NATRELLE Silicone-Filled Breast Implants 20-750Recalls & reported problems
Allergan, Inc. · NATRELLE Style 20-750 High 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 Allergan Natrelle silicone gel breast implant is placed inside the breast. Reports mostly describe the implant tearing open and tightening or hardening of tissue around it, often with removal of the implant. There are 26 reports that name its identifier, including 26 injuries and no deaths. No recalls name this device.
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
- 30
- Deaths reported
- 0
- Injuries reported
- 30
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 10888628001794), received between Aug 13, 2019 and Sep 22, 2026 — classified as 30 injuries.
The most frequently reported specific device problem is “Material Rupture” (17 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 Rupture17
- Device Appears to Trigger Rejection7
- Patient-Device Incompatibility7
- Adverse Event Without Identified Device or Use Problem1
- Material Invagination1
- Migration1
Patient problems
- Capsular Contracture14
- Failure of Implant9
- No Clinical Signs, Symptoms or Conditions5
- Lymphoma1
- Seroma1
- Unspecified Infection1
- Wrinkling1
Recent adverse event reports
The 25 most recent of 30 reports, in the reporter's own words as published by the FDA.
InjurySep 22, 2026Material Rupture
Healthcare professional reported via the National Breast Implant Registry (NBIR) "Suspected/Actual Rupture/Deflation". This record is for the right side. The device was explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50854497 ↗InjurySep 16, 2026Material Rupture
Healthcare professional reported "Suspected/Actual Rupture/Deflation" and "Correction of Asymmetry" through the National Breast Implant Registry (NBIR). This record is for the left side. Device was explanted. The patient underwent capsulectomy.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50791435 ↗InjurySep 16, 2026Material Invagination
Healthcare professional reported "Wrinkling/Rippling", "History of Cardiac Disease", "History of Hypertension and other" through the National Breast Implant Registry (NBIR). This record is for the right side. Device was explanted. The patient underwent capsulectomy.
Patient problems: Wrinkling
MAUDE report 50791334 ↗InjuryJul 17, 2026Material Rupture
HEALTHCARE PROFESSIONAL REPORTED A RUPTURE. THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE WAS EXPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25857569 ↗InjuryJul 17, 2026Material Rupture
HEALTHCARE PROFESSIONAL REPORTED A RUPTURE. THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE WAS EXPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25857535 ↗InjuryMay 26, 2026Device Appears to Trigger Rejection; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "POSSIBLE RUPTURE". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture; No Clinical Signs, Symptoms or Conditions
MAUDE report 25295372 ↗InjuryFeb 20, 2026Material Rupture
PATIENT REPORTED, VIA BREAST IMPLANT FOLLOW-UP STUDY (BIFS), HAVING BEEN DIAGNOSED WITH "NON-HODGKINS LYMPHOMA". SIDE UNSPECIFIED, THIS FILE IS FOR THE RIGHT SIDE. NO INDICATION OF TREATMENT OR SURGICAL REOPERATION. LATER HEALTHCARE PROFESSIONAL REPORTED "RUPTURED". DEVICE WAS EXPLANTED.
Patient problems: Lymphoma
MAUDE report 24405371 ↗InjuryFeb 18, 2026Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE WAS EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 24376897 ↗InjuryJan 6, 2026Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 23984339 ↗InjuryJan 3, 2026Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED AND WILL BE RETURNED.
Patient problems: Failure of Implant
MAUDE report 23953619 ↗InjuryJan 3, 2026Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED AND WILL BE RETURNED.
Patient problems: Failure of Implant
MAUDE report 23953617 ↗InjuryOct 16, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "INTACT, CAPSULAR CONTRACTURE BAKER GRADE IV." THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 23313940 ↗InjurySep 11, 2025Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "EXCHANGE FROM TEXTURED TO SMOOTH DEVICES DUE TO THE PATIENT'S CONCERN WITH THE PRODUCT". LATER, HEALTHCARE PROFESSIONAL REPORTED "POSSIBLE RUPTURE". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 23026570 ↗InjuryAug 5, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "CAPSULECTOMY (LEFT SIDE) BAKER GRADE 4." THE DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 22719388 ↗InjuryJun 27, 2025Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE IV", "UP IN THE NECK IN THE CLAVICLE, HARDENING, STARTING TO HURT" AND "RUPTURE". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 22349430 ↗InjuryJun 25, 2025Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN, "LOWER" AND "RUPTURE". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 22327910 ↗InjuryJun 12, 2025Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "POSSIBLE LEFT-SIDE RUPTURE". DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 22196805 ↗InjuryNov 27, 2023Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED PATIENT COMPLAINED OF RUPTURED RIGHT IMPLANT AND LATER CONFIRMED RIGHT IMPLANT WAS RUPTURED. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 18210947 ↗InjurySep 26, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED A RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN. DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 17815358 ↗InjuryJun 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "HEMATOMA, SEROMA, SCARRING, INFECTION". THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Seroma; Unspecified Infection
MAUDE report 14598777 ↗InjuryApr 9, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III. ADDITIONALLY, HEALTHCARE PROFESSIONAL REPORTED "CREASE/FOLDING OF IMPLANT." DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 11640081 ↗InjuryAug 18, 2020Patient-Device Incompatibility; Patient-Device Incompatibility
InjuryJun 18, 2020Patient-Device Incompatibility; Patient-Device Incompatibility
HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 10167801 ↗InjuryJun 17, 2020Patient-Device Incompatibility; Patient-Device Incompatibility
HEALTHCARE PROFESSIONAL REPORTED A RIGHT SIDE CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 10164947 ↗InjuryJan 30, 2020Material Rupture; Migration; Material Rupture; Migration
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-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-
- 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
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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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