MENTOR MemoryShape Breast Implant 3541708Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00081317005537), received between Oct 1, 2019 and Aug 22, 2024 — classified as 18 injuries.

The most frequently reported specific device problem is “Material Rupture” (10 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.

• InjuryAug 22, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION SURGERY WITH IMPLANTATION OF A 775CC MENTOR MEMORYSHAPE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH BILATERALLY RUPTURED BREAST IMPLANTS DURING AN IN-OFFICE VISIT WITH A MEDICAL PROFESSIONAL. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT WITH 740CC (LEFT-SIDED) AND 775CC (RIGHT-SIDED) MENTOR MEMORYGEL BOOST BREAST IMPLANTS ON (B)(6) 2024. THIS REPORT IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 20024228 ↗
• InjuryApr 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT PRIMARY BREAST RECONSTRUCTION WITH A 775CC MENTOR MEMORYSHAPE BREAST IMPLANT EXPERIENCED LEFT SIDED CUTANEOUS CONTOUR DEFORMITY POST PROCEDURE. THERE WAS A WRINKLE DETECTED. THE ISSUE WAS DISCOVERED THROUGH MAGNETIC RESONANCE IMAGING. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Wrinkling

  MAUDE report 19130498 ↗
• InjuryNov 1, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH A MENTOR MEMORYSHAPE, 775CC SILICONE BREAST IMPLANT EXPERIENCED BILATERAL SYMPTOMATIC RUPTURES AND LEFT SIDE RIPPLING POSTOPERATIVE. 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.

  Patient problems: Wrinkling

  MAUDE report 18051384 ↗
• InjuryNov 1, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH A MENTOR MEMORYSHAPE, 775CC SILICONE BREAST IMPLANT EXPERIENCED BILATERAL SYMPTOMATIC RUPTURES AND LEFT SIDE RIPPLING POSTOPERATIVE. 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.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18051276 ↗
• InjuryMar 16, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 38-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION SURGERY WITH IMPLANTATION OF A 775CC MENTOR MEMORYSHAPE BREAST IMPLANT GEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT EXPERIENCED DISCOMFORT OF THE LEFT BREAST. USING MAGNETIC RESONANCE IMAGING THE PATIENT WAS DIAGNOSED WITH A RUPTURED LEFT BREAST IMPLANT. ADDITIONALLY, SHE WAS DIAGNOSED WITH BILATERAL CONTOUR IRREGULARITIES AND ANIMATION PROBLEMS OF HER BREASTS. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT WITH 320CC MENTOR MEMORYGEL BOOST BREAST IMPLANT ON (B)(6) 2023. THIS REPORT IS FOR THE LEFT BREAST PROSTHESIS. REFER TO MANUFACTURING REPORT NUMBER 1645337-2023-03032 FOR THE CONTRALATERAL EVENT.

  Patient problems: Deformity/ Disfigurement; Wrinkling

  MAUDE report 16558269 ↗
• InjuryMar 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 38-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION SURGERY WITH IMPLANTATION OF A 775CC MENTOR MEMORYSHAPE BREAST IMPLANT GEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT EXPERIENCED DISCOMFORT OF THE LEFT BREAST. USING MAGNETIC RESONANCE IMAGING THE PATIENT WAS DIAGNOSED WITH A RUPTURED LEFT BREAST IMPLANT. ADDITIONALLY, SHE WAS DIAGNOSED WITH BILATERAL CONTOUR IRREGULARITIES AND ANIMATION PROBLEMS OF HER BREASTS. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT WITH 320CC MENTOR MEMORYGEL BOOST BREAST IMPLANT ON (B)(6) 2023. THIS REPORT IS FOR THE RIGHT BREAST PROSTHESIS. REFER TO MANUFACTURING REPORT NUMBER 1645337-2023-03031 FOR THE CONTRALATERAL EVENT.

