Natrelle INSPIRA Breast Implants SRF-365Recalls & reported problems

Summary

The FDA's MAUDE database contains 403 adverse event reports that list this exact device (DI 10888628007314), received between May 7, 2019 and Sep 30, 2026 — classified as 401 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (239 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 403 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Material Rupture

  Patient reported "rupture" and "felt something weird on breast". This record is for the left side. The device remains implanted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50946807 ↗
• InjurySep 28, 2026Device Appears to Trigger Rejection

  Patient reported a "capsular contracture (unknown baker grade)". Later healthcare professional reported "Capsular Contracture Baker grade III". This record is for the left side. The device remains implanted. Montelukast was prescribed.

  Patient problems: Capsular Contracture

  MAUDE report 50916740 ↗
• InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50831451 ↗
• InjurySep 17, 2026Device Appears to Trigger Rejection; Material Rupture

  Healthcare professional reported Capsular Contracture Baker grade unknown and ¿Rupture¿. Later healthcare professional reported ¿Capsular Contracture Baker grade III¿. This record is for the right side. Device remains implanted.

  Patient problems: Capsular Contracture

  MAUDE report 50797309 ↗
• InjuryAug 30, 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 50514563 ↗
• InjuryAug 24, 2026Device Appears to Trigger Rejection

  Patient reported "capsular contracture Baker grade II and burning". Later healthcare professional reported "capsular contracture, Baker grade II, burning and exchange". This record is for the right side. Device remains implanted.

  Patient problems: Capsular Contracture

  MAUDE report 50422017 ↗
• InjuryAug 24, 2026Device Appears to Trigger Rejection

  Device has been explanted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50421579 ↗
• InjuryAug 19, 2026Device Appears to Trigger Rejection

  Healthcare professional reported: "capsular contracture, Baker grade IV". This record is for the right-side device. The device remains implanted.

  Patient problems: Capsular Contracture

  MAUDE report 50324712 ↗
• InjuryAug 7, 2026Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 50173096 ↗
• InjuryAug 6, 2026Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 50162302 ↗
• InjuryJul 30, 2026Device Appears to Trigger Rejection

  Healthcare professional reported "capsular contracture Baker grade IV". Patient was prescribed with Singulair. This record is for the left side. Device remains implanted.

  Patient problems: Capsular Contracture

  MAUDE report 50090457 ↗
• InjuryJun 11, 2026Device Appears to Trigger Rejection

  Healthcare Professional reported "Capsular Contracture Baker grade III". This record is for the left side. Device was explanted.

  Patient problems: Capsular Contracture

  MAUDE report 25480053 ↗
• InjuryJun 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 25457701 ↗
• InjuryJun 5, 2026Material Rupture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25408688 ↗
• InjuryApr 22, 2026Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 24952774 ↗
• MalfunctionApr 21, 2026Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "IMPLANT RUPTURED DURING SURGERY, NOT SURE AS TO WHY IT RUPTURED". THIS RECORD IS FOR AN UNKNOWN SIDE. DEVICE WAS NOT IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 24942506 ↗
• InjuryApr 11, 2026Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED ¿PAIN¿. THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.

  Patient problems: Pain

  MAUDE report 24847687 ↗
• InjuryApr 10, 2026Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED ¿PAIN¿. THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.

  Patient problems: Pain

  MAUDE report 24840813 ↗
• InjuryApr 2, 2026Malposition of Device; Migration

  HEALTHCARE PROFESSIONAL REPORTED "DEVICE MIGRATION/IMPLANT MALPOSITION, CHANGE SHAPE/SIZE/STYLE". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE WAS EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 24772131 ↗
• InjuryMar 17, 2026Device Appears to Trigger Rejection

  PATIENT REPORTED "NO COMPLAINT AGAINST THE DEVICE". LATER PATIENT REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III/IV WITH "PAIN". LATER HEALTHCARE PROFESSIONAL REPORTED "PAIN" THIS RECORD IS FOR THE RIGHT SIDE. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 24621045 ↗
• InjuryMar 12, 2026Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED THROUGH NATIONAL BREAST IMPLANT REGISTRY (NBIR) A " CAPSULAR CONTRACTURE, BAKER GRADE (3)" AND A "CHANGE SHAPE/SIZE/STYLE". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE WAS EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 24586420 ↗
• InjuryMar 12, 2026Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED THROUGH NATIONAL BREAST IMPLANT REGISTRY (NBIR) A " CAPSULAR CONTRACTURE, BAKER GRADE (3)" AND A "CHANGE SHAPE/SIZE/STYLE ". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE WAS EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 24582564 ↗
• InjuryFeb 27, 2026Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED CAPSULAR CONTRACTION GRADE 4 FOR RIGHT SIDE. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 24477458 ↗
• InjuryJan 5, 2026Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "IMPLANT EXCHANGE WITH NO COMPLAINT AGAINST THE DEVICE". HEALTHCARE PROFESSIONAL LATER REPORTED "CAPSULAR CONTRACTURE BAKER GRADE IV". THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED AND IT WILL BE RETURNED.

  Patient problems: Capsular Contracture

  MAUDE report 23955843 ↗
• InjuryDec 10, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "GRADE III CAPSULAR CONTRACTURE WITH WATERFALL DEFORMITY". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED. DEVICE WILL BE RETURNED.

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

  MAUDE report 23768105 ↗

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