NATRELLE Silicone-Filled Breast Implants 10-330Recalls & reported problems
Allergan, Inc. · NATRELLE Style 10-330 Moderate profile |smooth|round|silicone · Class 3 · Implant
All models of Natrelle Breast Implants (1167) · NATRELLE Silicone-Filled Breast Implants (128)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Natrelle silicone breast implant has 41 adverse event reports, mostly describing implant rupture and capsular contracture, with 41 injuries and no deaths. There are no recalls naming this device. Activity rose sharply, with 25 reports in the last 12 months versus 3 in the prior 12 months.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 40
- Deaths reported
- 0
- Injuries reported
- 40
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 40 adverse event reports that list this exact device (DI 10888628001251), received between Dec 10, 2019 and Sep 17, 2026 — classified as 40 injuries.
The most frequently reported specific device problem is “Material Rupture” (36 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.
Reports received per month
Most reported problems
Device problems
- Material Rupture36
- Device Appears to Trigger Rejection4
- Patient-Device Incompatibility3
- No Apparent Adverse Event2
- Malposition of Device1
Patient problems
- Failure of Implant19
- No Clinical Signs, Symptoms or Conditions17
- Capsular Contracture7
Recent adverse event reports
The 25 most recent of 40 reports, in the reporter's own words as published by the FDA.
InjurySep 17, 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 50809790 ↗InjurySep 17, 2026Material Rupture
Patient reported "rupture". This record is for right side. The device was explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50803547 ↗InjurySep 11, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50742644 ↗InjurySep 4, 2026Device Appears to Trigger Rejection; Material Rupture
Healthcare professional reported "Capsular contracture Baker grade III/IV", "pain", "discomfort". Later, healthcare professional reported "Rupture". This record is for the right side. Device was explanted.
Patient problems: Capsular Contracture
MAUDE report 50616687 ↗InjuryJul 20, 2026Device Appears to Trigger Rejection; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE" AND "CAPSULAR CONTRACTURE, BAKER GRADE IV". LATER HEALTHCARE PROFESSIONAL REPORTED "HOLE, NON-SPECIFIC". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 25883726 ↗InjuryJun 11, 2026Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "EXCHANGE WITH NO COMPLAINT AGAINST THE DEVICE". LATER HEALTHCARE PROFESSIONAL REPORTED "IMPLANT RUPTURE FOUND DURING SURGERY". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25474420 ↗InjuryApr 23, 2026Material Rupture
DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24971028 ↗InjuryApr 22, 2026Material Rupture
PATIENT REPORTED "RUPTURE, CALCIFICATION ON IMPLANT, SMALL PERICARDIAL EFFUSION AND LOW WHITE BLOOD CELL COUNT". SMALL PERICARDIAL EFFUSION AND LOW WHITE BLOOD CELL COUNT ARE CONSIDERED NOT DEVICE RELATED. THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE REMAINS IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24955966 ↗InjuryApr 16, 2026Material Rupture
PATIENT REPORTED "RUPTURE, BURNING SENSATION, LUMPS". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24896902 ↗InjuryMar 23, 2026Malposition of Device
HEALTHCARE PROFESSIONAL REPORTED "NO COMPLAINT AGAINST THE DEVICE". LATER HEALTHCARE PROFESSIONAL REPORTED "DOUBLE BUBBLE". THIS RECORD IS FOR RIGHT SIDE. THE DEVICE WAS EXPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24664163 ↗InjuryMar 19, 2026Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24644235 ↗InjuryMar 19, 2026Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE". THIS RECORD IS FOR LEFT SIDE. THE DEVICE WAS EXPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24643909 ↗InjuryMar 18, 2026Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "DISCOMFORT IN THE AFFECTED BREAST, DESCRIBED AS MILD WITH A SEVERITY OF 3/10 ON A PAIN SCALE, CHARACTERIZED AS "JUST UNCOMFORTABLE." HAS A NOTICEABLE CHANGE IN THE SHAPE OF THE RIGHT BREAST, DESCRIBED AS "MIS-SHAPED. INTRACAPSULAR RUPTURE". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE REMAINS IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24627056 ↗InjuryMar 13, 2026Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "INTRACAPSULAR RUPTURE". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24597288 ↗InjuryMar 11, 2026Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE". THIS RECORD IS FOR LEFT SIDE. THE DEVICE WAS EXPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24571548 ↗InjuryMar 11, 2026Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE WAS EXPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24571544 ↗InjuryMar 4, 2026Material Rupture
HEALTHCARE PROFESSIONAL REPORTED RUPTURE FOR RIGHT SIDE. PREVIOUSLY REPORTED WRINKLING. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 24506525 ↗InjuryFeb 12, 2026Material Rupture
PATIENT REPORTED OF THE RIGHT SIDE DEVICE: "RUPTURE". THE DEVICE REMAINS IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24327292 ↗InjuryFeb 11, 2026Material Rupture
PATIENT REPORTED OF THE LEFT SIDE DEVICE: "RUPTURE". THE DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 24315611 ↗InjuryJan 27, 2026Material Rupture
HEALTHCARE PROFESSIONAL REPORTED RUPTURE VIA NATIONAL BREAST IMPLANT REGISTRY. THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 24189825 ↗InjuryJan 14, 2026Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE WAS EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 24066970 ↗InjuryDec 8, 2025Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 23743097 ↗InjuryNov 10, 2025Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "POSSIBLE RUPTURE". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 23511676 ↗InjuryNov 5, 2025Material Rupture; Material Rupture
PATIENT REPORTED "RUPTURE". THIS RECORD IS FOR LEFT SIDE. THE DEVICE WAS EXPLANTED. THE DEVICE RETURNED.
Patient problems: Failure of Implant
MAUDE report 23479909 ↗InjuryOct 23, 2025Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE". THIS RECORD IS FOR RIGHT SIDE. THE DEVICE WAS EXPLANTED. THE DEVICE WILL BE RETURNED.
Patient problems: Failure of Implant
MAUDE report 23366380 ↗
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 · TerminatedNatrelle 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 · TerminatedNatrelle 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, ClassifiedNatrelle 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, ClassifiedNatrelle 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-
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- MENTOR MemoryGel Breast Implant 3503504BCMentor Texas L.P. · Prosthesis, breast, noninflatable, internal, silicone gel-filled1,749 reports
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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