MENTOR MemoryShape Breast Implant 3341409Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 00081317005117), received between Jun 19, 2019 and Aug 3, 2026 — classified as 31 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 25 most recent of 31 reports, in the reporter's own words as published by the FDA.

• InjuryAug 3, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient implanted with two MENTOR MemoryShape Breast Implants experienced symptoms including excessive sleep, extreme fatigue, brain fog, memory loss, cognitive disfunction, hair loss, dry eye, mouth, vision problems, difficulty swallowing, choking, difficulty breathing, digestive issues, food intolerance, temperature intolerance, anxiety, depression, frequent urination, vertigo, dizziness, rippling, thin skin, tightening of skin, inflamed rash, heavy weight on chest, and pain post-operatively. As a result, the patient underwent explantation on (b)(6) 2026.

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

  MAUDE report 50118589 ↗
• InjurySep 19, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH TWO MENTOR MEMORYSHAPE BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT SUFFERED LEFT BREAST CAPSULAR CONTRACTURE (BAKER GRADE III) AND RIGHT BREAST IMPLANT RUPTURE. AS A RESULT, THE PATIENT UNDERWENT BILATERAL BREAST IMPLANT REMOVAL AND REPLACEMENT SURGERY ON (B)(6) 2024. THE REPLACEMENT DEVICES WERE NON-MENTOR. THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 20263554 ↗
• InjuryJun 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS FILE WAS CREATED TO DOCUMENT 5 YEAR FOLLOW-UP BREAST-Q RECONSTRUCTION (POST-OPERATIVE) DETAILS REPORTING "ANISOMASTIA" IN IMEDIDATA. AFFECTED SIDE HAS NOT BEEN CLARIFIED. PER IMEDIDATA SN (B)(6); REF: 3341409 BELONG TO RIGHT SIDE. SN (B)(6); REF 3341409. BELONGS TO LEFT SIDE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 19490347 ↗
• InjuryApr 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 51-YEAR-OLD FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH 555CC MENTOR MEMORYSHAPE BREAST IMPLANT AND EXPERIENCED BREAST PTOSIS ON THE LEFT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2024, AND REPLACED WITH A 495CC MENTOR MEMORYSHAPE BREAST IMPLANT WITH SERIAL NUMBER (B)(6).

  Patient problems: Deformity/ Disfigurement

  MAUDE report 19136241 ↗
• InjuryFeb 14, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 51-YEAR-OLD FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A 555CC MENTOR MEMORYSHAPE BREAST IMPLANT AND EXPERIENCED A RUPTURE ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT IS TO UNDERGO DEVICE EXPLANTATION ON (B)(6) 2024.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18707889 ↗
• InjurySep 7, 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 AUGMENTATION REVISION WITH TWO 555CC MENTOR MEMORYSHAPE BREAST IMPLANT AND EXPERIENCED BILATERAL BREAST PTOSIS POST-OPERATIVELY. THE PATIENT MENTIONED THAT HER BREAST ALWAYS SAGGED AND SETTLED AND WANTED PERKY ROUND BREAST. IT WAS ALSO REPORTED THAT THE PATIENT EXPERIENCED A RUPTURE ON THE LEFT SIDE. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2023. THIS REPORT IS FOR THE RIGHT SIDE DEVICE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 17702621 ↗
• InjurySep 7, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 38-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH TWO 555CC MENTOR MEMORYSHAPE BREAST IMPLANT AND EXPERIENCED BILATERAL BREAST PTOSIS POST-OPERATIVELY. THE PATIENT MENTIONED THAT HER BREAST ALWAYS SAGGED AND SETTLED AND WANTED PERKY ROUND BREAST. IT WAS ALSO REPORTED THAT THE PATIENT EXPERIENCED A RUPTURE ON THE LEFT SIDE. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2023. THIS REPORT IS FOR THE LEFT SIDE DEVICE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 17702614 ↗
• InjuryJun 20, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 63-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION WITH TWO 555CC MENTOR MEMORYSHAPE BREAST IMPLANTS AND EXPERIENCED BILATERAL RUPTURE POST-OPERATIVELY, WHICH WAS DIAGNOSED WITH AN MRI. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2023. THIS REPORT IS FOR THE LEFT SIDE DEVICE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 17166580 ↗
• InjuryJun 20, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 63-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION WITH TWO 555CC MENTOR MEMORYSHAPE BREAST IMPLANTS AND EXPERIENCED BILATERAL RUPTURE POST-OPERATIVELY, WHICH WAS DIAGNOSED WITH AN MRI. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2023. THIS REPORT IS FOR THE RIGHT SIDE DEVICE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 17166573 ↗
• InjuryOct 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS EVENT IS ASSOCIATED WITH THE GLOW CLINICAL TRIAL (SUBJECT ID: (B)(6)). IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION WITH A 475CC (RIGHT) AND A 555CC (LEFT) MENTOR MEMORYSHAPE BREAST IMPLANT AND EXPERIENCED BILATERAL CUTANEOUS CONTOUR DEFORMITY POST-OPERATIVELY. THE PATIENT WAS PRESENTED WITH WRINKLING WHICH REQUIRED FAT GRAFTING. 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: Wrinkling