  Patient problems: Deformity/ Disfigurement; Wrinkling

  MAUDE report 16557983 ↗
• InjuryJan 6, 2022Material Rupture; Adverse Event Without Identified Device or Use Problem; Material Rupture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT WHO UNDERWENT A BREAST RECONSTRUCTION REVISION WITH TWO 775CC MENTOR MEMORYSHAPE, SILICONE BREAST IMPLANT HAS EXPERIENCED BILATERAL RUPTURES, CAPSULAR CONTRACTURES UNKNOWN GRADES, AND UNEXPLAINED SYSTEMIC SYMPTOMS POSTOPERATIVELY, INCLUDING SEROMA, PNEUMOTHRORAX, SUNKEN CHEST -SJOGRENS, RAYNAUDS, IBS, ASTHMA, AND OTHER AUTOIMMUNE DISORDERS. THE PATIENT REPORTED THAT AT THE TIME OF THE REMOVAL OF THE IMPLANT, DOCTOR PUNCTURED HER LUNG AND CAUSED THE PNEUMOTHORAX. THE PATIENT ALSO REPORTED THAT SHE WENT TO 35 DIFFERENT DOCTORS IN ARIZONA AND TESTED FOR EVERYTHING THAT THE DOCTORS PRESCRIBED, THE RESULT INDICATED THAT SHE DIDN'T HAVE AUTOIMMUNE HEPATITIS, IT WAS DERMATOMYOSITIS WHICH MEANT SHE HAD TO TAKE THE IMPLANTS OUT. AS A RESULT, PATIENT UNDERWENT BILATERAL REMOVAL WITHOUT REPLACEMENT ON (B)(6) 2017. THIS REPORT RELATES TO THE RIGHT PROSTHESIS.

  Patient problems: Autoimmune Disorder; Capsular Contracture; Seroma

  MAUDE report 13180345 ↗
• InjuryJan 6, 2022Material Rupture; Adverse Event Without Identified Device or Use Problem; Material Rupture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT WHO UNDERWENT A BREAST RECONSTRUCTION REVISION WITH TWO 775CC MENTOR MEMORYSHAPE, SILICONE BREAST IMPLANT HAS EXPERIENCED BILATERAL RUPTURES, CAPSULAR CONTRACTURES UNKNOWN GRADES, AND UNEXPLAINED SYSTEMIC SYMPTOMS POSTOPERATIVELY, INCLUDING SEROMA, PNEUMOTHRORAX, SUNKEN CHEST -SJOGRENS, RAYNAUDS, IBS, ASTHMA, AND OTHER AUTOIMMUNE DISORDERS. THE PATIENT REPORTED THAT AT THE TIME OF THE REMOVAL OF THE IMPLANT, DOCTOR PUNCTURED HER LUNG AND CAUSED THE PNEUMOTHORAX. THE PATIENT ALSO REPORTED THAT SHE WENT TO 35 DIFFERENT DOCTORS IN (B)(6) AND TESTED FOR EVERYTHING THAT THE DOCTORS PRESCRIBED, THE RESULT INDICATED THAT SHE DIDN'T HAVE (B)(6), IT WAS DERMATOMYOSITIS WHICH MEANT SHE HAD TO TAKE THE IMPLANTS OUT. AS A RESULT, PATIENT UNDERWENT BILATERAL REMOVAL WITHOUT REPLACEMENT ON (B)(6) 2017. THIS REPORT RELATES TO THE LEFT PROSTHESIS.

  Patient problems: Autoimmune Disorder; Capsular Contracture; Seroma

  MAUDE report 13178719 ↗
• InjurySep 10, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION PRIMARY WITH A MENTOR MEMORYSHAPE BREAST IMPLANT 775CC AND EXPERIENCED RUPTURE AND A LUMP OF DEAD SKIN ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH UNSPECIFIED GEL BREAST IMPLANTS ON (B)(6) 2021. THE LUMP WAS REMOVED DURING THE EXPLANTATION SURGERY.

  Patient problems: Capsular Contracture; Deformity/ Disfigurement; Necrosis; Wrinkling

  MAUDE report 12453944 ↗
• InjuryDec 15, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD HISPANIC FEMALE PATIENT UNDERWENT PRIMARY BREAST RECONSTRUCTION SURGERY WITH 775CC MENTOR MEMORYSHAPE BREAST IMPLANT ON BOTH SIDES AND EXPERIENCED BILATERAL IMPLANT RUPTURE AND BILATERAL BREAST PAIN POSTOPERATIVELY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT IS FOR THE PATIENT¿S LEFT-SIDED DEVICE.

  Patient problems: Capsular Contracture; Pain

  MAUDE report 11014484 ↗
• InjuryDec 15, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD HISPANIC FEMALE PATIENT UNDERWENT PRIMARY BREAST RECONSTRUCTION SURGERY WITH 775CC MENTOR MEMORYSHAPE BREAST IMPLANT ON BOTH SIDES AND EXPERIENCED BILATERAL IMPLANT RUPTURE AND BILATERAL BREAST PAIN POSTOPERATIVELY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT IS FOR THE PATIENT¿S RIGHT-SIDED DEVICE.

