MENTOR MemoryShape Breast Implant 3541358Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 00081317005483), received between May 16, 2019 and Feb 4, 2026 — classified as 31 injuries.

The most frequently reported specific device problem is “Material Rupture” (13 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 31 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 4, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH A MENTOR MEMORYSHAPE BREAST IMPLANT GEL BREAST PROSTHESIS DEVELOPED BAKER GRADE IV CAPSULAR CONTRACTURE IN HER LEFT BREAST POST IMPLANTATION. THE CAPSULAR CONTRACTURE WAS DIAGNOSED VIA A PHYSICAL EXAM. AS A RESULT, THE PATIENT IS SCHEDULED TO UNDERGO EXPLANTATION.

  Patient problems: Capsular Contracture

  MAUDE report 24261112 ↗
• InjuryDec 23, 2025Material Rupture; Material Rupture

  A FEMALE PATIENT WHO UNDERWENT A BREAST AUGMENTATION PRIMARY WITH MENTOR MEMORYSHAPE¿ MM 395CC SILICONE PROSTHESIS EXPERIENCED BILATERAL SYMPTOMATIC RUPTURES AND BILATERAL CAPSULAR CONTRACTURES GRADE II ON THE LEFT, AND GRADE III ON THE RIGHT-SIDE POST OPERATION. THE RUPTURES WERE DISCOVERED DURING THE SURGERY. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REPLACEMENTS PER FOLLOWING: LEFT CATALOG NUMBER 3505504BC, SERIAL NUMBER (B)(6), RIGHT CATALOG 3505504BC, RIGHT SERIAL NUMBER (B)(6), AND BILATERAL SUBTOTAL ANTERIOR CAPSULECTOMIES AND LOWER POLE CAPSULOTOMY ON (B)(6) 2025. THIS REPORT RELATES TO THE RIGHT SIDE.

  Patient problems: Capsular Contracture

  MAUDE report 23882964 ↗
• InjuryDec 23, 2025Material Rupture; Material Rupture

  A FEMALE PATIENT WHO UNDERWENT A BREAST AUGMENTATION PRIMARY WITH MENTOR MEMORYSHAPE¿ MM 395CC SILICONE PROSTHESIS EXPERIENCED BILATERAL SYMPTOMATIC RUPTURES AND BILATERAL CAPSULAR CONTRACTURES GRADE II ON THE LEFT, AND GRADE III ON THE RIGHT-SIDE POST OPERATION. THE RUPTURES WERE DISCOVERED DURING THE SURGERY. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REPLACEMENTS PER FOLLOWING: LEFT CATALOG NUMBER 3505504BC, SERIAL NUMBER (B)(6), RIGHT CATALOG 3505504BC, RIGHT SERIAL NUMBER (B)(6), AND BILATERAL SUBTOTAL ANTERIOR CAPSULECTOMIES AND LOWER POLE CAPSULOTOMY ON (B)(6) 2025. THIS REPORT RELATES TO THE LEFT SIDE.

  Patient problems: Capsular Contracture

  MAUDE report 23882919 ↗
• InjuryDec 23, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 395CC MENTOR MEMORYSHAPE BREAST IMPLANT EXPERIENCED A RUPTURE ON LEFT SIDE 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; Cyst(s); Deformity/ Disfigurement

  MAUDE report 23880595 ↗
• InjurySep 17, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 395CC 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

  MAUDE report 23076087 ↗
• InjuryMay 1, 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 395CC MENTOR MEMORYSHAPE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, DURING A TEN-YEAR FOLLOW-UP, THE PATIENT REPORTED DISSATISFACTION WITH THE AMOUNT OF RIPPLING (WRINKLING) OF THE IMPLANTS THAT COULD BE SEEN AND FELT, FIRMNESS OF THE BREASTS, THE POSITION OF THE IMPLANTS ON THE CHEST, AND HOW THE BREASTS SAT/HUNG. ADDITIONALLY, THERE WAS PAIN IN THE BREAST AREA AT TIMES. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Capsular Contracture

