MENTOR SILTEX CONTOUR PROFILE SPECTRUM 3542514Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00081317002161), received between Oct 24, 2018 and Dec 12, 2025 — classified as 11 injuries.

The most frequently reported specific device problem is “Material Rupture” (7 reports).

2 other recalls cover devices cleared under the same FDA submission (P990075); they may or may not involve this specific model.

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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryDec 12, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF AN UNDISCLOSED MENTOR TEXTURED SALINE IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT UNDERWENT BILATERAL EXCHANGE WITH MENTOR GEL IMPLANTS ON (B)(6) 2025. A DEFLATED RIGHT IMPLANT WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 23791397 ↗
• InjuryMay 9, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE WHO UNDERWENT BREAST RECONSTRUCTION REVISION WITH A MENTOR SILTEX CONTOUR PROFILE SPECTRUM 550CC SALINE PROSTHESIS EXPERIENCED SPONTANEOUS LEFT SIDED DEFLATION POST PROCEDURE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 14341983 ↗
• InjurySep 21, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE WHO UNDERWENT PRIMARY BREAST RECONSTRUCTION WITH A MENTOR SILTEX CONTOUR PROFILE SPECTRUM 550CC SALINE PROSTHESIS EXPERIENCED SPONTANEOUS LEFT SIDED DEFLATION POST PROCEDURE. THE DEVICE BECAME SMALLER AND BEGAN TO APPEAR CONCAVE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 12509731 ↗
• InjuryNov 5, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION REVISION WITH SALINE MENTOR SILTEX CONTOUR PROFILE SPECTRUM 550CC BREAST IMPLANT AND EXPERIENCED DEFLATION ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT REMOVAL ON (B)(6) 2020.

  Patient problems: No Code Available

  MAUDE report 10794515 ↗
• InjuryNov 4, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) FEMALE WHO UNDERWENT BREAST RECONSTRUCTION PRIMARY WITH A 550 CC MENTOR SILTEX CONTOUR PROFILE SPECTRUM, SALINE BREAST IMPLANT EXPERIENCED RIGHT SIDED DEFLATION POST PROCEDURE. THE DEFLATION WAS DIAGNOSED BY A PHYSICIAN. AS A RESULT, THE DEVICE WAS EXPLANTED ON (B)(6) 2020.

  Patient problems: No Code Available

  MAUDE report 10786244 ↗
• InjuryOct 29, 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 WHO UNDERWENT PRIMARY BREAST RECONSTRUCTION SURGERY WITH MENTOR SILTEX CONTOUR PROFILE SPECTRUM IMPLANTS (SPEC SILTEX CONTOUR 550CC, DATE OF IMPLANTATION (B)(6) 2010) WAS DIAGNOSED WITH PRIMARY RIGHT BREAST BIA-ALCL IN (B)(6) 2020. THE PATIENT ALSO HAD A RECENT DIAGNOSIS OF LEFT SIDED METASTATIC DISEASE (LEFT BREAST CANCER RECURRENCE WHICH SPREAD TO THE LEFT AXILLA AND SKIN). AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION OF THE DEVICES ON (B)(6) 2020. REFERENCE MANUFACTURER'S REPORT NUMBER 1645337-2020-13478 FOR THE LEFT-SIDED EVENT. IN 2010, THE PATIENT WAS DIAGNOSED WITH LEFT BREAST CANCER. SHE RECEIVED CHEMOTHERAPY. SUBSEQUENTLY, SHE UNDERWENT A BILATERAL SIMPLE MASTECTOMY WITH SENTINEL LYMPH NODE MAPPING ON (B)(6) 2010 WITH IMMEDIATE RECONSTRUCTION USING ALLODERM AND PLACEMENT OF THE MENTOR SILTEX CONTOUR PROFILE SPECTRUM IMPLANTS BILATERALLY. THUS, THE PATIENT HAS ONLY HAD A MENTOR BRAND EXCLUSIVE IMPLANT HISTORY WITH THE MENTOR SPECTRUM IMPLANTS BEING HER FIRST AND ONLY SET OF IMPLANTS. IN (B)(6) 2020, THE PATIENT REPORTED TRAUMA TO HER BREAST WHICH OCCURRED AFTER A FALL. THE FALL OCCURRED A MONTH PRIOR. SHE RE

  Patient problems: Anaplastic Large Cell Lymphoma; Breast Mass; Injury; No Code Available; Seroma

