MENTOR MemoryShape Breast Implant 3541408Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 00081317005490), received between May 9, 2019 and Jun 23, 2025 — classified as 29 injuries.

The most frequently reported specific device problem is “Material Rupture” (11 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 29 reports, in the reporter's own words as published by the FDA.

• InjuryJun 23, 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 REVISION WITH TWO MENTOR MEMORYSHAPE BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT DEVELOPED BILATERAL BREAST PTOSIS (GRADE II). AS A RESULT, THE PATIENT UNDERWENT BILATERAL BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2025. DURING THE SURGERY, THE RIGHT BREAST IMPLANT WAS DISCOVERED TO HAVE RUPTURED. SUBSEQUENTLY, BOTH THE IMPLANTS WERE REPLACED WITH MENTOR GEL IMPLANTS. THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 22309444 ↗
• InjuryFeb 3, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH MENTOR MEMORYSHAPE BREAST IMPLANTS 440CC AND EXPERIENCED BILATERAL RUPTURE POST-OPERATIVELY, WHICH WAS CONFIRMED VIA MRI. AS A RESULT, THE PATIENT IS SCHEDULED FOR REMOVAL ON (B)(6) 2025. THIS REPORT IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Cyst(s); Deformity/ Disfigurement; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21294562 ↗
• InjuryFeb 3, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH MENTOR MEMORYSHAPE BREAST IMPLANTS 440CC AND EXPERIENCED BILATERAL RUPTURE POST-OPERATIVELY, WHICH WAS CONFIRMED VIA MRI. AS A RESULT, THE PATIENT IS SCHEDULED FOR REMOVAL ON (B)(6) 2025. THIS REPORT IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Cyst(s); Deformity/ Disfigurement; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21294561 ↗
• InjuryNov 10, 2024Material Rupture; Adverse Event Without Identified Device or Use Problem; Material Rupture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 55-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH 440CC MENTOR MEMORYSHAPE BREAST IMPLANT AND EXPERIENCED BREAST MASS AND IMPLANT SITE FLUID COLLECTION ON HER LEFT SIDE POSTOPERATIVELY. THE PATIENT HAS CONSULTED WITH THE HEALTHCARE PROFESSIONAL. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

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

  MAUDE report 20649038 ↗
• InjuryJun 5, 2024Adverse 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 440CC MENTOR MEMORYSHAPE BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT EXPERIENCED BREAST PAIN AND ANISOMASTIA ON AN UNDISCLOSED SIDE, WHICH WERE CONFIRMED BY A MEDICAL PROFESSIONAL. AT THE TIME OF THIS REPORT, MENTOR HAS NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. DEVICE IDENTITIES WERE PROVIDED FOR BOTH IMPLANTED PROSTHESES, BUT THE SIDE OF COMPLICATION WAS NOT DISCLOSED. AS SUCH, BOTH DEVICE IDENTITIES WERE POPULATED IN THE LOT AND SERIAL NUMBER FIELDS. BOTH DEVICES SHARE THE SAME CATALOG.

  Patient problems: Breast Discomfort/Pain; Deformity/ Disfigurement

  MAUDE report 19470356 ↗
• InjuryApr 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 440CC MENTOR MEMORYSHAPE BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA MAMMOGRAM, ULTRASOUND, PHYSICAL EXAMINATION AND MRI, WITH LEFT BREAST IMPLANT RUPTURE AND BILATERAL BREAST PTOSIS. AS A RESULT, THE PATIENT UNDERWENT BILATERAL BREAST IMPLANT REMOVAL AND REPLACEMENT SURGERY ON (B)(6) 2024. THE REPLACEMENT DEVICES WERE: (LEFT) 450CC MENTOR MEMORYGEL BOOST BREAST IMPLANT CATALOG: SMPB450 LOT: 9983296 SN: (B)(6) AND (RIGHT) 450CC MENTOR MEMORYGEL BOOST BREAST IMPLANT CATALOG: SMPB450 LOT: 9919798 SN: (B)(6). THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS. COMPLICATIONS ON THE LEFT BREAST/IMPLANT HAVE BEEN REPORTED UNDER MRN: 1645337-2023-11330.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 19015541 ↗
• InjuryJan 24, 2024Material Rupture; Adverse Event Without Identified Device or Use Problem; Material Rupture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 440CC MENTOR MEMORYSHAPE BREAST IMPLANT DEVELOPED A LATE ONSET SEROMA IN THE RIGHT BREAST COMPLICATED BY OPENING OF A WOUND AND THE RIGHT IMPLANT EXTRUSION. IT WAS ALSO NOTED THAT A SURGEON PERFORMED A NEEDLE BIOPSY TO TEST THE SEROMA FLUID FOR ALCL AND FOUND A RUPTURE OF THE RIGHT IMPLANT. THE SEROMA FLUID WAS SENT TO PATHOLOGY/CYTOLOGY AND CULTURES FOR TESTING WITH NEGATIVE RESULT. IT WAS ALSO REPORTED THAT THE PATIENT DEVELOPED CAPSULAR CONTRACTURE, BAKER GRADE III-IV. AS A RESULT, THE PATIENT UNDERWENT THE RIGHT IMPLANT EXPLANTATION ON (B)(6) 2023.

