MENTOR MemoryShape Breast Implant 3541308Recalls & reported problems

Summary

The FDA's MAUDE database contains 44 adverse event reports that list this exact device (DI 00081317005476), received between May 6, 2019 and Sep 16, 2026 — classified as 44 injuries.

The most frequently reported specific device problem is “Material Rupture” (14 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 44 reports, in the reporter's own words as published by the FDA.

• InjurySep 16, 2026Material Rupture

  It was reported that a patient involved in a clinical study underwent a Breast Augmentation Revision Surgery with implantation of a 355cc MENTOR MemoryShape Breast Implant prosthesis. Post-operatively, the patient reported having fallen and afterwards having pain. Computerized Tomography Imaging was performed and identified a ruptured right implant. In addition, a nodule on the margin of the right implant was observed and recommended for further correlation with Mammogram and/or Ultrasound. At the time of this report, Mentor has received no information regarding explantation or an expected explantation date.The date of event and implantation were provided to Mentor as a best estimate.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: Breast Discomfort/Pain; Breast Mass

  MAUDE report 50792302 ↗
• InjuryApr 28, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST RECONSTRUCTION REVISION SURGERY WITH IMPLANTATION OF A 355CC MENTOR MEMORYSHAPE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT REPORTED HAVING PAIN IN THE MIDDLE LEFT CHEST AREA AND IS UNCERTAIN IF THE IMPLANTS ARE CAUSING THE ISSUES AS SHE HAS PRE-EXISTING HEART PROBLEMS BUT DIAGNOSTIC IMAGING DOESN'T APPEAR TO INDICATE ANY ISSUES. A CONSULTATION WITH A MEDICAL PROFESSIONAL HAS BEEN CONDUCTED. NO DIAGNOSIS HAS BEEN PROVIDED. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. 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: Pain

  MAUDE report 25021466 ↗
• InjuryOct 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION, AS PART OF A CLINICAL STUDY, WITH TWO 355CC MENTOR MEMORYSHAPE BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT DEVELOPED RIGHT BREAST CAPSULAR CONTRACTURE (BAKER GRADE II). AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Capsular Contracture

  MAUDE report 23400153 ↗
• InjurySep 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 355CC MENTOR MEMORYSHAPE BREAST IMPLANT EXPERIENCED CAPSULAR CONTRACTURE 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: Capsular Contracture

  MAUDE report 23017146 ↗
• InjuryJul 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH TWO 355CC MENTOR MEMORYSHAPE BREAST IMPLANT EXPERIENCED BILATERAL CAPSULAR CONTRACTURE AND A RUPTURE 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: Capsular Contracture

  MAUDE report 22413762 ↗
• InjuryJul 7, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH TWO 355CC MENTOR MEMORYSHAPE BREAST IMPLANT EXPERIENCED BILATERAL CAPSULAR CONTRACTURE AND A RUPTURE 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: Capsular Contracture

  MAUDE report 22413760 ↗
• InjuryJan 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT BREAST SURGERY WITH 355CC MENTOR MEMORYSHAPE BREAST IMPLANT ON BOTH SIDES AND EXPERIENCED BREAST IMPLANT RUPTURE ON HER LEFT SIDE. AS A RESULT, THE DEVICE WAS EXPLANTED ON (B)(6) 2024. ON (B)(6) 2024, MENTOR BECAME AWARE THAT PATIENT EXPERIENCED BILATERAL DISSATISFACTION WITH BREASTS AND LEFT SIDE RUPTURE WAS FOUND DURING BILATERAL REMOVAL SURGERY ON (B)(6) 2024. THE DEVICES WERE DISCARDED PER INFORMATION RECEIVED. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT-SIDED DEVICE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 21073932 ↗
• InjuryDec 6, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE WHO UNDERWENT A BREAST AUGMENTATION REVISION WITH A MENTOR MEMORYSHAPE¿ MM, SILICONE, 355CC, SILICONE PROSTHESIS EXPERIENCED BILATERAL CAPSULAR CONTRACTURES, GRADE III-IV ON THE RIGHT AND GRADE IL ON THE LEFT AND SYMPTOMATIC RUPTURE ON THE RIGHT SIDE POSTOPERATIVE. ACCORDING TO THE CONSULTATION NOTE, THIS PATIENT HAD A DIGITAL DIAGNOSTIC MAMMOGRAM WITH ULTRASOUND ON (B)(6) 2024 AND (B)(6) 2024 WHICH SHOWS SEVERAL OVOID ECHOGENIC NODULES IN THE AXILLA COMPATIBLE WITH EXTRACAPSULAR SILICONE. SHE HAS A CLASS III-IV CONTRACTURE ON THE RIGHT SIDE AND CLASS II ON THE LEFT SIDE WITH AN APPARENT RUPTURE OF THE RIGHT BREAST IMPLANT. AS A RESULT, PATIENT SCHEDULED FOR BILATERAL REPLACEMENTS WITH UNSPECIFIED PROSTHESIS ON (B)(6) 2025. THIS REPORT RELATES TO THE RIGHT SIDE.

