IDEAL IMPLANT 59501Recalls & reported problems
Ideal Implant Incorporated · Round, smooth-surface, saline-filled breast implant. · Class 3
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This is an Ideal Implant 59501, a round, smooth-surface, saline-filled breast implant. The 27 reports filed between March 2019 and June 2023 mostly describe the implant losing its saline and flattening, along with material rupture and capsules tightening around the implant; no deaths and 27 injuries 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
- 27
- Deaths reported
- 0
- Injuries reported
- 27
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 10851795006114), received between Mar 25, 2019 and Jun 14, 2023 — classified as 27 injuries.
The most frequently reported specific device problem is “Deflation Problem” (8 reports).
1 other recall cover devices cleared under the same FDA submission (P120011); 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.
Most reported problems
Device problems
- Deflation Problem8
- Insufficient Device Problem Information7
- Adverse Event Without Identified Device or Use Problem5
- Unintended Deflation4
- Failure to Fold3
- Material Rupture2
- Appropriate Device Problem Term/Code Not Available1
- Loss of or Failure to Bond1
Patient problems
- Insufficient Information9
- No Clinical Signs, Symptoms or Conditions8
- Capsular Contracture4
- No Known Impact Or Consequence To Patient4
- Deformity/ Disfigurement1
- Failure of Implant1
- Unspecified Infection1
Recent adverse event reports
The 25 most recent of 27 reports, in the reporter's own words as published by the FDA.
InjuryJun 14, 2023Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
InjuryMay 2, 2023Failure to Fold; Insufficient Device Problem Information; Failure to Fold; Insufficient Device Problem Information
ALLEGED DEFLATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16857838 ↗InjuryMar 1, 2023Material Integrity Problem; Insufficient Device Problem Information; Material Integrity Problem; Insufficient Device Problem Information
ALLEGED DEFLATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16464390 ↗InjuryJan 11, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
ALLEGED DEFLATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16142376 ↗InjuryJan 11, 2023Loss of or Failure to Bond; Insufficient Device Problem Information; Loss of or Failure to Bond; Insufficient Device Problem Information
ALLEGED DEFLATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16142369 ↗InjuryJan 11, 2023Failure to Fold; Insufficient Device Problem Information; Failure to Fold; Insufficient Device Problem Information
ALLEGED DEFLATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16142363 ↗InjurySep 30, 2022Failure to Fold; Insufficient Device Problem Information; Failure to Fold; Insufficient Device Problem Information
ALLEGED DEFLATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15511606 ↗InjuryAug 1, 2022Material Perforation; Unintended Deflation; Material Perforation
ALLEGED DEFLATION.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 15138842 ↗InjuryMay 26, 2022Deflation Problem
InjuryMay 9, 2022Material Rupture
InjuryApr 8, 2022Adverse Event Without Identified Device or Use Problem
InjuryFeb 22, 2022Deflation Problem
InjuryFeb 15, 2022Material Rupture
InjuryDec 29, 2021Deflation Problem
InjuryJul 1, 2021Deflation Problem
InjuryJul 1, 2021Deflation Problem
InjuryDec 10, 2020Unintended Deflation
InjuryDec 10, 2020Unintended Deflation
InjuryNov 12, 2020Unintended Deflation
InjuryFeb 6, 2020Adverse Event Without Identified Device or Use Problem
InjuryDec 2, 2019Deflation Problem
DEFLATION RESULTING IN EXPLANTATION
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9398757 ↗InjuryDec 2, 2019Deflation Problem
CAPSULE CONTRACTURE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9398752 ↗InjuryNov 1, 2019Adverse Event Without Identified Device or Use Problem
InjuryNov 1, 2019Adverse Event Without Identified Device or Use Problem
InjuryNov 1, 2019Patient-Device Incompatibility
Recalls under the same FDA submission
These recalls involve devices cleared under P120011. One submission often covers many models, so check the product and lot details in each record.
- Z-2219-2019 · Mar 18, 2019 · TerminatedIDEAL IMPLANT Structured Breast Implant, saline breast implant, in the following sizes: 210cc, 240cc, 270cc, 300cc, 335cc, 370cc, 405cc, 440cc, 475cc, 515cc, 555cc, 595cc, 635cc,
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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