Ideal Saline-Filled Breast Implant:
- Approval Date: Nov. 14, 2014
- Medical Device Recall Search
- FDA Overview – Saline Breast Implants
- FDA PMA P120011
- Approval Order (Post-Approval Study Conditions)
- Summary of Safety & Effectiveness (Heavy Metals, pg. 8)
- Labeling Pamphlet #1 (for patients, from 2014)
- Labelling Pamphlet #2 (for physicians, from 2014)
- Post Approval Study
- Supplements: *S001, S002, S003, S004, S005, S007, S008
Ideal Saline Post-Approval Studies:
1. Conduct a Focus Group Study to evaluate whether Ideal Saline-filled breast implants for Breast Augmentation Surgery brochure effectively communicate the risks and benefits of breast implant surgery to women interested in primary or revision breast augmentation, according to the protocol version dated 3/18/14. Upon completion of the focus group study, Ideal must submit a Final Report of the Focus Group Study findings and suggested revision of patient and physician labeling based on those findings.
2. Conduct a Device Explant Analyses for all Ideal Saline-filled breast implants that are retrieved, per explant analysis protocol version dated 7/7/14. ON an annual basis, you must report the results of these Device Explant Analyses in the PMA Annual Reports.
3. Post-Approval PMA Study (PACS): Per post-approval protocol version dated February 27. 2014, this study will consist of the continued follow-up of the premarket enrolled participants. Study participants will be followed annually for 10 years in order to asses the long-term clinical performance of their device. The patient and physical labeling must be updated to reflect 5 and 10 year PAVS study findings on the safety and effectiveness of the device, as soon as these data are available, as well as any other time point deemed necessary by FDA if significantly new information from this study becomes available.
4. Ideal must also agree to participate as a stakeholder in developing the National Breast Implant Registry.
“Post-approval studies (PAS) are conditions of device approval. A sponsor’s failure to comply with any post-approval requirement may be grounds for withdrawing approval.” – FDA
If you wish for more information on them or have questions, you can contact: Julie Unger, Project Manager for the Post-Approval Studies program. Her email is julie.[email protected] and phone number is (301) 796-6134.
For a timeline of Ideal Saline Breast Implants, click here.
FDA MAUDE – Adverse Reaction Reports – Inclusive of Ideal Saline Breast Implants:
I had breast augmentation from dr (b)(6) , (b)(6) 2017. (b)(6) is when i started getting symptoms. Fever, body chills, nausea, headache, high blood pressure. I have had extensive blood work. Ct scans, mris, and bone marrow. I have been seen by an internist, infectious disease doctor, and a rheumatologist. Link.
Inadequate valve strap bond. Link.