MENTOR MemoryShape Breast Implant 3541208Recalls & reported problems

Summary

The FDA's MAUDE database contains 50 adverse event reports that list this exact device (DI 00081317005452), received between Nov 19, 2018 and Oct 23, 2025 — classified as 50 injuries.

The most frequently reported specific device problem is “Material Rupture” (20 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 50 reports, in the reporter's own words as published by the FDA.

• InjuryOct 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 280CC MENTOR MEMORYSHAPE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT PRESENTED WITH FIRM BREASTS AND A RUPTURED RIGHT IMPLANT. SHE WAS DIAGNOSED WITH BILATERAL CAPSULAR CONTRACTURE (BAKER GRADE RATINGS WERE NOT PROVIDED). AS A RESULT, THE PATIENT UNDERWENT BILATERAL IMPLANT REMOVAL WITHOUT REPLACEMENT ON (B)(6) 2025. THIS REPORT IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 23375151 ↗
• InjurySep 16, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 280CC MENTOR MEMORYSHAPE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT UNDERWENT BILATERAL IMPLANT REMOVAL WITHOUT REPLACEMENT ON (B)(6) 2025, FOR AN UNDISCLOSED REASON. HOWEVER, DURING THE SURGERY, A RUPTURED RIGHT IMPLANT WAS DISCOVERED. THERE WERE NO REPORTED PROCEDURAL DELAYS OR PATIENT CONSEQUENCES DUE TO THE FINDING. 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: Capsular Contracture; Deformity/ Disfigurement

  MAUDE report 23067049 ↗
• InjuryJun 23, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 39-YEAR-OLD HISPANIC FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A 315CC (LEFT) MENTOR MEMORYSHAPE BREAST IMPLANT AND A 280CC (RIGHT) MENTOR MEMORYSHAPE BREAST IMPLANT AND EXPERIENCED BILATERAL RUPTURES POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025. THIS REPORT IS FOR THE RIGHT SIDE DEVICE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 22311201 ↗
• InjuryMar 26, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH A MENTOR MEMORY SHAPE BREAST IMPLANT 280CC GEL BREAST PROSTHESIS THAT RUPTURED POST IMPLANTATION. RUPTURE OF THE PATIENT¿S LEFT BREAST PROSTHESIS WAS DIAGNOSED VIA A PHYSICAL EXAM AND VIA MRI. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 21702753 ↗
• InjuryMar 19, 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 AUGMENTATION REVISION SURGERY WITH IMPLANTATION OF A 280CC MENTOR MEMORYSHAPE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH A RUPTURED LEFT BREAST IMPLANT BY A MAGNETIC RESONANCE IMAGING. IMAGING ALSO IDENTIFIED A TRACE AMOUNT OF EXTRACAPSULAR FLUID ALONG THE LEFT IMPLANT. ADDITIONALLY, SHE WAS DIAGNOSED WITH BILATERAL BREAST PTOSIS AND WATERFALL DEFORMITIES. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL WITHOUT REPLACEMENTS ON (B)(6) 2025. THIS REPORT IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 21644655 ↗
• InjuryJan 28, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH IMPLANTATION OF A 280CC MENTOR MEMORYSHAPE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH A RUPTURED LEFT BREAST IMPLANT BY A MEDICAL PROFESSIONAL. 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.

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

  MAUDE report 21254481 ↗
• InjuryJun 18, 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 PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 280CC MENTOR MEMORYSHAPE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH A RUPTURED LEFT BREAST IMPLANT AND BILATERAL BAKER GRADE II CAPSULAR CONTRACTURE OF THE BREASTS DURING AN IN-OFFICE VISIT WITH A MEDICAL PROFESSIONAL. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT WITH 290CC MENTOR MEMORYGEL BOOST BREAST IMPLANTS ON (B)(6), 2024. THIS REPORT IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 19563734 ↗
• InjuryMay 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNSPECIFIED BREAST SURGERY WITH 280CC MENTOR MEMORYSHAPE BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT EXPERIENCED BAKER GRADE IV CAPSULAR CONTRACTURE OF THE LEFT BREAST AND BAKER GRADE III CAPSULAR CONTRACTURE OF THE RIGHT BREAST, WHICH WERE CONFIRMED DURING A PHYSICAL EXAM. THE PATIENT REPORTED EXPERIENCING PAIN, SWELLING, AND HARDNESS OF THE LEFT BREAST. IT WAS ALSO REPORTED THAT THE PATIENT HAD A MAMMOGRAM WHICH INDICATED POSSIBLE ALCL OF THE LEFT BREAST. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL SURGERY ON (B)(6) 2024. UPON REMOVAL, THE PATIENT¿S LEFT PROSTHESIS WAS DISCOVERED TO BE RUPTURED. A PATHOLOGY/CYTOLOGY REPORT FOR THE LEFT BREAST WAS PROVIDED, AND THE DIAGNOSIS WAS NEGATIVE FOR MALIGNANCY. THE OPERATIVE REPORT INDICATED THAT THE PATIENT ALSO EXPERIENCED A LATE ONSET SEROMA OF THE LEFT BREAST AND A GRANULOMA OF THE LEFT BREAST. THIS REPORT IS FOR THE RIGHT IMPLANT. REFER TO MANUFACTURING REPORT NUMBER 1645337-2024-02543 FOR THE CONTRALATERAL EVENT.

