NATRELLE Silicone-Filled Breast Implants 40-400Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10888628001961), received between Feb 9, 2012 and Sep 10, 2026 — classified as 8 injuries.

The most frequently reported specific device problem is “Material Rupture” (4 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjurySep 10, 2026Material Rupture

  Healthcare professional reported "rupture". This record is for the right side. The device remains implanted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50715296 ↗
• InjuryMar 30, 2026Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED OF THE RIGHT SIDE DEVICE: "RUPTURE". THE DEVICE WAS EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 24719241 ↗
• InjuryNov 26, 2025Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "GRADE II CAPSULAR CONTRACTURE", "RUPTURE AND IS INTRACAPSULAR IN NATURE", AND "PTOSIS: GRADE 2-MODERATE". THIS RECORD IS FOR THE LEFT SIDE. DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 23661003 ↗
• InjuryOct 30, 2025Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "IMPLANT RUPTURE" CONFIRMED WITH MRI. THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED AND REPLACED AND WILL NOT BE RETURNED.

  Patient problems: Failure of Implant

  MAUDE report 23424870 ↗
• InjuryJul 7, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 22412806 ↗
• InjuryJun 13, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  PHYSICIAN REPORTED UNKNOWN SIDE CAPSULAR CONTRACTURE BAKER GRADE III. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 22201782 ↗
• InjuryAug 5, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED A RIGHT SIDE "CONTRACTURE," BAKER GRADE UNKNOWN. DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 12281419 ↗
• InjuryFeb 9, 2012No Apparent Adverse Event

  HEALTH PROFESSIONAL REPORTED A RIGHT SIDE PAIN, SEROMA AND POSSIBLE LYMPHOMA. ADDITIONAL INFORMATION NOTES THAT THE PATIENT PRESENTED WITH A COMPLAINT OF PAIN AND RIGHT BREAST SWELLING. EXPLANT AND REPLACEMENT TOOK PLACE ON (B)(6) 2011 WITH SILICONE DEVICES. PRELIMINARY RESULTS SHOW POSSIBLE ALCL OF THE CAPSULE. THE PATIENT RETURNS TO THE OFFICE AND AFTER DISCUSSING THE RESULTS, THE PATIENT AND THE SURGEON DECIDE ON BILATERAL EXPLANT SURGERY OF THE NEW DEVICES. EXPLANT SURGERY TOOK PLACE ON (B)(6) 2011. FINAL DIAGNOSIS OF EXTRANODAL N/K T CELL LYMPHOMA NASAL TYPE IS MADE USING CAPSULE FROM BLOCK SECTIONS. THE PATHOLOGIST NOTES THIS IS NOT ALCL.

  Patient problems: Breast Mass; Lymphoma; Pain; Seroma

  MAUDE report 2452703 ↗

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-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-