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Q: What is the FDA approval process for the IDEAL IMPLANT?
Breast implants are considered to be Class III devices by the US Food & Drug Administration (FDA). Class III devices are the most extensively regulated and require a pre-market approval application (PMA) before commercial sales can begin. Even though the FDA has approved standard saline-filled breast implants, this new saline-filled implant must still go through the complete regulatory approval process, including pre-clinical testing, an application for an investigational device exemption (IDE) to permit clinical testing, a two-year U.S. clinical trial with a plan for ten-year follow-up, and a PMA submission.
Q: What is Ideal Implant Incorporated?
Ideal Implant Incorporated is a company that was established to develop, manufacture and market a new breast implant with the first new technology in more than 20 years. Plastic surgeons provided most of the funding for the company, helped with the implant design and are the majority owners. Ideal Implant Incorporated is unique - it is the plastic surgeons’ breast implant company.
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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.
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 implant, 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: How was the IDEAL IMPLANT developed?
The Company worked diligently over several years to refine the design of the IDEAL IMPLANT. Input from many plastic surgeons who are investors and/or who participated in market research interviews guided this process to obtain the best possible design.
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: Who manufactures the IDEAL IMPLANT?
The Company worked 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 chose manufacturing facilities with ISO-13485 certified quality systems so women and their surgeons can have confidence in the IDEAL IMPLANT.
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