Natrelle Inspira Cohesive Breast Implants SCLP-360Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10888628029729), received between Jun 14, 2019 and May 20, 2025 — classified as 8 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (3 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryMay 20, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "BAKER 4 CAPSULAR CONTRACTURE". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 22057248 ↗
• InjuryAug 4, 2022Device Appears to Trigger Rejection; Adverse Event Without Identified Device or Use Problem; Device Appears to Trigger Rejection; Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTED RIGHT SIDE "INFECTION" AND THAT THEY "ALMOST DIED." THE DEVICE WAS EXPLANTED.

  Patient problems: Capsular Contracture; Unspecified Infection

  MAUDE report 15169938 ↗
• InjuryJun 1, 2022Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture

  PATIENT REPORTED LEFT SIDE RUPTURE. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture; Failure of Implant; Unspecified Infection

  MAUDE report 14569025 ↗
• InjuryOct 21, 2021Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE RUPTURE. DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 12677570 ↗
• InjuryOct 21, 2021Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE RUPTURE. DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 12673470 ↗
• InjuryNov 23, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "CAPSULAR CONTRACTURE, BAKER 3-4". DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 10886871 ↗
• InjuryJun 14, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

  PATIENT REPORTED LEFT SIDE, "CONTRACTED", BAKER GRADE NOT SPECIFIED. DEVICE WAS EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 8699704 ↗
• InjuryJun 14, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

  PATIENT REPORTED RIGHT SIDE, "CONTRACTED", BAKER GRADE NOT SPECIFIED. DEVICE WAS EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 8699594 ↗

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-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
• 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-