Natrelle INSPIRA Breast Implants SRX-800Recalls & reported problems

Summary

The FDA's MAUDE database contains 187 adverse event reports that list this exact device (DI 10888628007635), received between May 8, 2019 and Sep 17, 2026 — classified as 186 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (94 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 187 reports, in the reporter's own words as published by the FDA.

• InjurySep 17, 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 50809417 ↗
• InjurySep 11, 2026Device Appears to Trigger Rejection

  Patient problems: Capsular Contracture

  MAUDE report 50744162 ↗
• InjurySep 11, 2026Device Appears to Trigger Rejection

  Patient problems: Capsular Contracture

  MAUDE report 50743877 ↗
• InjuryAug 21, 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 50383280 ↗
• InjuryAug 17, 2026Device Appears to Trigger Rejection

  Healthcare professional reported "capsular contracture, Baker grade IV". This record is for the left side. Device remains implanted.

  Patient problems: Capsular Contracture

  MAUDE report 50274053 ↗
• InjuryJul 15, 2026Device Appears to Trigger Rejection; Material Rupture

  PATIENT REPORTED "RUPTURE". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED.

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

  MAUDE report 25834002 ↗
• InjuryJul 8, 2026Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 25747764 ↗
• InjuryJun 24, 2026Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 25609851 ↗
• InjuryJun 19, 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 25557031 ↗
• InjuryMay 29, 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 25333782 ↗
• InjuryApr 29, 2026Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "SCAR CONTRACTURE". HEALTHCARE PROFESSIONAL LATER REPORTED "SEROMA, MODERATE FLUID AROUND BREAST IMPLANT" VIA MRI. THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE WAS EXPLANTED.

  Patient problems: Capsular Contracture; Seroma

  MAUDE report 25028622 ↗
• InjuryMar 25, 2026Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL THROUGH SALES REPRESENTATIVE REPORTED CAPSULAR CONTRACTURE BAKER GRADE III. LATER, HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE IV". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 24685196 ↗
• InjuryJan 30, 2026Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED CAPSULAR CONTRACTURE BAKER GRADE IV. THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 24225980 ↗
• InjuryJan 26, 2026Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL DID NOT REPORT AN EVENT. THEN HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN". TREATMENT: ALBUTEROL, IBUPROFEN, LORATADINE, LOSARTAN, PANTOPRAZOLE, ROSUVASTATIN, SEMAGLUTIDE-WEIGHT MANAGEMENT SUBQ. THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 24183842 ↗
• InjuryDec 9, 2025Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "SUSPECTED/ACTUAL RUPTURE/DEFLATION" VIA NATIONAL BREAST IMPLANT REGISTRY. THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE HAS BEEN EXPLANTED AND REPLACED. IT IS UNKNOWN IF THE DEVICE WILL BE RETURNED.

  Patient problems: Failure of Implant

  MAUDE report 23761150 ↗
• InjuryNov 14, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 23560559 ↗
• InjuryOct 31, 2025Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "RUPTURED IMPLANT". THIS RECORD IS FOR UNKNOWN SIDE. DEVICE WAS EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 23434411 ↗
• InjuryOct 29, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "GRADE 4 CAPSULE CONTRACTURE" THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE WAS EXPLANTED, REPLACED AND RETURNED.

  Patient problems: Capsular Contracture

  MAUDE report 23410774 ↗
• InjuryOct 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED "CLOUDY SPOTS ON THE IMPLANT". LATER, OPERATIVE REPORT STATED "IMPROVE OF SYMMETRY". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE WAS EXPLANTED AND WILL BE RETURNED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 23351531 ↗
• InjuryOct 10, 2025Material Rupture; Material Rupture

  PATIENT REPORTED LEFT SIDE PAIN, STIFFNESS/ HARDNESS. LATER, PATIENT REPORTED "LEAKING, SWOLLEN AND HARD." VIA MRI. DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 23266792 ↗
• InjurySep 29, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE IV". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE WAS EXPLANTED AND REPLACED WITH ABBVIE DEVICES.

  Patient problems: Capsular Contracture

  MAUDE report 23168630 ↗
• InjurySep 26, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  PATIENT REPORTED AND HEALTHCARE PROFESSIONAL CONFIRMED RIGHT SIDE CAPSULAR CONTRACTURE BAKER GRADE IV. THE DEVICE HAS BEEN EXPLANTED AND REPLACED. TOTAL CAPSULECTOMY WAS PERFORMED.

  Patient problems: Capsular Contracture

  MAUDE report 23161653 ↗
• InjurySep 25, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE IV" THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE WAS EXPLANTED AND REPLACED. DEVICE WAS RETURNED.

  Patient problems: Capsular Contracture

  MAUDE report 23146945 ↗
• InjurySep 19, 2025Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED ¿RUPTURED¿. THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE WAS EXPLANTED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 23096629 ↗
• InjurySep 15, 2025Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "INTRACAPSULAR RUPTURE" AND "BAKER GRADE: 1" CONFIRMED VIA ULTRASOUND. LATER HEALTHCARE PROFESSIONAL REPORTED "ECHOGENIC INTRACAPSULAR FLUID". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED AND REPLACED. DEVICE HAS BEEN DISCARDED.

  Patient problems: Failure of Implant

  MAUDE report 23049350 ↗

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-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