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About the IDEAL IMPLANT
Q. What is the IDEAL IMPLANT?
The IDEAL IMPLANT is a patent-protected, investigational, saline-filled breast implant that uses no new materials, fillers or manufacturing processes. It is made from only standard saline implant shells, valves and patches, with only saline as the filler. Its unique design has a series of implant shells of increasing size nested together to give it internal structure and to control movement of the saline. It is designed to contour to the chest wall and feel similar to a silicone gel implant.
Q: How is this implant different from current breast implants?
Recognizing women’s desire for the safety of saline and for an implant that feels natural, the IDEAL IMPLANT offers a new concept in breast implant technology to answer this unmet need.
The IDEAL IMPLANT has an internal structure that is engineered and designed to alter the movement of the saline filler. This is what makes it behave like it is filled with a thicker and more viscous material. Since only standard saline and silicone gel implants are currently available to plastic surgeons, the IDEAL IMPLANT may in the future provide women a desirable alternative.
Q: If the IDEAL IMPLANT uses no new materials, how is this really any different from saline implants currently available on the market?
The unique internal structure provides support to the upper pole and edges of the outer shell, so when held upright, the edges do not wrinkle and the upper pole does not collapse. It seems that this reduction in wrinkles and folds may result in a lower deflation rate than for current saline implants.
Unlike current saline implants, the IDEAL IMPLANT shell geometry is designed so the implant conforms to a convex surface such as the chest wall, with its edges low and close to the surface.
Q: Is the surgical procedure for the IDEAL IMPLANT similar to the procedure for current saline and gel implants?
The IDEAL IMPLANT is designed to require a relatively small incision since it is inserted empty and then filled with saline through self-sealing valves. It is designed to allow for sub-muscular or sub-glandular position with standard surgical techniques.
Q: What if the implant ruptures?
The IDEAL IMPLANT is designed for obvious detection of a deflation on physical examination. As the implant deflates, the body absorbs the saline.
Q: Will the IDEAL IMPLANT come in a variety of sizes?
The IDEAL IMPLANT is available in the fourteen most popular sizes from 184 cc to 600 cc.
Q: What are Ideal Implant Incorporated’s plans for manufacturing the IDEAL IMPLANT?
The Company is working with recognized U.S. leaders in silicone medical device manufacturing to provide superior materials, workmanship and inspection so the finished implant meets the highest standards. The Company has chosen manufacturing facilities with ISO-13485 certified quality systems so women and their surgeons can have confidence in the IDEAL IMPLANT.
Q: When will the IDEAL IMPLANT begin its clinical trial?
With FDA approval of the investigational device exemption (IDE), Ideal Implant Incorporated will conduct a clinical study of the IDEAL IMPLANT in women who are undergoing primary breast augmentation or replacement of existing augmentation implants.
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