Natrelle Inspira SoftTouch Breast Implants SSL-200Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 10888628032514), received between Oct 3, 2019 and Apr 20, 2026 — classified as 20 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (13 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 18, 2026.

Most reported problems

Recent adverse event reports

The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• InjuryApr 20, 2026Device Appears to Trigger Rejection; Material Rupture

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

  Patient problems: Capsular Contracture

  MAUDE report 24934026 ↗
• InjuryMar 16, 2026Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III, CHANGE SHAPE/SIZE/STYLE". THIS RECORD IS FOR THE LEFT SIDE. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 24612628 ↗
• InjuryAug 12, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE IV. THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 22786523 ↗
• InjuryJul 8, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "CAPSULAR CONTRACTURE BAKER GRADE IV". DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 22442311 ↗
• InjuryJul 6, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III". THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 22408524 ↗
• InjuryJun 17, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "GRADE III CAPSULAR CONTRACTURE." THE DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 22236088 ↗
• InjuryJun 16, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE "GRADE IV CAPSULAR CONTRACTURE." THE DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 22215510 ↗
• InjuryJun 9, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 22169030 ↗
• InjuryFeb 29, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCRE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE, BAKER GRADE III ". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 18806655 ↗
• InjuryFeb 27, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN ". THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 18791214 ↗
• InjuryOct 4, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  PATIENT REPORTED LEFT SIDE "HAS ALSO TIGHTENED UP" AND "BOTH BREASTS ARE MISSHAPEN." DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 15540049 ↗
• InjuryDec 16, 2021Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED VIA NBIR A LEFT SIDE RUPTURE, CAPSULAR CONTRACTURE, BAKER GRADE III, MIGRATION, AND CORRECTION OF ASYMMETRY. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 13019357 ↗
• InjuryMar 29, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE IV. DEVICE HAS BEEN EXPLANTED AND DISCARDED AFTER SURGERY.

  Patient problems: Capsular Contracture

  MAUDE report 11580866 ↗
• InjuryNov 9, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE REASON FOR REMOVAL AS "CAPSULAR CONTRACTURE,¿ BAKER GRADE NOT SPECIFIED. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 10808887 ↗
• InjuryNov 6, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 10802286 ↗
• InjurySep 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED ¿RIGHT SIDE INFECTED¿. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 10508170 ↗
• InjuryApr 8, 2020Material Rupture; Patient-Device Incompatibility; Material Rupture; Patient-Device Incompatibility

  DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 9941238 ↗
• InjuryMar 6, 2020Material Rupture; Material Rupture

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

  Patient problems: Failure of Implant

  MAUDE report 9798819 ↗
• InjuryMar 4, 2020Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "BILATERAL RUPTURED SILICONE IMPLANTS LESS THAN FIVE YEARS AFTER THE IMPLANTS WERE PLACED." DEVICE HAS BEEN EXPLANTED. THIS RECORD IS FOR THE LEFT SIDE.

  Patient problems: Failure of Implant

  MAUDE report 9786220 ↗
• InjuryOct 3, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 9153545 ↗

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
• 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-
• 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,TR