MENTOR MemoryGel Breast Implant 3546007Recalls & reported problems

Summary

The FDA's MAUDE database contains 63 adverse event reports that list this exact device (DI 00081317000754), received between Apr 4, 2018 and Nov 6, 2024 — classified as 63 injuries.

The most frequently reported specific device problem is “Material Rupture” (51 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 63 reports, in the reporter's own words as published by the FDA.

• InjuryNov 6, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH TWO 600CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED BILATERAL RUPTURES AND SYMPTOMS INCLUDING THYROID NODULES, AUTOIMMUNE ISSUES, GASTROESOPHAGEAL REFLUX DISEASE, SORES, AND A BREAST CYST POST-OPERATIVELY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

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

  MAUDE report 20621402 ↗
• InjuryNov 6, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH TWO 600CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED BILATERAL RUPTURES AND SYMPTOMS INCLUDING THYROID NODULES, AUTOIMMUNE ISSUES, GASTROESOPHAGEAL REFLUX DISEASE, SORES, AND A BREAST CYST POST-OPERATIVELY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

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

  MAUDE report 20621260 ↗
• InjurySep 16, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 52-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH TWO 600CC MENTOR MEMORYGEL BREAST IMPLANTS AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE (BAKER GRADE UNKNOWN) AND BILATERAL RUPTURES POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2024 AND REPLACED WITH TWO 450CC MENTOR MEMORYGEL BREAST IMPLANTS (CATALOG NUMBER 3504501BC). THIS REPORT IS FOR THE RIGHT-SIDE DEVICE.

  Patient problems: Capsular Contracture

  MAUDE report 20232377 ↗
• InjurySep 16, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 52-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH TWO 600CC MENTOR MEMORYGEL BREAST IMPLANTS AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE (BAKER GRADE UNKNOWN) AND BILATERAL RUPTURES POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2024 AND REPLACED WITH TWO 450CC MENTOR MEMORYGEL BREAST IMPLANTS (CATALOG NUMBER 3504501BC). THIS REPORT IS FOR THE LEFT SIDE DEVICE.

  Patient problems: Capsular Contracture

  MAUDE report 20230847 ↗
• InjuryAug 14, 2024Material Rupture; Migration; Material Rupture; Migration

  IT WAS REPORTED THAT A 48-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH TWO 600CC MENTOR MEMORYGEL BREAST IMPLANTS AND EXPERIENCED BILATERAL RUPTURES AND DEVICE MIGRATION ON THE RIGHT SIDE POST-OPERATIVELY. IT WAS REPORTED THAT THE RIGHT BREAST PROSTHESIS FLIPPED. AS A RESULT, THE PATIENT IS TO UNDERGO BILATERAL DEVICE EXPLANTATION ON (B)(6) 2024. THIS REPORT IS FOR THE RIGHT SIDE DEVICE.

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

  MAUDE report 19986778 ↗
• InjuryAug 14, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 48-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH TWO 600CC MENTOR MEMORYGEL BREAST IMPLANTS AND EXPERIENCED BILATERAL RUPTURES AND DEVICE MIGRATION ON THE RIGHT SIDE POST-OPERATIVELY. IT WAS REPORTED THAT THE RIGHT BREAST PROSTHESIS FLIPPED. AS A RESULT, THE PATIENT IS TO UNDERGO BILATERAL DEVICE EXPLANTATION ON (B)(6) 2024. THIS REPORT IS FOR THE LEFT SIDE DEVICE.

  Patient problems: Capsular Contracture; Deformity/ Disfigurement

  MAUDE report 19986777 ↗
• InjuryDec 15, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE WHO UNDERWENT A BREAST RECONSTRUCTION REVISION WITH A MENTOR MEMORYGEL, 600CC SILICONE PROSTHESIS EXPERIENCED RIGHT-SIDED SILENT RUPTURE, AND CHEST INJURY POSTOPERATIVE. PATIENT HAD CAR ACCIDENT AND THE IMPLANT RUPTURED. THE ULTRASOUND AND OTHER SCAN CONFIRMED THE ISSUE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

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

  MAUDE report 18336199 ↗
• InjuryNov 15, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 72-YEAR-OLD FEMALE PATIENT UNDERWENT REVISION BREAST RECONSTRUCTION SURGERY WITH 600CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED BREAST IMPLANT RUPTURE ON HER RIGHT SIDE POSTOPERATIVELY; DIAGNOSED VIA MRI. THE PATIENT HAS CONSULTED WITH THE HEALTHCARE PROFESSIONAL. AS A RESULT, THE PATIENT IS SCHEDULED FOR REPLACEMENT SURGERY ON (B)(6) 2024. PATIENT IS PART OF ADJUNCT STUDY: (B)(6) .

