MENTOR MemoryShape Breast Implant 3341402Recalls & reported problems

Summary

The FDA's MAUDE database contains 91 adverse event reports that list this exact device (DI 00081317005247), received between Jul 24, 2018 and Oct 28, 2025 — classified as 90 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Rupture” (22 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 91 reports, in the reporter's own words as published by the FDA.

• InjuryOct 28, 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 SURGERY WITH IMPLANTATION OF A 620CC MENTOR MEMORYSHAPE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT PRESENTED WITH DELAYED WOUND HEALING WHICH REQUIRED DEBRIDEMENT/CLOSURE OF THE WOUND. THE CORRECTIVE SURGERY WAS PERFORMED. THE PRINCIPAL INVESTIGATOR ASSESSED THIS EVENT AS MILD IN SEVERITY, NON-SERIOUS, NOT RELATED TO THE DEVICE.

  Patient problems: Impaired Healing

  MAUDE report 23407942 ↗
• InjuryMay 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST RECONSTRUCTION PRIMARY WITH MENTOR MEMORYSHAPE BREAST IMPLANTS 620CC AND EXPERIENCED BILATERAL INFECTION AND BILATERAL IMPLANT SITE FLUID COLLECTION POST-OPERATIVELY. THE FLUID WAS SENT FOR EVALUATION AND REPORTEDLY CONTAINED ¿ABNORMAL CELLS¿. AS A RESULT, THE PATIENT UNDERWENT REMOVAL ON (B)(6) 2025. THIS REPORT IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Post Operative Wound Infection; Seroma

  MAUDE report 21944929 ↗
• InjuryMay 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST RECONSTRUCTION PRIMARY WITH MENTOR MEMORYSHAPE BREAST IMPLANTS 620CC AND EXPERIENCED BILATERAL INFECTION AND BILATERAL IMPLANT SITE FLUID COLLECTION POST-OPERATIVELY. THE FLUID WAS SENT FOR EVALUATION AND REPORTEDLY CONTAINED ¿ABNORMAL CELLS¿. AS A RESULT, THE PATIENT UNDERWENT REMOVAL ON (B)(6) 2025. THIS REPORT IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Post Operative Wound Infection; Seroma

  MAUDE report 21944926 ↗
• InjuryApr 28, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 620CC MENTOR MEMORYSHAPE BREAST IMPLANT EXPERIENCED A RUPTURE ON THE LEFT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025.

  Patient problems: Deformity/ Disfigurement; Granuloma

  MAUDE report 21918945 ↗
• InjuryApr 23, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION WITH MENTOR MEMORYSHAPE BREAST IMPLANTS 620CC AND EXPERIENCED RUPTURE ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH NON-MENTOR IMPLANTS ON (B)(6) 2025.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 21893184 ↗
• InjuryMar 7, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 620CC MENTOR MEMORYSHAPE BREAST IMPLANT EXPERIENCED A RUPTURE, BREAST PAIN, AND WRINKLING ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025.

  Patient problems: Breast Discomfort/Pain; Granuloma; No Clinical Signs, Symptoms or Conditions; Paresthesia

  MAUDE report 21549205 ↗
• InjuryJan 3, 2025Material Rupture; Material Rupture

  A FEMALE PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH MENTOR MEMORYSHAPE 620CC SILICONE PROSTHESES EXPERIENCED A RIGHT-SIDED SILENT RUPTURE POSTOPERATIVELY, WHICH WAS CONFIRMED THROUGH ULTRASOUND, CT SCAN, AND POSSIBLE MRI EXAMINATIONS. CONSEQUENTLY, THE PATIENT SCHEDULED FOR BILATERAL REMOVAL OF THE PROSTHESES ON (B)(6) 2025.

  Patient problems: Capsular Contracture; Deformity/ Disfigurement; Granuloma

  MAUDE report 21074090 ↗
• InjuryOct 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A BLACK FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION REVISION WITH TWO 620CC MENTOR MEMORYSHAPE BREAST IMPLANTS AND EXPERIENCED LEUKEMIA POST-OPERATIVELY. THE PATIENT STATED THAT SHE BELIEVES THAT IMPLANTING THE BREAST PROSTHESIS CAUSED HER TO HAVE LEUKEMIA. GENERALIZED ILLNESS SYMPTOMS INCLUDING GETTING ¿REALLY SICK¿, SWEATS, LOSING WEIGHT, DRY MOUTH, AND KIDNEY FAILURE WERE ALSO REPORTED. IN ADDITION, IT WAS MENTIONED THAT BOTH PATIENT¿S BREASTS WERE HARD AND HAD ENCAPSULATED. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2023, AND REPLACED WITH A 500CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST PROSTHESES. THIS REPORT IS FOR THE LEFT SIDE DEVICE.

