MENTOR MemoryShape Breast Implant 3341452Recalls & reported problems

Summary

The FDA's MAUDE database contains 98 adverse event reports that list this exact device (DI 00081317005254), received between Jul 24, 2018 and May 28, 2026 — classified as 98 injuries.

The most frequently reported specific device problem is “Material Rupture” (21 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 98 reports, in the reporter's own words as published by the FDA.

• InjuryMay 28, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 685CC MENTOR MEMORYSHAPE BREAST IMPLANT EXPERIENCED A RUPTURE ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2026.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 25325401 ↗
• InjuryApr 27, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION PROCEDURE WITH A MENTOR MEMORYSHAPE BREAST IMPLANT GEL BREAST PROSTHESIS THAT RUPTURED POST IMPLANTATION. RUPTURE OF THE PATIENT¿S LEFT BREAST PROSTHESIS WAS REPORTED. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION WITH NO REPLACEMENT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 25010057 ↗
• InjuryApr 22, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 685 CC MENTOR MEMORYSHAPE BREAST IMPLANT EXPERIENCED ASYMMETRY ON THE LEFT SIDE POST-OPERATIVELY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 24956696 ↗
• InjuryOct 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST RECONSTRUCTION REVISION WITH TWO 685CC MENTOR MEMORYSHAPE BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH BILATERAL BREAST SKIN THINNESS. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Breast Discomfort/Pain; Paresthesia; Seroma; Wrinkling

  MAUDE report 23423542 ↗
• InjuryOct 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST RECONSTRUCTION REVISION WITH TWO 685CC MENTOR MEMORYSHAPE BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH BILATERAL BREAST SKIN THINNESS. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Breast Discomfort/Pain; Paresthesia; Seroma; Wrinkling

  MAUDE report 23423537 ↗
• InjurySep 16, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST SURGERY WITH IMPLANTATION OF A 685CC MENTOR MEMORYSHAPE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT REPORTED EXPERIENCING A RUPTURED RIGHT IMPLANT USING MAGNETIC RESONANCE IMAGING. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. FOLLOW-UPS ARE BEING CONDUCTED. IF MORE INFORMATION BECOMES AVAILABLE, MENTOR WILL SUBMIT A SUPPLEMENTAL REPORT ACCORDINGLY.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 23064287 ↗
• InjuryJul 11, 2025Material Rupture; Material Rupture

  A FEMALE PATIENT WHO UNDERWENT A BREAST AUGMENTATION PRIMARY WITH MENTOR MEMORYSHAPE¿ MH 685CC SILICONE, EXPERIENCE BILATERAL SILENT RUPTURES POST OPERATION. THE IMPLANTS WERE NOTED TO BE RUPTURED BY MRI EXAMINATION. AS A RESULT, THE PATIENT SCHEDULED FOR BILATERAL REMOVAL SURGERY ON (B)(6) 2025. THIS REPORT RELATES TO ONE OF THE TWO SIDES.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 22480488 ↗
• InjuryMay 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT INVOLVED IN A CLINICAL STUDY UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH IMPLANTATION OF A 685CC MENTOR MEMORYSHAPE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, ON A 10-YEAR FOLLOW-UP QUESTIONNAIRE, THE PATIENT ANSWERED THAT SHE WAS VERY DISSATISFIED WITH THE AMOUNT OF RIPPLING (WRINKLING) OF THE IMPLANTS THAT SHE COULD SEE AND FEEL. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Wrinkling

  MAUDE report 22092259 ↗
• InjuryMay 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT INVOLVED IN A CLINICAL STUDY UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH IMPLANTATION OF A 685 CC MENTOR MEMORYSHAPE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, ON A 10-YEAR FOLLOW-UP QUESTIONNAIRE, THE PATIENT ANSWERED THAT SHE WAS VERY DISSATISFIED WITH THE AMOUNT OF RIPPLING (WRINKLING) OF THE IMPLANTS THAT SHE COULD SEE AND FEEL. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Wrinkling

  MAUDE report 22091600 ↗
• InjuryApr 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST RECONSTRUCTION, AS PART OF A CLINICAL STUDY, WITH TWO 685CC MENTOR MEMORYSHAPE BREAST IMPLANTS. POST-OPERATIVELY, DURING THE 5 YEAR FOLLOW-UP VISIT THE PATIENT REPORTED BREAST CANCER STAGE IV. AT THIS TIME, MENTOR HAS RECEIVED VERY LIMITED INFORMATION REGARDING THIS EVENT, BASED ON THE INFORMATION PROVIDED, THE PATIENT SUFFERED BREAST CANCER RECURRENCE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Breast Cancer; Cancer