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18145497 ↗
• InjuryOct 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT BREAST AUGMENTATION WITH 600CC MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED BILATERAL CAPSULAR CONTRACTURE POST PROCEDURE. THE RIGHT SIDED CAPSULAR CONTRACTURE IS BAKER GRADE III. THE LEFT SIDED CAPSULAR CONTRACTURE IS BAKER GRADE II. AS A RESULT, EXPLANT IS PLANNED FOR (B)(6) 2023. SEE 1645337-2023-12436 FOR CONTRALATERAL PROSTHESIS REPORT.

  Patient problems: Capsular Contracture

  MAUDE report 17971390 ↗
• InjuryOct 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT BREAST AUGMENTATION WITH 600CC MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED BILATERAL CAPSULAR CONTRACTURE POST PROCEDURE. THE RIGHT SIDED CAPSULAR CONTRACTURE IS BAKER GRADE III. THE LEFT SIDED CAPSULAR CONTRACTURE IS BAKER GRADE II. AS A RESULT, EXPLANT IS PLANNED FOR (B)(6) 2023. SEE 1645337-2023-12435 FOR CONTRALATERAL PROSTHESIS REPORT.

  Patient problems: Capsular Contracture

  MAUDE report 17971389 ↗
• InjuryAug 31, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 45-YEAR-OLD FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION SURGERY WITH MENTOR MEMORYGEL BREAST IMPLANTS (GEL SILTEX MOD-RND 600CC, DATE OF IMPLANT (B)(6) 2009 AND EXPERIENCED BREAST IMPLANT RUPTURE BILATERALLY CONFIRMED BY MRI AND COMPLICATED BY GRANULOMA FORMATION IN BOTH AXILLA REGIONS. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION ON (B)(6) 2023. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT-SIDED DEVICE.

  Patient problems: Granuloma

  MAUDE report 17664694 ↗
• InjuryAug 31, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 45-YEAR-OLD FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION SURGERY WITH MENTOR MEMORYGEL BREAST IMPLANTS (GEL SILTEX MOD-RND 600CC, DATE OF IMPLANT (B)(6) 2009) AND EXPERIENCED BREAST IMPLANT RUPTURE BILATERALLY CONFIRMED BY MRI AND COMPLICATED BY GRANULOMA FORMATION IN BOTH AXILLA REGIONS. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION ON (B)(6) 2023. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT-SIDED DEVICE.

  Patient problems: Granuloma

  MAUDE report 17664692 ↗
• InjuryMay 1, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 46-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH 600CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT EXPERIENCED BILATERAL RUPTURE OF HER PROSTHESES, WHICH WAS CONFIRMED BY A MEDICAL PROFESSIONAL. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH UNSPECIFIED NATRELLE BREAST IMPLANTS ON (B)(6) 2023. 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 LEFT IMPLANT. REFER TO MANUFACTURING REPORT NUMBER 1645337-2023-05050 FOR THE CONTRALATERAL EVENT.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 16845939 ↗
• InjuryMay 1, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 46-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH 600CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT EXPERIENCED BILATERAL RUPTURE OF HER PROSTHESES, WHICH WAS CONFIRMED BY A MEDICAL PROFESSIONAL. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH UNSPECIFIED NATRELLE BREAST IMPLANTS ON (B)(6) 2023. 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 IMPLANT. REFER TO MANUFACTURING REPORT NUMBER 1645337-2023-05051 FOR THE CONTRALATERAL EVENT.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 16845937 ↗
• InjuryDec 13, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 37-YEAR-OLD CAUCASIAN FEMALE WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH A 550CC MENTOR MEMORYGEL BREAST IMPLANT (RIGHT) AND A 600CC MENTOR MEMORYGEL BREAST IMPLANT (LEFT) EXPERIENCED LEFT SIDED RUPTURE, LEFT SIDED GRANULOMA, LEFT SIDED BREAST PAIN, AND RIGHT SIDED PTOSIS POST PROCEDURE. MAGNETIC RESONANCE IMAGING, MAMMOGRAPHY, AND ULTRASOUND DETECTED THE PRESENCE OF GRANULOMA AND RUPTURE. THE PTOSIS WAS ASSOCIATED WITH A DEFORMITY IN WHICH THE BREAST IMPLANT WAS SITTING HIGH ON THE CHEST WALL. AS A RESULT, EXPLANT IS SCHEDULED FOR (B)(6) 2022. SEE 1645337-2022-14997 FOR CONTRALATERAL PROSTHESIS REPORT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Breast Discomfort/Pain; Granuloma