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

  MAUDE report 20428971 ↗
• InjuryOct 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A BLACK FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION REVISION WITH TWO 620CC MENTOR MEMORYSHAPE BREAST IMPLANTS AND EXPERIENCED LEUKEMIA POST-OPERATIVELY. THE PATIENT STATED THAT SHE BELIEVES THAT IMPLANTING THE BREAST PROSTHESIS CAUSED HER TO HAVE LEUKEMIA. GENERALIZED ILLNESS SYMPTOMS INCLUDING GETTING ¿REALLY SICK¿, SWEATS, LOSING WEIGHT, DRY MOUTH, AND KIDNEY FAILURE WERE ALSO REPORTED. IN ADDITION, IT WAS MENTIONED THAT BOTH PATIENT¿S BREASTS WERE HARD AND HAD ENCAPSULATED. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2023 AND REPLACED WITH A 500CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST PROSTHESES. THIS REPORT IS FOR THE RIGHT-SIDE DEVICE.

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

  MAUDE report 20428946 ↗
• InjuryJun 6, 2024Migration; Migration

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION, AS PART OF A CLINICAL STUDY, WITH TWO 620CC MENTOR MEMORYSHAPE BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT WAS DISSATISFIED DUE TO BREAST WRINKLING ON AN UNSPECIFIED BREAST. IN ADDITION, THE PATIENT WAS ALSO DIAGNOSED WITH BILATERAL BREAST IMPLANT DISPLACEMENT. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. SINCE IT WAS NOT SPECIFIED WHICH BREAST SIDE HAD THE WRINKLING, IT WILL BE REPORTED UNDER THE RIGHT SIDE FOR NOW. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN CLARIFYING INFORMATION IS OBTAINED. THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement; Wrinkling

  MAUDE report 19480737 ↗
• InjuryJun 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT BREAST RECONSTRUCTION WITH 620CC MENTOR MEMORYSHAPE BREAST IMPLANTS EXPERIENCED BREAST PAIN AND RIPPLING POST PROCEDURE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. MULTIPLE LOT (7437830/7435418) AND SERIAL NUMBERS (B)(6) WERE PROVIDED. HOWEVER, IT IS UNCLEAR WHICH DEVICES WERE IMPACTED. THIS IS REFLECTED IN SECTION D. THIS PATIENT WAS PART OF A POST APPROVAL STUDY.

  Patient problems: Breast Discomfort/Pain; Deformity/ Disfigurement; Wrinkling

  MAUDE report 19468352 ↗
• InjuryJun 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS FILE WAS CREATED TO DOCUMENT THE IMEDIDATA CSEN ALERT BREAST-Q AUGMENTATION (POST-OPERATIVE) 5 YEAR FOLLOW-UP, BREAST PAIN.

  Patient problems: Breast Discomfort/Pain; Deformity/ Disfigurement

  MAUDE report 19464172 ↗
• InjuryJun 4, 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 620CC MENTOR MEMORYSHAPE BREAST IMPLANT EXPERIENCED ASYMMETRY ON AN UNSPECIFIED SIDE POST-OPERATIVELY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. MENTOR WAS PROVIDED TWO SERIAL NUMBERS (B)(6) BUT IT IS UNKNOWN WHICH SERIAL WAS THE IMPACTED DEVICE. IF FURTHER INFORMATION IS RECEIVED, A SUPPLEMENTAL WILL BE SENT.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 19460778 ↗
• InjuryJun 4, 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 620CC MENTOR MEMORYSHAPE BREAST IMPLANT EXPERIENCED ASYMMETRY ON AN UNSPECIFIED 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 19460620 ↗
• InjuryJun 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS FILE WAS CREATED TO DOCUMENT 5Y FOLLOW UP BREAST-Q AUGMENTATION (POST-OPERATIVE) REPORTING "PATIENT DISSATISFACTION" IN IMEDIDATA. THIS EVENT IS ASSOCIATED WITH THE GLOW CLINICAL TRIAL, SUBJECT ID: (B)(6). ON (B)(6) 2021 THE PATIENT¿S FIFTH-YEAR FOLLOW-UP WAS COMPLETED WHERE THE PATIENT REPORTED ISSUES WITH RIPPLING/WRINKLING AND ASYMMETRY VIA THE ¿BREAST-Q AUGMENTATION (POST-OPERATIVE)¿. THE RELATIONSHIP TO THE DEVICE WAS NOT PROVIDED AT THE TIME OF THIS REVIEW. SHOULD MORE INFORMATION BECOME AVAILABLE, THIS NOTE WILL BE UPDATED AND THE CASE WILL BE REASSESSED.

