Natrelle INSPIRA Breast Implants SRM-275Recalls & reported problems

Summary

The FDA's MAUDE database contains 289 adverse event reports that list this exact device (DI 10888628007062), received between May 13, 2019 and Sep 30, 2026 — classified as 286 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (170 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 289 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Material Rupture; Malposition of Device

  Patient reported "deflated", "I can flip my implants, my implants move around, it feels squishy, noticing they're dropping, from where they were up in my chest they got lower", "they're moving", "chest they got lower", "really soft" and "feel like the jelly can come out of it". This record is for the left side. Device remains implanted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50945354 ↗
• InjurySep 14, 2026Device Appears to Trigger Rejection; Material Rupture; Migration

  Healthcare professional reported "rupture, Capsular Contracture Baker Grade Unknown". Healthcare professional later reported "Breast hypomastia; ptosis; capsule contraction; implant bottoming out". This record is for the right side. The device was explanted. Patient was prescribed a Capsulectomy.

  Patient problems: Capsular Contracture

  MAUDE report 50763400 ↗
• InjurySep 9, 2026Material Rupture

  Healthcare professional reported "Suspected/Actual Rupture/Deflation" via the National Breast Implant Registry (NBIR). This record is for left side. The device has been explanted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50689413 ↗
• InjurySep 6, 2026Material Rupture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50641260 ↗
• InjuryAug 16, 2026Material Rupture

  Device has been explanted and replaced.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50268229 ↗
• InjuryAug 7, 2026Material Rupture

  Healthcare professional reported "Rupture". This record is for the right side. Device was explanted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50175425 ↗
• InjuryJun 17, 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 25538006 ↗
• InjuryJun 4, 2026Device Appears to Trigger Rejection

  PATIENT REPORTED "NO COMPLAINT AGAINST THE DEVICE". LATER HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III/IV. THIS RECORD IS FOR LEFT SIDE. THE DEVICE WAS EXPLANTED AND DISCARDED. PATIENT WAS PRESCRIBED ANTIBIOTICS.

  Patient problems: Capsular Contracture

  MAUDE report 25398756 ↗
• InjuryMay 1, 2026Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED VIA NATIONAL BREAST IMPLANT REGISTRY (NBIR) MANUFACTURER REGISTRY SPECIFIC DATA REPORT (MRSDR) "CAPSULAR CONTRACTURE BAKER GRADE III". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 25057036 ↗
• InjuryApr 26, 2026Malposition of Device

  HEALTHCARE PROFESSIONAL REPORTED "IMPLANT MALPOSITIONING". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE WAS EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 24993464 ↗
• InjuryFeb 25, 2026Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "NECROSIS", "PAIN" AND "ABNORMAL APPEARANCE". LATER HEALTHCARE PROFESSIONAL REPORTED "BAKER GRADE III CAPSULAR CONTRACTURE". THIS RECORD IS FOR THE RIGHT SIDE THE DEVICE WAS EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture; Necrosis

  MAUDE report 24444108 ↗
• InjuryJan 29, 2026Malposition of Device; Migration

  HEALTHCARE PROFESSIONAL REPORTED VIA THE NATIONAL BREAST IMPLANT REGISTRY (NBIR) "DEVICE MIGRATION/IMPLANT MALPOSITION". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 24218488 ↗
• InjuryJan 29, 2026Malposition of Device; Migration

  HEALTHCARE PROFESSIONAL REPORTED VIA THE NATIONAL BREAST IMPLANT REGISTRY (NBIR) "DEVICE MIGRATION/IMPLANT MALPOSITION" AND "CORRECTION OF ASYMMETRY". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 24218470 ↗
• InjuryDec 10, 2025Migration; Migration

  HEALTHCARE PROFESSIONAL VIA NATIONAL BREAST IMPLANT REGISTRY (NBIR) REPORTED "DEVICE MIGRATION/IMPLANT MALPOSITION, CHANGE SHAPE/SIZE/STYLE". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED. RETURN STATUS IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 23769664 ↗
• InjuryDec 4, 2025Migration; Migration

  HEALTHCARE PROFESSIONAL VIA NATIONAL BREAST IMPLANT REGISTRY (NBIR) REPORTED "DEVICE MIGRATION/IMPLANT MALPOSITION, CHANGE SHAPE/SIZE/STYLE". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED. RETURN STATUS IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 23720497 ↗
• InjuryDec 4, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED ¿DISPROPORTION OF BREAST¿. LATER HEALTHCARE PROFESSIONAL REPORTED "LEVEL III CAPSULAR CONTRACTURE". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED AND REPLACED AND IT WILL NOT BE RETURNED.

  Patient problems: Capsular Contracture

  MAUDE report 23715980 ↗
• InjuryOct 27, 2025Malposition of Device; Migration; Malposition of Device; Migration

  HEALTHCARE PROFESSIONAL REPORTED "DEVICE MIGRATION/IMPLANT MALPOSITION" AND "CHANGE SHAPE/SIZE/STYLE" VIA NBIR. THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE WAS EXPLANTED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 23393916 ↗
• InjurySep 16, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III WITH PAIN/TENDERNESS. THE DEVICE HAS BEEN EXPLANTED AND REPLACED WITH A NON-ABBVIE DEVICE.

  Patient problems: Capsular Contracture

  MAUDE report 23066183 ↗
• InjurySep 10, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE, BAKER GRADE IV" CONFIRMED VIA CT SCAN. THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 23017677 ↗
• InjurySep 8, 2025Material Rupture; Material Rupture

  PATIENT REPORTED LEFT SIDE RUPTURE. DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 22994228 ↗
• InjuryAug 27, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED VIA NBIR LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III. DEVICE WAS EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 22906920 ↗
• InjuryAug 26, 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. THE DEVICE WAS EXPLANTED AND REPLACED. TREATMENT FOR SYMPTOMS REPORTED AS SINGULAIR.

  Patient problems: Capsular Contracture

  MAUDE report 22900570 ↗
• InjuryAug 21, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED SINGULAIR WAS USED TO FOR TREATMENT OF SYMPTOMS.

  Patient problems: Capsular Contracture

  MAUDE report 22861638 ↗
• InjuryAug 5, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 22720354 ↗
• InjuryJul 31, 2025Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED INITIALLY REPORTED LEFT SIDE "EXCHANGE WITH NO COMPLAINT AGAINST THE DEVICE" AND LATER REPORTED RUPTURE. THE DEVICE WAS EXPLANTED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 22675922 ↗

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-