Natrelle INSPIRA Breast Implants SRM-360Recalls & reported problems

Summary

The FDA's MAUDE database contains 353 adverse event reports that list this exact device (DI 10888628007116), received between May 7, 2019 and Sep 29, 2026 — classified as 353 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (206 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 353 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2026Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 50936472 ↗
• InjurySep 23, 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 50863338 ↗
• InjurySep 10, 2026Device Appears to Trigger Rejection

  Healthcare professional reported "capsular contracture Baker grade lll". This record is for right side. The devic was explanted.

  Patient problems: Capsular Contracture

  MAUDE report 50715832 ↗
• InjuryAug 16, 2026Material Rupture

  Healthcare professional reported "ruptured". This record is for the right side. Device was explanted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50266221 ↗
• InjuryAug 12, 2026Material Rupture

  Patient reported left side rupture and "stinging sensation on the side and underneath." The device remains implanted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50224554 ↗
• InjuryJul 7, 2026Device Appears to Trigger Rejection

  Healthcare professional reported "early capsular contracture Baker grade III", "not sure, probably bacterial related". Healthcare professional later reported "Hardening of the left breast within the first few months of augmentation by original surgery that was performed 2 years ago. The left implant sides much higher on the chest wall and is more form with a grade 3 capsule". This record is for the left side. Device was explanted.

  Patient problems: Capsular Contracture

  MAUDE report 25734873 ↗
• InjuryJun 18, 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 25543363 ↗
• InjuryJun 12, 2026Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED OF THE LEFT SIDE DEVICE: BAKER GRADE IV CAPSULAR CONTRACTURE. THE PATIENT UNDERWENT CAPSULECTOMY SURGERY AS TREATMENT. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 25487101 ↗
• InjuryJun 12, 2026Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED OF THE RIGHT SIDE DEVICE: BAKER GRADE IV CAPSULAR CONTRACTURE. THE PATIENT UNDERWENT CAPSULECTOMY SURGERY AS TREATMENT. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 25486839 ↗
• InjuryJun 7, 2026Device Appears to Trigger Rejection

  PATIENT REPORTED "EXCHANGE WITH NO COMPLAINT AGAINST THE DEVICE". HEALTHCARE PROFESSIONAL LATER REPORTED "EXCHANGE WITH NO COMPLAINT AGAINST THE DEVICE". HEALTHCARE PROFESSIONAL LATER REPORTED ¿REASON FOR REMOVAL: CAPSULAR CONTRACTURE¿. HEALTHCARE PROFESSIONAL LATER REPORTED "WAS THE LEFT SIDE EXPERIENCING SYMPTOMS OF CAPSULAR CONTRACTURE? NO". HEALTHCARE PROFESSIONAL LATER REPORTED "CAPSULAR CONTRACTURE" BAKER GRADE IV. THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 25422371 ↗
• InjuryMay 18, 2026Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 25202666 ↗
• InjuryMay 8, 2026Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED A "CURRENT IMPLANT R " AND THAT IMPLANT "APPEARS TO BE LEAKING". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE REMAINS IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25123883 ↗
• InjuryApr 14, 2026Material Rupture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24874242 ↗
• InjuryMar 18, 2026Device Appears to Trigger Rejection

  PATIENT REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III/IV". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 24635443 ↗
• InjuryFeb 11, 2026Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 24315207 ↗
• InjuryJan 22, 2026Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 24153939 ↗
• InjuryJan 12, 2026Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "EXCHANGE WITH NO COMPLAINT AGAINST THE DEVICE". THEN HEALTHCARE PROFESSIONAL REPORTED "RUPTURE". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED AND REPLACED. DEVICE WILL BE RETURNED.

  Patient problems: Failure of Implant

  MAUDE report 24036007 ↗
• InjuryNov 14, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 23557749 ↗
• InjuryNov 12, 2025Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "RUPTURE". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE REMAINS IMPLANTED. EXPLANT SURGERY IS NOT YET SCHEDULED AND THE EXPLANTED DEVICE WILL BE RETURNED.

  Patient problems: Failure of Implant

  MAUDE report 23536216 ↗
• InjuryOct 20, 2025Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "RUPTURE" CONFIRMED VIA MRI. THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 23337068 ↗
• InjuryOct 17, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN". LATER, HEALTHCARE PROFESSIONAL REPORTED "STAGE 3". THIS RELATES TO THE RIGHT SIDE. THE DEVICE WAS EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 23324449 ↗
• InjuryOct 1, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  DEVICE WAS EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 23192267 ↗
• InjurySep 26, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 23155327 ↗
• InjurySep 15, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III. THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 23052710 ↗
• InjuryAug 25, 2025Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "RUPTURE" DIAGNOSED VIA ULTRASOUND. THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 22888961 ↗

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