  Patient problems: Capsular Contracture; Pain

  MAUDE report 11014300 ↗
• InjuryOct 27, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE WHO UNDERWENT BREAST RECONSTRUCTION REVISION WITH A MENTOR MEMORYSHAPE 775 CC SILICONE PROSTHESIS EXPERIENCED RIGHT SIDED PAIN, AND UNSPECIFIED ISSUES POST PROCEDURE. PATIENT INDICATED THAT EVER SINCE HER SURGERY, SHE HAS BEEN EXPERIENCING BREAST PAIN (FOR THE PAST 3 YEARS) AND SHE WASN¿T SURE IF THAT WAS NORMAL. PATIENT MENTIONED SHE KEPT HAVING COMPLICATIONS ON HER RIGHT IMPLANT AND HAD TO HAVE IT REMOVED. AS A RESULT PATIENT REPLACED THE RIGHT PROSTHESIS WITH SN#: (B)(4), CAT#:3541708 ON (B)(6) 2018.

  Patient problems: No Code Available; Pain

  MAUDE report 10741456 ↗
• InjurySep 2, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION PRIMARY WITH A MENTOR MEMORYSHAPE BREAST IMPLANT 775CC AND SUFFERED FROM A BILATERAL CAPSULAR CONTRACTURE BAKER GRADE BAKER GRADE IV ON THE RIGHT AND BAKER GRADE III ON THE LEFT BREAST IMPLANT AND RUPTURE ON THE LEFT BREAST IMPLANT. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS MEDWATCH IS FOR THE LEFT BREAST IMPLANT.

  Patient problems: Capsular Contracture; No Code Available

  MAUDE report 10480866 ↗
• InjurySep 2, 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 RECONSTRUCTION PRIMARY WITH A MENTOR MEMORYSHAPE BREAST IMPLANT 775CC AND SUFFERED FROM A BILATERAL CAPSULAR CONTRACTURE BAKER GRADE BAKER GRADE IV ON THE RIGHT AND BAKER GRADE III ON THE LEFT BREAST IMPLANT AND RUPTURE ON THE LEFT BREAST IMPLANT. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS MEDWATCH IS FOR THE RIGHT BREAST IMPLANT.

  Patient problems: Capsular Contracture; No Code Available; Wrinkling

  MAUDE report 10480864 ↗
• 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) CAUCASIAN FEMALE WHO UNDERWENT PRIMARY BREAST RECONSTRUCTION WITH A 480CC MENTOR MEMORYSHAPE BREAST IMPLANT (LEFT) AND A 775CC MENTOR MEMORYSHAPE BREAST IMPLANT (RIGHT) EXPERIENCED SYMPTOMS CONSISTENT WITH BILATERAL CAPSULAR CONTRACTURE POST PROCEDURE. BILATERAL PAIN, HARDNESS OF THE IMPLANTS, AND MISSHAPEN IMPLANTS WERE ALL REPORTED. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. SEE 1645337-2019-22676 FOR CONTRALATERAL PROSTHESIS REPORT.

  Patient problems: Capsular Contracture

  MAUDE report 9247072 ↗
• InjuryOct 18, 2019Adverse 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 RECONSTRUCTION REVISION WITH MENTOR MEMORYGEL BREAST IMPLANT 300CC (LEFT) AND MENTOR MEMORYSHAPE BREAST IMPLANT 775CC (RIGHT) AND EXPERIENCED CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN ON THE LEFT SIDE AND PAIN, A BREAST MASS, AND SEROMA ON THE RIGHT SIDE 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: Breast Mass; Pain; Seroma

  MAUDE report 9211170 ↗
• InjuryOct 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 UNDERWENT A BREAST RECONSTRUCTION PROCEDURE WITH 775CC MENTOR MEMORYSHAPE BREAST IMPLANTS AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT BILATERAL DEVICE REMOVAL ON (B)(6) 2019. THE PATIENT¿S RIGHT BREAST NIPPLE EXHIBITED DISCHARGE PRIOR TO REMOVAL. THIS REPORT IS FOR THE PATIENT'S RIGHT-SIDED DEVICE.

  Patient problems: Capsular Contracture; Local Reaction; No Code Available

  MAUDE report 9141570 ↗
• InjuryOct 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 UNDERWENT A BREAST RECONSTRUCTION PROCEDURE WITH 775CC MENTOR MEMORYSHAPE BREAST IMPLANTS AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT BILATERAL DEVICE REMOVAL ON (B)(6) 2019. THE PATIENT¿S RIGHT BREAST NIPPLE EXHIBITED DISCHARGE PRIOR TO REMOVAL. THIS REPORT IS FOR THE PATIENT'S LEFT-SIDED DEVICE.

  Patient problems: Capsular Contracture; No Code Available

  MAUDE report 9141565 ↗