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About the Clinical Trial
Q: When will the IDEAL IMPLANT clinical trial begin?
With FDA approval of the investigational device exemption (IDE), Ideal Implant Incorporated will conduct a U.S. clinical study of the IDEAL IMPLANT in women who are undergoing primary breast augmentation or replacement of existing augmentation implants.
Q. Who is eligible to participate in the clinical trial?
Healthy women who are interested in undergoing primary breast augmentation or replacement of existing augmentation implants and are willing to participate in the follow-up program. In addition to normal follow-up visits, additional follow-up visits will be required as a part of this research study. Women who enroll in the trial are making a commitment to complete yearly follow-up visits for 10 years. This is necessary so that complete information can be collected on long-term safety from use of the IDEAL IMPLANT.
Q. Will participants in the trial receive free implants and surgery?
Neither the surgical procedure nor the investigational breast implants will be free of charge; women will pay the usual price for their breast implant procedure including the surgeon’s fee, surgical facility charges, anesthesia fee and study implants.
Payment will be made for participation in the non-active treatment phase of this study, the follow-up visits over 10-years. If a woman completes ALL of the required follow-up visits, she will receive a lump sum payment from an independent Trust Fund established by Ideal Implant Incorporated. The required follow-up visits are at 2 months, 6 months, 1, 2, 3, 4, 5, 6, 7, 8, 9, and 10 years after your surgical procedure.
In addition, the Trust Fund will act as a financial protection plan to reduce a woman's financial risk should Ideal Implant Incorporated cease operations and/or the study be terminated. In that case, a woman could use her Trust Fund payment toward the cost of removal or replacement of her study implants.
Q: How will Ideal Implant Incorporated encourage patients to adhere to the follow-up visit schedule?
In addition to normal follow-up visits, additional follow-up visits will be required as a part of this research study. Women who enroll in the trial are making a commitment to complete yearly follow-up visits for 10 years. This is necessary so that complete information can be collected on long-term safety and side effects resulting from use of the IDEAL IMPLANT.
Payment will be made for participation in the non-active treatment phase of this study, the follow-up visits over 10-years. If a woman completes ALL of the required follow-up visits, she will receive a lump sum payment from an independent Trust Fund established by Ideal Implant Incorporated. The terms of the Trust Fund are described in the Clinical Trial / Financial section of this website. The required follow-up visits are at 2 months, 6 months, 1, 2, 3, 4, 5, 6, 7, 8, 9, and 10 years after the surgical procedure.
In addition, the Trust Fund will act as a financial protection plan to reduce a woman's financial risk should Ideal Implant Incorporated cease operations and/or the study be terminated. In that case, a woman could use her Trust Fund payment toward the cost of removal or replacement of her study implants.
Q: Is the surgical procedure for the IDEAL IMPLANT similar to the procedure for current saline and silicone gel implants?
The IDEAL IMPLANT requires a relatively small incision since it is inserted empty and then filled with saline through self-sealing valves. It was 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.
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