  Patient problems: Capsular Contracture

  MAUDE report 19221085 ↗
• InjuryApr 19, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT INVOLVED IN A CLINICAL STUDY UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 280CC MENTOR MEMORYSHAPE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH A RUPTURED LEFT BREAST IMPLANT DURING AN IN-OFFICE VISIT WITH A MEDICAL PROFESSIONAL. AS A RESULT, THE PATIENT IS SCHEDULED FOR BREAST IMPLANT REMOVAL ON (B)(6) 2024.

  Patient problems: Capsular Contracture; Deformity/ Disfigurement

  MAUDE report 19143473 ↗
• InjuryApr 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 49-YEAR-OLD CAUCASIAN FEMALE WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH A MENTOR MENTORMEMORYSHAPE¿ MM, 280CC SILICONE PROSTHESIS EXPERIENCED BILATERAL CAPSULAR CONTRACTURE, GRADE III ON THE LEFT, AND GRADE II ON THE RIGHT-SIDE POST PROCEDURE. THE ISSUE WAS DIAGNOSED BY PHYSICAL EXAMINATION. AS A RESULT, PATIENT SCHEDULED FOR BILATERAL REMOVAL ON (B)(6) 2024. THIS REPORT RELATES TO THE LEFT SIDE.

  Patient problems: Capsular Contracture

  MAUDE report 19067918 ↗
• InjuryApr 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 49-YEAR-OLD CAUCASIAN FEMALE WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH A MENTOR MENTORMEMORYSHAPE¿ MM, 280CC SILICONE PROSTHESIS EXPERIENCED BILATERAL CAPSULAR CONTRACTURE, GRADE III ON THE LEFT, AND GRADE II ON THE RIGHT-SIDE POST PROCEDURE. THE ISSUE WAS DIAGNOSED BY PHYSICAL EXAMINATION. AS A RESULT, PATIENT SCHEDULED FOR BILATERAL REMOVAL ON (B)(6) 2024. THIS REPORT RELATES TO THE RIGHT SIDE.

  Patient problems: Capsular Contracture

  MAUDE report 19067904 ↗
• InjuryFeb 29, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNSPECIFIED BREAST SURGERY WITH A 280CC MENTOR MEMORYSHAPE BREAST IMPLANT. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH SUSPECTED LEFT-SIDED ANAPLASTIC LARGE CELL LYMPHOMA (BIA-ALCL). IT WAS ALSO REPORTED THAT FINDINGS FROM AN MRI PERFORMED INDICATED POSSIBLE ALCL. THE PATIENT REPORTED EXPERIENCING PAIN, SWELLING, AND HARDNESS OF HER LEFT BREAST. AS A RESULT, THE PATIENT UNDERWENT REMOVAL SURGERY ON (B)(6) 2024. UPON REMOVAL, IT WAS DISCOVERED THAT THE PATIENT¿S LEFT PROSTHESIS WAS RUPTURED. THERE WERE NO PATIENT CONSEQUENCES OR SURGICAL DELAYS REPORTED DUE TO THE RUPTURE DISCOVERED DURING THE REVISION SURGERY. AT THIS TIME, THE PATHOLOGY REPORT IS PENDING. ANAPLASTIC LARGE CELL LYMPHOMA (BIA-ALCL) IS A KNOWN POTENTIAL COMPLICATION THAT MAY BE ASSOCIATED WITH THE USE OF THE MENTOR MEMORYSHAPE GEL BREAST IMPLANTS AND IS LISTED AS SUCH IN THE INSTRUCTIONS FOR USE (IFU). BASED ON THE REPORT SOURCE (I.E., HCP), THIS IS CLASSIFIED AS A SUSPECTED CASE OF BIA-ALCL. PER THE INFORMATION PROVIDED, THE PATIENT WAS IMPLANTED WITH MENTOR BREAST IMPLANTS AT THE TIME OF DIAGNOSIS, HOWEVER, THE BREAST IMPLANT HISTORY IS UNKNOWN, THEREFORE THIS CASE I