  MAUDE report 15971826 ↗
• InjuryOct 26, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 65-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 600CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH BILATERAL RUPTURING OF HER IMPLANTS DURING A CONSULTATION WITH A MEDICAL PROFESSIONAL. AS A RESULT, THE PATIENT IS SCHEDULED FOR BILATERAL REMOVAL AND REPLACEMENT WITH 600CC MENTOR MEMORYGEL BREAST IMPLANT ON (B)(6) 2022. REFER TO MANUFACTURING REPORT NUMBER 1645337-2022-12875 FOR THE CONTRALATERAL EVENT.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 15672759 ↗
• InjuryOct 26, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 65-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 600CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH BILATERAL RUPTURING OF HER IMPLANTS DURING A CONSULTATION WITH A MEDICAL PROFESSIONAL. AS A RESULT, THE PATIENT IS SCHEDULED FOR BILATERAL REMOVAL AND REPLACEMENT WITH 600CC MENTOR MEMORYGEL BREAST IMPLANT ON (B)(6) 2022. REFER TO MANUFACTURING REPORT NUMBER 1645337-2022-12874 FOR THE CONTRALATERAL EVENT.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 15672757 ↗
• InjuryMay 18, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH TWO 600CC MENTOR MEMORYGEL BREAST IMPLANTS AND EXPERIENCED BILATERAL RUPTURE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING AN OFFICE VISIT. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2022. THIS REPORT IS FOR THE LEFT SIDE DEVICE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 14432215 ↗
• InjuryMay 18, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH TWO 600CC MENTOR MEMORYGEL BREAST IMPLANTS AND EXPERIENCED BILATERAL RUPTURE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING AN OFFICE VISIT. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2022. THIS REPORT IS FOR THE RIGHT SIDE DEVICE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 14432158 ↗
• InjuryJan 25, 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 REVISION SURGERY WITH IMPLANTATION OF A 600CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, DURING A PHYSICAL EXAM, THE PATIENT WAS OBSERVED TO HAVE A SINGLE CONSPICUOUS RIGHT AXILLARY LYMPH NODES. MAMMOGRAM AND ULTRASOUND IMAGING WERE PERFORMED ON THE PATIENT. AS A RESULT, THE PATIENT WILL UNDERGO REMOVAL AND REPLACEMENT ON (B)(6) 2022. THIS REPORT IS FOR THE RIGHT BREAST PROSTHESIS. REFER TO MANUFACTURING REPORT NUMBER 1645337-2022-00723 FOR THE CONTRALATERAL EVENT.

  Patient problems: Swollen Lymph Nodes/Glands

  MAUDE report 13350174 ↗
• InjuryJan 25, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH IMPLANTATION OF A 600CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, DURING A PHYSICAL EXAM, THE PATIENT WAS OBSERVED TO HAVE A RUPTURED LEFT BREAST PROSTHESIS AND MULTIPLE LARGE LEFT AXILLARY LYMPH NODES. MAMMOGRAM AND ULTRASOUND IMAGING WERE PERFORMED ON THE PATIENT. AS A RESULT, THE PATIENT WILL UNDERGO REMOVAL AND REPLACEMENT ON (B)(6) 2022. THIS REPORT IS FOR THE LEFT BREAST PROSTHESIS. REFER TO MANUFACTURING REPORT NUMBER 1645337-2022-00722 FOR THE CONTRALATERAL EVENT.

