Natrelle INSPIRA Breast Implants SRX-495Recalls & reported problems

Summary

The FDA's MAUDE database contains 172 adverse event reports that list this exact device (DI 10888628007543), received between May 14, 2019 and Sep 9, 2026 — classified as 172 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (119 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 172 reports, in the reporter's own words as published by the FDA.

• InjurySep 9, 2026Device Appears to Trigger Rejection

  Healthcare professional reported Capsular Contracture Baker Grade III. Patient was prescribed with Singulair. This record is for the left side. The device remains implanted.

  Patient problems: Capsular Contracture

  MAUDE report 50698001 ↗
• InjuryJul 29, 2026Device Appears to Trigger Rejection

  Healthcare professional reported "capsular contracture, Baker grade III". This record is for the left side. The device was explanted. Patient was prescribed Montelukast.

  Patient problems: Capsular Contracture

  MAUDE report 50075203 ↗
• InjuryJul 13, 2026Device Appears to Trigger Rejection

  Healthcare professional reported Capsular Contracture Baker grade III. Healthcare professional then reported "Hole on bottom" made by the explant surgery. Patient was prescribed with Singular. This record is for the right side. Device was explanted.

  Patient problems: Capsular Contracture

  MAUDE report 25804426 ↗
• InjuryJun 30, 2026Device Appears to Trigger Rejection

  Healthcare professional reported "capsular contracture, Baker grade III". This record is for the left side. Device has been explanted.

  Patient problems: Capsular Contracture

  MAUDE report 25673939 ↗
• InjuryJun 9, 2026Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE LLL". PATIENT HAD SINGULAIR AND VITAMIN E TREATMENT. THIS RECORD IS FOR RIGHT SIDE. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 25443355 ↗
• InjuryJun 3, 2026Device Appears to Trigger Rejection

  PATIENT REPORTED "NO COMPLAINT AGAINST THE DEVICE". LATER HEALTHCARE PROFESSIONAL REPORTED "ABNORMAL IMPLANT POSITIONING, AT MINIMUM BAKER GRADE III CAPSULAR CONTRACTURE WITH FEATURES APPROACHING/CONSISTENT WITH BAKER GRADE IV CAPSULAR CONTRACTURE". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 25386104 ↗
• InjuryMay 15, 2026Device Appears to Trigger Rejection

  PATIENT REPORTED "CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN". LATER HEALTHCARE PROFESSIONAL REPORTED CAPSULAR CONTRACTURE BAKER GRADE III AND "ABNORMAL IMPLANT POSITIONING". THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 25184654 ↗
• InjuryMar 26, 2026Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE, BAKER GRADE IV". PATIENT WAS PRESCRIBED SINGULAIR. THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 24705825 ↗
• InjuryMar 10, 2026Device Appears to Trigger Rejection

  Healthcare professional reported "Grade III Capsular Contracture". Healthcare professional later reported "Any creases". This record is for the right side. The device was explanted.

  Patient problems: Capsular Contracture

  MAUDE report 24565290 ↗
• InjurySep 29, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 23168140 ↗
• InjurySep 19, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  PATIENT REPORTED RIGHT SIDE ¿CAPSULAR CONTRACTURE BAKER GRADE IV AND PAIN¿ AND "KEPT GOING UP, HIGHER AND HIGHER, WHEN RAISING ARMS IT CAUSED PAINS OR WHEN I WAS SLEEPING IT WAS CAUSING PAIN AND IT WOULD FEEL REALLY HIGH ON MY CHEST". DEVICE WAS EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 23100101 ↗
• InjurySep 19, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  PATIENT REPORTED RIGHT SIDE "CAPSULAR CONTRACTURE WITH UNKNOWN BAKER GRADE, BUT ALSO STATED "IT FEELS LIKE ITS A III/IV", "PAIN, AND IS AN INCH AND A HALF HIGHER THAN THE OTHER SIDE, WITH HARDNESS". HEALTHCARE PROFESSIONAL LATER REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III AND ALSO STATED "IMPLANT IS MOVING UP, AND HAVING PAIN AND NUMBNESS" VIA CT SCAN. PATIENT ADDITIONALLY REPORTED "PAIN", AND "BLOOD PRESSURE DROPPING INTO THE 80'S SYSTOLIC/50'S DIASTOLIC". TREATMENT: SINGULAIR, GABAPENTIN 300 MG. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 23093745 ↗
• InjurySep 18, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  DEVICE WAS EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 23091765 ↗
• InjurySep 17, 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. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 23074007 ↗
• InjurySep 11, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 23027557 ↗
• InjurySep 11, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE DEVICE WAS EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 23025946 ↗
• InjuryJul 18, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 22542864 ↗
• InjuryJun 10, 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 22180329 ↗
• InjuryApr 23, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE IV. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 21895957 ↗
• InjuryApr 9, 2025Material Rupture; Material Rupture

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

  Patient problems: Failure of Implant

  MAUDE report 21809255 ↗
• InjuryNov 17, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED A RIGHT SIDE CAPSULAR CONTRACTURE BAKER GRADE IV AND FLUID FOUND AROUND IMPLANT. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture; Seroma

  MAUDE report 18163503 ↗
• InjuryOct 31, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 18043906 ↗
• InjuryOct 26, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED CAPSULAR CONTRACTURE BAKER GRADE III. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 18016563 ↗
• InjuryOct 11, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED, RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE IV. LATER, HEALTHCARE PROFESSIONAL REPORTED, "CAPSULAR CONTRACTURE OF THE RIGHT BREAST WITH SIGNIFICANT CAPSULAR HARDENING, SUPERIOR DISPLACEMENT OF THE IMPLANT AND RIGHT BREAST PAIN". DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 17917020 ↗
• InjurySep 29, 2023Device Appears to Trigger Rejection; No Apparent Adverse Event; Device Appears to Trigger Rejection; No Apparent Adverse Event

  HEALTHCARE PROFESSIONAL REPORTED EXCHANGE WITH NO COMPLAINT AGAINST THE DEVICE. LATER HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN. DEVICE HAS BEEN EXPLANTED.

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

  MAUDE report 17841418 ↗

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