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

  MAUDE report 18810737 ↗
• InjuryJan 25, 2024Off-Label Use; Adverse Event Without Identified Device or Use Problem; Off-Label Use; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A CAUCASIAN FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH A 280CC MENTOR MEMORYSHAPE BREAST IMPLANT ON BOTH SIDES AND EXPERIENCED GENERALIZED ILLNESS SYMPTOMS INCLUDING MEMORY ISSUES, FATIGUE, MUSCLE ISSUES, JOINT ISSUES, AUTOIMMUNE RESPONSES, AND ANXIETY POSTOPERATIVELY. IT WAS REPORTED THAT THE DEVICES WERE REMOVED TWO YEARS AFTER DATE OF IMPLANT IN 2009 AND RE-IMPLANTED FOR RELOCATION PURPOSES. THE PATIENT IS SCHEDULED FOR BILATERAL REPLACEMENT SURGERY WITH MENTOR GEL DEVICES ON (B)(6) 2024. 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 18579714 ↗
• InjuryJan 25, 2024Off-Label Use; Adverse Event Without Identified Device or Use Problem; Off-Label Use; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A CAUCASIAN FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH A 280CC MENTOR MEMORY SHAPE BREAST IMPLANT ON BOTH SIDES AND EXPERIENCED GENERALIZED ILLNESS SYMPTOMS INCLUDING MEMORY ISSUES, FATIGUE, MUSCLE ISSUES, JOINT ISSUES, AUTOIMMUNE RESPONSES, AND ANXIETY POSTOPERATIVELY. IT WAS REPORTED THAT THE DEVICES WERE REMOVED TWO YEARS AFTER DATE OF IMPLANT IN 2009 AND RE-IMPLANTED FOR RELOCATION PURPOSES. THE PATIENT IS SCHEDULED FOR BILATERAL REPLACEMENT SURGERY WITH MENTOR GEL DEVICES ON (B)(6) 2024. 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 18579701 ↗
• InjuryJan 1, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH A MENTOR MEMORYSHAPE BREAST IMPLANT 280CC GEL BREAST PROSTHESIS THAT RUPTURED POST IMPLANTATION. RUPTURE OF THE PATIENT¿S RIGHT BREAST PROSTHESIS WAS DIAGNOSED DURING AN OFFICE VISIT. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2023.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18423291 ↗
• InjuryNov 17, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 65-YEAR-OLD FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 280CC MENTOR MEMORYSHAPE BREAST IMPLANT AND EXPERIENCED A RUPTURE ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS DIAGNOSED DURING SURGERY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2023.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18162184 ↗
• InjuryNov 14, 2023Adverse 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 280CC MENTOR MEMORYSHAPE BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH LEFT BREAST TENDERNESS. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Breast Discomfort/Pain

  MAUDE report 18133734 ↗
• InjuryOct 10, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 41-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT BREAST SURGERY WITH 280CC MENTOR MEMORYSHAPE BREAST IMPLANT ON BOTH SIDES AND EXPERIENCED BILATERAL BREAST IMPLANT RUPTURES, AND BILATERAL CAPSULAR CONTRACTURE; BAKER GRADE III POSTOPERATIVELY. AS A RESULT, THE PATIENT IS SCHEDULED FOR SURGERY ON (B)(6) 2023. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT-SIDED DEVICE.

  Patient problems: Capsular Contracture

  MAUDE report 17905848 ↗
• InjuryOct 10, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 41-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT BREAST SURGERY WITH 280CC MENTOR MEMORYSHAPE BREAST IMPLANT ON BOTH SIDES AND EXPERIENCED BILATERAL BREAST IMPLANT RUPTURES, AND BILATERAL CAPSULAR CONTRACTURE; BAKER GRADE III POSTOPERATIVELY. AS A RESULT, THE PATIENT IS SCHEDULED FOR SURGERY ON (B)(6) 2023. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT-SIDED DEVICE.