  Patient problems: Swollen Lymph Nodes/Glands

  MAUDE report 13350126 ↗
• InjuryJan 11, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH A MENTOR MEMORYGEL BREAST IMPLANT 600CC GEL BREAST PROSTHESIS THAT RUPTURED POST IMPLANTATION. RUPTURE OF THE PATIENT¿S RIGHT BREAST PROSTHESIS WAS REPORTED. ADDITIONALLY, A BIOPSY WAS PERFORMED TO RULE OUT CANCER AND FLUID WAS ASPIRATED. PATHOLOGY RESULTS ARE STILL PENDING. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Deformity/ Disfigurement; Local Reaction

  MAUDE report 13227781 ↗
• InjuryJan 5, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT WITH NO HISTORY OF HORMONE REPLACEMENT THERAPY UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 600CC MENTOR MEMORYGEL BREAST IMPLANTS, EXPERIENCED BILATERAL BREAST CAPSULAR CONTRACTURES ON (B)(6) 2021 (BAKER GRADE III ON THE RIGHT AND BAKER GRADE IV ON THE LEFT). THE PATIENT HAD MAGNETIC RESONANCE IMAGING (MRI) WITHOUT CONTRAST PRIOR TO PRESENTING TO THE REPORTING HCP OFFICE. MRI WITH CONTRAST PERFORMED ON (B)(6) 2021 SHOWED THE FOLLOWING: RIGHT BREAST WITH ABNORMAL, INTRACAPSULAR IMPLANT RUPTURE; SMALL AMOUNT OF FLUID SURROUNDING THE IMPLANT RUPTURE CONFINED TO THE FIBROUS CAPSULE. LEFT BREAST SHOWED IMPLANT RUPTURE WITH LARGE AMOUNT OF FLUID ACCUMULATING OUTSIDE THE CONFINES OF THE SILICONE IMPLANT, BUT WITHIN THE FIBROUS CAPSULE. THE PATIENT WAS SEEN IN THE OFFICE ON (B)(6) 2021; THE PAIN, HARDNESS, AND SWELLING IN HER LEFT BREAST HAVE WORSENED SIGNIFICANTLY. THE PHYSICIAN FEELS PATIENT COULD HAVE BIA-ALCL IN HER LEFT BREAST. ULTRASOUND-GUIDED FINE NEEDLE ASPIRATION WAS PERFORMED ON (B)(6) 2021. THE RESULTS ARE PENDING. THE PATIENT HAS BEEN TENTATIVELY SCHEDULED FOR BREAST IMPLANT REMOVAL ON (B)(6) 2022. THIS MEDWATCH FORM IS FOR THE R

  Patient problems: Capsular Contracture

  MAUDE report 13170584 ↗
• InjuryJan 5, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT WITH NO HISTORY OF HORMONE REPLACEMENT THERAPY UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 600CC MENTOR MEMORYGEL BREAST IMPLANTS, EXPERIENCED BILATERAL BREAST CAPSULAR CONTRACTURES ON (B)(6) 2021 (BAKER GRADE III ON THE RIGHT AND BAKER GRADE IV ON THE LEFT). THE PATIENT HAD MAGNETIC RESONANCE IMAGING (MRI) WITHOUT CONTRAST PRIOR TO PRESENTING TO THE REPORTING HCP OFFICE. MRI WITH CONTRAST PERFORMED ON (B)(6) 2021 SHOWED THE FOLLOWING: RIGHT BREAST WITH ABNORMAL, INTRACAPSULAR IMPLANT RUPTURE; SMALL AMOUNT OF FLUID SURROUNDING THE IMPLANT RUPTURE CONFINED TO THE FIBROUS CAPSULE. LEFT BREAST SHOWED IMPLANT RUPTURE WITH LARGE AMOUNT OF FLUID ACCUMULATING OUTSIDE THE CONFINES OF THE SILICONE IMPLANT, BUT WITHIN THE FIBROUS CAPSULE. THE PATIENT WAS SEEN IN THE OFFICE ON (B)(6) 2021; THE PAIN, HARDNESS, AND SWELLING IN HER LEFT BREAST HAVE WORSENED SIGNIFICANTLY. THE PHYSICIAN FEELS PATIENT COULD HAVE BIA-ALCL IN HER LEFT BREAST. ULTRASOUND-GUIDED FINE NEEDLE ASPIRATION WAS PERFORMED ON (B)(6) 2021. THE RESULTS ARE PENDING. THE PATIENT HAS BEEN TENTATIVELY SCHEDULED FOR BREAST IMPLANT REMOVAL ON (B)(6) 2022. THIS MEDWATCH FORM IS FOR THE L

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

  MAUDE report 13170568 ↗
• InjuryOct 17, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT WHO UNDERWENT PRIMARY BREAST RECONSTRUCTION SURGERY WITH TWO 600CC MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED BILATERAL CAPSULAR CONTRACTURE BAKER GRADE III AND RUPTURE POST PROCEDURE. AS A RESULT, PATIENT HAS A PLANNED EXPLANTATION ON (B)(6) 2022. THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 12643964 ↗