NATRELLE Silicone-Filled Breast Implants 20-550Recalls & reported problems
Allergan, Inc. · NATRELLE Style 20-550 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 breast implant is a silicone gel-filled implant used in breast augmentation or reconstruction. All 88 reports are injuries, many describing the implant rupturing or the scar capsule around it tightening, known as capsular contracture, and some noting removal. No deaths are listed. Reports rose from 4 in the prior 12 months to 21 in the last 12 months. 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
- 93
- Deaths reported
- 0
- Injuries reported
- 93
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 93 adverse event reports that list this exact device (DI 10888628001756), received between May 14, 2019 and Sep 29, 2026 — classified as 93 injuries.
The most frequently reported specific device problem is “Material Rupture” (42 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 Rupture42
- Device Appears to Trigger Rejection28
- Patient-Device Incompatibility22
- Adverse Event Without Identified Device or Use Problem5
- Improper or Incorrect Procedure or Method1
- No Apparent Adverse Event1
Patient problems
- Capsular Contracture50
- Failure of Implant30
- No Clinical Signs, Symptoms or Conditions7
- Unspecified Infection3
- Bacterial Infection1
- Cellulitis1
- Pallor1
- Swelling/ Edema1
Recent adverse event reports
The 25 most recent of 93 reports, in the reporter's own words as published by the FDA.
InjurySep 29, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50939791 ↗InjurySep 16, 2026Adverse Event Without Identified Device or Use Problem
Healthcare professional reported "fluid build up". Healthcare professional reported "pain after a motor vehicle accident". Later healthcare professional reported "capsule grade 1". Patient had a capsulorrhaphy. This record is for the left side. Device was explanted.
Patient problems: Swelling/ Edema
MAUDE report 50785889 ↗InjurySep 8, 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 50670546 ↗InjuryAug 28, 2026Material Rupture
Patient reported "rupture". This record is for an unknown side. Device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50508280 ↗InjuryAug 23, 2026Material Rupture
Healthcare professional reported "rupture". This record is for right side. The device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50396181 ↗InjuryAug 6, 2026Device Appears to Trigger Rejection
Later, healthcare professional reported Capsular Contracture Baker grade III. This record is for the left side. Device was explanted.
Patient problems: Capsular Contracture
MAUDE report 50159587 ↗InjuryAug 5, 2026Device Appears to Trigger Rejection
Patient reported "capsular contracture Baker grade unknown". This record is for the right side. Device remains implanted.
Patient problems: Capsular Contracture
MAUDE report 50136696 ↗InjuryJul 21, 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 25896364 ↗InjuryJun 11, 2026Material Rupture
PATIENT REPORTED "IMPLANT IS REALLY HIGH NEAR COLLAR BONE, HARD, THROBBING AND PAINFUL" & "RUPTURE, WARM, SORE, REALLY HIGH AND HARD, PAIN, STARTING TO HURT EVERYDAY NOW, WENT HARD, TOO BIG, LOT BIGGER THAN MY LEFT." . THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25472039 ↗InjuryMar 6, 2026Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 24535700 ↗InjuryFeb 26, 2026Material Rupture
PATIENT REPORTED "BREAST INFECTION, PAIN, AND REDNESS". PATIENT ADDITIONALLY REPORTED "LUPUS, TIRED/SLUGGISH, AND "WEIGHT GAIN" THESE EVENTS ARE NOT RELATED TO THE DEVICE. LATER PATIENT REPORTED "RUPTURE". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE REMAINS IMPLANTED.
Patient problems: Unspecified Infection
MAUDE report 24462120 ↗InjuryFeb 25, 2026Material Rupture
PATIENT REPORTED "BREAST INFECTION, REDNESS, ACHES, PAIN IN THE BREAST". "CELLULITIS/STAPH INFECTION". PATIENT ADDITIONALLY REPORTED "LUPUS, TIRED/SLUGGISH, AND "WEIGHT GAIN;" THESE EVENTS ARE NOT RELATED TO THE DEVICE. PATIENT WAS ADMITTED TO AN UNKNOWN HOSPITAL FOR THREE DAYS AND WAS TREATED WITH UNKNOWN INTRAVENOUS MEDICATIONS. LATER PATIENT REPORTED "RUPTURE". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE REMAINS IMPLANTED.
Patient problems: Cellulitis; Unspecified Infection
MAUDE report 24443729 ↗InjuryFeb 17, 2026Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 24362001 ↗InjuryFeb 16, 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 24351693 ↗InjuryFeb 16, 2026Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 24347215 ↗InjuryJan 29, 2026Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE DISCOVERED DURING SURGERY". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 24211259 ↗InjuryJan 28, 2026Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE, BAKER GRADE III". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 24198503 ↗InjuryJan 22, 2026Device Appears to Trigger Rejection; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURES BAKER GRADE IV". LATER HEALTHCARE PROFESSIONAL REPORTED "RUPTURE". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 24154587 ↗InjuryDec 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT REPORTED VIA BIFS (BREAST IMPLANT FOLLOW-UP STUDY) "RAYNAUDS' PHENOMENON (NUMBNESS, PAIN, OR COLOR CHANGES IN THE FINGERS AND TOES OFTEN BROUGHT ON BY THE COLD OR EMOTIONAL DISTRESS)". PATIENT ALSO REPORTED "ENLARGED LYMPH NODES IN [THEIR] GROIN", WHICH IS NOT DEVICE-RELATED. LATER HEALTHCARE PROFESSIONAL REPORTED "NO COMPLAINT AGAINST THE DEVICE". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: Pallor
MAUDE report 23844542 ↗InjuryDec 11, 2025Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED AND REPLACED. THE DEVICE WILL BE RETURNED.
Patient problems: Failure of Implant
MAUDE report 23782919 ↗InjuryDec 11, 2025Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED AND REPLACED. THE DEVICE WILL BE RETURNED.
Patient problems: Failure of Implant
MAUDE report 23782456 ↗InjuryDec 10, 2025Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE". TREATMENT: ANTIBIOTICS. THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE WAS EXPLANTED AND REPLACED. IT WILL NOT BE RETURNED.
Patient problems: Failure of Implant
MAUDE report 23771561 ↗InjuryDec 5, 2025Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE REMAINS IMPLANTED AND IT WILL NOT BE RETURNED.
Patient problems: Failure of Implant
MAUDE report 23724228 ↗InjuryDec 2, 2025Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE WAS EXPLANTED AND REPLACED. THE DEVICE WILL BE RETURNED.
Patient problems: Failure of Implant
MAUDE report 23697024 ↗InjuryNov 26, 2025Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 23662956 ↗
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-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-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-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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