Posted on Jun 17, 2009, 11 a.m.
By gary clark
A new breast implant, developed by Ideal Implant Inc., has been designed to offer the natural look of silicon gel, without the safety concerns. Clinical trials involving 500 women who will be the first to receive the implant will soon be underway in Georgia, Florida, Texas and California.
Breast augmentation is one of the most popular cosmetic procedures; however, women must still choose between the safety of saline implants or the natural look of silicon gel. Now, with the first major new breast implant technology in over 20 years, they may be able to get the benefits of both types of implants. According to Inventor Robert S. Hamas, M.D., the Ideal Implant® Saline-filled Breast Implant is designed to provide natural results similar to silicone gel implants, but without such safety concerns as difficulty detecting silent ruptures requiring MRI scans, diffusion of small silicone compounds into the tissues, and possible long-term side effects. The implant will soon be the focus of a new clinical trial about to get underway.
"With advances in healthcare technology and an awakening of environmental consciousness, Americans are more aware of what we put into our bodies than ever before - we eat organic food, avoid pesticides, and scrutinize labels," says Dr. Hamas, a noted plastic surgeon. "Women seeking breast augmentation are increasingly informed about the potential risks and benefits. I designed the Ideal Implant to meet the needs of today's women, who want a natural result but prefer the safety of saline."
As Dr. Hamas explains, the implant is composed of a series of implant shells of increasing size nested together. The internal perforated shells control saline movement to reduce "sloshing and bouncing." The implant is engineered to conform to the chest wall with the edge low in order to minimize the unattractive wrinkling on the sides typically found in standard saline implants.
The clinical trial has been designed to provide the U.S. Food and Drug Administration the data required to establish the safety and effectiveness of the implant. It will involve selected plastic surgeons in Atlanta, Dallas, Houston, Southeast Florida and Southern California who will enroll approximately 500 women, the first to have the opportunity to "test drive" the implant. The trial is open to any healthy woman who is planning to undergo her first breast augmentation or planning to replace an existing augmentation implant. Ideal Implant Inc. is offering a follow-up incentive plan to patients who complete all required follow-up visits for the trial.
News Release: New breast implant designed as alternative to silicone gel www.earthtimes.org May 28, 2009