IDEAL IMPLANT clinical trial features lump-sum payment to participants

Sep 3 2009

Like many women, Teri did her research before making the decision to undergo breast augmentation. As a health-conscious mother seeking a better fit in her clothes, she was dissatisfied with the current breast implant choices of saline for safety or silicone gel for a more natural look, yet with bothersome potential risks. A clinical trial of the IDEAL IMPLANT^® Saline-filled Breast Implant offered Teri a new “hybrid” design, combining both the natural result of silicone gel with the safety of saline for peace of mind. The trial also features a unique lump-sum payment to participants from a trust fund.

An Ideal Implant

While the silicone gel implant has a certain appeal, many women like Teri are uncomfortable with the possibility of a silent rupture, undetectable except with an MRI scan. Because of this, they often chose a saline-filled implant, even though they may be dissatisfied with the resulting wrinkling, bouncing and globular look. As a new “hybrid” alternative, the IDEAL IMPLANT was designed to meet the needs of today’s women, who want a natural result but prefer the safety of saline in their body over silicone gel.

“This is the first improvement in the basic design of the saline-filled breast implant since it was introduced over 30 years ago,” says Robert S. Hamas, M.D., the plastic surgeon inventor of the IDEAL IMPLANT.” While other manufactures have focused only on silicone gel, this breast implant company is majority owned by plastic surgeons and we listened to our patients - women have clearly expressed their desire for an improved saline-filled breast implant.”

The IDEAL IMPLANT was developed following years of testing and input from women and plastic surgeons alike. On the outside, it looks like a standard saline implant, except the edges have been lowered enabling it to contour better to the chest wall. On the inside it simply contains a series of additional implant shells that are nested together. This internal structure was engineered for control of saline movement to reduce bouncing and for support of the implant edges to minimize wrinkling.

Breast augmentation tops the list for most performed cosmetic surgical procures in the U.S., according to recent statistics. Standard saline implants represent about 55 percent of all breast augmentations, despite FDA approval of silicone gel implants in 2006. This reflects the preference for saline over silicone gel among women like Teri.

“After doing our research, both my sister and I wanted to be a part of the IDEAL IMPLANT clinical trial. I felt good about the fact that all the materials were already in use in FDA-approved saline implants, yet the basic design was so much more advanced,” says Teri. “I can’t believe no one tried to improve the saline implant before this!”

Clinical Trial & Payment Plan

The FDA-approved clinical trial is being conducted in select areas nationwide, giving a limited number of women the opportunity to be among the first to have this new breast implant. A unique payment plan was developed as a financial incentive for women to complete all their follow-up visits over 10 years to provide the FDA with data establishing safety and effectiveness of the IDEAL IMPLANT. Women enrolled in the trial will receive a lump sum payment from an independent trust fund established by Ideal Implant Incorporated. When each woman has her surgery, $3,500 is deposited into the Participants’ Trust Fund and invested in a stock and bond portfolio. Based on historical market returns, the $3,500 will likely grow to between about $8,000 and $12,000 over the 10 years of the study.

“My husband and I are very excited about the substantial Trust Fund payment that will help supplement our son’s college savings plan,” adds Teri.

Only plastic surgeons certified by the American Board of Plastic Surgery were selected as investigators in this clinical trial. They are located in Atlanta, Dallas, Houston, Southeast Florida, and Southern California and are enrolling a total of 500 women undergoing a first breast augmentation or the replacement of their existing standard saline or silicone gel augmentation implants. Due to the difficult economic times, some plastic surgeons are offering women special pricing for breast augmentation with the IDEAL IMPLANT as part of the clinical trial.

Women interested in the IDEAL IMPLANT are encouraged to make a consultation appointment with one of the plastic surgeon investigators to get acquainted and learn about breast augmentation.

http://www.idealimplant.com/