  Patient problems: Capsular Contracture

  MAUDE report 17905842 ↗
• InjuryAug 30, 2023Adverse 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 CAUCASIAN FEMALE PATIENT UNDERWENT BREAST RECONSTRUCTION SURGERY WITH MENTOR GLOW STUDY GEL DEVICES ON (B)(6) 2016. ADVERSE EVENT # 1. SKIN CANCER - BASAL CELL CARCINOMA (NON-MELANOMA). ON MAY 17, 2021, THE PATIENT WAS NEWLY DIAGNOSED WITH BASAL CELL CARCINOMA (NON-MELANOMA) ON THE RIGHT SIDE OF THE BODY. THE EVENT WAS TREATED WITH A SECONDARY PROCEDURE. THE EVENT WAS RESOLVED ON (B)(6) 2021. ADVERSE EVENT # 2. SQUAMOUS CELL CARCINOMA OF LEFT RADIAL DORSUM HAND. ON (B)(6) 2021, THE PATIENT WAS NEWLY DIAGNOSED WITH BASAL CELL CARCINOMA (NON-MELANOMA) ON THE RIGHT SIDE OF THE BODY. THE EVENT WAS TREATED WITH A SECONDARY PROCEDURE. THE EVENT WAS RESOLVED ON (B)(6) 2021. ADVERSE EVENT # 3. SUPERFICIAL BASAL CELL CARCINOMA OF RIGHT PROXIMAL FOREARM. ON (B)(6) 2021 THE PATIENT WAS NEWLY DIAGNOSED WITH SUPERFICIAL BASAL CELL CARCINOMA OF THE RIGHT PROXIMAL FOREARM. THE EVENT WAS TREATED WITH A SECONDARY PROCEDURE. THE EVENT WAS RESOLVED ON (B)(6) 2022. ADVERSE EVENT # 4. SQUAMOUS CELL CARCINOMA IN MID-CHEST SITE. ON (B)(6) 2022, THE PATIENT WAS NEWLY DIAGNOSED WITH SQUAMOUS CELL CARCINOMA IN T

  Patient problems: Deformity/ Disfigurement; Seroma

  MAUDE report 17656171 ↗
• InjuryMar 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 48-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH MENTOR MEMORYSHAPE BREAST IMPLANT 280CC GEL BREAST PROSTHESIS WHEN THE LEFT BREAST PROSTHESIS RUPTURED POST IMPLANTATION. RUPTURE OF THE PATIENT¿S LEFT BREAST PROSTHESIS WAS DIAGNOSED DURING AN OFFICE VISIT. ADDITIONALLY, THE PATIENT DEVELOPED WRINKLING IN BOTH BREASTS POST IMPLANTATION. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION ON (B)(6) 2023. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT BREAST PROSTHESIS. REFER TO MANUFACTURER REPORT NUMBER 1645337-2023-01968 FOR THE REPORT FOR THE PATIENT¿S LEFT BREAST PROSTHESIS.

  Patient problems: Wrinkling

  MAUDE report 16527186 ↗
• InjuryFeb 22, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 48-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A MENTOR MEMORYSHAPE BREAST IMPLANT 280CC GEL BREAST PROSTHESIS THAT RUPTURED POST IMPLANTATION. RUPTURE OF THE PATIENT¿S LEFT BREAST PROSTHESIS WAS DIAGNOSED DURING AN OFFICE VISIT. AS A RESULT, THE PATIENT IS SCHEDULED TO UNDERGO EXPLANTATION ON (B)(6) 2023.

  Patient problems: Deformity/ Disfigurement; Wrinkling

  MAUDE report 16419413 ↗
• InjuryJan 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 55-YEAR-OLD CAUCASIAN FEMALE PATIENT WHO UNDERWENT AN UNSPECIFIED BREAST SURGERY WITH MENTOR MEMORYSHAPE BREAST IMPLANT 280CC GEL BREAST PROSTHESES DEVELOPED CAPSULAR CONTRACTURE IN BOTH OF BREASTS POST IMPLANTATION (BAKER GRADE II IN LEFT BREAST, BAKER GRADE IV IN RIGHT BREAST). ADDITIONALLY, IT WAS REPORTED THAT THE RIGHT BREAST CAPSULE FILLED UP WITH FLUID (SEROMA). AS A RESULT, THE PATIENT UNDERWENT ASPIRATION AND 700ML OF FLUID WAS DRAINED. THE PATIENT LATER UNDERWENT BILATERAL EXPLANTATION ON (B)(6) 2022. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT BREAST PROSTHESIS. REFER TO MANUFACTURER REPORT NUMBER 1645337-2022-13969 FOR THE REPORT FOR THE PATIENT¿S RIGHT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 16118283 ↗
• InjuryNov 17, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT REVISION BREAST AUGMENTATION WITH A 280CC MENTOR MEMORYSHAPE BREAST IMPLANT ON BOTH SIDES AND EXPERIENCED BILATERAL BREAST IMPLANT RUPTURE POSTOPERATIVELY. AS A RESULT, BOTH IMPLANTS WERE EXPLANTED AND REPLACED WITH SIMILAR MENTOR PROSTHESIS ON (B)(6) 2022. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT-SIDED DEVICE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 15819062 ↗
• InjuryNov 17, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT REVISION BREAST AUGMENTATION WITH A 280CC MENTOR MEMORYSHAPE BREAST IMPLANT ON BOTH SIDES AND EXPERIENCED BILATERAL BREAST IMPLANT RUPTURE POSTOPERATIVELY. AS A RESULT, BOTH IMPLANTS WERE EXPLANTED AND REPLACED WITH SIMILAR MENTOR PROSTHESIS ON (B)(6) 2022. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT-SIDED DEVICE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 15818762 ↗