NATRELLE Silicone-Filled Breast Implants 20-600Recalls & reported problems
Allergan, Inc. · NATRELLE Style 20-600 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
These are Allergan Natrelle silicone-filled breast implants. Most of the 58 reports describe implants that rupture or leak, or scar tissue that tightens around them (capsular contracture), sometimes with swelling or fluid collection. All 58 reports involve injuries, with no deaths. There are no recalls naming this device. Reports rose from 6 in the previous 12 months to 15 in the most recent 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
- 63
- Deaths reported
- 0
- Injuries reported
- 63
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 63 adverse event reports that list this exact device (DI 10888628001763), received between May 22, 2019 and Sep 22, 2026 — classified as 63 injuries.
The most frequently reported specific device problem is “Material Rupture” (41 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 Rupture41
- Device Appears to Trigger Rejection15
- Patient-Device Incompatibility7
- Adverse Event Without Identified Device or Use Problem5
- Device Dislodged or Dislocated1
- Fluid/Blood Leak1
- Migration1
- No Apparent Adverse Event1
Patient problems
- Failure of Implant25
- Capsular Contracture22
- No Clinical Signs, Symptoms or Conditions10
- Seroma2
- Swollen Lymph Nodes2
- Deformity/ Disfigurement1
- Pain1
- Swollen Lymph Nodes/Glands1
Recent adverse event reports
The 25 most recent of 63 reports, in the reporter's own words as published by the FDA.
InjurySep 22, 2026Device Appears to Trigger Rejection; Material Rupture
Healthcare professional reported "capsular contracture Baker grade IV and ruptured". This record is for the left side. The device remains implanted.
Patient problems: Capsular Contracture
MAUDE report 50859942 ↗InjurySep 17, 2026Material Rupture
Healthcare professional reported ¿rupture¿. This record is for the right side. Device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50804267 ↗InjurySep 15, 2026Material Rupture
Patient reported "rupture". This record is for the right side. Device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50776544 ↗InjurySep 15, 2026Material Rupture
Patient reported "rupture". This record is for the left side. Device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50776319 ↗InjurySep 13, 2026Material Rupture
Healthcare professional reported "rupture". This record is for the left side. Device was explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50747557 ↗InjuryAug 25, 2026Material Rupture
Later, healthcare professional reported right side rupture.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50426722 ↗InjuryAug 20, 2026Device Appears to Trigger Rejection; Material Rupture
Healthcare professional reported "possible rupture" and "capsular contracture baker grade III". This record is for the right side. Device remains implanted.
Patient problems: Capsular Contracture
MAUDE report 50347541 ↗InjuryAug 5, 2026Device Appears to Trigger Rejection; Material Rupture
Patient reported "possible rupture" and "can feel the pocket". This record is for the left side. Device remains implanted.
Patient problems: Capsular Contracture; No Clinical Signs, Symptoms or Conditions
MAUDE report 50136755 ↗InjuryJul 15, 2026Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "INTRACAPSULAR RUPTURE" AGAINST THE RIGHT SIDE. THE DEVICE REMAINS IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25834287 ↗InjuryJun 22, 2026Material Rupture; No Apparent Adverse Event
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25579179 ↗InjuryJun 10, 2026Material Rupture
HEALTHCARE PROFESSIONAL REPORTED THROUGH AN ABBVIE SALES REPRESENTATIVE "RUPTURE". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE WAS EXPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25457356 ↗InjuryMay 21, 2026Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE". THIS RECORD IS FOR LEFT SIDE. THE DEVICE REMAINS IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25244086 ↗InjuryMar 23, 2026Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 24662515 ↗InjuryFeb 5, 2026Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURED IMPLANT". LATER HEALTHCARE PROFESSIONAL REPORTED "TOTAL RUPTURE". PATIENT UNDERWENT CAPSULECTOMY. THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 24272741 ↗InjuryJan 14, 2026Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 24067538 ↗InjuryDec 18, 2025Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture
DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 23843099 ↗InjuryDec 8, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III". THIS RECORD IS FOR THE RIGHT-SIDE. DEVICE REMAINS IMPLANTED. DEVICE WILL BE RETURNED.
Patient problems: Capsular Contracture
MAUDE report 23741616 ↗InjuryDec 4, 2025Material Rupture; Material Rupture
InjuryDec 3, 2025Material Rupture; Material Rupture
InjuryNov 19, 2025Material Rupture; Material Rupture
PATIENT REPORTED "RUPTURE". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED, IT'S UNKNOWN IF IT WILL BE RETURNED.
Patient problems: Failure of Implant
MAUDE report 23595596 ↗InjuryOct 29, 2025Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE" CONFIRMED WITH MAMMOGRAM. THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 23415171 ↗InjuryOct 28, 2025Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE" CONFIRMED WITH MAMMOGRAM. THIS RECORD IS FOR THE LEFT SIDE. DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 23405398 ↗InjuryOct 16, 2025Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE IV, RUPTURE" THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 23319137 ↗InjuryAug 15, 2025Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE ¿RUPTURED¿, CONFIRMED VIA ULTRASOUND. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 22816635 ↗InjuryJul 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT REPORTED "NO COMPLAINT AGAINST THE DEVICE". LATER HEALTHCARE PROFESSIONAL REPORTED "FLUID". THIS IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Seroma
MAUDE report 22507658 ↗
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
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- 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
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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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