  Patient problems: Deformity/ Disfigurement; Wrinkling

  MAUDE report 19448757 ↗
• InjuryFeb 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED, VIA A LEGAL DOCUMENT, THAT A FEMALE PATIENT WHO UNDERWENT BREAST RECONSTRUCTION REVISION SURGERY WITH MENTOR MENTOR MEMORYSHAPE¿ MH 620CC GEL BREAST IMPLANTS (RIGHT IMPLANT SERIAL NUMBER (B)(6) AND LOT NUMBER 7426246; LEFT SERIAL NUMBER (B)(6) AND LOT NUMBER 7457987) ON 31-AUG-2017 WAS DIAGNOSED WITH ANAPLASTIC LARGE CELL LYMPHOMA (BIA-ALCL). THE AFFECTED SIDE WAS NOT SPECIFIED. PER THE INITIAL INFORMATION PROVIDED, THE PATIENT WAS IMPLANTED WITH AN UNKNOWN TISSUE EXPANDER (REPORTED UNDER 1645337-2024-02326) IN 2009 FOLLOWING A BILATERAL MASTECTOMY DUE TO BREAST CANCER. THE PATIENT UNDERWENT RECONSTRUCTION SURGERY WITH MENTOR BREAST IMPLANTS ON (B)(6) 2017. IN (B)(6) 2022 THE PATIENT¿S BREASTS BEGAN TO SWELL AND SHE EXPERIENCED ¿OTHER ADVERSE EVENTS¿. THE PATIENT WAS ULTIMATELY DIAGNOSED WITH BIA-ALCL. BREAST IMPLANT REMOVAL SURGERY WAS PERFORMED ON (B)(6) 2022 AND A SECOND RECONSTRUCTION WAS PERFORMED ON (B)(6) 2023. PER THE LIMITED INFORMATION PROVIDED BY THE SALES REPRESENTATIVE, IT¿S UNKNOWN IF THE BREAST RECONSTRUCTION SURGERY PERFORMED IN 2009 WAS SINGLE-STAGE OR DOUBLE-STAGE, HOWEVER, THE SURGEON WHO OPERATED ON THE PATIENT IS A KNOWN ALLERGAN CUSTOMER, IMPL

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

  MAUDE report 18773606 ↗
• InjuryFeb 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED, VIA A LEGAL DOCUMENT, THAT A FEMALE PATIENT WHO UNDERWENT BREAST RECONSTRUCTION REVISION SURGERY WITH MENTOR MENTOR MEMORYSHAPE¿ MH 620CC GEL BREAST IMPLANTS (RIGHT IMPLANT SERIAL NUMBER (B)(6) AND LOT NUMBER 7426246; LEFT SERIAL NUMBER (B)(6) AND LOT NUMBER 7457987) ON (B)(6) 2017 WAS DIAGNOSED WITH ANAPLASTIC LARGE CELL LYMPHOMA (BIA-ALCL). THE AFFECTED SIDE WAS NOT SPECIFIED. PER THE INITIAL INFORMATION PROVIDED, THE PATIENT WAS IMPLANTED WITH AN UNKNOWN TISSUE EXPANDER IN 2009 (REPORTED UNDER 1645337-2024-02326) FOLLOWING A BILATERAL MASTECTOMY DUE TO BREAST CANCER. THE PATIENT UNDERWENT RECONSTRUCTION SURGERY WITH MENTOR BREAST IMPLANTS ON (B)(6) 2017. IN (B)(6) 2022 THE PATIENT¿S BREASTS BEGAN TO SWELL AND SHE EXPERIENCED ¿OTHER ADVERSE EVENTS¿. THE PATIENT WAS ULTIMATELY DIAGNOSED WITH BIA-ALCL. BREAST IMPLANT REMOVAL SURGERY WAS PERFORMED ON (B)(6) 2022 AND A SECOND RECONSTRUCTION WAS PERFORMED ON (B)(6) 2023. PER THE LIMITED INFORMATION PROVIDED BY THE SALES REPRESENTATIVE, IT¿S UNKNOWN IF THE BREAST RECONSTRUCTION SURGERY PERFORMED IN 2009 WAS SINGLE-STAGE OR DOUBLE-STAGE, HOWEVER, THE SURGEON WHO OPERATED ON THE PATIENT IS A KNOWN ALLERGAN CUSTOMER, IMPL