  MAUDE report 21943746 ↗
• InjuryMay 1, 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 395CC MENTOR MEMORYSHAPE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, DURING A TEN YEAR FOLLOW-UP, THE PATIENT REPORTED DISSATISFACTION WITH THE AMOUNT OF RIPPLING (WRINKLING) OF THE IMPLANTS THAT COULD BE SEEN AND FELT, FIRMNESS OF THE BREASTS, THE POSITION OF THE IMPLANTS ON THE CHEST, AND HOW THE BREASTS SAT/HUNG. ADDITIONALLY, THERE WAS PAIN IN THE BREAST AREA AT TIMES. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Capsular Contracture

  MAUDE report 21943375 ↗
• InjuryJan 9, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 395CC MENTOR MEMORYSHAPE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH RIGHT BREAST BAKER GRADE III CAPSULAR CONTRACTURE AND BILATERALLY RUPTURED BREAST IMPLANT BY A MEDICAL PROFESSIONAL. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT WITH 400CC (LEFT-SIDED) AND 525CC (RIGHT-SIDED) MENTOR MEMORYGEL BREAST IMPLANTS ON COLONOVIDEOSCOPE. THIS REPORT IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 21120520 ↗
• InjuryJul 23, 2024Material Rupture; Material Integrity Problem; Material Rupture; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION PROCEDURE WITH A MENTOR MEMORYSHAPE BREAST IMPLANT 395CC GEL BREAST PROSTHESIS THAT RUPTURED POST IMPLANTATION. RUPTURE OF THE PATIENT¿S LEFT BREAST PROSTHESIS WAS DIAGNOSED VIA A PHYSICAL EXAM AND VIA MRI. AS A RESULT, THE PATIENT IS SCHEDULED TO UNDERGO EXPLANTATION ON (B)(6)2024.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 19811939 ↗
• InjuryJun 20, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH TWO 395CC MENTOR MEMORYSHAPE BREAST IMPLANTS EXPERIENCED BILATERAL RUPTURES 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 19578137 ↗
• InjuryJun 20, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH TWO 395CC MENTOR MEMORYSHAPE BREAST IMPLANTS EXPERIENCED BILATERAL RUPTURES 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 19578067 ↗
• InjuryJan 12, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 395CC MENTOR MEMORYSHAPE BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA MAMMOGRAM/ULTRASOUND, WITH LEFT BREAST IMPLANT RUPTURE. THE PATIENT ALSO FELL PRIOR TO THE RUPTURE. AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL AND REPLACEMENT SURGERY ON DECEMBER 11, 2023. DURING THE REMOVAL SURGERY, THE RIGHT BREAST IMPLANT WAS ALSO FOUND TO BE RUPTURED. SUBSEQUENTLY, THE IMPLANTS WERE REPLACED WITH THE FOLLOWING DEVICES: (LEFT) 270CC MENTOR MEMORYGEL XTRA BREAST IMPLANT CATALOG: SMPX270, LOT: 99553,16 SN: (B)(6) AND (RIGHT) 270CC MENTOR MEMORYGEL XTRA BREAST IMPLANT CATALOG: SMPX270, LOT: 9964615, SN: (B)(6). THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS. THE LEFT BREAST IMPLANT HAS BEEN REPORTED UNDER MRN: 1645337-2023-15124.

  Patient problems: Crushing Injury; Deformity/ Disfigurement

  MAUDE report 18504585 ↗
• InjuryDec 26, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 395CC MENTOR MEMORYSHAPE BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA MAMMOGRAM/ULTRASOUND, WITH LEFT BREAST IMPLANT RUPTURE. THE PATIENT ALSO FELL PRIOR TO THE RUPTURE. AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2023.

  Patient problems: Crushing Injury; Deformity/ Disfigurement

  MAUDE report 18394743 ↗
• InjuryAug 1, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 60-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH 395CC MENTOR MEMORYSHAPE BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT EXPERIENCED CALCIFICATIONS IN THE RIGHT BREAST AND FLUID AROUND THE LEFT BREAST IMPLANT, WHICH WERE CONFIRMED VIA MAMMOGRAM. THE PATIENT THEN HAD A LEFT-SIDED ULTRASOUND-GUIDED FLUID ASPIRATION, WHERE SEROUS FLUID WAS COLLECTED. A PATHOLOGY REPORT WAS PROVIDED, AND THERE WAS NO EVIDENCE OF ANAPLASTIC LARGE CELL LYMPHOMA OR MALIGNANCY. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH 480CC MENTOR MEMORYGEL BOOST BREAST IMPLANTS ON (B)(6) 2023. DURING THE EXPLANTATION PROCEDURE, 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. THIS REPORT IS FOR THE LEFT IMPLANT. REFER TO MANUFACTURING REPORT NUMBER 1645337-2023-08916 FOR THE CONTRALATERAL EVENT.

