Natrelle INSPIRA Breast Implants SRM-345Recalls & reported problems

Summary

The FDA's MAUDE database contains 410 adverse event reports that list this exact device (DI 10888628007109), received between May 15, 2019 and Sep 30, 2026 — classified as 410 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (251 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 410 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Device Appears to Trigger Rejection; Material Rupture

  Healthcare professional reported "Capsular contracture" Baker Grade III/IV, "visual deformity", "a lot of pain" and "hurts a lot". Healthcare professional also reported "Breast cancer" which is not device related. Healthcare professional later reported "rupture". Patient received radiation treatment. This record is for the left side. Device has been explanted.

  Patient problems: Capsular Contracture

  MAUDE report 50945738 ↗
• InjurySep 28, 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 50915851 ↗
• InjurySep 23, 2026Device Appears to Trigger Rejection

  Patient problems: Capsular Contracture

  MAUDE report 50875370 ↗
• InjurySep 15, 2026Device Appears to Trigger Rejection

  Patient reported "Capsular Contracture Baker grade unknown" and "tried to squeeze the implant but could not since it was incapsulated". Later, healthcare professional reported "Capsular Contracture Baker grade IV". This record is for the left side. Device remains implanted.

  Patient problems: Capsular Contracture

  MAUDE report 50778760 ↗
• InjurySep 13, 2026Device Appears to Trigger Rejection

  Patient problems: Capsular Contracture

  MAUDE report 50747536 ↗
• InjurySep 13, 2026Device Appears to Trigger Rejection; Material Rupture

  Patient problems: Capsular Contracture

  MAUDE report 50747533 ↗
• InjurySep 12, 2026Device Appears to Trigger Rejection

  Patient problems: Capsular Contracture

  MAUDE report 50746392 ↗
• InjuryAug 21, 2026Device Appears to Trigger Rejection; Material Rupture

  Healthcare Professional reported "shape deformity, intermittent dull aching and Capsular Contracture baker grade IV". This record is for the left side. Device remains implanted.

  Patient problems: Capsular Contracture

  MAUDE report 50369837 ↗
• InjuryAug 16, 2026Material Rupture

  The device has been explanted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50266301 ↗
• InjuryAug 3, 2026Device Appears to Trigger Rejection; Material Rupture

  Patient reported ¿breast implant has again burst¿, ¿pain in arm pit and along the breast¿, ¿shape has also changed¿, ¿severe infection where they needed IV antibiotics¿, ¿it was draining there was mucus that came out¿, ¿fever¿, ¿malaise¿, and ¿breast implant is the one that was recalled¿. Later healthcare professional reported ¿Capsular Contracture Baker grade unknown¿. This record is for the left side. Device was explanted.

  Patient problems: Capsular Contracture; Unspecified Infection

  MAUDE report 50120282 ↗
• InjuryJul 27, 2026Device Appears to Trigger Rejection

  Healthcare professional reported "Capsular Contracture Baker grade unknown". Healthcare professional later reported "capsular contracture Baker grade III". Patient was prescribed Singulair. This record is for the right side. The device was explanted.

  Patient problems: Capsular Contracture

  MAUDE report 50031618 ↗
• InjuryJul 27, 2026Device Appears to Trigger Rejection; Material Rupture

  Healthcare professional reported "Capsular Contracture Baker grade unknown". Healthcare professional later reported "capsular contracture Baker grade III". Healthcare professional later reported "Hole, non-specific". Patient was prescribed Singulair. This record is for the left side. The device was explanted.

  Patient problems: Capsular Contracture

  MAUDE report 50031617 ↗
• InjuryJul 16, 2026Device Appears to Trigger Rejection; Material Rupture

  Device has been explanted and replaced.

  Patient problems: Capsular Contracture

  MAUDE report 25846911 ↗
• InjuryJul 15, 2026Device Appears to Trigger Rejection

  Healthcare professional reported "I need return boxes for warranty cases". Healthcare professional then reported Capsular Contracture Baker grade III. This record is for the rigtht side. Device was explanted.

  Patient problems: Capsular Contracture

  MAUDE report 25827219 ↗
• InjuryJul 4, 2026Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED ¿CAPSULAR CONTRACTURE BAKER GRADE III¿. LATER HEALTHCARE PROFESSIONAL REPORTED ¿PAIN¿. THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 25710084 ↗
• InjuryJun 25, 2026Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE GRADE 3". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 25620588 ↗
• InjuryJun 25, 2026Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE GRADE 3". THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 25620473 ↗
• InjuryJun 12, 2026Device Appears to Trigger Rejection; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED NO COMPLAINT AGAINST THE DEVICE. HEALTHCARE PROFESSIONAL LATER REPORTED CAPSULAR CONTRACTURE BAKER GRADE II. HEALTHCARE PROFESSIONAL LATER REPORTED CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN. THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 25494121 ↗
• InjuryJun 10, 2026Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE", BAKER GRADE UNKNOWN, ¿THE BREAST IS COMPOSED OF SCATTERED FIBROGLANDULAR TISSUE¿, ¿ASYMMETRIC ROUNDED APPEARANCE¿, ¿STIR HYPERINTENSE OVAL ENHANCING MASS¿ AND ¿OVAL ENHANCING MASS, PROBABLY BENIGN INTRAMAMMARY LYMPH NODE¿. LATER, HEALTHCARE PROFESSIONAL REPORTED CAPSULAR CONTRACTURE, BAKER GRADE IV. THIS RECORD IS FOR THE RIGHT SIDE. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 25458535 ↗
• InjuryJun 10, 2026Device Appears to Trigger Rejection

  Healthcare professional reported "Capsular Contracture", Baker Grade Unknown, ¿The breast is composed of scattered fibroglandular tissue¿, ¿there is an oval enhancing mass¿, ¿asymmetric prominent left axillary lymph nodes, a representative probably lymph node¿. Later, 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 25456755 ↗
• InjuryJun 5, 2026Material Rupture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25418278 ↗
• InjuryJun 5, 2026Device Appears to Trigger Rejection; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "INTRACAPSULAR RUPTURE", "EXTRACAPSULAR RUPTURE" AND "ADDITIONAL EXTRAVASATED SILICONE ALONG THE POSTERIOR UPPER INNER ASPECT OF THE IMPLANT". THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED.

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

  MAUDE report 25418250 ↗
• InjuryJun 5, 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 25409779 ↗
• InjuryMay 14, 2026Device Appears to Trigger Rejection; No Apparent Adverse Event

  Later healthcare professional reported "Capsular Contracture", Baker grade was not provided. This record is for the left side. Device has been explanted.

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

  MAUDE report 25173538 ↗
• InjuryMay 11, 2026Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 25137845 ↗

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-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-