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.