  Patient problems: Capsular Contracture; Seroma

  MAUDE report 17432758 ↗
• InjuryJul 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 60-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH 395CC MENTOR MEMORYSHAPE BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT EXPERIENCED CALCIFICATIONS IN THE RIGHT BREAST AND FLUID AROUND THE LEFT BREAST IMPLANT, WHICH WERE CONFIRMED VIA MAMMOGRAM. THE PATIENT THEN HAD A LEFT-SIDED ULTRASOUND-GUIDED FLUID ASPIRATION, WHERE SEROUS FLUID WAS COLLECTED. A PATHOLOGY REPORT WAS PROVIDED, AND THERE WAS NO EVIDENCE OF ANAPLASTIC LARGE CELL LYMPHOMA OR MALIGNANCY. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH 480CC MENTOR MEMORYGEL BOOST BREAST IMPLANTS ON (B)(6) 2023. DURING THE EXPLANTATION PROCEDURE, 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. THIS REPORT IS FOR THE RIGHT IMPLANT. REFER TO MANUFACTURING REPORT NUMBER 1645337-2023-08915 FOR THE CONTRALATERAL EVENT.

  Patient problems: Calcium Deposits/Calcification

  MAUDE report 17427419 ↗
• InjuryDec 7, 2022Adverse 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 PRIMARY BREAST AUGMENTATION WITH TWO 395CC MENTOR MEMORYSHAPE BREAST IMPLANTS AND SUFFERED SPONTANEOUS RIGHT BREAST IMPLANT RUPTURE, POST-OPERATIVELY. THE RUPTURE WAS CONFIRMED BY A MAMMOGRAM AND AN MRI. AS A RESULT, THE PATIENT UNDERWENT BILATERAL BREAST IMPLANT REMOVAL AND REPLACEMENT SURGERY ON (B)(6) 2022. THE LEFT BREAST CAPSULE WAS DISCOVERED TO BE THICKENED. SUBSEQUENTLY, THE PATIENT UNDERWENT BILATERAL CAPSULECTOMIES AND REPLACEMENT WITH THE FOLLOWING DEVICES: (RIGHT) 450CC MENTOR MEMORYGEL BOOST BREAST IMPLANT CATALOG: SMPB450 LOT: 9782949 SN: (B)(4) AND (LEFT) 450CC MENTOR MEMORYGEL BOOST BREAST IMPLANT CATALOG: SMPB450 LOT: 9716316 SN: (B)(4). THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS. COMPLICATION ON THE RIGHT BREAST/IMPLANT HAS BEEN REPORTED UNDER MRN: 1645337-2022-09344.

  Patient problems: Capsular Contracture

  MAUDE report 15937018 ↗
• InjurySep 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS EVENT IS ASSOCIATED WITH THE GLOW CLINICAL TRIAL. IT WAS REPORTED THAT A FEMALE PATIENT WHO UNDERWENT AUGMENTATION SURGERY WITH MENTOR GLOW STUDY GEL DEVICES ON (B)(6) 2015. ADVERSE EVENT # 1. IMPLANT PALPABILITY/ VISIBILITY, (LEFT SIDE, IMPLANT SERIAL NUMBER: (B)(4) DOI: (B)(6) 2015). ON (B)(6) 2016, SHE PRESENTED WITH IMPLANT PALPABILITY/ VISIBILITY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THE PRINCIPAL INVESTIGATOR ASSESSED THIS EVENT AS MILD IN SEVERITY, NON-SERIOUS, PROBABLY RELATED TO THE DEVICE. SHOULD MORE INFORMATION BECOME AVAILABLE, THIS NOTE WILL BE UPDATED AND CASE REASSESSED.

