Payment
Payment for Study Participation
Participants did not receive any payment for being in the active treatment phase of this study, that is, the surgical procedure for breast augmentation or breast implant replacement. All costs for this active treatment phase of the study were the participant's responsibility including the surgeon’s fee, surgical facility charges, anesthesia fee and study implants.
Participants will only receive payment for participation in the non-active treatment phase of this study, that is, the follow-up visits over 10 years that give information on safety, efficacy and outcome of the study implants. Long-term follow-up data collection is extremely important to detect unexpected side effects of the study implant during long-term implantation. For this reason, the required follow-up visits may be beneficial to participants and/or other women in the future by detecting possible side effects and by providing complete long-term safety information. Since 10-year safety, efficacy and outcome data is vital to this implant study, there is a follow-up visit incentive plan. If a participant completes ALL of the required follow-up visits during the 10-year non-active treatment phase of the study, the participant 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 the surgical procedure.
In addition, the Trust Fund will act as a financial protection plan to reduce a participant's financial risk should Ideal Implant Incorporated cease operations and/or the study be terminated. In that case, a participant could use her Trust Fund payment toward the cost of removal or replacement of her study implants.
The terms of this Trust Fund are detailed here:
- When each participant has her operative procedure, Ideal Implant Incorporated will deposit $3500.00 into the Trust Fund.
- The Trust Fund will invest in a diversified portfolio of asset class funds comprised of equity (stocks), fixed income (bonds) and cash.
- Depending on the stock/bond market, the $3500.00 deposit may grow during the 10 years of the study. Optimally, the deposit may more than double or triple in value over the 10-year period. The value will fluctuate so that a participant’s share, when redeemed, may be worth more or less than the $3500.00 originally deposited. The range of returns on a simulated portfolio of 80% stocks and 20% bonds over the 10-year periods from the one ending in December 1998 to the one ending in December 2007, less a 0.35% annual fee, was 8.70% to 13.20%, with an average of 11.08%. Based on these historical returns, the $3500.00 deposit will grow to between $8083.00 and $12,136.00, with an average of $10,010.00, during the 10 years of the study. (Past performance is no guarantee of future results. Market conditions and economic events may impact the return of an investment portfolio. The investment return and principal value will fluctuate so that a patient’s share, when redeemed, may be worth more or less than the $3500.00 deposited originally. There can be no assurance that any portfolio will achieve its investment objective.)
- When the last participant completes her 10-year follow-up visit, the Trust Fund will be closed. Each participant who remained in the study and completed all her required follow-up visits will receive her share of the Trust Fund. This will equal the total amount in the Trust Fund divided by the total number of participants that remained in the study.
- In the event a participant misses ANY required follow-up visit, she will be discontinued from the study and lose her share of the Trust Fund. In that case, her share will remain in the Trust Fund to be divided among those who remain in the study. 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.
- A participant will be able to learn the current value of her share of the Trust Fund on the IDEAL IMPLANT Study Website using her study identification number. At any given time, a participant's share will equal the total amount in the Trust Fund divided by the total number of participants that remain in the study.
- In the event a participant has her study implants removed without replacement with study implants, the patient must continue with all required follow-up visits to remain in the study.
- In the event a participant has her study implants removed and replaced with non-study implants, the participant is discontinued from the study and will receive a payment of $290.00 for each required follow-up visit completed while she was in the study.
- Each participant will designate a beneficiary for her share of the Trust Fund in case of her death, with the requirement that the death certificate and clinical information relating to the study implants be disclosed to the Study Doctor and Ideal Implant Incorporated.
- In the event a participant dies, the participant's designated beneficiary will receive a payment for her pro rated share of the Trust Fund value at the time of her death.
- In the event Ideal Implant Incorporated ceases operations and/or the study is terminated, the Trust Fund will be closed and each participant in the study who has completed all her required follow-up visits as of that date, will receive a payment for her pro rated share of the funds.
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