NATRELLE Silicone-Filled Breast Implants 20-280Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 10888628001657), received between Sep 27, 2017 and Sep 10, 2026 — classified as 21 injuries.

The most frequently reported specific device problem is “Material Rupture” (13 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 21 most recent of 21 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 left side. Device remains implanted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50718017 ↗
• InjuryJul 27, 2026Material Rupture

  Healthcare professional reported "rupture". Later, healthcare professional reported " Hole, non-specific". This record is for the left side. Device was explanted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50014640 ↗
• InjuryJul 27, 2026Material Rupture

  Patient reported "exchange with no complaint against the device". Healthcare professional later reported "exchange with no complaint against the device". Healthcare professional later reported "possible implant rupture". This record is for the left side. Device was explanted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50003763 ↗
• InjuryMar 13, 2026Material Rupture

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

  Patient problems: Failure of Implant

  MAUDE report 24594866 ↗
• InjuryNov 21, 2025Peeled/Delaminated; Material Rupture; Peeled/Delaminated; Material Rupture

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

  Patient problems: Failure of Implant

  MAUDE report 23623527 ↗
• InjuryOct 20, 2025Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "RUPTURE". THE DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 23341237 ↗
• InjuryOct 16, 2025Material Rupture; No Apparent Adverse Event; Material Rupture; No Apparent Adverse Event

  HEALTHCARE PROFESSIONAL REPORTED "RUPTURED BREAST IMPLANT". LATER, HEALTHCARE PROFESSIONAL REPORTED "IMPLANT APPEARED RUPTURED ON ULTRASOUND BUT WAS INTACT". THIS RELATES TO THE LEFT SIDE. DEVICE WAS EXPLANTED.

  Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23312165 ↗
• InjuryAug 4, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 22701241 ↗
• InjuryMar 12, 2024Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED RUPTURE FOR RIGHT SIDE. DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 18891001 ↗
• InjurySep 14, 2023Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE RUPTURE (CONFIRMED WITH MAMMOGRAM). DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 17751105 ↗
• InjuryFeb 13, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  PATIENT REPORTED LEFT SIDE CAPSULAR CONTRACTURE BAKER GRADE IV.

  Patient problems: Capsular Contracture

  MAUDE report 16362248 ↗
• InjuryOct 21, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 15650533 ↗
• InjuryApr 25, 2022Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE RUPTURE. DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 14198344 ↗
• InjuryMar 23, 2022Material Rupture; Material Rupture

  PATIENT REPORTED LEFT SIDE RUPTURE. DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 13863107 ↗
• InjuryFeb 12, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE BAKER GRADE IV. THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 9702241 ↗
• InjuryFeb 9, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE BAKER GRADE IV. THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 9685163 ↗
• InjuryFeb 9, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  HEALTHCARE PROFESSIONAL REPORTED CAPSULAR CONTRACTURE (GRADE IV) ON THE RIGHT SIDE. THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 9685160 ↗
• InjuryFeb 9, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  HEALTHCARE PROFESSIONAL REPORTED CAPSULAR CONTRACTURE (GRADE IV) ON THE LEFT SIDE. THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 9685155 ↗
• InjuryJan 29, 2020Material Rupture; Migration; Material Rupture; Migration

  PATIENT REPORTED LEFT SIDE "SEVERE RUPTURE", "DEVICE EXPLODED," "LUMPS DISCOVERED TO BE GEL ESCAPING OUT OF THE BODY," AND "BECAUSE OF THE PAIN, DEVICE REMOVED. THEY FELT LIKE THEY WERE HAVING A HEART ATTACK, THAT'S HOW BAD IT WAS HURTING." ADDITIONALLY, HEALTHCARE PROFESSIONAL REPORTED CAPSULAR CONTRACTURE, BAKER GRADE III, "CHEST PAIN," AND "BREAST PAIN." PATIENT ALSO REPORTED "SICK AS A FREAKING DOG," "THYROID ON FIRE," "HORRIBLE RASHES ALL OVER THEIR LEGS"; THESE ARE NOT DEVICE RELATED. HEALTHCARE PROFESSIONAL ALSO REPORTED "FATIGUE, COLD/HEAT INTOLERANCE, LOW LIBIDO, NUMBNESS/TINGLING, COLD HANDS/FEET, NIGHT SWEATS, HORMONE IMBALANCE, SOB, JOINT PAIN/SORENESS, BRAIN FOG/MEMORY LOSS, LEG SWELLING/PAIN, DRY SKIN/MOUTH/EYES, BREAST FIBROIDS, FOOD ALLERGIES, PANIC ATTACKS, SIGNIFICANT WEIGHT GAIN/LOSS"; THESE ARE NOT DEVICE RELATED. DEVICE HAS BEEN EXPLANTED AND DISCARDED AFTER SURGERY.

  Patient problems: Pain

  MAUDE report 9642374 ↗
• InjuryDec 19, 2019Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE RUPTURE. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 9497561 ↗
• InjurySep 27, 2017Patient-Device Incompatibility; Patient-Device Incompatibility

  HEALTHCARE PROFESSIONAL REPORTED A RIGHT-SIDE CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 6897459 ↗

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-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