  MAUDE report 21895283 ↗
• InjuryApr 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST RECONSTRUCTION, AS PART OF A CLINICAL STUDY, WITH TWO 685CC MENTOR MEMORYSHAPE BREAST IMPLANTS. POST-OPERATIVELY, DURING THE 5 YEAR FOLLOW-UP VISIT THE PATIENT REPORTED BREAST CANCER STAGE IV. AT THIS TIME, MENTOR HAS RECEIVED VERY LIMITED INFORMATION REGARDING THIS EVENT, BASED ON THE INFORMATION PROVIDED, THE PATIENT SUFFERED BREAST CANCER RECURRENCE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Breast Cancer; Cancer

  MAUDE report 21895267 ↗
• InjuryMar 7, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 685CC MENTOR MEMORYSHAPE BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT SUFFERED LEFT BREAST IMPLANT LEAK. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 21544472 ↗
• InjuryFeb 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FEMALE PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH MENTOR MEMORYSHAPE IMPLANTS, SPECIFICALLY 620CC ON THE RIGHT AND 685CC ON THE LEFT, EXPERIENCED A RIGHT-SIDED SYMPTOMATIC RUPTURE, ACQUIRED DEFORMITY NOS, GRANULOMA, AND BILATERAL CAPSULAR CONTRACTURES OF UNKNOWN GRADE POSTOPERATIVELY. THESE COMPLICATIONS, INCLUDING THE RUPTURE AND GRANULOMA, WERE CONFIRMED VIA ULTRASOUND, CT SCAN, AND POSSIBLE MRI EXAMINATIONS. ADDITIONALLY, THE PATIENT DEVELOPED MINIMAL PERI-IMPLANT FLUID ON THE LEFT SIDE AND BILATERAL MAMMARY ADENOPATHY, WITH THE RIGHT SIDE BEING GREATER THAN THE LEFT (LEFT SIDE MEASURING 0.7 CM, CONSIDERED A VARIANT OF NORMAL). AS A RESULT, ON (B)(6) 2025, THE PATIENT UNDERWENT RIGHT IMPLANT EXPLANTATION, FOLLOWED BY A BILATERAL CAPSULECTOMY AND IMPLANT REMOVAL. THIS WAS SUCCEEDED BY SECONDARY RECONSTRUCTION OF THE RIGHT PECTORALIS MUSCLE, WHICH INCLUDED A BILATERAL IMPLANT EXCHANGE UTILIZING AN ACELLULAR DERMAL MATRIX (ADM) GRAFT, EMPLOYING ALLERGAN IMPLANTS. THIS REPORT SPECIFICALLY PERTAINS TO THE LEFT SIDE.

  Patient problems: Capsular Contracture

  MAUDE report 21333825 ↗
• InjuryFeb 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO HAD A 685CC MENTOR MEMORYSHAPE BREAST IMPLANT PLACED EXPERIENCED BILATERAL BAKER GRADE III CAPSULAR CONTRACTURE POST PROCEDURE. AS A RESULT, REPLACEMENT WITH NON-MENTOR GEL IMPLANTS WAS PERFORMED ON (B)(6) 2024.

  Patient problems: Capsular Contracture

  MAUDE report 21312549 ↗
• InjuryFeb 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO HAD A 685CC MENTOR MEMORYSHAPE BREAST IMPLANT PLACED EXPERIENCED BILATERAL BAKER GRADE III CAPSULAR CONTRACTURE POST PROCEDURE. AS A RESULT, REPLACEMENT WITH NON-MENTOR GEL IMPLANTS WAS PERFORMED ON (B)(6) 2024.

  Patient problems: Capsular Contracture

  MAUDE report 21312544 ↗
• InjuryJan 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 57-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION REVISION WITH A 685CC MENTOR MEMORYSHAPE BREAST IMPLANT ON BOTH SIDES AND EXPERIENCED A RUPTURE ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS DIAGNOSED WITH AN MRI. THE BREAST WAS DESCRIBED AS ¿SOFTER¿. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2024. ON (B)(6) 2025, MENTOR BECAME AWARE THAT THE PATIENT ALSO EXPERIENCED LEFT SIDE CAPSULAR CONTRACTURE; BAKER GRADE UNKNOWN IN ADDITION TO RIGHT SIDE RUPTURE, AND UNDERWENT BILATERAL REPLACEMENT SURGERY WITH SERIAL NUMBER (B)(6) ON THE RIGHT SIDE, AND WITH (B)(6) ON THE LEFT SIDE ON (B)(6) 2024. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT-SIDED DEVICE.

