Patient enrollment for the FDA-approved clinical trial of the IDEAL IMPLANT ended in January 2010. The trial of the IDEAL IMPLANT was limited to 502 women - 399 for primary breast augmentation and 102 for replacement of their existing saline-filled or silicone gel-filled augmentation implants. There were no reconstruction patients in this trial. Ideal Implant Incorporated is committed to sponsoring a well-controlled trial to prove the safety and effectiveness of the IDEAL IMPLANT in women having either primary breast augmentation or replacement of their existing augmentation implants.
Women who enrolled in the trial made a commitment to complete yearly follow-up visits for 10 years. This was necessary so that complete information could be collected on the long-term safety of the IDEAL IMPLANT.
Before a new medical device can be used in patients as part of a clinical trial, it must pass rigorous pre-clinical tests mandated by FDA to prove that the materials and methods used in its manufacture are safe. These test results for the IDEAL IMPLANT have been thoroughly evaluated by FDA.
Recognized leaders in manufacturing of silicone implants have provided the best possible materials, workmanship and inspection so the IDEAL IMPLANT meets the highest standards. All manufacturing facilities are in the United States and have ISO-13485 certified quality systems, so women and their surgeons can have confidence in the IDEAL IMPLANT.