Natrelle INSPIRA Breast Implants SRF-415Recalls & reported problems

Summary

The FDA's MAUDE database contains 730 adverse event reports that list this exact device (DI 10888628007338), received between May 8, 2019 and Sep 25, 2026 — classified as 728 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (437 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 730 reports, in the reporter's own words as published by the FDA.

• InjurySep 25, 2026Material Invagination; Device Appears to Trigger Rejection

  Patient problems: Capsular Contracture

  MAUDE report 50905808 ↗
• InjurySep 25, 2026Material Rupture

  Healthcare professional reported "rupture and exchange". This record is for the right side. Device remains implanted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50900398 ↗
• InjurySep 25, 2026Device Appears to Trigger Rejection

  Patient reported "capsular contracture Baker Grade III". This record is for the right side. Device remains implanted.

  Patient problems: Capsular Contracture

  MAUDE report 50898404 ↗
• InjurySep 23, 2026Device Appears to Trigger Rejection

  Patient problems: Capsular Contracture

  MAUDE report 50876077 ↗
• InjurySep 21, 2026Device Appears to Trigger Rejection; Material Rupture

  Patient reported "rupture", "capsular contracture baker grade unknown" and "chest pain". Patient was prescribed with Tramadol 50 mg for 1 week. This record is for the left side. Device remains implanted.

  Patient problems: Capsular Contracture

  MAUDE report 50839893 ↗
• InjurySep 18, 2026Device Appears to Trigger Rejection

  Patient reported "capsular contracture baker grade unknown with pain". Patient received massages and Singulair as treatment. This record is for the left side. The device remains implanted.

  Patient problems: Capsular Contracture

  MAUDE report 50819156 ↗
• InjurySep 15, 2026Device Appears to Trigger Rejection

  Healthcare professional reported "HEMATOMA" and "EXCHANGE OF CAPSULAR CONTRACTURE OF LEFT BREAST". "LARGE BRUISE of BREAST, TENDER TO TOUCH". This record is for the left side. Device was explanted.

  Patient problems: Capsular Contracture

  MAUDE report 50776160 ↗
• InjurySep 10, 2026Material Rupture

  Healthcare professional reported "rupture". This record is for the left side. Device remains implanted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50717796 ↗
• InjurySep 8, 2026Device Appears to Trigger Rejection

  Healthcare professional reported "capsular contracture" Baker grade IV. This record is for the right side. Device was explanted.

  Patient problems: Capsular Contracture

  MAUDE report 50677116 ↗
• InjurySep 4, 2026Device Appears to Trigger Rejection

  Healthcare professional reported "capsular contracture" Baker grade IV. This record is for the left side. Device was explanted.

  Patient problems: Capsular Contracture

  MAUDE report 50616018 ↗
• InjuryAug 24, 2026Device Appears to Trigger Rejection

  Healthcare professional reported "Capsular Contracture Baker Grade III" and "exchange". This record is for the left side. Device remains implanted.

  Patient problems: Capsular Contracture

  MAUDE report 50418055 ↗
• InjuryAug 6, 2026Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 50168207 ↗
• InjuryAug 3, 2026Device Appears to Trigger Rejection; Material Rupture

  Patient reported "rupture". Healthcare professional reported "rupture". Additionally healthcare professional reported "Capsular Contracture Baker grade 4". This record is for the right side. Device was explanted.

  Patient problems: Capsular Contracture

  MAUDE report 50123726 ↗
• InjuryAug 3, 2026Device Appears to Trigger Rejection

  Patient did not report a complaint against the device. Later healthcare professional reported "contracture". Healthcare professional later reported "Grade 4". This record is for the left side. Device was explanted.

  Patient problems: Capsular Contracture

  MAUDE report 50123686 ↗
• InjuryJul 27, 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 50002743 ↗
• InjuryJul 1, 2026Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III", "LOOKED PRETTY MESSED UP" AND "WASN'T HAPPY". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE WAS EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 25678751 ↗
• InjuryJul 1, 2026Device Appears to Trigger Rejection; Material Rupture

  Healthcare professional reported "rupture found during surgery with capsular contracture Baker grade III", "looked pretty messed up" and "wasn't happy". This record is for the right side. The device was explanted.

  Patient problems: Capsular Contracture

  MAUDE report 25676389 ↗
• InjuryJun 26, 2026Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE" BAKER GRADE UNKNOWN. THIS RECORD IS FOR THE LEFT SIDE. DEVICE HAS BEEN EXPLANTED. PATIENT UNDERWENT A INFERIOR CAPSULOTOMY.

  Patient problems: Capsular Contracture

  MAUDE report 25634711 ↗
• InjuryJun 26, 2026Device Appears to Trigger Rejection; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE" BAKER GRADE UNKNOWN, "INTRACAPSULAR AND EXTRACAPSULAR RUPTURE", "WAS COMPLETELY RUPTURED, THE SHELL WAS IN TWO PIECES, THE SILICONE WAS FREE-FLOATING WITHIN THE BREAST" AND "BIOPSY-PROVEN BENIGN ENHANCING MASS". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE HAS BEEN EXPLANTED. PATIENT UNDERWENT A INFERIOR CAPSULOTOMY

  Patient problems: Capsular Contracture

  MAUDE report 25634545 ↗
• InjuryJun 12, 2026Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "CAPSULE". HEALTHCARE PROFESSIONAL LATER REPORTED "CAPSULAR CONTRACTURE BAKER GRADE IV"; SINGULAIR PRESCRIBED.. THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 25485135 ↗
• InjuryJun 9, 2026Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 25449062 ↗
• InjuryJun 3, 2026Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "RUPTURE". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE REMAINS IMPLANTED.

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

  MAUDE report 25386375 ↗
• InjuryJun 2, 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 25362044 ↗
• InjuryMay 8, 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 25130826 ↗
• InjuryApr 24, 2026Fluid/Blood Leak

  HEALTHCARE PROFESSIONAL REPORTED VIA NATIONAL BREAST IMPLANT REGISTRY (NBIR) MANUFACTURER REGISTRY SPECIFIC DATA REPORT (MRSDR) "SUSPECTED/ACTUAL RUPTURE/DEFLATION". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24982294 ↗

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-