MENTOR MemoryGel Breast Implant 3544550Recalls & reported problems

Summary

The FDA's MAUDE database contains 74 adverse event reports that list this exact device (DI 00081317001126), received between Mar 18, 2019 and May 6, 2026 — classified as 73 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Rupture” (35 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 74 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 6, 2026Appropriate Device Problem Term/Code Not Available

  ONE 550CC MENTOR MEMORYGEL BREAST IMPLANT (PATIENT'S RIGHT SIDE) WAS RECEIVED BY THE MENTOR FAILURE ANALYSIS LAB ON APRIL 28, 2026, WITH NO ACCOMPANYING INFORMATION. THE DEVICE WAS RECEIVED WITH NO COMPLAINT INFORMATION ATTACHED OR ASSOCIATED WITH AN EXISTING COMPLAINT. ON (B)(6) 2026, THE PRODUCT INVESTIGATION DETERMINED THAT THE BREAST PROSTHESIS HAD A TEAR ON THE POSTERIOR VIEW, BETWEEN THE UNION OF THE SHELL AND PATCH. THIS WILL BE CONSERVATIVELY REPORTED TO FDA. THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25107888 ↗
• InjuryDec 10, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT WITH MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED RUPTURE ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 23770096 ↗
• InjuryOct 29, 2025Migration; Migration

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH TWO 550CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED BILATERAL DEVICE MIGRATIONS AND BREAST PAIN POST-OPERATIVELY. 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 23414788 ↗
• InjuryOct 29, 2025Migration; Migration

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH TWO 550CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED BILATERAL DEVICE MIGRATIONS AND BREAST PAIN POST-OPERATIVELY. 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 23414784 ↗
• InjuryMar 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT, WITH A HISTORY OF INVASIVE DUCTAL CARCINOMA IN THE RIGHT BREAST DIAGNOSED IN (B)(6) 2016, UNDERWENT BREAST RECONSTRUCTION SURGERY WITH TWO 550CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH RIGHT-SIDED BREAST IMPLANT ASSOCIATED ANAPLASTIC LARGE CELL LYMPHOMA (BIA-ALCL). THE PATIENT ALSO PRESENTED WITH A RIGHT-SIDED LATE ONSET SEROMA. AS A RESULT, THE PATIENT UNDERWENT RIGHT BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2025. 1,000 CC OF FLUID WAS COLLECTED FROM THE RIGHT BREAST AND SENT TO PATHOLOGY. THE POST-OPERATIVE PATHOLOGY REPORT READS AS FOLLOWS: RIGHT BREAST SEROMA: LARGE, ATYPICAL CELLS CONSISTENT WITH BREAST IMPLANT-ASSOCIATED ANAPLASTIC LARGE CELL LYMPHOMA. BY IMMUNOHISTOCHEMISTRY THE LARGE CELLS EXPRESS CD30 (STRONG) AND ARE NEGATIVE FOR ALK1. THE OVERALL FINDINGS INCLUDING THE HISTORY AND LOCATION ARE CONSISTENT WITH BREAST IMPLANT-ASSOCIATED ANAPLASTIC LARGE CELL LYMPHOMA. ON (B)(6) 2025, THE PATIENT UNDERWENT RIGHT BREAST IMPLANT REPLACEMENT SURGERY. DURING THE SURGERY, THE PATIENT WAS DIAGNOSED WITH LEFT BREAST CAPSULAR CONTRACTURE (BAKER GRADE UNSPECIFIED), AND UNDERWENT LEFT BREAST CAPSULECTOMY AND B

