Natrelle Inspira SoftTouch Breast Implants SSLP-440Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10888628032781), received between Nov 24, 2020 and Aug 9, 2026 — classified as 13 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (9 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryAug 9, 2026Device Appears to Trigger Rejection

  Healthcare professional reported "Capsular contracture" Baker Grade III. This record is for the right side. Device remains implanted. Patient was prescribed Singulair.

  Patient problems: Capsular Contracture

  MAUDE report 50188883 ↗
• InjuryMar 13, 2026Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "RUPTURE". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 24591845 ↗
• InjuryNov 2, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN". DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 18056277 ↗
• InjuryNov 1, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED ¿CAPSULAR CONTRACTURE¿ BAKER GRADE UNKNOWN. THIS RELATES TO THE LEFT SIDE. DEVICE WAS EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 18047018 ↗
• InjuryJul 3, 2023Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL ADDITIONALLY REPORTED "ANY CREASES," NO OBVIOUS HOLE," AND "SEEMED TO BE A SMALL ANT ON OUTSIDE SHELL." DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 17245594 ↗
• InjuryJun 30, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED CAPSULAR CONTRACTURE, BAKER GRADE IV.THE DEVICE HAS BEEN EXPLANTED. THIS RELATES TO THE LEFT SIDE.

  Patient problems: Capsular Contracture

  MAUDE report 17239887 ↗
• InjuryMay 1, 2023Material Rupture; Material Rupture

  PATIENT CALLED TO REPORT RIGHT SIDE DEFLATION AND THE IMPLANT WOULD MIGRATE TO THE RIGHT SIDE ARMPIT. HEALTHCARE PROFESSIONAL REPORTED A RIGHT SIDE RUPTURE DISCOVERED DURING SURGERY. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 16848492 ↗
• InjuryApr 20, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROVIDER REPORTED A LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III. THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 16779884 ↗
• InjuryApr 20, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROVIDER REPORTED A RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III. THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 16779640 ↗
• InjuryJan 13, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE EXCHANGE WITH NO COMPLAINT AGAINST THE DEVICE. HEALTHCARE PROFESSIONAL LATER REPORTED A CAPSULAR CONTRACTURE, BAKER GRADE III. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 16164898 ↗
• InjuryJan 13, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "BUCKLING". HEALTHCARE PROFESSIONAL LATER REPORTED A CAPSULAR CONTRACTURE BAKER GRADE III. DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 16156833 ↗
• InjuryJul 29, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED CAPSULAR CONTRACTURE, BAKER GRADE III, AGAINST LEFT SIDE DEVICE. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 15134332 ↗
• InjuryNov 24, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE BAKER GRADE III, SEVERE DISTORTION IMPLANT, AND THE BACK OF THE IMPLANT IS ACTUALLY FACING MEDIALLY. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 10896232 ↗

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