  MAUDE report 15620835 ↗
• InjuryMar 18, 2022Adverse 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 AUGMENTATION PRIMARY WITH MENTOR MEMORYSHAPE BREAST IMPLANTS 555CC AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE BAKER GRADE IV POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT REMOVAL ON (B)(6) 2022. THIS REPORT IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 13809214 ↗
• InjuryMar 18, 2022Adverse 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 AUGMENTATION PRIMARY WITH MENTOR MEMORYSHAPE BREAST IMPLANTS 555CC AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE BAKER GRADE IV POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT REMOVAL ON (B)(6) 2022. THIS REPORT IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 13809211 ↗
• InjuryJul 29, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT WHO HAD A 555CC MENTOR MEMORYSHAPE BREAST IMPLANT PLACED EXPERIENCED RIGHT SIDED RUPTURE POST PROCEDURE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 12250578 ↗
• InjuryJul 15, 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 FEMALE PATIENT WHO UNDERWENT BREAST AUGMENTATION REVISION EXPERIENCED SOMEWHAT PROLONGED DRAINING POSTOPERATIVELY. AN US WAS COMPLETED ON (B)(6) 2018 AND SHOWED BILATERALLY RELATIVELY SMALL PERI IMPLANT FLUID COLLECTIONS, WHICH SHOULD DIMINISH, AND MILD BILATERAL AXILLARY ADENOPATHY, LIKELY REACTIVE. THE PATIENT EXPERIENCED LYMPHADENOPATHY, EARLY ONSET SEROMA BILATERALLY. NO PRODUCT ISSUE, SUCH AS RUPTURE, WAS REPORTED. NO REVISION WAS SCHEDULED AS OF YET. THIS MEDWATCH IS FOR THE RIGHT SIDE.

  Patient problems: Seroma; Swollen Lymph Nodes/Glands

  MAUDE report 12178370 ↗
• InjuryJul 15, 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 FEMALE PATIENT WHO UNDERWENT BREAST AUGMENTATION REVISION EXPERIENCED SOMEWHAT PROLONGED DRAINING POSTOPERATIVELY. AN US WAS COMPLETED ON (B)(6) 2018 AND SHOWED BILATERALLY RELATIVELY SMALL PERI IMPLANT FLUID COLLECTIONS, WHICH SHOULD DIMINISH, AND MILD BILATERAL AXILLARY ADENOPATHY, LIKELY REACTIVE. THE PATIENT EXPERIENCED LYMPHADENOPATHY, EARLY ONSET SEROMA BILATERALLY. NO PRODUCT ISSUE, SUCH AS RUPTURE, WAS REPORTED. NO REVISION WAS SCHEDULED AS OF YET. THIS MEDWATCH IS FOR THE LEFT SIDE.

  Patient problems: Seroma; Swollen Lymph Nodes/Glands

  MAUDE report 12178369 ↗
• InjuryJun 3, 2021Migration; Migration

  IT WAS REPORTED THAT A CAUCASIAN FEMALE PATIENT, WHO'S UNDERGONE BREAST RECONSTRUCTION, AS PART OF A CLINICAL STUDY, WITH TWO 555CC MENTOR MEMORYSHAPE BREAST IMPLANTS ON (B)(6) 2020 , SUFFERED BILATERAL BREAST WRINKLING, POST-PROCEDURE. ON (B)(6) 2020 , THE PATIENT UNDERWENT BILATERAL BREAST SURGICAL INTERVENTION (FAT GRAFTING) AND THE ISSUES WERE RESOLVED. HOWEVER, ON (B)(6) 2020 , THE PATIENT WAS THEN DIAGNOSED WITH BILATERAL IMPLANT MALPOSITION/DISPLACEMENT. THE PATIENT UNDERWENT AN UNSPECIFIED SURGICAL INTERVENTION TO RESOLVED THAT ISSUE ON AN UNSPECIFIED DATE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF CLARIFYING INFORMATION IS RECEIVED. THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Wrinkling