  Patient problems: Capsular Contracture

  MAUDE report 21257991 ↗
• InjuryNov 18, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 57-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION REVISION WITH A 685CC MENTOR MEMORYSHAPE BREAST IMPLANT AND EXPERIENCED A RUPTURE ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS DIAGNOSED WITH AN MRI. THE BREAST WAS DESCRIBED AS ¿SOFTER¿. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2024.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 20707986 ↗
• InjurySep 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE WHO UNDERWENT A BREAST AUGMENTATION PRIMARY WITH A MENTOR MEMORYSHAPE, 685CC, SILICONE PROSTHESIS EXPERIENCED BILATERAL SKIN REACTION, AND LEFT SIDED SYMPTOMATIC RUPTURE POSTOPERATIVE. THE PATIENT REPORTED RASH, DEFLATION AND SHAPE CHANGE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT RELATES TO THE RIGHT SIDE.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 20296344 ↗
• InjurySep 24, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE WHO UNDERWENT A BREAST AUGMENTATION PRIMARY WITH A MENTOR MEMORYSHAPE, 685CC, SILICONE PROSTHESIS EXPERIENCED BILATERAL SKIN REACTION, AND LEFT SIDED SYMPTOMATIC RUPTURE POSTOPERATIVE. THE PATIENT REPORTED RASH, DEFLATION AND SHAPE CHANGE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT RELATES TO THE LEFT SIDE.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 20296258 ↗
• InjurySep 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SAFETY NOTE: IMPACTED PRODUCT NUMBER: IP-(B)(4). MENTOR MEMORYSHAPE¿ MH 685CC GEL IMPLANTS LEFT BREAST NOTES: IT WAS REPORTED, VIA A HEALTH CARE PROFESSIONAL REPORT, THAT A FEMALE PATIENT WHO UNDERWENT BREAST AUGMENTATION SURGERY WITH MENTOR MEMORYSHAPE¿ MH 685CC MENTOR GEL BREAST IMPLANTS ON (B)(6) 2016. BIA-ALCL WAS OBSERVED ON AN UNKNOWN DATE FROM PATHOLOGY FINDINGS OF GUIDED NEEDLE ASPIRATION ¿ ¿PATIENT POSITIVE FOR BIA-ALCL¿. IMPLANT REMOVAL IS SCHEDULED FOR (B)(6) 2024.

  Patient problems: Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA ALCL); Lymphoma; Seroma; Skin Inflammation/ Irritation

  MAUDE report 20263660 ↗
• InjuryJul 17, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST RECONSTRUCTION REVISION SURGERY WITH IMPLANTATION OF A 685CC MENTOR MEMORYSHAPE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT REPORTED EXPERIENCING A RUPTURED LEFT BREAST IMPLANT CONFIRMED USING MAGNETIC RESONANCE IMAGING AND FLUID IN THE LUNGS PER X-RAY IMAGING. A CONSULTATION WITH A MEDICAL PROFESSIONAL HAS BEEN CONDUCTED. 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.

  Patient problems: Local Reaction

  MAUDE report 19763047 ↗
• InjuryJul 8, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION SURGERY WITH IMPLANTATION OF A 685CC MENTOR MEMORYSHAPE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH A RUPTURED RIGHT BREAST IMPLANT DURING AN EXAM 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.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 19690635 ↗
• InjuryMay 24, 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 685CC MENTOR MEMORYSHAPE BREAST IMPLANT EXPERIENCED WRINKLING/RIPPLING ON THE LEFT SIDE POST-OPERATIVELY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Autoimmune Disorder; Deformity/ Disfigurement; Wrinkling

  MAUDE report 19392207 ↗
• InjuryFeb 26, 2024Material Rupture; Adverse Event Without Identified Device or Use Problem; Material Rupture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH 685CC MENTOR MEMORYSHAPE BREAST IMPLANTS EXPERIENCED BILATERAL CUTANEOUS CONTOUR DEFORMITY, LEFT SIDED BREAST PAIN, AND LIFT SIDED FLUID COLLECTION POST PROCEDURE. THERE WAS FLUID FORMATION AROUND THE PATIENT¿S LEFT BREAST INHIBITING MOVEMENT. A DIMPLE FORMED ON THE LEFT BREAST ACCOMPANIED BY PAIN. THIS WAS FOLLOWED BY DIMPLE FORMATION ON THE RIGHT SIDED. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. SEE 1645337-2024-02383 FOR CONTRALATERAL PROSTHESIS REPORT.

  Patient problems: Breast Discomfort/Pain; Fluid Discharge; Wrinkling

  MAUDE report 18784652 ↗
• InjuryFeb 26, 2024Material Rupture; Adverse Event Without Identified Device or Use Problem; Material Rupture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH 685CC MENTOR MEMORYSHAPE BREAST IMPLANTS EXPERIENCED BILATERAL CUTANEOUS CONTOUR DEFORMITY, LEFT SIDED BREAST PAIN, AND LIFT SIDED FLUID COLLECTION POST PROCEDURE. THERE WAS FLUID FORMATION AROUND THE PATIENT¿S LEFT BREAST INHIBITING MOVEMENT. A DIMPLE FORMED ON THE LEFT BREAST ACCOMPANIED BY PAIN. THIS WAS FOLLOWED BY DIMPLE FORMATION ON THE RIGHT SIDED. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. SEE 1645337-2024-02382 FOR CONTRALATERAL PROSTHESIS REPORT.

  Patient problems: Pain; Wrinkling

  MAUDE report 18784651 ↗