  Patient problems: Capsular Contracture; Granuloma

  MAUDE report 20864919 ↗
• InjuryOct 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 44-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A 355CC MENTOR MEMORYSHAPE BREAST IMPLANT AND EXPERIENCED CAPSULAR CONTRACTURE (BAKER GRADE 4) ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS DIAGNOSED WITH AN EXAM. AS A RESULT, THE PATIENT IS TO UNDERGO DEVICE EXPLANTATION ON (B)(6) 2024.

  Patient problems: Capsular Contracture

  MAUDE report 20527245 ↗
• InjuryOct 15, 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 REVISION FOR RIGHT SIDED DUCTAL CARCINOMA WITH 355CC MENTOR MEMORYSHAPE BREAST IMPLANTS EXPERIENCED LEFT SIDED RUPTURE AND RIGHT SIDED DUCTAL CARCINOMA RECURRENCE POST PROCEDURE. THE RIGHT SIDED DUCTAL CARCINOMA WAS REVEALED THROUGH BIOPSY. LUMPECTOMY WAS PERFORMED AND THE PATIENT RECEIVED RADIATION TREATMENT. SUBSEQUENTLY, MAGNETIC RESONANCE IMAGING REVEALED THE RUPTURE ON THE LEFT SIDE. AS A RESULT, EXPLANT WITHOUT REPLACEMENT AND FAT TRANSFER WAS PERFORMED ON (B)(6) 2024. THE PATIENT'S CONDITION IS IMPROVED.

  Patient problems: Breast Cancer

  MAUDE report 20451467 ↗
• InjuryOct 10, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT BREAST RECONSTRUCTION REVISION FOR RIGHT SIDED DUCTAL CARCINOMA WITH A 355CC MENTOR MEMORYSHAPE BREAST IMPLANT EXPERIENCED LEFT SIDED RUPTURE POST PROCEDURE. MAGNETIC RESONANCE IMAGING REVEALED THE RUPTURE. AS A RESULT, EXPLANT WITHOUT REPLACEMENT AND FAT TRANSFER WAS PERFORMED ON (B)(6) 2024. THE PATIENT'S CONDITION IS IMPROVED.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 20424493 ↗
• InjurySep 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 355CC MENTOR MEMORYSHAPE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH STAGE II/III INVASIVE DUCTAL CARCINOMA OF THE LEFT BREAST INVOLVING 2-3 LYMPH NODES (LEFT-SIDED BREAST CANCER). AS A RESULT, THE PATIENT UNDERWENT A BILATERAL MASTECTOMY PROCEDURE WITHOUT ANY REPORTED BREAST IMPLANT REMOVAL. THE CAUSE FOR RIGHT-SIDED MASTECTOMY WAS NOT PROVIDED. 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. THIS REPORT IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Breast Cancer; Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20311584 ↗
• InjurySep 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION WITH TWO 355CC MENTOR MEMORYSHAPE BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT SUFFERED UNSPECIFIED RHEUMATOLOGICAL DISEASE. THE PATIENT'S RIGHT WRIST, POINTER FINGER, AND LEFT THUMB HAD ARTHRITIS LIKE SYMPTOMS AND ARE PAINFUL. 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Autoimmune Disorder

  MAUDE report 20138268 ↗
• InjurySep 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION WITH TWO 355CC MENTOR MEMORYSHAPE BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT SUFFERED UNSPECIFIED RHEUMATOLOGICAL DISEASE. THE PATIENT'S RIGHT WRIST, POINTER FINGER, AND LEFT THUMB HAD ARTHRITIS LIKE SYMPTOMS AND ARE PAINFUL. 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Autoimmune Disorder

  MAUDE report 20138267 ↗
• InjuryDec 27, 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 AUGMENTATION SURGERY WITH IMPLANTATION OF A 355CC MENTOR MEMORYSHAPE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH LEFT BREAST CANCER. 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: Breast Cancer

