NATRELLE Saline-Filled Breast Implants 68LP-200Recalls & reported problems
Allergan, Inc. · NATRELLE Style 68LP-200 Low 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 is an Allergan Natrelle Style 68LP-200 low-profile round saline breast implant. The 33 adverse event reports mostly describe implants losing their saline through leaking or rupturing, along with scarring that tightens around the implant (capsular contracture); 32 reports involved injuries and no deaths were reported. Several describe removal and replacement of the implant. There are no recalls naming 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
- 34
- Deaths reported
- 0
- Injuries reported
- 33
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 10888628000544), received between Aug 14, 2019 and Sep 10, 2026 — classified as 33 injuries, 1 malfunction.
The most frequently reported specific device problem is “Fluid/Blood Leak” (28 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 Leak28
- Device Appears to Trigger Rejection3
- Material Rupture2
- Patient-Device Incompatibility2
- Device Contaminated During Manufacture or Shipping1
Patient problems
- Failure of Implant26
- Capsular Contracture5
- No Clinical Signs, Symptoms or Conditions2
- Fluid Discharge1
Recent adverse event reports
The 25 most recent of 34 reports, in the reporter's own words as published by the FDA.
InjurySep 10, 2026Fluid/Blood Leak
Healthcare professional reported "Deflation", "Leak/ripple" and "Leak/nipple". This record is for the left side. Device was explanted.
Patient problems: Fluid Discharge
MAUDE report 50713888 ↗InjuryJul 9, 2026Fluid/Blood Leak
PATIENT REPORTED A DEFLATION. HEALTHCARE PROFESSIONAL REPORTED A DEFLATION. THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25771819 ↗InjuryMar 3, 2026Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED "RUPTURED" AGAINST A SALINE DEVICE. THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 24497039 ↗InjuryNov 20, 2025Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED "REMOVAL, BREAST IMPLANT, RUPTURED". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 23610376 ↗InjuryNov 17, 2025Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED "REMOVAL, BREAST IMPLANT, RUPTURED". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 23575867 ↗InjurySep 9, 2025Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED "DEFLATION" CONFIRMED VIA PHYSICAL EXAMINATION. THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 23005072 ↗InjuryJun 9, 2025Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED "DEFLATION". THIS RECORD IS FOR THE "LEFT" SIDE. THE DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 22169912 ↗InjuryMay 31, 2025Fluid/Blood Leak; Fluid/Blood Leak
PATIENT REPORTED "LEAK, HANGING, AND SHAPED DIFFERENTLY". THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 22120746 ↗InjuryApr 29, 2025Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED "DEFLATION". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 21929025 ↗InjuryOct 5, 2023Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED A RIGHT SIDE DEFLATION. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 17877902 ↗InjurySep 18, 2023Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED, "LEFT SIDE EXCHANGE WITH NO COMPLAINT AGAINST THE DEVICE". HEALTHCARE PROFESSIONAL LATER REPORTED, LEFT SIDE DEFLATION. DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 17769926 ↗InjuryFeb 20, 2023Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED A RIGHT SIDE DEFLATION. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 16404987 ↗InjuryDec 21, 2022Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE DEFLATION. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 16030516 ↗MalfunctionNov 30, 2022Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
HEALTHCARE PROFESSIONAL REPORTED "HUMAN HAIR STUCK TO IMPLANT". DEVICE WAS NOT IMPLANTED AND HAS BEEN DISCARDED. NO PATIENT CONTACT. SURGERY WAS COMPLETED WITH A BACKUP DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15889360 ↗InjuryNov 22, 2022Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "DEFLATION." THE DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 15847444 ↗InjuryOct 3, 2022Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE RUPTURE. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 15530266 ↗InjurySep 14, 2022Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE DEFLATION. DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 15421484 ↗InjuryAug 22, 2022Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE DEFLATION. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 15266012 ↗InjuryAug 3, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE IV. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 15155845 ↗InjuryJul 21, 2022Fluid/Blood Leak; Fluid/Blood Leak
PATIENT REPORTED RIGHT SIDE DEFLATION. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 15071209 ↗InjuryJul 21, 2022Fluid/Blood Leak; Fluid/Blood Leak
PATIENT REPORTED LEFT SIDE DEFLATION. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 15071203 ↗InjuryApr 13, 2022Fluid/Blood Leak; Device Appears to Trigger Rejection; Fluid/Blood Leak; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE DEFLATION AND CAPSULAR CONTRACTURES, BAKER GRADES III/IV. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 14094083 ↗InjuryApr 12, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURES, BAKER GRADES IV AND EXCHANGE FROM TEXTURED TO SMOOTH. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 14085311 ↗InjuryDec 28, 2021Fluid/Blood Leak; Fluid/Blood Leak
InjuryDec 8, 2021Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE DEFLATION. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 12962797 ↗
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
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- 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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