  MAUDE report 11932313 ↗
• InjuryJun 3, 2021Migration; Migration

  IT WAS REPORTED THAT A CAUCASIAN FEMALE PATIENT, WHO'S UNDERGONE BREAST RECONSTRUCTION, AS PART OF A CLINICAL STUDY, WITH TWO 555CC MENTOR MEMORYSHAPE BREAST IMPLANTS ON (B)(6) 2020, SUFFERED BILATERAL BREAST WRINKLING, POST-PROCEDURE. ON (B)(6) 2020, THE PATIENT UNDERWENT BILATERAL BREAST SURGICAL INTERVENTION (FAT GRAFTING) AND THE ISSUES WERE RESOLVED. HOWEVER, ON (B)(6) 2021, THE PATIENT WAS THEN DIAGNOSED WITH BILATERAL IMPLANT MALPOSITION/DISPLACEMENT. THE PATIENT UNDERWENT AN UNSPECIFIED SURGICAL INTERVENTION TO RESOLVED THAT ISSUE ON AN UNSPECIFIED DATE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF CLARIFYING INFORMATION IS RECEIVED. THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Breast Cancer; Wrinkling

  MAUDE report 11932310 ↗
• InjuryFeb 26, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE UNDERWENT BREAST RECONSTRUCTION WITH 555CC MENTOR MEMORYSHAPE BREAST IMPLANTS AND EXPERIENCED RUPTURE ON THE RIGHT SIDE POSTOPERATIVELY. THE RUPTURE WAS CONFIRMED WITH AN MRI. AS A RESULT, THE PATIENT UNDERWENT DEVICE REMOVAL AND REPLACEMENT WITH UNSPECIFIED SALINE BREAST IMPLANTS ON (B)(6) 2021.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 11389347 ↗
• InjuryJan 23, 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 A REVISION BREAST AUGMENTATION WITH TWO MENTOR MEMORYSHAPE BREAST IMPLANT PROSTHESES (LEFT: 555CC, RIGHT: 395CC) EXPERIENCED LEFT-SIDED SEROMA AND RIGHT-SIDED BREAST ABSCESS POSTOPERATIVELY. ABOUT 4.5 WEEKS AFTER THE IMPLANTATION DAY, THE PATIENT EXPERIENCED WARM FEELING, SWELLING, AND REDNESS IN HER LEFT BREAST, AND ANTIBIOTICS WERE PRESCRIBED. HOWEVER, THE PATIENT¿S SYMPTOMS DID NOT IMPROVE. THE DIAGNOSIS WAS CONFIRMED BASED ON PHYSICAL EXAMINATION. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL WITHOUT REPLACEMENT ON (B)(6) 2020. UPON EXPLANTATION, THE DEVICES WERE DISCARDED AND ARE NOT AVAILABLE FOR PRODUCT EVALUATION. THE TEST RESULTS ON COLLECTED FLUIDS FROM BOTH BREASTS INDICATED MODERATE WHITE BLOOD CELLS AND NO EVIDENCE OF YEAST, FUNGAL, OR ORGANISM ELEMENTS. THE PATIENT¿S SYMPTOMS HAVE BEEN IMPROVED AFTER THE REMOVAL SURGERY. THE EVENT DATE WAS ESTIMATED AS (B)(6) 2020 BASED ON AVAILABLE INFORMATION. THIS REPORT IS FOR THE LEFT-SIDED PROSTHESIS.

  Patient problems: Seroma

  MAUDE report 11220227 ↗
• InjuryJan 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED (VIA FDA MW5097425) THAT A FEMALE PATIENT, WHO'S UNDERGONE BREAST PROSTHESIS IMPLANTATION SURGERY POST PREVENTATIVE DOUBLE MASTECTOMY WITH TWO 555CC MENTOR MEMORYSHAPE BREAST IMPLANTS, SUFFERED SEVERAL UNEXPLAINED SYSTEMIC SYMPTOMS, INCLUDING INCREASED FATIGUE, MUSCLE SORENESS, JOINT ISSUES, CHRONIC INFECTIONS, MONO, SEVERE ANEMIA, CONTRACTED THE FLU, BODY PAIN IN MUSCLES AND JOINTS, POOR RECOVERY FROM ANY ACTIVITY, CHRONIC FATIGUE, NERVE ISSUES, APHASIA, CHRONIC HEADACHES, INCREASED/SEVERE ANXIETY, FINGER AND ANKLE SWELLING, LITTLE TO NO LIBIDO, POOR SLEEPING PATTERNS, CHRONIC FACIAL RASH WITH SWELLING, DRY HAIR, DRY SKIN, DRY MOUTH, AND DRY EYES. NO DEVICE ISSUE SUCH AS RUPTURE WAS REPORTED. THE ROOT CAUSE OF THE PATIENT¿S SYMPTOMS IS UNCLEAR. AS A RESULT, THE PATIENT UNDERWENT BILATERAL IMPLANT EXPLANTATION ON (B)(6) 2020. SYMPTOMS WERE REPORTEDLY BEGAN TO RESIDE ALMOST IMMEDIATELY AFTER THE IMPLANTS REMOVAL. PATIENT IS 75% HEALED AND THEIR THYROID HAS SHOWN IMPROVEMENT FOR THE FIRST TIME SINCE DIAGNOSIS IN 2011. THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS.

