IDEAL IMPLANT 55501Recalls & 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 a round, smooth-surface, saline-filled breast implant made by Ideal Implant. The 54 reports mostly describe the implant losing its saline and flattening, along with scar tissue tightening around it (capsular contracture). There are no deaths, 52 injuries, and 2 malfunctions; 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
- 55
- Deaths reported
- 0
- Injuries reported
- 53
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 55 adverse event reports that list this exact device (DI 10851795006107), received between Sep 28, 2017 and Aug 18, 2026 — classified as 53 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Deflation Problem” (19 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.
Reports received per month
Most reported problems
Device problems
- Deflation Problem19
- Adverse Event Without Identified Device or Use Problem17
- Unintended Deflation9
- Insufficient Device Problem Information7
- Patient Device Interaction Problem2
- Appropriate Device Problem Term/Code Not Available1
- Burst Container or Vessel1
- Failure to Fold1
Patient problems
- Capsular Contracture15
- Insufficient Information15
- No Clinical Signs, Symptoms or Conditions9
- Failure of Implant7
- No Known Impact Or Consequence To Patient6
- Unspecified Infection2
- Breast Discomfort/Pain1
- No Information1
Recent adverse event reports
The 25 most recent of 55 reports, in the reporter's own words as published by the FDA.
InjuryAug 18, 2026Adverse Event Without Identified Device or Use Problem; Unintended Deflation
Patient has a history of anxiety attacks which led her to have to visit a cardiologist in (B)(6) 2026. During this visit, the doctor took x-rays and discovered that her left implant had ruptured. She is otherwise healthy, she is just experiencing pain and discomfort from ruptured implant.Additional information received 09/28/2026 - The surgery took place on 9/11/26. During the procedure, we discovered the implant was not ruptured.
Patient problems: Breast Discomfort/Pain; Failure of Implant
MAUDE report 50308248 ↗InjuryMar 3, 2025Unintended Deflation; Unintended Deflation
InjuryFeb 24, 2025Unintended Deflation; Unintended Deflation
SUSPECTED DEFLATION OF THE RIGHT BREAST IMPLANT.
Patient problems: Failure of Implant
MAUDE report 21447171 ↗InjuryJun 14, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
ALLEGED DEFLATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17132164 ↗InjuryJun 14, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
ALLEGED DEFLATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17132052 ↗InjuryJun 8, 2023Patient Device Interaction Problem; Patient Device Interaction Problem
CAPSULE CONTRACTURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17084764 ↗InjuryJun 8, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
ALLEGED DEFLATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17084760 ↗InjuryApr 17, 2023Failure to Fold; Insufficient Device Problem Information; Failure to Fold; Insufficient Device Problem Information
InjurySep 30, 2022Insufficient Device Problem Information; Patient Device Interaction Problem; Insufficient Device Problem Information; Patient Device Interaction Problem
ALLEGED DEFLATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15512041 ↗InjurySep 30, 2022Insufficient Device Problem Information; Insufficient Device Problem Information
ALLEGED DEFLATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15512000 ↗InjurySep 30, 2022Insufficient Device Problem Information; Insufficient Device Problem Information
ALLEGED DEFLATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15511935 ↗InjuryAug 2, 2022Adverse Event Without Identified Device or Use Problem
InjuryJul 27, 2022Adverse Event Without Identified Device or Use Problem
InjuryJul 27, 2022Adverse Event Without Identified Device or Use Problem
InjuryJul 12, 2022Unintended Deflation
InjuryJun 29, 2022Deflation Problem
InjuryJun 29, 2022Deflation Problem
InjuryJun 29, 2022Unintended Deflation
ALLEGED DEFLATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14856162 ↗InjuryMay 16, 2022Unintended Deflation
InjuryMay 16, 2022Unintended Deflation
InjuryApr 1, 2022Adverse Event Without Identified Device or Use Problem
CAPSULE CONTRACTURE REPORTED AS THE REASON FOR EXPLANTATION.
Patient problems: Capsular Contracture
MAUDE report 13973469 ↗InjuryMar 19, 2022Adverse Event Without Identified Device or Use Problem
InjuryMar 9, 2022Deflation Problem
InjuryNov 11, 2021Deflation Problem
InjuryOct 22, 2021Adverse Event Without Identified Device or Use Problem
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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