  MAUDE report 18401184 ↗
• InjuryMar 7, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 54-YEAR-OLD CAUCASIAN FEMALE PATIENT INVOLVED IN A CLINICAL STUDY UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 355CC MENTOR MEMORYSHAPE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS UNDERGOING A IMPLANT EXCHANGE SURGERY FOR AN UNDISCLOSED REASON AND A RUPTURED RIGHT BREAST IMPLANT WAS DISCOVERED. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT WITH 480CC MENTOR MEMORYGEL BOOST BREAST IMPLANTS ON (B)(6) 2023. THERE WERE NO REPORTED PATIENT CONSEQUENCES OR PROCEDURAL DELAYS DUE TO THE DISCOVERY.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 16498399 ↗
• InjuryMar 2, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 41-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH MENTOR MEMORYSHAPE BREAST IMPLANTS 355CC AND EXPERIENCED POSSIBLE BILATERAL RUPTURE POST-OPERATIVELY. AS A RESULT, THE PATIENT IS SCHEDULED FOR REMOVAL ON (B)(6) 2023. THIS REPORT IS FOR THE RIGHT BREAST PROSTHESIS.

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

  MAUDE report 16469498 ↗
• InjuryMar 2, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 41-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH MENTOR MEMORYSHAPE BREAST IMPLANTS 355CC AND EXPERIENCED POSSIBLE BILATERAL RUPTURE POST-OPERATIVELY. AS A RESULT, THE PATIENT IS SCHEDULED FOR REMOVAL ON (B)(6) 2023. THIS REPORT IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16469490 ↗
• InjuryOct 21, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 36-YEAR-OLD HISPANIC/LATINO FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 335CC MENTOR MEMORYSHAPE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT EXPERIENCED ASYMMETRY/PTOSIS OF HER BREASTS AND OTHER UNSPECIFIED MEDICAL ISSUES. DUE TO THE MEDICAL ISSUES, THE MEDICAL PROFESSIONAL STATED SHE HAD BREAST IMPLANT ILLNESS. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL WITHOUT REPLACEMENT ON (B)(6) 2022. DURING THE REMOVAL SURGERY, HER THE LEFT BREAST IMPLANT WAS DISCOVERED TO BE RUPTURED. THERE WERE NO REPORTED PATIENT CONSEQUENCES OR PROCEDURAL DELAYS. THIS REPORT IS FOR THE LEFT BREAST PROSTHESIS. REFER TO MANUFACTURING REPORT NUMBER 1645337-2022-12640 FOR THE CONTRALATERAL EVENT.

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

  MAUDE report 15655315 ↗
• InjuryOct 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 36-YEAR-OLD HISPANIC/LATINO FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 335CC MENTOR MEMORYSHAPE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT EXPERIENCED ASYMMETRY/PTOSIS OF HER BREASTS AND OTHER UNSPECIFIED MEDICAL ISSUES. DUE TO THE MEDICAL ISSUES, THE MEDICAL PROFESSIONAL STATED SHE HAD BREAST IMPLANT ILLNESS. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL WITHOUT REPLACEMENT ON (B)(6) 2022. DURING THE REMOVAL SURGERY, HER THE LEFT BREAST IMPLANT WAS DISCOVERED TO BE RUPTURED. THERE WERE NO REPORTED PATIENT CONSEQUENCES OR PROCEDURAL DELAYS. THIS REPORT IS FOR THE RIGHT BREAST PROSTHESIS. REFER TO MANUFACTURING REPORT NUMBER 1645337-2022-12641 FOR THE CONTRALATERAL EVENT.

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

  MAUDE report 15655138 ↗
• InjuryAug 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION PROCEDURE WITH MENTOR MEMORYSHAPE BREAST IMPLANT 355CC GEL BREAST PROSTHESES AND SUFFERED SEVERAL UNEXPLAINED SYSTEMIC SYMPTOMS, INCLUDING FIBROMYALGIA, PAIN, SLEEP DISORDERS, FATIGUE, SKIN THAT PERSISTENTLY FEELS TIGHT OR STRETCHED, SKIN RASH, DRY EYES, DRY MOUTH, DIZZINESS, AND MUSCLE WEAKNESS. NO DEVICE ISSUE SUCH AS RUPTURE WAS REPORTED. THE ROOT CAUSE OF THE PATIENT¿S SYMPTOMS IS UNCLEAR. 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: Autoimmune Disorder

