NATRELLE Saline-Filled Breast Implants 68-180Recalls & reported problems
Allergan, Inc. · NATRELLE Style 68MP-180 Moderate Projection |smooth|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
Quick summary
This Natrelle saline-filled breast implant is used to enlarge or replace breast tissue. The 37 reports describe implants losing fluid or deflating, some rupturing during surgery, and scar tissue tightening around the implant that made it hard and painful. All 37 reports involved injuries, and no deaths were reported. 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
- 39
- Deaths reported
- 0
- Injuries reported
- 39
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 10888628000179), received between Feb 20, 2018 and Aug 11, 2026 — classified as 39 injuries.
The most frequently reported specific device problem is “Fluid/Blood Leak” (26 reports).
5 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
Most reported problems
Device problems
- Fluid/Blood Leak26
- Device Appears to Trigger Rejection8
- Patient-Device Incompatibility4
- Material Rupture3
- Adverse Event Without Identified Device or Use Problem1
- Deflation Problem1
Patient problems
- Failure of Implant25
- Capsular Contracture12
- No Clinical Signs, Symptoms or Conditions1
- Unspecified Infection1
Recent adverse event reports
The 25 most recent of 39 reports, in the reporter's own words as published by the FDA.
InjuryAug 11, 2026Fluid/Blood Leak
Healthcare professional reported "Deflation". This record is for the left side. Device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50204658 ↗InjuryJul 21, 2026Fluid/Blood Leak; Device Appears to Trigger Rejection
Healthcare professional reported "partial implant leak and capsular contracture Baker grade III"; Singulair prescribed. Healthcare professional later reported "apparent deflation, device intentionally deflated to measure volume". This record is for the left side. The device has been explanted.
Patient problems: Capsular Contracture
MAUDE report 25898438 ↗InjuryNov 28, 2025Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED "DEFLATION". PATIENT LATER REPORTED "PAIN AND DEFLATION". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 23674050 ↗InjuryJul 29, 2025Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "IMPLANT RUPTURED DURING THE IMPLANTATION PROCESS¿. DEVICE WAS NOT IMPLANTED AND DISCARDED.
Patient problems: Failure of Implant
MAUDE report 22654873 ↗InjuryJul 17, 2025Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE DEFLATION AND RIPPLING. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 22530495 ↗InjuryApr 26, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 21915749 ↗InjuryMar 3, 2025Fluid/Blood Leak; Material Rupture; Fluid/Blood Leak; Material Rupture
HEALTHCARE PROFESSIONAL LATER REPORTED RIGHT SIDE "DEFLATED." VIA MAMMOGRAM. THE DEVICE HAS BEEN EXPLANTED AND REPLACED. PREVIOUS MEDWATCH SUBMISSION NOTED "RUPTURE." UPON FURTHER INFORMATION, ALLERGAN HAS DETERMINED THAT THE EVENT OF "RUPTURE" DID NOT OCCUR.
Patient problems: Failure of Implant
MAUDE report 21504847 ↗InjuryNov 9, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III. THE DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 18107880 ↗InjuryNov 8, 2023Fluid/Blood Leak; Fluid/Blood Leak
InjurySep 28, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED CAPSULAR CONTRACTURE, BAKER GRADE III. DEVICE HAS BEEN EXPLANTED. THIS RELATES TO THE LEFT SIDE.
Patient problems: Capsular Contracture
MAUDE report 17833793 ↗InjurySep 18, 2023Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE RUPTURE. DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 17769816 ↗InjurySep 18, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED, LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III. DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 17769795 ↗InjurySep 6, 2023Fluid/Blood Leak; Fluid/Blood Leak
InjuryMay 25, 2023Fluid/Blood Leak; Fluid/Blood Leak
THE DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 17007452 ↗InjuryApr 18, 2023Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE "GRADUALLY DEFLATING." DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 16765786 ↗InjuryApr 5, 2023Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE DEFLATION. DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 16682771 ↗InjuryApr 3, 2023Fluid/Blood Leak; Fluid/Blood Leak
COMPANY REPRESENTATIVE REPORTED RIGHT SIDE DEFLATION. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 16665377 ↗InjuryDec 20, 2022Fluid/Blood Leak; Fluid/Blood Leak
PATIENT REPORTED AND HEALTHCARE PROFESSIONAL CONFIRMED LEFT SIDE "DEFLATION". DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 16018675 ↗InjuryOct 23, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
PATIENT REPORTED RIGHT CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN AND "PAIN IN THE ARMS AND SHOULDERS". DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 15656476 ↗InjuryOct 23, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
PATIENT REPORTED LEFT CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN AND "PAIN IN THE ARMS AND SHOULDERS". DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 15656474 ↗InjurySep 15, 2022Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED "DEFLATION" AGAINST RIGHT DEVICE. THE DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 15434683 ↗InjuryApr 28, 2022Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE DEFLATION. PATIENT CALLED TO REPORT ¿I¿VE HAD THESE IMPLANTS FOR FIVE YEARS AND LEFT SIDE IS RUPTURED. MY BREAST IS VERY FLAT. I WANT IT OUT, I DON¿T WANT THEM REPLACED.¿ DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 14246285 ↗InjuryApr 19, 2022Fluid/Blood Leak; Device Appears to Trigger Rejection; Fluid/Blood Leak; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE "DEFLATION AND CAPSULAR CONTRACTURE (BAKER GRADE III)." THE DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 14141974 ↗InjuryApr 1, 2022Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE DEFLATION. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 13973452 ↗InjuryMar 23, 2022Fluid/Blood Leak; Fluid/Blood Leak
HEALTH CARE PROFESSIONAL REPORTED LEFT SIDE DEFLATION. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 13859469 ↗
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-2451-2019 · Jul 24, 2019 · Open, ClassifiedNatrelle, Saline-Filled Breast Implant Biocell Full Height with Fill Tube, Sterile, for the following style numbers: Style 163:163-360CC, 163-440CC, 163-530CC, 163-655CC, 163-7
- 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
- MENTOR Smooth Round Moderate Profile 3501650Mentor Texas L.P. · Prosthesis, breast, inflatable, internal, saline2,187 reports
- 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
- 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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