  Patient problems: Capsular Contracture

  MAUDE report 21655031 ↗
• InjuryMar 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT, WITH A HISTORY OF INVASIVE DUCTAL CARCINOMA IN THE RIGHT BREAST DIAGNOSED IN (B)(6) 2016, UNDERWENT PRIMARY BREAST RECONSTRUCTION SURGERY WITH TWO 550CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH RIGHT-SIDED BREAST IMPLANT ASSOCIATED ANAPLASTIC LARGE CELL LYMPHOMA (BIA-ALCL). THE PATIENT ALSO PRESENTED WITH A RIGHT-SIDED LATE ONSET SEROMA. AS A RESULT, THE PATIENT ALSO UNDERWENT BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2025. 1,000 CC OF FLUID WAS COLLECTED FROM THE RIGHT BREAST AND SENT TO PATHOLOGY. THE POST-OPERATIVE PATHOLOGY REPORT READS AS FOLLOWS: RIGHT BREAST SEROMA: LARGE, ATYPICAL CELLS CONSISTENT WITH BREAST IMPLANT-ASSOCIATED ANAPLASTIC LARGE CELL LYMPHOMA. BY IMMUNOHISTOCHEMISTRY THE LARGE CELLS EXPRESS CD30 (STRONG) AND ARE NEGATIVE FOR ALK1. THE OVERALL FINDINGS INCLUDING THE HISTORY AND LOCATION ARE CONSISTENT WITH BREAST IMPLANT-ASSOCIATED ANAPLASTIC LARGE CELL LYMPHOMA. ON FEBRUARY 26, 2025, THE PATIENT UNDERWENT LEFT BREAST CAPSULECTOMY AND BILATERAL BREAST IMPLANT EXCHANGE WITH TWO MENTOR 545CC SMOOTH ROUND GEL IMPLANTS.

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

  MAUDE report 21598628 ↗
• InjuryDec 4, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH A 500CC MENTOR MEMORYGEL BREAST IMPLANT (LEFT) AND A 550CC MENTOR MEMORYGEL BREAST IMPLANT (RIGHT) EXPERIENCED SPONTANEOUS BILATERAL RUPTURE AND BILATERAL BAKER GRADE III CAPSULAR CONTRACTURE POST PROCEDURE. AS A RESULT, REPLACEMENT WITH MENTOR GEL BOOST WAS PERFORMED ON (B)(6) 2024 .

  Patient problems: Capsular Contracture

  MAUDE report 20846652 ↗
• InjuryOct 30, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION PROCEDURE WITH A MENTOR MEMORYGEL BREAST IMPLANT 550CC GEL BREAST PROSTHESIS THAT RUPTURED POST IMPLANTATION. RUPTURE OF THE PATIENT¿S LEFT BREAST PROSTHESIS WAS DIAGNOSED VIA ULTRASOUND. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH NATRELLE INSPIRA GEL BREAST PROSTHESES ON (B)(6) 2024.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 20569807 ↗
• InjuryApr 24, 2024Material Rupture; Material Rupture

  ON MARCH 14, 2024, MENTOR RECEIVED TWO 550CC MENTOR MEMORYGEL BREAST IMPLANTS THAT COULD NOT ASSOCIATED WITH ANY WITH ANY EXISTING COMPLAINT FILE. ON APRIL 10, 2024, ANALYSIS OF THESE DEVICES REVEALED EVIDENCE OF POSSIBLE DEVICE RUPTURE. THESE DEVICES WERE EXPLANTED ON (B)(6) 2024. SEE 1645337-2024-04852 FOR CONTRALATERAL PROSTHESIS REPORT.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 19174117 ↗
• InjuryApr 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A MENTOR MEMORYGEL, 550CC SILICONE BREAST IMPLANT EXPERIENCED BILATERAL CAPSULAR CONTRACTURES UNKNOWN GRADE, BILATERAL PTOSIS, RIGHT SIDED BREAST LYMPHADENOPATHY AND SYMPTOMATIC RUPTURE POSTOPERATIVE. THE REPORT STATED THAT THE RIGHT IMPLANT IS LEAKING, AND THERE IS A GOLF BALL SIZE LUMP UNDER HER ARM. MULTIPLE SCANS AND BIOPSY WERE PERFORMED. MENTOR HASN'T RECEIVED ANY REPORT AS OF NOW. AS A RESULT, PATIENT UNDERWENT BILATERAL CAPSULECTOMY, MASTOPEXY, RIGHT SIDED LYMPH NODE EXCISION, AND BILATERAL REPLACEMENTS AS FOLLOW: L CAT:SMHB545 SN: (B)(6)/ R CAT:SMHB545 SN: (B)(6) ON (B)(6) 2024. THIS REPORT RELATES TO THE LEFT SIDE.