  MAUDE report 15219345 ↗
• InjuryAug 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION PROCEDURE WITH MENTOR MEMORY SHAPE BREAST IMPLANT 355CC GEL BREAST PROSTHESES AND SUFFERED SEVERAL UNEXPLAINED SYSTEMIC SYMPTOMS, INCLUDING FIBROMYALGIA, PAIN, SLEEP DISORDERS, FATIGUE, SKIN THAT PERSISTENTLY FEELS TIGHT OR STRETCHED, SKIN RASH, DRY EYES, DRY MOUTH, DIZZINESS, AND MUSCLE WEAKNESS. NO DEVICE ISSUE SUCH AS RUPTURE WAS REPORTED. THE ROOT CAUSE OF THE PATIENT¿S SYMPTOMS IS UNCLEAR. 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: Autoimmune Disorder; Wrinkling

  MAUDE report 15219329 ↗
• InjuryJul 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT IS WITH THE GLOW STUDY. IT WAS REPORTED THAT A CAUCASIAN FEMALE PATIENT WHO UNDERWENT BREAST AUGMENTATION REVISION SURGERY WITH TWO 355CC MENTOR MEMORYSHAPE BREAST IMPLANTS EXPERIENCED RHEUMATOID ARTHRITIS, OSTEOARTHRITIS, JOINT STIFFNESS, PAIN, JOINT SWELLING, SLEEP DISORDERS, CHANGES IN THE COLOR OF FINGERS, NUMBNESS IN FINGERS AND CHANGES IN TEMPERATURE IN FINGERS POST PROCEDURE. THE PATIENT WAS DIAGNOSED WITH RHEUMATOID ARTHRITIS, WHICH IS STILL ONGOING AND IS BEING TREATED WITH 200 MG OF HYDROXYCHLOROQUINE ONCE A DAY. THE PRINCIPAL INVESTIGATOR-ASSESSED THIS EVENT AS MODERATE IN SEVERITY, NOT SERIOUS, AND NOT RELATED TO THE DEVICE. HOWEVER, THE RELATIONSHIP OF THE EVENT TO THE DEVICE CANNOT BE EXCLUDED. DURING THE PATIENT¿S SEVEN-YEAR FOLLOW-UP VISIT ON (B)(6) 2021, THE PATIENT REPORTED HAVING OSTEOARTHRITIS. 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: Autoimmune Disorder

  MAUDE report 15090640 ↗
• InjuryJul 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT IS WITH THE GLOW STUDY. IT WAS REPORTED THAT A CAUCASIAN FEMALE PATIENT WHO UNDERWENT BREAST AUGMENTATION REVISION SURGERY WITH TWO 355CC MENTOR MEMORYSHAPE BREAST IMPLANTS EXPERIENCED RHEUMATOID ARTHRITIS, OSTEOARTHRITIS, JOINT STIFFNESS, PAIN, JOINT SWELLING, SLEEP DISORDERS, CHANGES IN THE COLOR OF FINGERS, NUMBNESS IN FINGERS AND CHANGES IN TEMPERATURE IN FINGERS POST PROCEDURE. THE PATIENT WAS DIAGNOSED WITH RHEUMATOID ARTHRITIS, WHICH IS STILL ONGOING AND IS BEING TREATED WITH 200 MG OF HYDROXYCHLOROQUINE ONCE A DAY. THE PRINCIPAL INVESTIGATOR-ASSESSED THIS EVENT AS MODERATE IN SEVERITY, NOT SERIOUS, AND NOT RELATED TO THE DEVICE. HOWEVER, THE RELATIONSHIP OF THE EVENT TO THE DEVICE CANNOT BE EXCLUDED. DURING THE PATIENT¿S SEVEN-YEAR FOLLOW-UP VISIT ON (B)(6) 2021, THE PATIENT REPORTED HAVING OSTEOARTHRITIS. 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: Autoimmune Disorder

  MAUDE report 15090639 ↗
• InjuryMar 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) YEAR OLD (B)(6) FEMALE WHO UNDERWENT A BREAST AUGMENTATION PRIMARY WITH A MENTOR MEMORYSHAPE, 335CC SILICONE BREAST IMPLANT EXPERIENCED RIGHT-SIDED CAPSULAR CONTRACTURE UNKNOWN GRADE POST PROCEDURE. THE ISSUE WAS DIAGNOSED BY THE SURGEON. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Capsular Contracture

  MAUDE report 13724928 ↗