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

  MAUDE report 11128018 ↗
• InjuryJan 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED (VIA FDA MW5097425) THAT A FEMALE PATIENT, WHO'S UNDERGONE BREAST PROSTHESIS IMPLANTATION SURGERY POST PREVENTATIVE DOUBLE MASTECTOMY WITH TWO 555CC MENTOR MEMORYSHAPE BREAST IMPLANTS, SUFFERED SEVERAL UNEXPLAINED SYSTEMIC SYMPTOMS, INCLUDING INCREASED FATIGUE, MUSCLE SORENESS, JOINT ISSUES, CHRONIC INFECTIONS, MONO, SEVERE ANEMIA, CONTRACTED THE FLU, BODY PAIN IN MUSCLES AND JOINTS, POOR RECOVERY FROM ANY ACTIVITY, CHRONIC FATIGUE, NERVE ISSUES, APHASIA, CHRONIC HEADACHES, INCREASED/SEVERE ANXIETY, FINGER AND ANKLE SWELLING, LITTLE TO NO LIBIDO, POOR SLEEPING PATTERNS, CHRONIC FACIAL RASH WITH SWELLING, DRY HAIR, DRY SKIN, DRY MOUTH, AND DRY EYES. NO DEVICE ISSUE SUCH AS RUPTURE WAS REPORTED. THE ROOT CAUSE OF THE PATIENT¿S SYMPTOMS IS UNCLEAR. AS A RESULT, THE PATIENT UNDERWENT BILATERAL IMPLANT EXPLANTATION ON (B)(6) 2020. SYMPTOMS WERE REPORTEDLY BEGAN TO RESIDE ALMOST IMMEDIATELY AFTER THE IMPLANTS REMOVAL. PATIENT IS 75% HEALED AND THEIR THYROID HAS SHOWN IMPROVEMENT FOR THE FIRST TIME SINCE DIAGNOSIS IN 2011. THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS.

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

  MAUDE report 11128002 ↗
• InjuryJul 16, 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 MEMORYSHAPE BREAST IMPLANT 555CC AND EXPERIENCED BILATERAL SEROMAS POST-OPERATIVELY, WHICH WERE CONFIRMED BY A PHYSICIAN. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2020. THIS REPORT IS FOR THE LEFT SIDE DEVICE.

  Patient problems: No Code Available; Seroma

  MAUDE report 10285531 ↗
• InjuryJul 16, 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 MEMORYSHAPE BREAST IMPLANT 555CC AND EXPERIENCED BILATERAL SEROMAS POST-OPERATIVELY, WHICH WERE CONFIRMED BY A PHYSICIAN. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2020. THIS REPORT IS FOR THE RIGHT SIDE DEVICE.

  Patient problems: No Code Available; Seroma

  MAUDE report 10285435 ↗
• InjuryMay 6, 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 WHO UNDERWENT BREAST AUGMENTATION WITH TWO 555CC MENTOR MEMORYSHAPE BREAST IMPLANTS, SUFFERED LEFT BREAST IMPLANT RUPTURE, LEFT BREAST PAIN, AND BILATERAL CAPSULAR CONTRACTURE; BAKER GRADE UNKNOWN, POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT BILATERAL IMPLANT EXPLANTATION ON (B)(6) 2020. THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture; No Code Available

  MAUDE report 10031293 ↗
• InjuryFeb 19, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT WHO UNDERWENT BREAST AUGMENTATION WITH TWO 555CC MENTOR MEMORYSHAPE BREAST IMPLANTS, SUFFERED LEFT BREAST IMPLANT RUPTURE AND BREAST PAIN, POST-OPERATIVELY. AS A RESULT, THE PATIENT WAS SCHEDULED FOR IMPLANT EXPLANTATION IN (B)(6)2020.

  Patient problems: Capsular Contracture; No Code Available; Pain

  MAUDE report 9729058 ↗