I'm on my second rupture since May 2020, and I was wondering if there's anything regarding FDA and Ideal implants?
Answer: IDEAL Implants 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.
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Answer: IDEAL Implants 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.
Helpful 6 people found this helpful
January 4, 2021
Answer: Deflation of Ideal implants is uncommon 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.
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January 4, 2021
Answer: Deflation of Ideal implants is uncommon 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.
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November 11, 2022
Answer: Ideal Implant update 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.
Helpful 1 person found this helpful
November 11, 2022
Answer: Ideal Implant update 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.
Helpful 1 person found this helpful
November 11, 2022
Answer: IDEAL Implants Available November 2020 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.
Helpful 5 people found this helpful
November 11, 2022
Answer: IDEAL Implants Available November 2020 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.
Helpful 5 people found this helpful
