Natrelle INSPIRA Breast Implants SRF-200Recalls & reported problems

Summary

The FDA's MAUDE database contains 58 adverse event reports that list this exact device (DI 10888628007239), received between Jun 19, 2019 and Jun 24, 2026 — classified as 57 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (37 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 58 reports, in the reporter's own words as published by the FDA.

• InjuryJun 24, 2026Device Appears to Trigger Rejection

  Patient reported "Capsular Contracture Baker Grade III". This record is for the right side. Device was explanted.

  Patient problems: Capsular Contracture

  MAUDE report 25616870 ↗
• InjuryApr 8, 2026Device Appears to Trigger Rejection

  PATIENT REPORTED CAPSULAR CONTRACTURE BAKER GRADE III AND "VERY LOW". THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 24817488 ↗
• InjuryApr 8, 2026Device Appears to Trigger Rejection

  PATIENT REPORTED CAPSULAR CONTRACTURE BAKER GRADE III AND "VERY LOW". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 24817410 ↗
• InjuryApr 3, 2026Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED NO COMPLAINT AGAINST THE DEVICE. LATER HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE IV AND SKIN TIGHTENING". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE WAS EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 24774795 ↗
• InjuryMar 18, 2026Device Appears to Trigger Rejection

  PATIENT REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III" AND "PAIN". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 24635127 ↗
• InjuryMar 17, 2026Device Appears to Trigger Rejection; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "POSSIBLE RUPTURE OF BREAST". LATER HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE IV AND SKIN TIGHTENING". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE WAS EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 24618201 ↗
• InjuryFeb 7, 2026Device Appears to Trigger Rejection

  PATIENT REPORTED "PAIN". PATIENT LATER REPORT "NIPPLES ARE SHRIVELING". HEALTHCARE PROFESSIONAL LATER REPORTED " NO COMPLAINT AGAINST THE DEVICE". LATER, PATIENT REPORTED "CAPSULAR CONTRACTURE", BAKER GRADE IV. LATER, HEALTHCARE PROFESSIONAL REPORTED CAPSULAR CONTRACTURE, BAKER GRADE III. THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 24285824 ↗
• InjuryOct 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 23210114 ↗
• InjurySep 30, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  PATIENT REPORTED LEFT SIDE CAPSULAR CONTRACTURE BAKER GRADE III. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 23181076 ↗
• InjuryAug 21, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  PATIENT REPORTED "CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN". LATER, HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 22862981 ↗
• InjuryJul 25, 2025Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED " RUPTURE" VIA "MRI" AND "CAPSULAR CONTRACTURE BAKER GRADE IV" VIA "ULTRASOUND". THIS RECORD IS FOR THE "RIGHT" SIDE. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 22609005 ↗
• InjuryJul 14, 2025Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED DURING IMPLANTATION SURGERY A "POSSIBLE LEAK" ONCE THE DEVICE WAS PLACED AND THE PHYSICIAN WENT TO CLOSE THE INCISION. PATIENT CONTACT WITH THE DEVICE OCCURRED. THE SURGERY WAS COMPLETED WITH A BACKUP. THIS RECORD IS FOR UNKNOWN SIDE. DEVICE WAS NOT IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 22502577 ↗
• InjuryJun 23, 2025Device Appears to Trigger Rejection; No Apparent Adverse Event; Device Appears to Trigger Rejection; No Apparent Adverse Event

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE IMPLANT EXCHANGE WITH NO COMPLAINT AGAINST THE DEVICE. DEVICE HAS BEEN EXPLANTED AND REPLACED.

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

  MAUDE report 22310228 ↗
• InjuryJun 20, 2025Device Appears to Trigger Rejection; No Apparent Adverse Event; Device Appears to Trigger Rejection; No Apparent Adverse Event

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

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

  MAUDE report 22299772 ↗
• InjuryJun 17, 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. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 22237801 ↗
• InjuryJun 17, 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 REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 22233646 ↗
• InjuryJun 3, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  PATIENT REPORTED RIGHT SIDE "PAIN AND CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN". PATIENT ADDITIONALLY REPORTED CAPSULAR CONTRACTURE BAKER GRADE IV AND "NIPPLES ARE SHRIVELING". HEALTHCARE PROFESSIONAL LATER CONFIRMED "CAPSULAR CONTRACTURE BAKER GRADE III". DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 22137709 ↗
• InjuryMay 13, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  PATIENT REPORTED "EXCHANGE WITH NO COMPLAINT AGAINST THE DEVICE". LATER, HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III". THIS REPORT IS FOR THE RIGHT SIDE. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 22012766 ↗
• InjuryMay 12, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  PATIENT REPORTED "CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN". LATER, HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III". THIS REPORT IS FOR THE LEFT SIDE. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 22006734 ↗
• InjuryApr 8, 2025Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "OPEN WOUND" AND "RUPTURE". THIS RECORD RELATES TO THE RIGHT SIDE. DEVICE WAS EXPLANTED.

  Patient problems: Wound Dehiscence

  MAUDE report 21802204 ↗
• InjuryAug 7, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE EXCHANGE WITH NO COMPLAINT AGAINST THE DEVICE. PHYSICIAN LATER REPORTED CONTRACTURE. DEVICE EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 19929814 ↗
• InjuryAug 21, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED CAPSULAR CONTRACTURE, BAKER GRADE III/IV. DEVICE REMAINS IMPLANTED. THIS RELATES TO THE LEFT SIDE.

  Patient problems: Capsular Contracture

  MAUDE report 17584298 ↗
• InjuryJun 7, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  PATIENT REPORTED LEFT SIDE CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN WITH "BURNS, PAIN, LARGE BALL, DEFORMED". DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture; Seroma

  MAUDE report 17083886 ↗
• InjuryJun 7, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  PATIENT REPORTED RIGHT SIDE CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN, "BURNS, PAIN, LARGE BALL, DEFORMED". DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture; Seroma

  MAUDE report 17082938 ↗
• InjuryMar 7, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  PATIENT REPORTED RIGHT SIDE CAPSULAR CONTRACTION BAKER GRADE III/IV. HEALTHCARE PROVIDER REPORTED RIGHT BAKER GRADE AS IV. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 16497628 ↗

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-