  Patient problems: Wrinkling

  MAUDE report 15340266 ↗
• InjuryAug 11, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 44-YEAR OLD CAUCASIAN FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 395CC MENTOR MEMORYSHAPE BREAST IMPLANTS AND SUFFERED SPONTANEOUS RIGHT BREAST IMPLANT RUPTURE, POST-OPERATIVELY. THE RUPTURE WAS CONFIRMED BY A MAMMOGRAM AND AN 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 15211101 ↗
• InjuryApr 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 A BREAST RECONSTRUCTION PROCEDURE WITH A MENTOR MEMORYSHAPE BREAST IMPLANT 395CC GEL DEVELOPED MUSCLE ACHES IN HER LEFT BREAST POST IMPLANTATION. THE PATIENT HAS AN IMPLANT IN ONLY HER LEFT BREAST. THE PATIENT REPORTED THAT SHE HAS BEEN SUFFERING FROM THE MUSCLE ACHES EVER SINCE SHE HAD HER SURGERY. 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 14136368 ↗
• InjuryJan 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) HISPANIC FEMALE PATIENT UNDERWENT PRIMARY BREAST RECONSTRUCTION SURGERY WITH 395CC MENTOR MEMORYSHAPE BREAST IMPLANT AND EXPERIENCED LEFT SIDE CAPSULAR CONTRACTURE; BAKER GRADE IV, AND LOCAL REACTION AS POCKET OF FLUID PALPATED AT THE LEFT UPPER OUTER QUADRANT IN THE TAIL OF SPENCE REGION. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Capsular Contracture; Local Reaction

  MAUDE report 13290475 ↗
• InjuryMay 19, 2021Adverse 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 BREAST RECONSTRUCTION PRIMARY WITH A MENTOR MEMORYSHAPE BREAST IMPLANT 395CC AND SUFFERED FROM A CAPSULAR CONTRACTURE ON THE RIGHT BREAST IMPLANT. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Capsular Contracture

  MAUDE report 11851977 ↗
• InjuryFeb 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A CAUCASIAN FEMALE PATIENT WHO UNDERWENT A BREAST AUGMENTATION REVISION WITH 395CC MENTOR MEMORYSHAPE BREAST IMPLANT EXPERIENCED INTERMITTENT BILATERAL BREAST PAIN POSTOPERATIVELY. IN ADDITION, THE PATIENT WAS ALSO DIAGNOSED WITH SKIN CANCER. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION WITHOUT REPLACEMENT ON (B)(6) 2021. THIS MEDWATCH REPORT IS FOR THE LEFT-SIDED IMPLANT.

  Patient problems: Breast Discomfort/Pain; Cancer; Cyst(s); Seroma

  MAUDE report 11390898 ↗
• InjuryFeb 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A CAUCASIAN FEMALE PATIENT WHO UNDERWENT A BREAST AUGMENTATION REVISION WITH 395CC MENTOR MEMORYSHAPE BREAST IMPLANT EXPERIENCED INTERMITTENT BILATERAL BREAST PAIN POSTOPERATIVELY. IN ADDITION, THE PATIENT WAS ALSO DIAGNOSED WITH SKIN CANCER. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION WITHOUT REPLACEMENT ON (B)(6) 2021. THIS MEDWATCH REPORT IS FOR THE RIGHT-SIDED IMPLANT.

  Patient problems: Breast Discomfort/Pain; Cancer; Seroma; Swollen Lymph Nodes/Glands

  MAUDE report 11390897 ↗
• InjuryNov 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FEMALE PATIENT UNDERWENT BREAST SURGERY WITH 395CC SALINE MENTOR MEMORYSHAPE BREAST IMPLANTS AND EXPERIENCED CAPSULAR CONTRACTURE ON THE RIGHT SIDE POSTOPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT DEVICE REMOVAL ON AN UNSPECIFIED DATE.

  Patient problems: Capsular Contracture; No Code Available

  MAUDE report 10880724 ↗
• 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 RIGHT BREAST PROSTHESIS.

  Patient problems: No Code Available

  MAUDE report 10228587 ↗