NATRELLE Saline-Filled Breast Implants 168-330Recalls & reported problems
Allergan, Inc. · NATRELLE 168-330 Moderate Projection BIOCELL |textured|round|saline · Class 3 · Implant
All models of Natrelle Breast Implants (1167) · NATRELLE Saline-Filled Breast Implants (103)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Natrelle saline-filled breast implant from Allergan is a textured round implant. The 38 reports mostly describe implants leaking or deflating, and the shell breaking down so the implant loses its shape, along with scarring around the implant and swelling; 38 injuries and no deaths were reported. One open recall, started in July 2019, concerns textured breast implants and a rare lymphoma risk. In the last 12 months 11 reports were filed, up from 1 in the prior 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
- 40
- Deaths reported
- 0
- Injuries reported
- 40
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 40 adverse event reports that list this exact device (DI 10888628000827), received between Feb 12, 2018 and Jul 27, 2026 — classified as 40 injuries.
The most frequently reported specific device problem is “Fluid/Blood Leak” (29 reports).
1 FDA recall record name this device's identifier, 1 still open.
4 other recalls cover devices cleared under the same FDA submission (P990074); 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
Recalls naming this device
- Jul 24, 2019Class IOpen, Classified
The action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher incidence of anaplastic large cell lymphoma (BIA-ALCL) in patients who have textured breast implants.
Z-2451-2019 · Root cause: Unknown/Undetermined by firm · Recall details · FDA record ↗
Most reported problems
Device problems
- Fluid/Blood Leak29
- Device Appears to Trigger Rejection6
- Adverse Event Without Identified Device or Use Problem2
- Patient-Device Incompatibility2
- Material Rupture1
Patient problems
- Failure of Implant27
- Capsular Contracture8
- No Clinical Signs, Symptoms or Conditions3
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Pain1
Recent adverse event reports
The 25 most recent of 40 reports, in the reporter's own words as published by the FDA.
InjuryJul 27, 2026Fluid/Blood Leak
Healthcare professional reported ¿deflation¿. This record is for the right side. Device was explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50016795 ↗InjuryJul 27, 2026Fluid/Blood Leak
Healthcare Professional reported "rupture". This record is for the left side. Device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50015356 ↗InjuryJun 17, 2026Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED "DEFLATION". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE WAS EXPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25536586 ↗InjuryApr 21, 2026Device Appears to Trigger Rejection
PATIENT REPORTED "IMPLANTS MADE THEM SICK, THEY HAD THYROID ISSUES, MIGRAINES, FIBROMYALGIA, FATIGUE, HYPERSENSITIVITY TO FOOD AND MEDICATIONS, AUTOIMMUNE ISSUES, RASHES ALL OVER", "MESSED UP MY WHOLE BODY AND I'M STILL MESSED UP", "STILL HAVE MIGRAINES WEEKLY, HAIR TEST FOUND HEAVY METALS, AND DIDN'T HEAL FROM A CERVICAL SPINE INJURY" WHICH ARE NOT DEVICE RELATED. LATER, HEALTHCARE PROFESSIONAL REPORTED CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN, "BREAST PAIN", "FREQUENT HEADACHES AND MIGRAINES", "NECK PAIN", "EXTREMITY NUMBNESS AND TINGLING". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 24935902 ↗InjuryApr 20, 2026Device Appears to Trigger Rejection
PATIENT REPORTED "IMPLANTS MADE THEM SICK, THEY HAD THYROID ISSUES, MIGRAINES, FIBROMYALGIA, FATIGUE, HYPERSENSITIVITY TO FOOD AND MEDICATIONS, AUTOIMMUNE ISSUES, RASHES ALL OVER", "MESSED UP MY WHOLE BODY AND I'M STILL MESSED UP", "STILL HAVE MIGRAINES WEEKLY, HAIR TEST FOUND HEAVY METALS, AND DIDN'T HEAL FROM A CERVICAL SPINE INJURY" WHICH ARE NOT DEVICE RELATED. LATER, HEALTHCARE PROFESSIONAL REPORTED CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN, "BREAST PAIN", "FREQUENT HEADACHES AND MIGRAINES, "NECK PAIN", "EXTREMITY NUMBNESS AND TINGLING". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 24929905 ↗InjuryMar 30, 2026Fluid/Blood Leak
PATIENT REPORTED "LEAKING". THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 24720646 ↗InjuryJan 27, 2026Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "DEFLATION". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 24195768 ↗InjuryJan 8, 2026Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 24006920 ↗InjuryJan 7, 2026Fluid/Blood Leak
InjuryDec 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL REPORTED "EXCHANGE OF TEXTURED DEVICES DUE TO PRODUCT CONCERN" AND "PTOSIS AND ATROPHY". THIS RECORD IS FOR LEFT SIDE. DEVICE REMAINS IMPLANTED AND WILL BE RETURNED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 23857921 ↗InjuryDec 18, 2025Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED "DEFLATION". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE WAS EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 23846388 ↗InjuryNov 12, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN, SUPERIOR DISPLACEMENT OF THE IMPLANTS, WATERFALL DEFORMITY, PAIN AND EXCHANGE FROM TEXTURED TO SMOOTH DEVICES DUE TO THE PATIENTS CONCERN WITH THE PRODUCT". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE REMAINS IMPLANTED AND IT WILL BE RETURNED.
