The IDEAL Implant company has been waiting for months for FDA clearance to ship their unique saline implants. They are now available to plastic surgeons. Our practice was the first in the region to incorporate these implants, offering the safety of saline and the feel of gel implants. The CEO has told us they are ready now:
"Dear IDEAL IMPLANT Network Surgeons and Office Staff:
We have finally received FDA approval to resume sales of the IDEAL IMPLANT, and inventory is now available in theonline storefor immediate shipping.We are happy to be back offering the IDEAL IMPLANT, and many women will be happy to learn they again have an alternative to silicone gel that feels natural without the risk of silent rupture.
Although the manufacturing change was minor (increasing the size of the punch hole in one of the patch layers), FDA did a very thorough review of related manufacturing processes, inspections and validations. Effectiveness of the increase in punch size was verified by microscopic analysis of posterior valves following multiple insertions of a fill tube plug to confirm the absence of any silicone particles that could affect the valve seal. We identified a problem, voluntarily took action, fixed it and FDA has granted approval, so you can again be confident in the safety and performance of the IDEAL IMPLANT.
While this recall has been difficult and frustrating for our company, our Network Surgeons, and particularly for patients, it was the right thing to do. I want to thank everyone for their understanding, patience and support during recent months.