NATRELLE Silicone-Filled Breast Implants 10-550Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10888628001329), received between Dec 29, 2020 and Sep 7, 2026 — classified as 5 injuries.

The most frequently reported specific device problem is “Material Rupture” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjurySep 7, 2026Material Rupture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50658485 ↗
• InjuryJan 26, 2026Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "RUPTURE". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED AND IT WAS REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 24176538 ↗
• InjurySep 29, 2023Material Rupture; Material Rupture

  PATIENT REPORTED A RIGHT SIDE RUPTURE. DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 17848143 ↗
• InjuryJun 13, 2023Device Appears to Trigger Rejection; Device Handling Problem; Device Appears to Trigger Rejection; Device Handling Problem

  PATIENT REPORTED LEFT SIDE "CAPSULAR CONTRACTURE POSSIBLE BAKER GRADE III/IV, REALLY HARD, TIGHTENING, WHEN TOUCHES BOTTOM OF BREAST FEELS RIPPLES AND IS NOT SMOOTH, OPENED, BIG KNOTS, FEELS A FOLD, FEELS LIKE SOMETHING THAT'S NOT SUPPOSED TO BE THERE, SCAR TISSUE". LATER, HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE BAKER GRADE III/IV AND THE FOLLOWING EVENTS THAT ARE NOT DEVICE RELATED: "BUT IT WAS "NICKED" DURING EXPLANT SURGERY, SO THERE IS A SMALL PUNCTURE" AND "PUNCTURED WHEN REMOVED". HEALTHCARE PROFESSIONAL ALSO REPORTED RUPTURE THAT IS NOT DEVICE RELATED. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 17121260 ↗
• InjuryDec 29, 2020Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 11091527 ↗

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-