  Patient problems: Capsular Contracture; Pocket Erosion; Seroma

  MAUDE report 18574034 ↗
• InjurySep 25, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 440CC MENTOR MEMORYSHAPE BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA MAMMOGRAM, ULTRASOUND, PHYSICAL EXAMINATION AND MRI, WITH LEFT BREAST IMPLANT RUPTURE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 17814931 ↗
• InjuryAug 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 64-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT REVISION BREAST AUGMENTATION WITH 440CC MENTOR MEMORYSHAPE BREAST IMPLANT ON BOTH SIDES AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE; BAKER GRADE IV POSTOPERATIVELY; DIAGNOSED AFTER PHYSICAL EXAM. THE PATIENT HAS CONSULTED WITH THE HEALTHCARE PROFESSIONAL. AS A RESULT, THE PATIENT IS SCHEDULED FOR BILATERAL REPLACEMENT SURGERY WITH MENTOR GEL DEVICES ON (B)(6), 2023. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT-SIDED DEVICE.

  Patient problems: Capsular Contracture

  MAUDE report 17557462 ↗
• InjuryAug 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 64-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT REVISION BREAST AUGMENTATION WITH 440CC MENTOR MEMORYSHAPE BREAST IMPLANT ON BOTH SIDES AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE; BAKER GRADE IV POSTOPERATIVELY; DIAGNOSED AFTER PHYSICAL EXAM. THE PATIENT HAS CONSULTED WITH THE HEALTHCARE PROFESSIONAL. AS A RESULT, THE PATIENT IS SCHEDULED FOR BILATERAL REPLACEMENT SURGERY WITH MENTOR GEL DEVICES ON (B)(6), 2023. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT-SIDED DEVICE.

  Patient problems: Capsular Contracture

  MAUDE report 17557460 ↗
• InjuryMay 25, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 59-YEAR-OLD FEMALE PATIENT INVOLVED IN A STUDY UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 440CC MENTOR MEMORYSHAPE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT EXPERIENCED BILATERALLY RUPTURED BREAST IMPLANTS. MAMMOGRAM IMAGING AND A CONSULTATION WITH A MEDICAL PROFESSIONAL HAS BEEN CONDUCTED.. 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. REFER TO MANUFACTURING REPORT NUMBER 1645337-2023-06170 FOR THE CONTRALATERAL EVENT.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 17002429 ↗
• InjuryMay 25, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 59-YEAR-OLD FEMALE PATIENT INVOLVED IN A STUDY UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 440CC MENTOR MEMORYSHAPE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT EXPERIENCED BILATERALLY RUPTURED BREAST IMPLANTS. MAMMOGRAM IMAGING AND A CONSULTATION WITH A MEDICAL PROFESSIONAL HAS BEEN CONDUCTED. 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. REFER TO MANUFACTURING REPORT NUMBER 1645337-2023-06171 FOR THE CONTRALATERAL EVENT.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 17002427 ↗
• InjuryMar 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 53-YEAR-OLD FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION SURGERY WITH IMPLANTATION OF A 440 CC MENTOR MEMORYSHAPE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS EXPERIENCED FATIGUE, SEVERE JOINT PAIN, JOINT STIFFNESS, INFLAMMATION, INFLAMMATION AROUND IMPLANTS, PAIN AROUND IMPLANTS, LUPUS SYMPTOMS, FIBROMYALGIA SYMPTOMS, BRAIN FOG, DEMENTIA, ELEVATED BLOOD PRESSURE, CHEST PAIN, JAW PAIN, AND LYMPH NODE PAIN. ADDITIONALLY, SHE STATES THAT SHE HAS BREAST IMPLANT ILLNESS. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. 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. REFER TO MANUFACTURING REPORT NUMBER 1645337-2023-02722 FOR THE CONTRALATERAL EVENT.