  Patient problems: Capsular Contracture

  MAUDE report 19044497 ↗
• InjuryFeb 23, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT WHO UNDERWENT AN UNKNOWN BREAST RECONSTRUCTION PRIMARY WITH A MENTOR MEMORYGEL, 550CC SILICONE, BREAST IMPLANT EXPERIENCED BILATERAL SILENT RUPTURE POSTOPERATIVE. THE ISSUE WAS CONFIRMED THROUGH MAMMOGRAM EXAMINATION. AS A RESULT, PATIENT UNDERWENT BILATERAL REMOVAL ON (B)(6) 2024. THIS REPORT RELATES TO ONE OF THE TWO SIDES.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18773035 ↗
• InjuryFeb 23, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT WHO UNDERWENT AN UNKNOWN BREAST RECONSTRUCTION PRIMARY WITH A MENTOR MEMORYGEL, 550CC SILICONE, BREAST IMPLANT EXPERIENCED BILATERAL SILENT RUPTURE POSTOPERATIVE. THE ISSUE WAS CONFIRMED THROUGH MAMMOGRAM EXAMINATION. AS A RESULT, PATIENT UNDERWENT BILATERAL REMOVAL ON (B)(6) 2024. THIS REPORT RELATES TO ONE OF THE TWO SIDES.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18773012 ↗
• InjuryFeb 22, 2024Migration; Migration

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST RECONSTRUCTION REVISION SURGERY WITH A 550CC MENTOR MEMORYGEL BREAST IMPLANT. POST-OPERATIVELY, THE PATIENT OBSERVED THAT HER RIGHT PROSTHESIS WAS POKING OUT THROUGH HER MUSCLE. THE PATIENT HAS CONSULTED WITH A MEDICAL PROFESSIONAL, BUT AT THE TIME OF THIS REPORT, MENTOR HAS 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

  MAUDE report 18764497 ↗
• InjuryFeb 9, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 550CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT SUFFERED LEFT BREAST IMPLANT RUPTURE. AS A RESULT, THE PATIENT UNDERWENT BILATERAL BREAST IMPLANT REMOVAL AND REPLACEMENT SURGERY ON (B)(6) 2023. THE REPLACEMENT DEVICES WERE: (LEFT) 700CC MENTOR MEMORYGEL XTRA BREAST IMPLANT CATALOG: SHPX700 LOT: 9944292 SN: (B)(6) AND (RIGHT) 700CC MENTOR MEMORYGEL XTRA BREAST IMPLANT CATALOG: SHPX700 LOT: 9570190 SN: (B)(6). UPON RECEIPT AND EVALUATION OF THE SUSPECT MEDICAL DEVICE AND THE CONTRALATERAL DEVICE (RIGHT IMPLANT), BOTH WERE FOUND TO BE RUPTURED. THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18681619 ↗
• InjuryFeb 7, 2024Material Rupture; Appropriate Device Problem Term/Code Not Available; Material Rupture; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 550CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED A RUPTURE ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6), 2024.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18661757 ↗
• InjuryNov 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH 550CC MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED LEFT SIDED RUPTURE, BILATERAL CAPSULAR CONTRACTURE, AND BILATERAL PTOSIS POST PROCEDURE. THE RUPTURE WAS DISCOVERED DURING EXPLANT. CAPSULECTOMY, CAPSULORRHAPHY, MASTOPEXY, AND IMPLANT REPLACEMENT WITH SILICONE DEVICES WAS PERFORMED ON (B)(6) 2023. SEE 1645337-2023-13311 FOR CONTRALATERAL PROSTHESIS REPORT.

  Patient problems: Capsular Contracture

  MAUDE report 18103053 ↗
• InjuryNov 9, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH 550CC MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED LEFT SIDED RUPTURE, BILATERAL CAPSULAR CONTRACTURE, AND BILATERAL PTOSIS POST PROCEDURE. THE RUPTURE WAS DISCOVERED DURING EXPLANT. CAPSULECTOMY, CAPSULORRHAPHY, MASTOPEXY, AND IMPLANT REPLACEMENT WITH SILICONE DEVICES WAS PERFORMED ON (B)(6) 2023. SEE 1645337-2023-13310 FOR CONTRALATERAL PROSTHESIS REPORT.