  Patient problems: Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA ALCL); Deformity/ Disfigurement

  MAUDE report 18773604 ↗
• InjuryJan 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 43-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT REVISION BREAST AUGMENTATION WITH 620CC MENTOR MEMORYSHAPE BREAST IMPLANT ON BOTH SIDES AND EXPERIENCED BREAST IMPLANT RUPTURE ON HER RIGHT SIDE POSTOPERATIVELY; DIAGNOSED PER MRI AND IN THE OFFICE. THE PATIENT HAS CONSULTED WITH THE HEALTHCARE PROFESSIONAL. ON (B)(6) 2024, MENTOR BECAME AWARE THAT THE REPLACEMENT DEVICES USED ON DECEMBER 27, 2023 WERE CATALOG NUMBER 3505504BC; SERIAL NUMBER (B)(6) ON THE LEFT SIDE, AND CATALOG NUMBER 3505504BC; SERIAL NUMBER (B)(6) ON THE RIGHT SIDE. PER INFORMATION RECEIVED ON JANUARY 8, 2024, AND JANUARY 18, 2024, MENTOR BECAME AWARE THAT THE RIGHT DEVICE WAS INTACT AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE; BAKER GRADE IV ON RIGHT, AND GRADE II/III ON THE LEFT SIDE, AND UNDERWENT BILATERAL REPLACEMENT SURGERY ON DECEMBER 27, 2023. IT WAS REPORTED THAT THE PATIENT WAS INVOLVED IN THE CAR ACCIDENT. IT WAS ALSO REPORTED THAT THE PATIENT DEVELOPED A SEROMA IN THE RIGHT BREAST. AT THIS TIME, THE RESULTS OF PATHOLOGY /CYTOLOGY REPORT HAVE NOT BEEN PROVIDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS CASE WILL BE RE-ASSESSED AND NOTES WILL BE UPDATED. THIS MEDWATCH RE

  Patient problems: Capsular Contracture

  MAUDE report 18602990 ↗
• InjuryJan 17, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST IMPLANTATION PROCEDURE WITH MENTOR MEMORYSHAPE BREAST IMPLANTS 620CC AND EXPERIENCED RUPTURE ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT REMOVAL ON (B)(6) 2023.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18530573 ↗
• InjuryDec 6, 2023Adverse 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, 620CC, SILICONE PROSTHESIS EXPERIENCED BILATERAL WOUND INFECTION POSTOPERATIVE. THE REPORT INDICATES DISSOLVABLE STITCHES ARE COMING OUT NOW - SOMETIMES THERE IS PAIN - PUSS COMING OUT AND BLEEDING. 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: Post Operative Wound Infection

  MAUDE report 18276077 ↗
• InjuryDec 5, 2023Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A FEMALE WHO UNDERWENT A BREAST AUGMENTATION PRIMARY WITH A MENTOR MEMORY SHAPE, 620CC, SILICONE PROSTHESIS EXPERIENCED BILATERAL WOUND INFECTION POSTOPERATIVE. THE REPORT INDICATES DISSOLVABLE STITCHES ARE COMING OUT NOW - SOMETIMES THERE IS PAIN - PUSS COMING OUT AND BLEEDING. 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: Post Operative Wound Infection

  MAUDE report 18268554 ↗
• InjuryDec 5, 2023Adverse 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 MEMORY SHAPE, 620CC, SILICONE PROSTHESIS EXPERIENCED BILATERAL WOUND INFECTION POSTOPERATIVE. THE REPORT INDICATES DISSOLVABLE STITCHES ARE COMING OUT NOW - SOMETIMES THERE IS PAIN - PUSS COMING OUT AND BLEEDING. 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: Post Operative Wound Infection