  MAUDE report 10757805 ↗
• InjuryOct 29, 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 WHO UNDERWENT PRIMARY BREAST RECONSTRUCTION SURGERY WITH MENTOR SILTEX CONTOUR PROFILE SPECTRUM IMPLANTS (SPEC SILTEX CONTOUR 550CC, DATE OF IMPLANTATION (B)(6) /2010) SECONDARY TO LEFT-SIDED INVASIVE LOBULAR CARCINOMA EXPERIENCED A RECENT DIAGNOSIS OF LEFT SIDED METASTATIC DISEASE (LEFT BREAST CANCER RECURRENCE WHICH SPREAD TO THE LEFT AXILLA AND SKIN). IN 2010, THE PATIENT WAS DIAGNOSED WITH LEFT BREAST CANCER AND RECEIVED CHEMOTHERAPY. SUBSEQUENTLY, SHE UNDERWENT A BILATERAL SIMPLE MASTECTOMY WITH SENTINEL LYMPH NODE MAPPING ON (B)(6) 2010 WITH IMMEDIATE RECONSTRUCTION USING ALLODERM AND PLACEMENT OF THE MENTOR SILTEX CONTOUR PROFILE SPECTRUM IMPLANTS BILATERALLY. ON (B)(6) 2020, THE PATIENT UNDERWENT AN MRI. THE MRI DISPLAYED THE LEFT BREAST MALIGNANCY WHICH CORRESPONDS TO A SPICULATED MASS. THE PATIENT HAS NOW UNDERGONE BILATERAL REMOVAL OF IMPLANTS AND CAPSULECTOMIES AS A RESULT OF THIS CANCER RECURRENCE, AS WELL AS A BIA-ALCL DIAGNOSIS ON THE CONTRALATERAL SIDE (REFERENCE MANUFACTURER'S REPORT NUMBER 1645337-2020-13475). THE EXPLANT TOOK PLACE ON (B)(6) 2020, AND THE PATIENT DID NOT RECEIVE REPLACEMENTS. THIS RE

  Patient problems: Cancer; No Code Available

  MAUDE report 10757729 ↗
• InjuryFeb 4, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT WHO UNDERWENT A BREAST RECONSTRUCTION PRIMARY WITH A 550CC TEXTURED MENTOR SILTEX CONTOUR PROFILE SPECTRUM SALINE BREAST IMPLANT HAS EXPERIENCED POSTOPERATIVE RIGHT-SIDED DEFLATION, CONFIRMED BY A PHYSICIAN. AS A RESULT, THE PATIENT UNDERWENT UNILATERAL EXPLANTATION AND REPLACEMENT WITH UNSPECIFIED BREAST IMPLANT ON (B)(6) 2020.

  Patient problems: No Code Available

  MAUDE report 9667754 ↗
• InjuryNov 21, 2019Adverse 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 RECONSTRUCTION PRIMARY WITH A 550CC TEXTURED MENTOR SILTEX CONTOUR PROFILE SPECTRUM SALINE BREAST IMPLANT AND EXPERIENCED POSTOPERATIVE BILATERAL CAPSULAR CONTRACTURE, BAKER GRADE 3 OR 4, CONFIRMED BY A PHYSICIAN. PATIENT REPORTED THAT SHE¿S A CANCER SURVIVOR AND SHE EXPERIENCED TIGHTNESS AND HARDNESS ON BOTH BREASTS, AND BOTH IMPLANTS NEVER DROPPED. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION WITHOUT REPLACEMENT ON (B)(6) 2019. THIS MEDWATCH REPORT IS FOR THE LEFT-SIDED IMPLANT.

  Patient problems: Capsular Contracture; No Code Available

  MAUDE report 9356251 ↗
• InjuryNov 21, 2019Adverse 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 RECONSTRUCTION PRIMARY WITH A 550CC TEXTURED MENTOR SILTEX CONTOUR PROFILE SPECTRUM SALINE BREAST IMPLANT AND EXPERIENCED POSTOPERATIVE BILATERAL CAPSULAR CONTRACTURE, BAKER GRADE 3 OR 4, CONFIRMED BY A PHYSICIAN. PATIENT REPORTED THAT SHE¿S A CANCER SURVIVOR AND SHE EXPERIENCED TIGHTNESS AND HARDNESS ON BOTH BREASTS, AND BOTH IMPLANTS NEVER DROPPED. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION WITHOUT REPLACEMENT ON (B)(6) 2019. THIS MEDWATCH REPORT IS FOR THE RIGHT-SIDED IMPLANT.

  Patient problems: Capsular Contracture; No Code Available

  MAUDE report 9356179 ↗
• InjuryOct 24, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6)-YEAR-OLD FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION REVISION WITH A SALINE MENTOR SILTEX CONTOUR PROFILE SPECTRUM 550CC AND EXPERIENCED DEFLATION ON THE RIGHT BREAST IMPLANT. THE DEFLATION WAS CONFIRMED BY THE HEALTHCARE PROFESSIONAL. AS A RESULT, THE PATIENT HAD UNDERGONE REMOVAL AND REPLACEMENT WITH GEL MENTOR MEMORYGEL BREAST IMPLANT 275CC, CATALOG NUMBER 3502754BC, SERIAL NUMBER (B)(4), LOT NUMBER 7599716 ON (B)(6) 2018.

  Patient problems: No Code Available

  MAUDE report 8001950 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P990075. One submission often covers many models, so check the product and lot details in each record.

• Z-0367-2022 · Sep 30, 2021 · Open, Classified
  MENTOR Saline-Filled Breast Implants are constructed from room temperature vulcanized silicone elastomer, made of polydimethylsiloxane. Surgeons inflate the silicone elastomer shel
• Z-2070-2017 · Mar 27, 2017 · Terminated
  Mentor Smooth Round SPECTRUM Post- Operatively Adjustable Saline Breast Implant, Product Code: 350-1490, UDI/GTIN: 00081317002048