MENTOR MemoryShape Breast Implant 3341109Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00081317005056), received between May 13, 2019 and Nov 7, 2023 — classified as 15 injuries.

The most frequently reported specific device problem is “Migration” (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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryNov 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT AN UNSPECIFIED BREAST SURGERY WITH A MENTOR MEMORYSHAPE BREAST IMPLANT 270CC GEL BREAST PROSTHESIS (LEFT DEVICE) AND A MENTOR MEMORYSHAPE BREAST IMPLANT 350CC GEL BREAST PROSTHESIS (RIGHT DEVICE) DEVELOPED PAIN IN BOTH OF HER BREASTS POST IMPLANTATION. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT BREAST PROSTHESIS.

  Patient problems: Breast Discomfort/Pain

  MAUDE report 18084289 ↗
• InjuryApr 11, 2023Migration; Migration

  IT WAS REPORTED THAT A 36-YEAR-OLD HISPANIC FEMALE PATIENT WHO UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH A MENTOR MEMORYSHAPE BREAST IMPLANT 255CC GEL BREAST PROSTHESIS (LEFT DEVICE) AND A MENTOR MEMORYSHAPE BREAST IMPLANT 270CC GEL BREAST PROSTHESIS (RIGHT DEVICE) DEVELOPED CAPSULAR CONTRACTURE (BAKER GRADE UNKNOWN) IN HER LEFT BREAST POST IMPLANTATION. ADDITIONALLY, IT WAS REPORTED THAT THE PATIENT¿S RIGHT BREAST PROSTHESIS ROTATED. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement; Wrinkling

  MAUDE report 16717943 ↗
• InjuryApr 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 62-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION REVISION WITH TWO 270CC MENTOR MEMORYSHAPE BREAST IMPLANTS AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE (BAKER GRADE 3-4) POST-OPERATIVELY. THE PATIENT HAD BILATERAL BREAST PAIN AND BILATERAL BREAST ASYMMETRY. THE PATIENT HAD REPORTED THAT SHE WAS INVOLVED A ¿BIKE ACCIDENT¿ IN 2017 WITH SIGNIFICANT LEFT ARM INJURY REQUIRING OPEN REDUCTION AND INTERNAL FIXATION AND FOLLOWING, HAS HAD LYMPHATIC ISSUES. IT WAS ALSO REPORTED THAT THE PATIENT EXPERIENCED GENERALIZED ILLNESS SYMPTOMS INCLUDING BREAST IMPLANT ILLNESSES AND LYMPHADENOPATHY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2022. THIS REPORT IS FOR THE RIGHT SIDE DEVICE.

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

  MAUDE report 16684209 ↗
• InjuryApr 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 62-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION REVISION WITH TWO 270CC MENTOR MEMORYSHAPE BREAST IMPLANTS AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE (BAKER GRADE 3-4) POST-OPERATIVELY. THE PATIENT HAD BILATERAL BREAST PAIN AND BILATERAL BREAST ASYMMETRY. THE PATIENT HAD REPORTED THAT SHE WAS INVOLVED A ¿BIKE ACCIDENT¿ IN 2017 WITH SIGNIFICANT LEFT ARM INJURY REQUIRING OPEN REDUCTION AND INTERNAL FIXATION AND FOLLOWING, HAS HAD LYMPHATIC ISSUES. IT WAS ALSO REPORTED THAT THE PATIENT EXPERIENCED GENERALIZED ILLNESS SYMPTOMS INCLUDING BREAST IMPLANT ILLNESSES AND LYMPHADENOPATHY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2022. THIS REPORT IS FOR THE LEFT SIDE DEVICE.

