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We have not seen new information from Health Canada or from the FDA despite the early ruptures seen with this device. I no longer can recommend this device to any patient after my patients have experienced several early ruptures. These rupture rates in mine and other practices do not correlate the published and marketed data from this company.
Ideal implants are FDA-cleared and have a reported 8-year deflation rate of 2.1% which is very low. There must be something else going on to explain 2 ruptures in 7 months.
The Ideal implant is now available. After a long hiatus due to operational issues they are back. I have been using them since they were first available and am eager to resume.
IDEAL implant company voluntarily took their implants off the market without FDA directions to do so as they found a few more ruputures than expected after changing manufacturer plants. They found that the valve assembly varied by a fraction of a millimeter which was the cause. This was corrected and due to increased demand they are back on the market as of November 2020 according to the Company's owner and inventor of the implant. With COVID they have decided to make sure that the supplies are adequate for all plastic surgeons in the US and Canada prior to its re-release. On a personal note, as a lead FDA investigator, I think these are great implants which will likely decrease the number of surgeries in your lifetime and if ruptured do not require a removal of the capsule, capsulectomy, when replaced compared to silicone implants. It is our most popular implant in my practice.
Although they are not yet available outside of the United States, IDEAL implants are an excellent potential product for the European markets. Global trends in implant preferences show that many patients are favoring saline implants, as a lower maintenance alternative with a good safety...
Ideal implants feel very close to silicone gel implants. In patients who already have some breast tissue or subcutaneous fat they feel the same. In real thin patients gel might have the edge but they still perform better than traditional saline.
Ideal implants are structured saline implants. They have a range of fill volumes. I generally recommend filling them towards the highest range especially if you are thin. The difference of 50cc is really not that great when you think about a 350cc implant (about 15%) - about a quarter of a bra...
