Is there any news about the Ideal breast implant? Is there anything regarding FDA and Ideal implants?

Question

I'm on my second rupture since May 2020, and I was wondering if there's anything regarding FDA and Ideal implants?

Mathew C. Mosher, MD · Answer

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.

Richard Baxter, MD · Answer

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.

Ronald Schuster, MD · Answer

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.

Larry S. Nichter, MD, MS, FACS · Answer

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.

Is there any news about the Ideal breast implant? Is there anything regarding FDA and Ideal implants?

Answers (4)

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