNOSIS WAS CONFIRMED BY A HEALTHCARE PROFESSIONAL. ALSO, DURING THE SAME CONSULTATION, A POTENTIAL IMPLANT EXCHANGE SURGERY WAS DISCUSSED, AND THE PATIENT WAS ASKED TO CONTINUE TAKING ANTIBIOTICS. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH TWO 700CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESES (CATALOG #:3505700BC, RIGHT SERIAL #: (B)(4)) ON (B)(6) 2020. THIS REPORT IS FOR THE LEFT PROSTHESIS.

  Patient problems: Capsular Contracture; No Code Available

  MAUDE report 9851077 ↗
• InjuryFeb 25, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION WITH MENTOR MEMORYGEL BREAST IMPLANT 700CC AND EXPERIENCED BILATERAL PAIN POST-OPERATIVELY. 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: Pain

  MAUDE report 9751929 ↗
• InjuryFeb 25, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION WITH MENTOR MEMORYGEL BREAST IMPLANT 700CC AND EXPERIENCED BILATERAL PAIN POST-OPERATIVELY. 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: Pain

  MAUDE report 9751924 ↗
• InjuryOct 28, 2019Off-Label Use; Migration; Off-Label Use; Migration

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE WHO UNDERWENT PRIMARY BREAST AUGMENTATION POST PROCEDURE WITH 700CC MENTOR MEMORYGEL BREAST IMPLANTS BEGAN EXPERIENCING PROBLEMS SHORTLY FOLLOWING THE PROCEDURE. SHE STATED THAT WHEN SHE WOULD FLEX HER LEFT SIDED MUSCLE THE MUSCLE WOULD MOVE UPWARDS, BUT THE IMPLANT WOULD STAY IN PLACE. ON (B)(6) 2012 A CAPSULECTOMY WAS PERFORMED AND THE SAME IMPLANT WAS RE-USED. THE EXPLANTING SURGEON STATED THERE WAS AN UNSPECIFIED DEFORMITY. THE RE-USE OF THESE IMPLANTS IS OFF LABEL USE. AFTER THE CAPSULECTOMY THE IMPLANT HAD RIPPED THROUGH THE BREAST WALL (NOT SKIN), CAUSED EXTREME RIPPLING, AND DENT / LUMPS WHERE THE IMPLANT IS BOTTOMING OUT. ALSO, PAIN AND BURNING IN THE LEFT BREAST DESCRIBED AS AN ELECTRICITY SENSATION WAS PRESENT. IMAGING WAS PERFORMED AND DID NOT SHOW A RUPTURE, HOWEVER, DID INDICATE THE PRESENCE OF SLIGHT TUMORS. THE PATIENT HAS STATED THAT SHE SUSPECTS BREAST IMPLANT ILLNESS. HOWEVER, THE ROOT CAUSE OF THE PATIENT¿S SYMPTOMS IS UNCLEAR. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT RELATES TO THE LEFT PROSTHESIS. SEE 1645337-2019-2

  Patient problems: Breast Mass; Capsular Contracture; Neurological Deficit/Dysfunction; No Code Available

  MAUDE report 9245363 ↗
• InjuryOct 28, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE WHO UNDERWENT PRIMARY BREAST AUGMENTATION POST PROCEDURE WITH 700CC MENTOR MEMORYGEL BREAST IMPLANTS BEGAN EXPERIENCING PROBLEMS SHORTLY FOLLOWING THE PROCEDURE. SHE STATED THAT WHEN SHE WOULD FLEX HER LEFT SIDED MUSCLE THE MUSCLE WOULD MOVE UPWARDS, BUT THE IMPLANT WOULD STAY IN PLACE. ON (B)(6) 2012, A CAPSULECTOMY WAS PERFORMED AND THE SAME IMPLANT WAS RE-USED. THE EXPLANTING SURGEON STATED THERE WAS AN UNSPECIFIED DEFORMITY. THE RE-USE OF THESE IMPLANTS IS OFF LABEL USE. AFTER THE CAPSULECTOMY THE IMPLANT HAD RIPPED THROUGH THE BREAST WALL (NOT SKIN), CAUSED EXTREME RIPPLING, AND DENT/ LUMPS WHERE THE IMPLANT IS BOTTOMING OUT. ALSO, PAIN AND BURNING IN THE LEFT BREAST DESCRIBED AS AN ELECTRICITY SENSATION WAS PRESENT. IMAGING WAS PERFORMED AND DID NOT SHOW A RUPTURE, HOWEVER, DID INDICATE THE PRESENCE OF SLIGHT TUMORS. THE PATIENT HAS STATED THAT SHE SUSPECTS BREAST IMPLANT ILLNESS. HOWEVER, THE ROOT CAUSE OF THE PATIENT¿S SYMPTOMS IS UNCLEAR. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT RELATES TO THE RIGHT PROSTHESIS. SEE 1645337-2019-

  Patient problems: No Code Available

  MAUDE report 9245352 ↗
• InjuryAug 1, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE WHO UNDERWENT PRIMARY BREAST RECONSTRUCTION WITH 700CC MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED SUSPECTED BILATERAL CAPSULAR CONTRACTURE (BAKER¿S GRADE UNKNOWN) AND ADDITIONAL UNEXPLAINED SYSTEMIC SYMPTOMS POST PROCEDURE. THE LEFT BREAST WAS STATED TO BE LARGER THAN THE RIGHT, HARD, AND HAVE A PULLING SENSATION. THIS PROBLEM WAS INDICATED TO BE BILATERAL. ADDITIONALLY, JOINT PAIN IN THE WRIST AND ELBOW, WEIGHT GAIN, AND HORRIBLE HEARTBURN WERE NOTED. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. NO DEVICE ISSUE SUCH AS RUPTURE WAS REPORTED. THE ROOT CAUSE OF THE PATIENT¿S SYMPTOMS IS UNCLEAR. SEE 1645337-2019-16336 FOR CONTRALATERAL PROSTHESIS REPORT.

  Patient problems: Capsular Contracture

  MAUDE report 8852977 ↗
• InjuryAug 1, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE WHO UNDERWENT PRIMARY BREAST RECONSTRUCTION WITH 700CC MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED SUSPECTED BILATERAL CAPSULAR CONTRACTURE (BAKER¿S GRADE UNKNOWN) AND ADDITIONAL UNEXPLAINED SYSTEMIC SYMPTOMS POST PROCEDURE. THE LEFT BREAST WAS STATED TO BE LARGER THAN THE RIGHT, HARD, AND HAVE A PULLING SENSATION. THIS PROBLEM WAS INDICATED TO BE BILATERAL. ADDITIONALLY, JOINT PAIN IN THE WRIST AND ELBOW, WEIGHT GAIN, AND HORRIBLE HEARTBURN WERE NOTED. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. NO DEVICE ISSUE SUCH AS RUPTURE WAS REPORTED. THE ROOT CAUSE OF THE PATIENT¿S SYMPTOMS IS UNCLEAR. SEE 1645337-2019-16335 FOR CONTRALATERAL PROSTHESIS REPORT.

  Patient problems: Capsular Contracture; No Code Available

  MAUDE report 8852976 ↗