Natrelle INSPIRA Breast Implants SRLP-540Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10888628006973), received between Jan 31, 2020 and Dec 26, 2025 — classified as 15 injuries.

The most frequently reported specific device problem is “Material Rupture” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryDec 26, 2025Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED VIA NBIR "SUSPECTED/ACTUAL RUPTURE/DEFLATION, CHANGE SHAPE/SIZE/STYLE, PTOSIS". THIS RECORD IS FOR RIGHT SIDE. THE DEVICE WAS EXPLANTED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 23899141 ↗
• InjuryJun 12, 2025Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED RUPTURE CONFIRMED VIA IN-OFFICE ULTRASOUND FOR RIGHT SIDE. DEVICE WAS EXPLANTED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 22198988 ↗
• InjuryNov 29, 2023Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE RUPTURE WITH FOLD. HEALTHCARE PROFESSIONAL LATER REPORTED "ANY CREASES ASSOCIATED WITH HOLE OBSERVED DURING SURGERY." DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 18226432 ↗
• InjuryJul 27, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  PATIENT, UNDERGONE CAPSULECTOMY. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17410416 ↗
• InjuryMar 3, 2023Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE "MISSHAPEN AND PAINFUL, POSSIBLY RUPTURED". DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 16482890 ↗
• InjuryNov 28, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED LEFT-SIDE CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN. DEVICE WAS IMPLANTED PRIOR TO THE RECOMMENDED AGE. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 15874541 ↗
• InjuryMay 26, 2022Device Appears to Trigger Rejection; Material Rupture; Device Handling Problem; Device Appears to Trigger Rejection; Material Rupture; Device Handling Problem

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

  Patient problems: Capsular Contracture; No Clinical Signs, Symptoms or Conditions

  MAUDE report 14518066 ↗
• InjuryMar 14, 2022Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "RIGHT SIDE RUPTURE." DEVICE EXPLANTED. RIGHT SIDE.

  Patient problems: Failure of Implant

  MAUDE report 13762696 ↗
• InjuryNov 3, 2021Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE "DISRUPTION/RUPTURE". THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 12748257 ↗
• InjuryOct 28, 2021Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 12715269 ↗
• InjuryApr 23, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL CONFIRMED, CAPSULAR CONTRACTURE, BAKER GRADE III. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 11717131 ↗
• InjuryApr 21, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  PATIENT WAS UNDER THE RECOMMENDED AGE FOR USE WHEN IMPLANTED. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 11703699 ↗
• InjuryOct 21, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

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

  Patient problems: Capsular Contracture

  MAUDE report 10715662 ↗
• InjuryJul 16, 2020Break; Break

  HEALTHCARE PROFESSIONAL REPORTED "RUPTURED." DEVICE WAS NOT IMPLANTED. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10284140 ↗
• InjuryJan 31, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 9652703 ↗

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-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-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-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-