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

  MAUDE report 16513395 ↗
• InjuryMar 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 53-YEAR-OLD FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION SURGERY WITH IMPLANTATION OF A 440 CC MENTOR MEMORYSHAPE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS EXPERIENCED FATIGUE, SEVERE JOINT PAIN, JOINT STIFFNESS, INFLAMMATION, INFLAMMATION AROUND IMPLANTS, PAIN AROUND IMPLANTS, LUPUS SYMPTOMS, FIBROMYALGIA SYMPTOMS, BRAIN FOG, DEMENTIA, ELEVATED BLOOD PRESSURE, CHEST PAIN, JAW PAIN, AND LYMPH NODE PAIN. ADDITIONALLY, SHE STATES THAT SHE HAS BREAST IMPLANT ILLNESS. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. 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. REFER TO MANUFACTURING REPORT NUMBER 1645337-2023-02725 FOR THE CONTRALATERAL EVENT.

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

  MAUDE report 16513391 ↗
• InjuryOct 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION, AS PART OF A CLINICAL TRIAL, WITH TWO 440CC MENTOR MEMORYSHAPE BREAST IMPLANTS, SUFFERED BILATERAL BREAST ASYMMETRY, POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT BILATERAL BREAST IMPLANT REMOVAL AND REPLACEMENT WITH UNSPECIFIED GEL IMPLANTS ON (B)(6) 2020. THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS ASYMMETRY ON THE LEFT BREAST HAS BEEN REPORTED UNDER MRN: 1645337-2020-04544.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 15629291 ↗
• InjurySep 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION, AS PART OF A CLINICAL STUDY, WITH TWO 440CC MENTOR MEMORYSHAPE BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT SUFFERED PERSISTENT SLEEP DISORDERS, PERSISTENT MEMORY PROBLEMS, BREAST PAIN ON THE LEFT SIDE, AND FLUID COLLECTION IN THE LEFT BREAST AREA, WHICH REQUIRED TREATMENT WITH THE FOLLOWING MEDICATIONS: BACTRIM DS, DILAUDID, GABAPENTIN, SOMA, TYLENOL #3, AND ALEVE. 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

  MAUDE report 15366300 ↗
• InjurySep 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION, AS PART OF A CLINICAL STUDY, WITH TWO 440CC MENTOR MEMORYSHAPE BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT SUFFERED PERSISTENT SLEEP DISORDERS, PERSISTENT MEMORY PROBLEMS, BREAST PAIN ON THE LEFT SIDE, AND FLUID COLLECTION IN THE LEFT BREAST AREA, WHICH REQUIRED TREATMENT WITH THE FOLLOWING MEDICATIONS: BACTRIM DS, DILAUDID, GABAPENTIN, SOMA, TYLENOL #3, AND ALEVE. 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; Seroma

  MAUDE report 15366257 ↗
• InjuryFeb 28, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) HISPANIC FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH A MENTOR MEMORYSHAPE BREAST IMPLANT 440CC AND EXPERIENCED RUPTURE ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED VIA MRI/MAMMOGRAM. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 13619575 ↗
• InjuryAug 16, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH A 440CC MENTOR MEMORYSHAPE BREAST IMPLANT AND EXPERIENCED BREAST IMPLANT RUPTURE ON HER RIGHT SIDE FOUND DURING BILATERAL REPLACEMENT WITH NON-MENTOR DEVICES ON (B)(6) 2021.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 12325312 ↗
• InjuryDec 8, 2020Adverse 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 WITH A MENTOR MEMORYSHAPE BREAST IMPLANT 440CC AND SUFFERED FROM A BILATERAL HEMATOMA. 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: Hematoma; No Clinical Signs, Symptoms or Conditions; Wrinkling

