Natrelle INSPIRA Breast Implants SRX-400Recalls & reported problems

Summary

The FDA's MAUDE database contains 206 adverse event reports that list this exact device (DI 10888628007505), received between Feb 16, 2018 and Sep 23, 2026 — classified as 204 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (144 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 206 reports, in the reporter's own words as published by the FDA.

• InjurySep 23, 2026Device Appears to Trigger Rejection

  Healthcare professional reported "capsular contracture baker grade III". Singulair treatment was prescribed. This record is for the left side. Device remains implanted.

  Patient problems: Capsular Contracture

  MAUDE report 50869158 ↗
• InjurySep 18, 2026Device Appears to Trigger Rejection

  Healthcare professional reported ¿Capsular Contracture Baker grade III/IV¿, ¿pain/mastalgia¿ and ¿symptoms of BII/asia¿. Later healthcare professional reported ¿Signs of bilateral capsular contracture¿, ¿mastalgia¿, ¿change is shape of breast¿, ¿hardening¿, ¿deformity in projection¿, Capsular Contracture Baker grade III/IV, ¿apathy¿, ¿fatigue¿ and ¿BII syndrome (breast implant illness)¿. This record is for the right side. Device remains implanted.

  Patient problems: Capsular Contracture

  MAUDE report 50821084 ↗
• InjurySep 18, 2026Device Appears to Trigger Rejection

  Healthcare professional reported ¿Capsular Contracture Baker grade III/IV¿, ¿pain/mastalgia¿ and ¿symptoms of BII/asia¿. Later healthcare professional reported ¿Signs of bilateral capsular contracture¿, ¿mastalgia¿, ¿change is shape of breast¿, ¿hardening¿, ¿deformity in projection¿, Capsular Contracture Baker grade III/IV, ¿apathy¿, ¿fatigue¿ and ¿BII syndrome (breast implant illness)¿. This record is for the left side. Device remains implanted.

  Patient problems: Capsular Contracture

  MAUDE report 50820701 ↗
• InjurySep 16, 2026Device Appears to Trigger Rejection

  Patient reported "sizing wasn't what I asked for" and "really hard and painful". Later patient reported Capsular Contracture Baker Grade III. Patient received wound treatments after surgery. This record is for the right side. The device remains implanted.

  Patient problems: Capsular Contracture

  MAUDE report 50792354 ↗
• InjurySep 14, 2026Device Appears to Trigger Rejection

  Patient problems: Capsular Contracture

  MAUDE report 50765053 ↗
• InjurySep 11, 2026Device Appears to Trigger Rejection

  Patient problems: Capsular Contracture

  MAUDE report 50744428 ↗
• InjurySep 11, 2026Device Appears to Trigger Rejection

  Patient reported "Capsular Contracture Baker Grade unknown" against the right side. Gabapentin and Singulair were prescribed. The device remains implanted.

  Patient problems: Capsular Contracture

  MAUDE report 50734809 ↗
• InjurySep 8, 2026Device Appears to Trigger Rejection

  Patient reported "stitches got infection", "capsular contracture baker grade unknown", "swollen", "pain", "hard" and "bruising" against the left side record. Gabapentin and Singulair were prescribed. The device remains implanted.

  Patient problems: Capsular Contracture; Swelling/ Edema; Unspecified Infection

  MAUDE report 50676770 ↗
• InjuryAug 25, 2026Device Appears to Trigger Rejection

  Healthcare professional reported "capsular contracture baker grade IV". This record is for the right side. Device remains implanted.

  Patient problems: Capsular Contracture

  MAUDE report 50434167 ↗
• InjuryAug 25, 2026Device Appears to Trigger Rejection

  Healthcare professional reported ¿Capsular Contracture Baker grade IV¿. Later healthcare professional reported ¿significant capsular hardening¿, ¿superior displacement¿ and ¿breast pain¿. Capsulectomy was performed. This record is for the left side. Device was explanted.

  Patient problems: Capsular Contracture

  MAUDE report 50430951 ↗
• InjuryAug 4, 2026Device Appears to Trigger Rejection

  Healthcare professional reported "Capsular contracture" Baker Grade unknown. This record is for the right side. Device was explanted.

  Patient problems: Capsular Contracture

  MAUDE report 50132256 ↗
• InjuryJul 27, 2026Device Appears to Trigger Rejection

  Healthcare professional reported "capsular contracture baker grade III" against the left side record. Singulair was prescribed, along with massages. The device remains implanted.

  Patient problems: Capsular Contracture

  MAUDE report 50015638 ↗
• InjuryJul 27, 2026Device Appears to Trigger Rejection

  Healthcare professional reported "capsular contracture baker grade III" against the right side record. Singulair was prescribed, along with massages. The device remains implanted.

  Patient problems: Capsular Contracture

  MAUDE report 50015626 ↗
• InjuryJun 16, 2026Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 25523604 ↗
• InjuryMay 8, 2026Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED VIA NATIONAL BREAST IMPLANT REGISTRY (NBIR) "CAPSULAR CONTRACTURE BAKER GRADE III". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 25125923 ↗
• InjuryApr 21, 2026Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED THROUGH NATIONAL BREAST IMPLANT REGISTRY HEALTHCARE "CAPSULAR CONTRACTURE BAKER GRADE III". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 24944448 ↗
• InjuryFeb 18, 2026Material Rupture

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

  Patient problems: Failure of Implant

  MAUDE report 24378456 ↗
• InjuryFeb 13, 2026Device 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 24330891 ↗
• InjuryDec 29, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  PATIENT REPORTED "CAPSULAR CONTRACTURE BAKER GRADE IV". THIS RECORD IS FOR RIGHT SIDE. DEVICE WAS EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 23918538 ↗
• InjuryDec 2, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED THROUGH NATIONAL BREAST IMPLANT REGISTRY (NBIR) "CAPSULAR CONTRACTURE BAKER GRADE III". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED AND REPLACE. IT IS UNKNOWN IF THE DEVICE WILL BE RETURNED.

  Patient problems: Capsular Contracture

  MAUDE report 23697104 ↗
• InjuryDec 2, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "FIRMNESS", CAPTURED AS CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN. THE DEVICE WAS EXPLANTED, REPLACED AND WILL BE RETURNED.

  Patient problems: Capsular Contracture

  MAUDE report 23691919 ↗
• InjuryOct 19, 2025Malposition of Device; Malposition of Device

  PATIENT REPORTED "CAPSULAR CONTRACTURE BAKER GRADE II". LATER, HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE RIGHT SIDE GRADE II". LATER HEALTHCARE PROFESSIONAL REPORTED "MAMMARY HYPOPLASIA" AND "IMPLANT ANIMATION DEFORMITY". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE WAS EXPLANTED, REPLACED AND RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23333633 ↗
• InjuryOct 17, 2025Migration; Migration

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE "DEVICE MIGRATION/IMPLANT MALPOSITION, WRINKLING/RIPPLING, CHANGE SHAPE/SIZE/STYLE". THE DEVICE WAS EXPLANTED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 23325366 ↗
• InjuryOct 15, 2025Migration; Migration

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "DEVICE MIGRATION/IMPLANT MALPOSITION, WRINKLING/RIPPLING, CHANGE SHAPE/SIZE/STYLE". THE DEVICE WAS EXPLANTED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 23295278 ↗
• InjuryOct 8, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE ¿CAPSULAR CONTRACTURE BAKER GRADE III IMPLANT EXCHANGE¿. DEVICE WAS EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 23245700 ↗

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