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

  MAUDE report 16684112 ↗
• InjuryOct 7, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 42-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 270CC (LEFT) AND A 305CC (RIGHT) MENTOR MEMORYSHAPE BREAST IMPLANTS AND EXPERIENCED A RUPTURE ON THE LEFT SIDE AND ANISOMASTIA ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2022. THIS REPORT IS FOR THE LEFT SIDE DEVICE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 15566481 ↗
• InjuryJul 6, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 76-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH TWO 270CC MENTOR MEMORYSHAPE BREAST IMPLANTS AND EXPERIENCED BILATERAL RUPTURE POST-OPERATIVELY, WHICH WAS CONFIRMED BY AN MRI. IT WAS ALSO REPORTED THE PATIENT HAD CAPSULAR CONTRACTURE (BAKER GRADE 3-4) ON THE RIGHT SIDE. 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: Capsular Contracture

  MAUDE report 14937208 ↗
• InjuryJul 6, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH TWO 270CC MENTOR MEMORYSHAPE BREAST IMPLANTS AND EXPERIENCED BILATERAL RUPTURE POST-OPERATIVELY, WHICH WAS CONFIRMED BY AN MRI. IT WAS ALSO REPORTED THE PATIENT HAD CAPSULAR CONTRACTURE (BAKER GRADE 3-4) ON THE RIGHT SIDE. 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: Deformity/ Disfigurement

  MAUDE report 14937170 ↗
• InjuryApr 15, 2022Migration; Migration

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 270CC MENTOR MEMORYSHAPE BREAST IMPLANT AND EXPERIENCED DEVICE MIGRATION ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS DIAGNOSED DURING A PHYSICAL. THE PATIENT REPORTED IT WAS UPSIDE DOWN WHEN SHE WOKE UP. THE PATIENT HAS NOT EXPLANTED HER IMPLANTS. IT WAS REPORTED THAT THE IMPLANT ROTATED BACK INTO THE CORRECT POSITION ON ITS OWN.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 14120754 ↗
• InjuryDec 31, 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 PRIMARY BREAST RECONSTRUCTION SURGERY WITH 270CC MENTOR MEMORYSHAPE BREAST IMPLANT ON BOTH SIDES AND EXPERIENCED GENERALIZED ILLNESS SYMPTOMS INCLUDING BRAIN FOG, EARS RINGING, VISION PROBLEMS, DENTAL PROBLEMS, SWOLLEN LYMPH NODES, INFECTION, BREATHING ISSUES, PAIN, ANXIETY, LEAKY GUT, NAUSEA, INCREASED SENSITIVITIES, SEIZURE, SWOLLEN LEGS, WEAKNESS, WEIGHT LOSS, AND TROUBLE SLEEPING. NO INDICATION OF WOUND INFECTION AS PATIENT REPORTS THE INFECTION IS IN A NODE/NODULE NEAR HER ARMPIT. SHE REPORTED THAT SHE DID HAVE A BIKE ACCIDENT BUT THE TRAUMA WAS TO THE BONE BETWEEN HER SHOULDER AND ELBOW WHICH REQUIRED SURGERY AND WAS TOLD HER IMPLANTS WERE INTACT. PATIENT ALSO REPORTED THAT THE FLUID IN HER CHEST WHERE HER IMPLANTS ARE LOCATED HAS BEEN TREATED AND CONTINUES TO BE TREATED WITH THORACENTESIS (SURGICAL INTERVENTION). AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT-SIDED DEVICE.

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

  MAUDE report 13127937 ↗
• InjuryDec 31, 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 PRIMARY BREAST RECONSTRUCTION SURGERY WITH 270CC MENTOR MEMORYSHAPE BREAST IMPLANT ON BOTH SIDES AND EXPERIENCED GENERALIZED ILLNESS SYMPTOMS INCLUDING BRAIN FOG, EARS RINGING, VISION PROBLEMS, DENTAL PROBLEMS, SWOLLEN LYMPH NODES, INFECTION, BREATHING ISSUES, PAIN, ANXIETY, LEAKY GUT, NAUSEA, INCREASED SENSITIVITIES, SEIZURE, SWOLLEN LEGS, WEAKNESS, WEIGHT LOSS, AND TROUBLE SLEEPING. NO INDICATION OF WOUND INFECTION AS PATIENT REPORTS THE INFECTION IS IN A NODE/NODULE NEAR HER ARMPIT. SHE REPORTED THAT SHE DID HAVE A BIKE ACCIDENT BUT THE TRAUMA WAS TO THE BONE BETWEEN HER SHOULDER AND ELBOW WHICH REQUIRED SURGERY AND WAS TOLD HER IMPLANTS WERE INTACT. PATIENT ALSO REPORTED THAT THE FLUID IN HER CHEST WHERE HER IMPLANTS ARE LOCATED HAS BEEN TREATED AND CONTINUES TO BE TREATED WITH THORACENTESIS (SURGICAL INTERVENTION). AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT-SIDED DEVICE.

