NATRELLE Silicone-Filled Breast Implants 20-650Recalls & reported problems
Allergan, Inc. · NATRELLE Style 20-650 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 breast implant is designed for breast reconstruction or augmentation. Reports mostly describe implant rupture and tightening of scar tissue around the implant, sometimes with implant removal. There are 42 adverse event reports naming its identifier, with no deaths and 42 injuries. No recalls name this device; reports increased from 7 in the previous 12 months to 15 in the latest 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
- 45
- Deaths reported
- 0
- Injuries reported
- 45
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 45 adverse event reports that list this exact device (DI 10888628001770), received between Jul 9, 2019 and Sep 28, 2026 — classified as 45 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 Rejection10
- Patient-Device Incompatibility5
- Adverse Event Without Identified Device or Use Problem4
- No Apparent Adverse Event2
Patient problems
- Failure of Implant20
- Capsular Contracture15
- No Clinical Signs, Symptoms or Conditions8
- Swollen Lymph Nodes/Glands2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Lymphoma1
Recent adverse event reports
The 25 most recent of 45 reports, in the reporter's own words as published by the FDA.
InjurySep 28, 2026Material Rupture
Healthcare professional did not report a complaint against device. Later reported "rupture". This record is for the left side. Device was explanted. Capsulotomy treatment was performed.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50921437 ↗InjurySep 16, 2026Material Rupture
Healthcare professional reported through National Breast Implant Registry (NBIR) "Suspected/Actual Rupture/Deflation". This record is for the right side. Device was explanted. Capsulectomy/Capsulotomy treatment was performed.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50786862 ↗InjurySep 15, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50782145 ↗InjurySep 14, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50763633 ↗InjurySep 9, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50701614 ↗InjuryAug 28, 2026Material Rupture; No Apparent Adverse Event
Healthcare professional reported "rupture". This record is for the right side. Device was explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50507851 ↗InjuryJul 1, 2026Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III" AND "PAIN". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 25676628 ↗InjuryMar 20, 2026Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE, BAKER GRADE IV". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 24651958 ↗InjuryMar 9, 2026Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED. PATIENT UNDERGO A CAPSULECTOMY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24546493 ↗InjuryFeb 20, 2026Adverse Event Without Identified Device or Use Problem
PATIENT REPORTED, VIA BREAST IMPLANT FOLLOW-UP STUDY (BIFS), HAVING BEEN DIAGNOSED WITH "NON-HODGKINS LYMPHOMA." SIDE UNSPECIFIED, THIS FILE IS FOR THE LEFT SIDE. NO INDICATION OF TREATMENT OR SURGICAL REOPERATION. LATER HEALTHCARE PROFESSIONAL REPORTED "LOCKED COMPROMISED". DEVICE WAS EXPLANTED.
Patient problems: Lymphoma
MAUDE report 24405330 ↗InjuryJan 14, 2026Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED AND REPLACED. DEVICE WILL NOT BE RETURNED.
Patient problems: Failure of Implant
MAUDE report 24068784 ↗InjuryDec 23, 2025Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE" AND "POSSIBLE FLIPPING". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE WAS EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 23881606 ↗InjuryNov 29, 2025Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE RUPTURE. THE DEVICE HAS BEEN EXPLANTED AND WILL BE RETURNED.
Patient problems: Failure of Implant
MAUDE report 23675908 ↗InjuryNov 18, 2025Material Rupture; Material Rupture
PATIENT REPORTED "RUPTURE", "INFLAMMATION", "BRAIN FOG", "MEMORY LOSS", " HAIR LOSS", "DRY EYES", "METALLIC TASTE IN MOUTH", "SLOW MUSCLE RECOVERY", "DIFFICULTY CONCENTRATING", "SEVERE CRAMPING IN LEGS AND FEET", "SKIN RASHES", AND "FATIGUE". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 23589441 ↗InjuryNov 17, 2025Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED ¿RUPTURE ¿. THIS RECORD IS FOR THE RIGHT-SIDE. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 23575776 ↗InjuryNov 13, 2025Material Rupture; Material Rupture
PATIENT REPORTED "RUPTURE", "INFLAMMATION", "BRAIN FOG", "MEMORY LOSS", " HAIR LOSS", "DRY EYES", "METALLIC TASTE IN MOUTH", "SLOW MUSCLE RECOVERY", "DIFFICULTY CONCENTRATING", "SEVERE CRAMPING IN LEGS AND FEET", "SKIN RASHES", AND "FATIGUE". THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 23546986 ↗InjuryNov 7, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 23495781 ↗InjuryNov 6, 2025Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE RUPTURE. THE DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 23493059 ↗InjuryOct 24, 2025Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE", DIAGNOSTIC TESTING PERFORMED: MRI. THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED AND DEVICES WILL BE RETURNED.
Patient problems: Failure of Implant
MAUDE report 23376319 ↗InjuryOct 23, 2025Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE" DIAGNOSED VIA MRI. THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED AND THE DEVICE WILL BE RETURNED.
Patient problems: Failure of Implant
MAUDE report 23368613 ↗InjuryOct 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL REPORTED "GRADE I CAPSULE" CONFIRMED VIA MRI AND "REDUNDANT AXILLARY ELASTOSIS". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 23294990 ↗InjuryAug 21, 2025Material Rupture; Material Rupture
InjuryJul 10, 2025Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE RUPTURE. DEVICE WAS EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 22472546 ↗InjuryFeb 13, 2025Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE RUPTURE. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 21373461 ↗InjuryDec 10, 2024Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE RUPTURE. DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 20893690 ↗
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 3504001BCMentor Texas L.P. · Prosthesis, breast, noninflatable, internal, silicone gel-filled2,130 reports
- 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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