Natrelle Inspira SoftTouch Breast Implants SSL-230Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10888628032521), received between May 17, 2019 and Apr 16, 2026 — classified as 14 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (8 reports).

4 other recalls cover devices cleared under the same FDA submission (P020056); 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 16, 2026.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryApr 16, 2026Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED VIA NATIONAL BREAST IMPLANT REGISTRY (NBIR) MANUFACTURER REGISTRY SPECIFIC DATA REPORT (MRSDR) "CAPSULAR CONTRACTURE, BAKER GRADE III". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 24900482 ↗
• InjuryFeb 13, 2024Material Rupture; Material Rupture

  UN-REPORTING RUPTURE.

  Patient problems: Failure of Implant

  MAUDE report 18694879 ↗
• InjuryJun 7, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  PHYSICIAN REPORTED RIGHT SIDE CAPSULAR CONTRACTURE BAKER GRADE III. ADDITIONAL REPORT OF "INTACT GEL IMPLANT WAS REMOVED AND FOUND TO HAVE A PROMINENT CREASE DEFORMITY LATERALLY". DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 17080346 ↗
• InjuryJun 6, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE BAKER GRADE III AND MALPOSITION. DEVICE HAS BEEN EXPLANTED, REPLACED, AND DISCARDED.

  Patient problems: Capsular Contracture

  MAUDE report 17074683 ↗
• InjuryJun 5, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE BAKER GRADE III/IV. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 17066390 ↗
• InjuryMay 17, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 16944974 ↗
• InjuryMay 4, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 16873477 ↗
• InjuryMay 4, 2023Material Rupture; Material Rupture

  HEALTHCARE PROVIDER REPORTED LEFT SIDE INTRACAPSULAR RUPTURE CONFIRMED BY MRI. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 16873111 ↗
• InjuryAug 30, 2021Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE RUPTURE. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 12387825 ↗
• InjuryAug 9, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  PATIENT REPRESENTATIVE REPORTED RIGHT SIDE CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN, ¿BREAST WERE MIS-SHAPEN,¿ ¿OBVIOUS BULGING,¿ ¿BIT MORE FULLNESS IN THE UPPER BREAST,¿ ¿PALPABLE FOLDS,¿ ¿HARD,¿ ¿IMPLANT REMOVAL TO REDUCE RISK OF BIA-ALCL,¿ ¿LIVING IN A STATE OF DISTRESS AND FEAR OF AN UNDETECTED CANCER SINCE,¿ AND ¿SUFFERING FROM THE EMOTIONAL DISTRESS.¿ PATIENT REPRESENTATIVE ADDITIONALLY REPORTED ¿PALPABLE MASSES,¿ AND ¿PALPABLE LUMPS" NOT RELATED TO THE DEVICE. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 12298404 ↗
• InjuryJun 29, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  PATIENT REPRESENTATIVE REPORTED A LEFT SIDE ¿CAPSULAR CONTRACTURE,¿ BAKER GRADE UNKNOWN, ¿BREAST WAS MISSHAPEN AND HARD,¿ ¿OBVIOUS BULGING,¿ ¿PATIENT REQUESTED IMPLANT REMOVAL TO REDUCE RISK OF BIA-ALCL,¿ ¿LIVING IN A STATE OF DISTRESS AND FEAR OF AN UNDETECTED CANCER SINCE," ¿SUFFERING FROM THE EMOTIONAL DISTRESS," AND EXPERIENCING ¿PALPABLE FOLDS." PATIENT ADDITIONALLY REPORTED ¿PALPABLE MASSES¿ AND ¿PALPABLE LUMPS¿ WHICH HAS BEEN DEEMED TO BE NOT DEVICE RELATED. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 12088385 ↗
• InjuryNov 11, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE NOT SPECIFIED. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 10822131 ↗
• InjuryJan 29, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  HEALTHCARE PROFESSIONAL ADDITIONALLY REPORTED "CREASES". DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 9642529 ↗
• InjuryMay 17, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

  HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE CAPSULAR CONTRACTURE BAKER GRADE III. DEVICE WAS EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 8620903 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P020056. One submission often covers many models, so check the product and lot details in each record.

• Z-0701-2020 · Nov 6, 2019 · Terminated
  Natrelle Inspira Sillicone-Filled Breast Implants for the following Styles and Sizes: 7607 SSM, 7608 SSF, 7609 SSX, 7513 SRL, 7514 SRLP, 7515 SRM, 7516 SRF, 7517 SRX, 7626 SCL, 762
• Z-0700-2020 · Nov 6, 2019 · Terminated
  Natrelle Silicone Filled Breast Implants for the following Styles and Sizes: Style 10, Style 15, Style 20, Style 40, Style 45 Style 10/UDI: NATRELLE Style 10-180 Gel Round Mod 108
• Z-2454-2019 · Jul 24, 2019 · Open, Classified
  Natrelle and McGhan Silicone-Filled Breast Implant BioCell Round Moderate Profile, Sterile, for the following style numbers: Style 110:110-090, 110-120, 110-150, 110-180, 110-210,
• Z-2453-2019 · Jul 24, 2019 · Open, Classified
  Natrelle Inspira, Silicone-Filled Breast Implants, Sterile, for the following style numbers: Style TRL: TRL-110TRL-125,TRL-140,TRL-170,TRL-200,TRL-230,TRL-260,TRL-290,TRL-320,TRL-