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

  MAUDE report 13127931 ↗
• InjuryDec 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS EVENT IS ASSOCIATED WITH THE MEN-15-003 CLINICAL TRIAL, PARTICIPANT (B)(6). IT WAS REPORTED THAT A CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 270CC (LEFT) AND 350CC (RIGHT) MENTOR MEMORYSHAPE BREAST IMPLANT AND EXPERIENCED DISSATISFACTION WITH THE PROCEDURE OUTCOME POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2021. THIS REPORT IS FOR THE LEFT SIDE DEVICE.

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

  MAUDE report 13111836 ↗
• InjuryJan 5, 2021Adverse 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 WHO UNDERWENT AN UNSPECIFIED BREAST AUGMENTATION WITH 270CC MENTOR MEMORYSHAPE BREAST IMPLANTS EXPERIENCED ABNORMAL MAMMOGRAM AND ULTRASOUNDS POSTOPERATIVELY. THE PATIENT REPORTED HAVING CONCERNS WITH TEXTURED IMPLANTS, AND PLANNING TO UNDERGO BREAST IMPLANT PROPHYLACTIC REMOVAL TO AVOID INJURY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING AN EXPECTED EXPLANTATION DATE. THIS MEDWATCH REPORT IS FOR THE LEFT-SIDED IMPLANT.

  Patient problems: Capsular Contracture; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11118457 ↗
• InjuryMay 15, 2019Migration; Migration

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT WHO UNDERWENT BREAST AUGMENTATION WITH TWO 270CC MENTOR MEMORYSHAPE BREAST IMPLANTS, SUFFERED RIGHT SIDE CAPSULAR CONTRACTURE BAKER GRADE III AND BILATERAL BREAST PAIN POST-OPERATIVELY. IT WAS ALSO REPORTED THAT THE IMPLANTS APPEARED TO BE ROTATED, ESPECIALLY ON THE LEFT. AS A RESULT, THE PATIENT WAS SCHEDULED FOR IMPLANT EXPLANTATION ON (B)(6) 2019. THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture; No Code Available; Pain

  MAUDE report 8614204 ↗
• InjuryMay 15, 2019Migration; Migration

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT WHO UNDERWENT BREAST AUGMENTATION WITH TWO 270CC MENTOR MEMORYSHAPE BREAST IMPLANTS, SUFFERED RIGHT SIDE CAPSULAR CONTRACTURE BAKER GRADE III AND BILATERAL BREAST PAIN POST-OPERATIVELY. IT WAS ALSO REPORTED THAT THE IMPLANTS APPEARED TO BE ROTATED, ESPECIALLY ON THE LEFT. AS A RESULT, THE PATIENT WAS SCHEDULED FOR IMPLANT EXPLANTATION ON (B)(6) 2019. THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture; No Code Available

  MAUDE report 8614203 ↗
• InjuryMay 13, 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 FEMALE PATIENT WHO UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH A MENTOR MEMORYSHAPE BREAST IMPLANT 270CC GEL BREAST PROSTHESIS DEVELOPED CAPSULAR CONTRACTURE (BAKER GRADE III) IN HER RIGHT BREAST. CAPSULAR CONTRACTURE WAS NOTICED BY A PHYSICIAN. AS A RESULT, THE PATIENT WILL UNDERGO EXPLANTATION ON (B)(6) 2019.

  Patient problems: Capsular Contracture; No Code Available

  MAUDE report 8605995 ↗