  MAUDE report 18268499 ↗
• InjuryOct 30, 2023Gel Leak; Gel Leak

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST RECONSTRUCTION REVISION SURGERY WITH IMPLANTATION OF A 620CC MENTOR MEMORYSHAPE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS BIT BY A SPIDER WHICH CAUSED CELLULITIS OF THE RIGHT NIPPLE. AFTERWARDS, MAGNETIC RESONANCE IMAGING WAS PERFORMED WHICH INDICATED A RUPTURED RIGHT BREAST IMPLANT AND A PROMINENT RIGHT AXILLARY LYMPH NODE. A SKIN BIOPSY OF THE RIGHT BREAST WAS ALSO PERFORMED WHICH INDICATED FREE SILICONE. DURING A CONSULTATION WITH A MEDICAL PROFESSIONAL, THE PATIENT REPORTED LEFT BREAST PAIN, NOT FEELING WELL, VISION CHANGES, DIFFICULTY SWALLOWING, COUGH, ABDOMINAL PAIN, VOMITING, CHANGE IN APPETITE, DIZZINESS, FREQUENT HEADACHES AND MIGRAINES. SUBSEQUENTLY, SHE WAS DIAGNOSED WITH BILATERAL BAKER GRADE IV CAPSULAR CONTRACTURE. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT WITH 685CC MENTOR MEMORYGEL BOOST BREAST IMPLANTS ON (B)(6) 2023. HOWEVER, THE REMOVED IMPLANTS WERE REPORTED TO INTACT. THIS REPORT IS FOR THE RIGHT BREAST PROSTHESIS. REFER TO MANUFACTURING REPORT NUMBER 1645337-2023-12838 FOR THE CONTRALATERAL EVENT.

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

  MAUDE report 18035862 ↗
• InjuryOct 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST RECONSTRUCTION REVISION SURGERY WITH IMPLANTATION OF A 620CC MENTOR MEMORYSHAPE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS BIT BY A SPIDER WHICH CAUSED CELLULITIS OF THE RIGHT NIPPLE. AFTERWARDS, MAGNETIC RESONANCE IMAGING WAS PERFORMED WHICH INDICATED A RUPTURED RIGHT BREAST IMPLANT AND A PROMINENT RIGHT AXILLARY LYMPH NODE. A SKIN BIOPSY OF THE RIGHT BREAST WAS ALSO PERFORMED WHICH INDICATED FREE SILICONE. DURING A CONSULTATION WITH A MEDICAL PROFESSIONAL, THE PATIENT REPORTED LEFT BREAST PAIN, NOT FEELING WELL, VISION CHANGES, DIFFICULTY SWALLOWING, COUGH, ABDOMINAL PAIN, VOMITING, CHANGE IN APPETITE, DIZZINESS, FREQUENT HEADACHES AND MIGRAINES. SUBSEQUENTLY, SHE WAS DIAGNOSED WITH BILATERAL BAKER GRADE IV CAPSULAR CONTRACTURE. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT WITH 685CC MENTOR MEMORYGEL BOOST BREAST IMPLANTS ON (B)(6) 2023. HOWEVER, THE REMOVED IMPLANTS WERE REPORTED TO INTACT. THIS REPORT IS FOR THE LEFT BREAST PROSTHESIS. REFER TO MANUFACTURING REPORT NUMBER 1645337-2023-12839 FOR THE CONTRALATERAL EVENT.

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

  MAUDE report 18035860 ↗
• InjuryMay 15, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 52-YEAR-OLD CAUCASIAN HISPANIC/LATINO FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH 620CC MENTOR MEMORYSHAPE BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT EXPERIENCED BILATERAL BREAST PAIN. AN ULTRASOUND CONFIRMED THAT BOTH OF THE PATIENT¿S IMPLANTS WERE RUPTURED. THE PATIENT HAS CONSULTED WITH A MEDICAL PROFESSIONAL, BUT AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT IS FOR THE RIGHT IMPLANT. REFER TO MANUFACTURING REPORT NUMBER 1645337-2023-05704 FOR THE CONTRALATERAL EVENT.

  Patient problems: Breast Discomfort/Pain

  MAUDE report 16930321 ↗