  Patient problems: Capsular Contracture

  MAUDE report 18103051 ↗
• InjuryNov 1, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A MENTOR MEMORYGEL, 550CC SILICONE BREAST IMPLANT EXPERIENCED RIGHT SIDED BREAST LYMPHADENOPATHY AND SYMPTOMATIC RUPTURE POSTOPERATIVE. THE REPORT STATED THAT THE RIGHT IMPLANT IS LEAKING, AND THERE IS A GOLF BALL SIZE LUMP UNDER HER ARM. MULTIPLE SCANS AND BIOPSY WERE PERFORMED. MENTOR HASN'T RECEIVED ANY REPORT AS OF NOW. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Capsular Contracture; Swollen Lymph Nodes/Glands

  MAUDE report 18048868 ↗
• InjuryOct 23, 2023Adverse 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 RECONSTRUCTION SURGERY WITH A LEFT-SIDED 550CC MENTOR MEMORYGEL BREAST IMPLANT AND A RIGHT-SIDED 600CC MENTOR MEMORYGEL BREAST IMPLANT. POST-OPERATIVELY, THE PATIENT EXPERIENCED BAKER GRADE II CAPSULAR CONTRACTURE OF THE LEFT BREAST AND BAKER GRADE III CAPSULAR CONTRACTURE OF THE RIGHT BREAST. IT WAS ALSO REPORTED THAT THE PATIENT EXPERIENCED A RUPTURE OF HER RIGHT PROSTHESIS, WHICH WAS CONFIRMED VIA MAGNETIC RESONANCE IMAGING. AS A RESULT, THE PATIENT IS SCHEDULED FOR REMOVAL SURGERY ON (B)(6) 2023. THIS REPORT IS FOR THE LEFT IMPLANT. REFER TO MANUFACTURING REPORT NUMBER 1645337-2023-12506 FOR THE CONTRALATERAL EVENT.

  Patient problems: Capsular Contracture

  MAUDE report 17986874 ↗
• InjurySep 20, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 550CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT SUFFERED 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 17785867 ↗
• InjuryAug 1, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 44-YEAR OLD CAUCASIAN FEMALE PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH TWO 550CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA PHYSICAL EXAMINATION, WITH LEFT BREAST ASYMMETRY, CAPSULAR CONTRACTURE (BAKER GRADE I), AND BREAST IMPLANT RUPTURE. AS A RESULT, THE PATIENT UNDERWENT BILATERAL BREAST IMPLANT REMOVAL AND REPLACEMENT ON (B)(6) 2023. THE REPLACEMENT DEVICES WERE: (LEFT) 650CC MENTOR MEMORYGEL XTRA BREAST IMPLANT CATALOG: SHPX650 LOT: 9794999 SN: (B)(6) AND (RIGHT) 650CC MENTOR MEMORYGEL XTRA BREAST IMPLANT CATALOG: SHPX650 LOT: 9621870 SN: (B)(6).

  Patient problems: Deformity/ Disfigurement

  MAUDE report 17439000 ↗
• InjuryMay 24, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 44-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A 550CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED A RUPTURE ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS DIAGNOSED DURING AN OFFICE VISIT. AS A RESULT, THE PATIENT IS TO UNDERGO EXPLANTATION ON (B)(6) 2023.

  Patient problems: Capsular Contracture; Deformity/ Disfigurement; Granuloma

  MAUDE report 16998166 ↗
• InjuryMay 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 49-YEAR-OLD FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 550CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED CAPSULAR CONTRACTURE (BAKER GRADE 4) ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2023.

  Patient problems: Capsular Contracture

  MAUDE report 16950289 ↗
• InjuryFeb 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 65-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A 500CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED CAPSULAR CONTRACTURE, BAKER GRADE 3 ON THE RIGHT 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 16374529 ↗
• InjuryDec 2, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 33-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH TWO 550CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED BILATERAL RUPTURES AND A CUTANEOUS CONTOUR DEFORMITY ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED VIA ULTRASOUND. 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 15908795 ↗