Natrelle Inspira Cohesive Breast Implants SCM-240Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10888628029835), received between Jul 2, 2019 and Apr 7, 2025 — classified as 17 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryApr 7, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  PATIENT REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III". DIAGNOSED VIA PHYSICAL EXAM. HEALTHCARE PROFESSIONAL LATER CONFIRMED RIGHT SIDE CAPSULAR CONTRACTURE BAKER GRADE III. THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 21784441 ↗
• InjuryMay 3, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 16865497 ↗
• InjuryMay 1, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE CAPSULAR CONTRACTURES, BAKER GRADES III/IV. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 16843845 ↗
• InjuryApr 13, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROVIDER RETURNED LEFT DEVICE. SO, IT WAS NOT DISCARDED.

  Patient problems: Capsular Contracture

  MAUDE report 16736964 ↗
• InjuryMar 28, 2023Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED RUPTURE. THE DEVICE HAS BEEN EXPLANTED. THIS RELATES TO THE LEFT SIDE.

  Patient problems: Failure of Implant

  MAUDE report 16629126 ↗
• InjuryFeb 1, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  SALES REPRESENTATIVE REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III CONTRACTIONS, HAD RADIATION AND THE TISSUE AROUND THE IMPLANT IS VERY TIGHT AND CAUSING DISCOMFORT WITH THE IMPLANT, IT¿S NOT THE IMPLANT ITSELF". DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 16279215 ↗
• InjuryJan 27, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "SUSPENSION OF CAPSULAR CONTRACTURE, CONTRACTIONS, HAD RADIATION AND THE TISSUE AROUND THE IMPLANT IS VERY TIGHT AND CAUSING DISCOMFORT WITH THE IMPLANT, IT¿S NOT THE IMPLANT ITSELF". HEALTHCARE PROFESSIONAL LATER REPORTED "CAPSULAR CONTRACTURE, BAKER GRADE III". DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 16258301 ↗
• InjuryDec 26, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 16046592 ↗
• InjuryOct 31, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED A RIGHT CAPSULAR CONTRACTURE, BAKER GRADE III. DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 15705203 ↗
• InjuryAug 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE INFECTION (EARLY ONSET). DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Unspecified Infection

  MAUDE report 15147420 ↗
• InjuryApr 5, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE UNSPECIFIED. DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 14017617 ↗
• InjuryNov 24, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  PATIENT REPORTED RIGHT SIDE CAPSULAR CONTRACTURE BAKER GRADE IV. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 10896512 ↗
• InjuryFeb 27, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

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

  Patient problems: Capsular Contracture

  MAUDE report 9764258 ↗
• InjuryJan 6, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

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

  Patient problems: Capsular Contracture

  MAUDE report 9553254 ↗
• InjuryJan 6, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

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

  Patient problems: Capsular Contracture

  MAUDE report 9553179 ↗
• InjuryAug 5, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

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

  Patient problems: Capsular Contracture

  MAUDE report 8862063 ↗
• InjuryJul 2, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

  HEALTH PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE IV. DEVICE WAS EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 8753158 ↗

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-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