Natrelle INSPIRA Breast Implants SRM-240Recalls & reported problems

Summary

The FDA's MAUDE database contains 157 adverse event reports that list this exact device (DI 10888628007048), received between May 17, 2019 and Sep 25, 2026 — classified as 157 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (77 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 25 most recent of 157 reports, in the reporter's own words as published by the FDA.

• InjurySep 25, 2026Material Rupture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50906288 ↗
• InjurySep 22, 2026Device Appears to Trigger Rejection

  Healthcare professional reported Capsular Contracture Baker grade unknown, ¿numbness¿, ¿posterior rash¿, ¿implant did not drop as expected¿, ¿still has implant riding high¿, ¿high and tight¿ and ¿sustained pneumothorax from dry needling¿. Later healthcare professional reported ¿Capsular Contracture Baker grade IV¿. Multiple chest tubes, physical therapy and dry needling were provided. Patient was hospitalized. This record is for the left side. Device remains implanted.

  Patient problems: Capsular Contracture

  MAUDE report 50849741 ↗
• InjurySep 22, 2026Device Appears to Trigger Rejection

  Healthcare professional reported Capsular Contracture Baker grade unknown, ¿implant did not drop as expected¿, ¿still has implant riding high¿, ¿high and tight¿ and ¿sustained pneumothorax from dry needling¿. Later healthcare professional reported ¿Capsular Contracture Baker grade III¿ Multiple chest tubes, physical therapy and dry needling were provided. Patient was hospitalized. This record is for the right side. Device remains implanted.

  Patient problems: Capsular Contracture

  MAUDE report 50849716 ↗
• InjurySep 7, 2026Device Appears to Trigger Rejection

  Patient problems: Capsular Contracture

  MAUDE report 50657452 ↗
• InjuryAug 25, 2026Device Appears to Trigger Rejection

  Healthcare professional reported "Capsular Contracture Baker grade 3". This record is for the left side. Device was explanted.

  Patient problems: Capsular Contracture

  MAUDE report 50439927 ↗
• InjuryJul 17, 2026Device Appears to Trigger Rejection; Material Rupture

  Healthcare professional reported "rupture". Healthcare professional later reported Capsular Contracture Baker grade unknown. This record is for the left side. Device was explanted.

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

  MAUDE report 25862219 ↗
• InjuryJul 17, 2026Device Appears to Trigger Rejection; Material Rupture

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

  Patient problems: Capsular Contracture

  MAUDE report 25862155 ↗
• InjuryJun 10, 2026Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "EXCHANGE WITH NO COMPLAINTS AGAINST THE DEVICE". LATER REPORTED "RUPTURE". THIS RECORD IS FOR A RIGHT SIDE. DEVICE REMAINS IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25465892 ↗
• InjuryMar 25, 2026Migration

  HEALTHCARE PROFESSIONAL REPORTED THROUGH NATIONAL BREAST IMPLANT REGISTRY "DEVICE MIGRATION" AND "IMPLANT MALPOSITION". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.

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

  MAUDE report 24688846 ↗
• InjuryMar 5, 2026Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 24517825 ↗
• InjurySep 11, 2025Material Rupture; Material Rupture

  PATIENT REPORTED "RUPTURE" DIAGNOSED VIA MRI. LATER HEALTHCARE PROFESSIONAL REPORTED "RUPTURE" DIAGNOSED VIA MAMMOGRAM /ULTRASOUND DONE ON (B)(6) 2025. THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE WAS EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 23034608 ↗
• InjuryJul 26, 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 WAS EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 22621549 ↗
• InjuryJul 18, 2025Malposition of Device; Malposition of Device

  HEALTHCARE PROFESSIONAL REPORTED "SHIFTED/DENTED IMPLANT". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 22541263 ↗
• InjuryJul 16, 2025Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE RUPTURE. HEALTHCARE PROFESSIONAL LATER REPORTED NODULES, THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 22520394 ↗
• InjuryJul 13, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  PATIENT REPORTED LEFT SIDE CAPSULAR CONTRACTURE BAKER GRADE IV WITH "PAIN" AND "FEEL A BIG BALL". DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 22491110 ↗
• InjuryJul 10, 2025Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE RUPTURE. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 22468646 ↗
• InjuryJun 15, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED VIA NATIONAL BREAST IMPLANT REGISTRY (NBIR) RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III. THE DEVICE WAS EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 22208781 ↗
• InjuryJun 13, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL VIA NBIR REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE WAS EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 22204677 ↗
• InjuryMay 12, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED CAPSULAR CONTRACTURE BAKER GRADE III. THIS RECORD IS FOR LEFT SIDE. THE DEVICE WAS EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 22004727 ↗
• InjuryMay 8, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 21990959 ↗
• InjuryApr 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 21805124 ↗
• InjuryJan 18, 2025Material Rupture; Material Rupture

  REGULATORY AGENCY REPORTING, ON BEHALF OF A HEALTHCARE PROFESSIONAL, RUPTURE OF THE DEVICE. THE AFFECTED SIDE IS UNKNOWN. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 21187559 ↗
• InjuryNov 29, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 18226467 ↗
• InjuryNov 20, 2023Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE RUPTURE AND CAPSULAR CONTRACTURE BAKER GRADE IV. DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 18173671 ↗
• InjuryNov 9, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROVIDER REPORTED RIGHT SIDE "ENCAPSULATED". HEALTHCARE PROVIDER CONFIRMED CAPSULAR CONTRACTURE BAKER GRADE IV. THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 18105565 ↗

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