  MAUDE report 10971572 ↗
• InjuryDec 8, 2020Adverse 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 WITH A MENTOR MEMORYSHAPE BREAST IMPLANT 440CC AND SUFFERED FROM A BILATERAL HEMATOMA. 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: Deformity/ Disfigurement; Hematoma; Wrinkling

  MAUDE report 10971543 ↗
• InjuryDec 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 REVISION BREAST AUGMENTATION WITH A 440CC MENTOR MEMORYSHAPE BREAST IMPLANT AND EXPERIENCED LEFT-SIDED LATE ONSET SEROMA AND SUSPECTED BREAST IMPLANT ASSOCIATED ANAPLASTIC LARGE-CELL LYMPHOMA POSTOPERATIVELY. THE PATIENT STARTED EXPERIENCING SWELLING, TIGHTNESS, AND INCREASED SIZE OF HER LEFT BREAST ON OR ABOUT (B)(6) 2020, ABOUT TWO WEEKS PRIOR TO REACHING OUT TO THE HEALTHCARE PROFESSIONAL¿S OFFICE. ON (B)(6) 2020, THE PATIENT UNDERWENT ULTRASOUND-GUIDED ASPIRATION OF THE SEROUS FLUID (ABOUT 350CC). PATHOLOGY REPORTS FOR THE SEROMA FLUID AND LEFT CAPSULE WERE RECEIVED ON (B)(6) 2020, RESPECTIVELY. IMMUNOHISTOCHEMICAL STAINING REVEALED THAT LARGE ATYPICAL CELLS ARE DIFFUSIVELY POSITIVE FOR CD30 AND NEGATIVE FOR ALK. FINAL DIAGNOSIS IS STILL PENDING. BASED ON THE PATHOLOGY AND CYTOLOGY REPORTS, THE PATIENT HAS SUSPECTED BIA-ALCL OF HER LEFT BREAST, PENDING FINAL DIAGNOSIS. THE PATIENT HAD A HISTORY OF MENTOR SMOOTH ROUND MODERATE PLUS PROFILE FROM (B)(6) 2003 TO (B)(6) 2014. ON (B)(6) 2020, THE PATIENT UNDERWENT BILATERAL CAPSULECTOMY AND EXPLANATION WITH NO REPLACEMENTS. PATIENT'S SYMPTOMS IMPROVED AFTER E

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

  MAUDE report 10935213 ↗
• InjuryJul 3, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD FEMALE PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION SURGERY WITH A 440CC MENTOR MEMORYSHAPE LEFT BREAST IMPLANT AND A 395CC MENTOR MEMORYSHAPE RIGHT BREAST IMPLANT EXPERIENCED BILATERAL RUPTURE POST PROCEDURE. 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: No Code Available

  MAUDE report 10228584 ↗
• InjuryMar 19, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION, AS PART OF A CLINICAL TRIAL, WITH TWO 440CC MENTOR MEMORYSHAPE BREAST IMPLANTS, SUFFERED LEFT BREAST ASYMMETRY POST-OPERATIVELY. THE PATIENT ALSO WANTED TO HAVE SMALLER IMPLANTS. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH AN UNSPECIFIED IMPLANT ON (B)(6) 2020.

  Patient problems: No Code Available

  MAUDE report 9855033 ↗
• InjuryNov 27, 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 UNDERWENT A BREAST SURGERY ON (B)(6) 2013 WITH A 440CC MENTOR MEMORYSHAPE BREAST IMPLANT. ON (B)(6) 2019, THE PATIENT'S IMPACTED DEVICE WAS EXPLANTED. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INDICATION OF THE PATIENT'S MEDICAL DIAGNOSIS FROM A PHYSICIAN, NOR HAS MENTOR BEEN PROVIDED WITH ANY ACCESS TO CYTOLOGY / PATHOLOGY REPORTS AND LAB RESULTS. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, MENTOR WILL SUBMIT THOSE UPDATES IN A SUPPLEMENTAL REPORT.

  Patient problems: No Code Available; Seroma

  MAUDE report 9385485 ↗