Natrelle INSPIRA Breast Implants SRM-310Recalls & reported problems

Summary

The FDA's MAUDE database contains 370 adverse event reports that list this exact device (DI 10888628007086), received between Jan 8, 2018 and Sep 30, 2026 — classified as 367 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (211 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 370 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Device Appears to Trigger Rejection

  Patient problems: Capsular Contracture

  MAUDE report 50954612 ↗
• InjurySep 30, 2026Material Rupture

  Healthcare professional reported "rupture". Later, healthcare professional reported "the inner silicone touched the patient". This record is for the right side. The device was explanted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50941676 ↗
• InjurySep 28, 2026Device Appears to Trigger Rejection

  Patient problems: Capsular Contracture

  MAUDE report 50926370 ↗
• InjurySep 18, 2026Material Rupture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50831088 ↗
• InjurySep 17, 2026Device Appears to Trigger Rejection

  Healthcare professional reported "Capsular Contracture Baker grade Unknown". This record is for the right side. Device remains implanted.

  Patient problems: Capsular Contracture

  MAUDE report 50803593 ↗
• InjurySep 17, 2026Material Invagination

  Healthcare professional reported through National Breast Implant Registry (NBIR) "Wrinkling/Rippling". This record is for the right side. Device was explanted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50802487 ↗
• InjurySep 14, 2026Material Rupture

  Healthcare professional reported through National Breast Implant Registry (NBIR) "Suspected/Actual Rupture/Deflation, Wrinkling/Rippling, Correction of Asymmetry". This record is for the left side. Device was explanted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50755994 ↗
• InjurySep 10, 2026Device Appears to Trigger Rejection

  Healthcare Professional reported "Capsular Contracture Baker Grade III¿. Patient started performing self massages as treatment. This record is for the left side. Device remains implanted.

  Patient problems: Capsular Contracture

  MAUDE report 50720264 ↗
• InjurySep 8, 2026Material Rupture

  Healthcare professional reported "rupture" and "dense breasts". Later, reported "abnormal echogenicity" and "suggestive intracapsular rupture". This record is for the left side. Device remains implanted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50669910 ↗
• InjurySep 2, 2026Material Rupture

  Healthcare professional reported "rupture" and "pain". Later stated "patient reports no pain". This record is for the right side. The device remains implanted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50567572 ↗
• InjuryAug 28, 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. Device remains implanted.

  Patient problems: Capsular Contracture

  MAUDE report 50499123 ↗
• InjuryAug 25, 2026Device Appears to Trigger Rejection

  Healthcare professional reported "Capsular contracture" Baker Grade III/IV. This record is for the left side. Device remains implanted. Patient was prescribed Singulair.

  Patient problems: Capsular Contracture

  MAUDE report 50442451 ↗
• InjuryAug 13, 2026Material Rupture

  Healthcare professional reported "exchange with no complaint against the device". Later healthcare professional reported "fractured implant" which was discovered during surgery. The device has been explanted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50234459 ↗
• InjuryJul 28, 2026Material Rupture

  Healthcare Professional reported "rupture". This record is for the right side. Device has been explanted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50057117 ↗
• InjuryJul 22, 2026Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 25902668 ↗
• InjuryJul 22, 2026Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE", BAKER GRADE "III-IV". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 25902453 ↗
• InjuryJul 16, 2026Device Appears to Trigger Rejection; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED A CAPSULAR CONTRACTURE BAKER GRADE III. LATER HEALTHCARE PROFESSIONAL REPORTED "HOLE IN RADIUS (EDGE) OBSERVED DURING SURGERY". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 25842049 ↗
• InjuryJul 1, 2026Material Rupture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25676719 ↗
• InjuryJun 22, 2026Device Appears to Trigger Rejection; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE, BAKER GRADE IV AND RUPTURE". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED. SINGULAIR WAS PRESCRIBED FOR CAPSULAR CONTRACTURE ON UNKNOWN DATE.

  Patient problems: Capsular Contracture

  MAUDE report 25579331 ↗
• InjuryJun 17, 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 25536040 ↗
• InjuryJun 9, 2026Device Appears to Trigger Rejection; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED OF THE LEFT SIDE DEVICE: RUPTURE. THE DEVICE REMAINS IMPLANTED.

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

  MAUDE report 25451607 ↗
• InjuryJun 9, 2026Device Appears to Trigger Rejection; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED OF THE RIGHT-SIDE DEVICE: RUPTURE AND CAPSULAR CONTRACTURE BAKER GRADE IV. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 25449636 ↗
• InjuryMay 28, 2026Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 25318570 ↗
• InjuryApr 23, 2026Material Rupture

  Patient reported "rupture". Later healthcare professional reported "rupture" and "ulcerative lesion of the right rib". This record is for the right side. Device has been explanted.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24968062 ↗
• InjuryApr 7, 2026Device Appears to Trigger Rejection

  Healthcare professional reported "Capsular contracture baker grade IV". This record is for the right side. Device was explanted.

  Patient problems: Capsular Contracture

  MAUDE report 24808863 ↗

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 108
• 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,TRL-
• 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, 110-210,