Patient problems: Capsular Contracture
MAUDE report 23535265 ↗InjuryNov 12, 2025Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED "DEFLATION AND SMALL SECTION CUT TO THE EDGE RID OF THE REST OF THE SOLID". THIS RECORD IS FOR THE "RIGHT" SIDE. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 23531934 ↗InjuryApr 22, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN AND "PATIENT¿S CONCERN WITH THE PRODUCT." HEALTHCARE PROFESSIONAL LATER REPORTED PAIN AND BAKER GRADE III. DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 21885789 ↗InjuryOct 31, 2024Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "TEXTURED," "CAPSULAR CONTRACTURES GRADE II," AND "POSSIBLE LEAKING". DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 20582617 ↗InjuryOct 24, 2024Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE "TEXTURED," "CAPSULAR CONTRACTURES GRADE II," AND "POSSIBLE LEAKING". DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 20522371 ↗InjurySep 19, 2023Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "DEFLATED IMPLANT." DEVICE WAS EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 17772979 ↗InjurySep 5, 2023Fluid/Blood Leak; Fluid/Blood Leak
PATIENT REPORTED RIGHT SIDE DEFLATION AND REMOVAL FROM TEXTURED TO SMOOTH DUE TO THE CONCERNS OF THE PRODUCT. LATER HEALTHCARE PROFESSIONAL CONFIRMED DEFLATION AND REMOVAL FROM TEXTURED TO SMOOTH DUE TO THE CONCERNS OF THE PRODUCT. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 17686256 ↗InjurySep 1, 2023Fluid/Blood Leak; Fluid/Blood Leak
PATIENT REPORTED DEFLATION. THE DEVICE HAS BEEN EXPLANTED. THIS RELATES TO THE LEFT SIDE.
Patient problems: Failure of Implant
MAUDE report 17671648 ↗InjuryAug 31, 2023Fluid/Blood Leak; Fluid/Blood Leak
PATIENT REPORTED RIGHT SIDE "LOSING VOLUME." DEVICE WAS EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 17662376 ↗InjuryJun 1, 2023Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL ADDITIONALLY REPORTED "ANY CREASE" AND "PARTICLES IN VALVE."
Patient problems: Failure of Implant
MAUDE report 17037600 ↗InjuryJan 20, 2023Fluid/Blood Leak; Fluid/Blood Leak
InjuryJan 1, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE EXCHANGE FROM TEXTURED TO SMOOTH DUE TO PRODUCT CONCERN. HEALTHCARE PROFESSIONAL LATER REPORTED RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 16081386 ↗InjuryOct 11, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
PATIENT REPORTED LEFT SIDE "I HAVE CAPSULAR CONTRACTURE WHICH FORMED IN BOTH BREASTS", "I NO LONGER HAVE MUCH SENSATION IN THE LEFT BREAST. " AND "I AM A PATIENT WHO RECEIVED BIOCELL MACROTEXTURED BREAST IMPLANTS." DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 15580609 ↗InjuryJul 20, 2022Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE DEFLATION. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 15065066 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under P990074. One submission often covers many models, so check the product and lot details in each record.
- Z-0699-2020 · Nov 6, 2019 · TerminatedNatrelle Saline-Filled Breast Implant, for the following Styles and sizes, Style LP, Style 68 HP, Style 68 MP, Style LP/UDI: NATRELLE Style 68LP-125 Saline Round Low 108886280
- Z-0337-06 · Dec 14, 2005 · TerminatedMcGhan Style 163-360cc Saline-Filled BIOCELL textured Breast Implants, Catalogue Number :163-360
- Z-0336-06 · Dec 14, 2005 · TerminatedMcGhan Style 468-380cc Saline-Filled BIOCELL textured Breast Implants, Catalog Number:468-380
- Z-0851-05 · May 5, 2005 · TerminatedStyle 363 Saline-Filled BIOCELL textured Breast Implants
Other Prosthesis, Breast, Inflatable, Internal, Saline devices
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- MENTOR Smooth Round Moderate Profile 3501660Mentor Texas L.P. · Prosthesis, breast, inflatable, internal, saline1,972 reports
- MENTOR Smooth Round Moderate Profile 3501670Mentor Texas L.P. · Prosthesis, breast, inflatable, internal, saline1,899 reports
- MENTOR Smooth Round Moderate Profile 3501645Mentor Texas L.P. · Prosthesis, breast, inflatable, internal, saline1,655 reports
- MENTOR Smooth Round Moderate Profile 3501655Mentor Texas L.P. · Prosthesis, breast, inflatable, internal, saline1,534 reports
- MENTOR Smooth Round Moderate Profile 3501640Mentor Texas L.P. · Prosthesis, breast, inflatable, internal, saline1,294 reports
- MENTOR Smooth Round Moderate Profile 3501680Mentor Texas L.P. · Prosthesis, breast, inflatable, internal, saline1,095 reports
- MENTOR Smooth Round Moderate Profile 3501635Mentor Texas L.P. · Prosthesis, breast, inflatable, internal, saline864 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 · each recall links to the FDA recall notice
- 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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