NATRELLE Silicone-Filled Breast Implants 45-800Recalls & reported problems

Summary

The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 10888628002142), received between Jan 14, 2020 and Sep 10, 2026 — classified as 36 injuries.

The most frequently reported specific device problem is “Material Rupture” (22 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 36 reports, in the reporter's own words as published by the FDA.

• InjurySep 10, 2026Material Rupture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50703621 ↗
• InjurySep 8, 2026Material Rupture

  Patient reported through regulatory agency "rupture". This record is for the left side. Device was explanted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50672141 ↗
• InjuryJun 2, 2026Material Rupture

  HEALTHCARE PROFESSIONAL, THROUGH SALES REPRESENTATIVE, REPORTED "RUPTURED". HEALTHCARE PROFESSIONAL LATER REPORTED "RUPTURED". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE WAS EXPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25365160 ↗
• InjuryApr 8, 2026Material Rupture

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

  Patient problems: Failure of Implant

  MAUDE report 24823628 ↗
• InjuryMar 31, 2026Material Rupture

  PATIENT REPORTED "RUPTURE". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 24750311 ↗
• InjuryFeb 11, 2026Material Rupture

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

  Patient problems: Failure of Implant

  MAUDE report 24312046 ↗
• InjuryFeb 10, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTED "SWOLLEN LYMPH NODES", "BOTHERSOME", "MAKING [THE PATIENT] SICK", "FEELS LIKE [THE PATIENT] HAS CAT TOYS IN [THE PATIENT'S] BREAST", "PAIN", "CRINKLING", "UNCOMFORTABLE", "HEADACHES", "HIVES", "BRAIN FOG", "THINNING HAIR", "SWOLLEN LIPS", "NEUROPATHY", "PROBLEMS SLEEPING", "JOINT PAIN", "CANT SWALLOW" AND "TONGUE SCALLOPING". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Swollen Lymph Nodes/Glands

  MAUDE report 24306348 ↗
• InjuryFeb 10, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTED "SWOLLEN LYMPH NODES", "BOTHERSOME", "MAKING HER SICK", "FEELS LIKE SHE HAS CAT TOYS IN HER BREAST", "PAIN", "CRINKLING", "UNCOMFORTABLE", "HEADACHES", "HIVES", "BRAIN FOG", "THINNING HAIR", "SWOLLEN LIPS", "NEUROPATHY", "PROBLEMS SLEEPING", "JOINT PAIN", "CANT SWALLOW" AND "TONGUE SCALLOPING". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE REMAINS IMPANTED.

  Patient problems: Swollen Lymph Nodes/Glands

  MAUDE report 24304169 ↗
• InjuryDec 29, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "NO COMPLAINT AGAINST THE DEVICE". LATER, HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE IV". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 23917749 ↗
• InjuryDec 29, 2025Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED ¿EXCHANGE WITH NO COMPLAINT AGAINST THE DEVICE¿. LATER HEALTHCARE PROFESSIONAL REPORTED ¿IMPLANT RUPTURE¿ AND ¿CAPSULAR CONTRACTURE BAKER GRADE IV¿. CAPSULECTOMY WAS PERFORMED. THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 23916683 ↗
• InjuryDec 17, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

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

  Patient problems: Deformity/ Disfigurement

  MAUDE report 23834504 ↗
• InjuryDec 12, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  HEALTHCARE PROFESSIONAL REPORTED "SYMMASTIA". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED AND REPLACED.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 23796512 ↗
• InjuryDec 1, 2025Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED ¿RUPTURE¿. LATER HEALTHCARE PROFESSIONAL REPORTED NO RUPTURE AND ¿CAPSULAR CONTRACTURE BAKER GRADE IV¿. CAPSULECTOMY WAS PERFORMED. THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture; Failure of Implant

  MAUDE report 23683690 ↗
• InjuryNov 19, 2025Material Rupture; Material Rupture

  DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 23595187 ↗
• InjuryMay 13, 2025Material Rupture; Material Rupture

  PATIENT REPORTED RUPTURE. RECORD IS FOR LEFT SIDE. DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 22015665 ↗
• InjuryApr 24, 2025Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED RUPTURE AND CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN. LATER HEALTHCARE PROFESSIONAL REPORTED "THE RIGHT BREAST IMPLANT DEMONSTRATES LINEAR FILLING DEFECT WITHIN THE IMPLANT SUBSTANCE SUGGESTIVE OF INTRACAPSULAR RIGHT BREAST IMPLANT RUPTURE" DIAGNOSED VIA ULTRASOUND AND PAIN IN LATERAL. THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 21904736 ↗
• InjuryApr 22, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN. LATER HEALTHCARE PROFESSIONAL REPORTED PAIN IN LATERAL BREAST. THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 21885304 ↗
• InjuryApr 15, 2025Material Rupture; Material Rupture

  PATIENT REPORTED "RUPTURE AND BREAST CANCER". THE EVENT OF "BREAST CANCER" IS CONSIDERED NOT DEVICE RELATED. THIS REPORT IS FOR THE LEFT SIDE. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 21844461 ↗
• InjuryApr 15, 2025Material Rupture; Material Rupture

  PATIENT REPORTED "RUPTURE AND BREAST CANCER", RUPTURE WAS CONFIRMED VIA CT SCAN. THIS REPORT IS FOR THE RIGHT SIDE. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 21842298 ↗
• InjuryJan 22, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE "CAPSULAR CONTRACTURE BAKER GRADE IV". HEALTHCARE PROFESSIONAL LATER REPORTED ¿INFERIOR POLE OF THE LEFT BREAST IS LESS FULL AND THE IMPLANT DOES HAVE SOME SUPERIOR MALPOSITION¿, ¿NIPPLE SENSATION", "INFERIOR POLE OF THE LEFT BREAST IS LESS FULL¿, ¿TINGLING OR NUMBNESS IN ENTIRE HAND", AND ¿SHOULDER PAIN". HEALTHCARE PROFESSIONAL ALSO REPORTED "NECK PAIN", "BACK PAIN", "UNHAPPY WITH APPEARANCE", "BREATHING PROBLEMS" ARE ALL NOT DEVICE RELATED. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 21210833 ↗
• InjuryOct 31, 2023Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "RUPTURED LEFT BREAST IMPLANT." DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 18040584 ↗
• InjuryAug 8, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  PATIENT REPORTED RIGHT CAPSULAR CONTRACTURE BAKER GRADE IV. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 17484354 ↗
• InjuryApr 25, 2023Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED RUPTURE. DEVICE HAS BEEN EXPLANTED. THIS RELATES TO THE RIGHT SIDE.

  Patient problems: Failure of Implant

  MAUDE report 16808681 ↗
• InjuryNov 30, 2022Material Rupture; Material Rupture

  PATIENT REPORTED LEFT SIDE RUPTURE, DOCTOR LATER CALLED AND CONFIRMED TO LEFT SIDE RUPTURE. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 15887442 ↗
• InjuryAug 29, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROVIDER REPORTED A "SPONTANEOUS EXTRUSION OF LEFT BREAST IMPLANT, HISTORY OF BREAST CANCER A BILATERAL MASTECTOMY, DEFORMITY OF RECONSTRUCTED BREAST." THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Erosion

  MAUDE report 15316931 ↗

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