NATRELLE Silicone-Filled Breast Implants 10-360Recalls & reported problems
Allergan, Inc. · NATRELLE Style 10-360 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 is a Natrelle silicone-filled breast implant made by Allergan. The 39 reports mostly describe implants rupturing or losing volume, along with hardening of the tissue around the implant and implant failure; no deaths were reported, and all 39 reports involved injuries. No recalls name this device. Reporting has risen sharply, from 2 reports in the previous 12 months to 28 in the latest 12.
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
- 34
- Deaths reported
- 0
- Injuries reported
- 34
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 10888628001268), received between Jul 7, 2020 and Sep 30, 2026 — classified as 34 injuries.
The most frequently reported specific device problem is “Material Rupture” (29 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 Rupture29
- Device Appears to Trigger Rejection6
- No Apparent Adverse Event1
- Patient-Device Incompatibility1
Patient problems
- Failure of Implant18
- No Clinical Signs, Symptoms or Conditions11
- Capsular Contracture7
- Seroma1
Recent adverse event reports
The 25 most recent of 34 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 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 50949740 ↗InjurySep 25, 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 50895452 ↗InjurySep 3, 2026Material Rupture
Healthcare professional reported "Rupture". This record is for the left side. The device has been explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50595652 ↗InjuryAug 19, 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 50332987 ↗InjuryAug 6, 2026Material Rupture
Healthcare professional reported "Implant Rupture". This record is for the right side. Device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50167423 ↗InjuryAug 6, 2026Material Rupture
Healthcare professional reported "Implant Rupture". This record is for the left side. Device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50167411 ↗InjuryJul 28, 2026Material Rupture
Healthcare professional reported "rupture". This record is for the left side. The device was explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50057790 ↗InjuryJun 9, 2026Material Rupture; No Apparent Adverse Event
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE ". THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25442044 ↗InjuryMay 1, 2026Material Rupture
Healthcare professional reported "rupture". This record is for the right side. Device has been explanted and replaced.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25060977 ↗InjuryApr 6, 2026Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE AND EXCHANGE" DIAGNOSED VIA MRI. THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE REMAINS IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24791179 ↗InjuryApr 6, 2026Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE AND EXCHANGE" DIAGNOSED VIA MRI. THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE REMAINS IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24791103 ↗InjuryMar 12, 2026Material Rupture
PATIENT REPORTED "RUPTURE". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 24576907 ↗InjuryMar 9, 2026Device Appears to Trigger Rejection; Material Rupture
DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture; Failure of Implant
MAUDE report 24553178 ↗InjuryFeb 23, 2026Material Rupture
PATIENT REPORTED "CAPSULAR CONTRACTURE" VIA BIFS (BREAST IMPLANT FOLLOW-UP STUDY) ANNUAL QUESTIONNAIRE. NO TREATMENT WAS PERFORMED. PATIENT LATER REPORTED "EXCHANGE WITH NO COMPLAINT AGAINST DEVICE". LATER HEALTHCARE PROFESSIONAL REPORTED "RUPTURE". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 24424029 ↗InjuryFeb 18, 2026Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE". THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 24383857 ↗InjuryFeb 18, 2026Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE". THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 24383806 ↗InjuryFeb 18, 2026Material Rupture
HEALTHCARE PROFESSIONAL THROUGH SALES REPRESENTATIVE REPORTED "RUPTURE". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 24377339 ↗InjuryJan 27, 2026Device Appears to Trigger Rejection; Material Rupture
LATER HEALTHCARE PROFESSIONAL REPORTED ¿THICK CALCIFIED CAPSULE¿ AND ¿CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN¿. CAPSULECTOMY WAS PERFORMED.
Patient problems: Capsular Contracture; Failure of Implant
MAUDE report 24194060 ↗InjuryJan 21, 2026Material Rupture
PATIENT REPORTED "RUPTURE" CONFIRMED VIA MRI. HEALTHCARE PROFESSIONAL LATER REPORTED INTRACAPSULAR RUPTURE, "HOLE, NON-SPECIFIC," "HOLE IN RADIUS (EDGE)," AND "HOLE ON PATCH SIDE." THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 24138494 ↗InjuryDec 16, 2025Material Rupture; Material Rupture
InjuryDec 5, 2025Material Rupture; Material Rupture
InjuryDec 3, 2025Material Rupture; Material Rupture
PATIENT REPORTED "RUPTURE". LATER HEALTHCARE PROFESSIONAL CONFIRMED THE EVENT. THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 23709039 ↗InjuryNov 29, 2025Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "SUSPECTED RUPTURE". THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED AND IT WILL BE RETURNED.
Patient problems: Failure of Implant
MAUDE report 23676883 ↗InjuryJul 30, 2025Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE". THIS RECORD IS FOR THE LEFT SIDE. DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 22668637 ↗InjuryJun 26, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE BAKER GRADE IV. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 22339715 ↗
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-
Other Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled devices
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- MENTOR MemoryGel Breast Implant 3504004BCMentor Texas L.P. · Prosthesis, breast, noninflatable, internal, silicone gel-filled2,012 reports
- MENTOR MemoryGel Breast Implant 3504504BCMentor Texas L.P. · Prosthesis, breast, noninflatable, internal, silicone gel-filled1,754 reports
- MENTOR MemoryGel Breast Implant 3503001BCMentor Texas L.P. · Prosthesis, breast, noninflatable, internal, silicone gel-filled1,752 reports
- MENTOR MemoryGel Breast Implant 3503504BCMentor Texas L.P. · Prosthesis, breast, noninflatable, internal, silicone gel-filled1,749 reports
- MENTOR MemoryGel Breast Implant 3504501BCMentor Texas L.P. · Prosthesis, breast, noninflatable, internal, silicone gel-filled1,690 reports
- MENTOR MemoryGel Breast Implant 3503251BCMentor Texas L.P. · Prosthesis, breast, noninflatable, internal, silicone gel-filled1,684 reports
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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