It's no secret that I'm a saline girl (no disrespect to my silicone sisters!), and it's been a long time since there was any news about advancements in saline breast implants. That's why I couldn't help but follow the progress of the "IDEAL Breast Implant" which is finally available to the public!
I've been following IDEAL for years (I first wrote about it way back in 2012), and I recently had the opportunity to ask the creator of the IDEAL implant, Dr. Robert Hamas, some questions that I've been holding on to for years.
Jenny Eden: As a plastic surgeon, you could have spent your time on a lot of different ideas. What gave you the idea for the Ideal Implant, and why did you decide to spend so much time and money creating it?
Dr. Robert Hamas: I got the idea for this implant in 1992 (yes, 1992), while in an airplane that hit turbulence. The ice in my drink kept it from sloshing, so it made me think of putting something inside a saline-filled implant to keep it from sloshing.
Dr. Hamas: I started with balloons and stroller netting for baffle material, then crude implant prototypes. After 12+ years of getting no interest from Mentor or Allergen, I started Ideal Implant in January of 2006.
I think the impetus for me was seeing what a ruptured silicone gel implant looks like inside the body (a sticky mess), and the struggle of removing it during plastic surgery. Then, I began to realize how much women were bothered by not knowing the status of their breast implants — intact or silently ruptured?
It is really an emotional issue for women. I felt there had to be a better type of breast implant.
Jenny Eden: For those who aren’t familiar with it, can you talk about all the biggest differences of the IDEAL Implant over traditional saline? Is the IDEAL Implant really going to be the “Silicone Killer?”
Dr. Hamas: The IDEAL Implant has a unique internal structure that minimizes the “bouncing,” “scalloping” and “wrinkling” associated with original saline breast implants.
The internal structure consists of a series of implant shells nested together and two separate chambers that hold saline. This simple, yet innovative internal structure is designed to control movement of the saline and support the implant edges to reduce wrinkling.
In addition, the edges have been lowered to better fit the natural curve of the chest wall. When held upright, the internal structure supports the upper portion of the implant to prevent collapsing.
The amount of saline used to fill the implant can be adjusted to correct for differences in the size of a woman’s breasts.
Jenny Eden:Since folding over and rubbing on itself is one of the things that causes breast implants to rupture, I don’t understand how the separate baffles in the Ideal Implant keep from doing that. It seems like rupture rates would be doubled, because there is double the amount of potential folding.
Can you speak to how the durability and complication potential for the Ideal Implant?
Dr. Hamas: Many people tried to develop a baffle for the saline implant... I tried many variations until I hit on the current design that keeps the baffle in place inside the implant.
In addition, there are no new materials or manufacturing methods. The baffles in this implant are “free floating” and have no connection point to the patch or to the shells. This removes the potential for mechanical failure.
They stay in place between the inner and outer shells, without attachment or folding, because they have the same shape and exactly the same proportions as the inner and outer shells. You could think of it like the toy Russian dolls that fit inside each other.
Jenny Eden: Speaking of rupturing, what was the length of your clinical trial and what was the rupture rate of the Ideal Implant in comparison to standard saline and silicone breast implants?
Dr. Hamas: Our U.S. clinical trial began in February 2009 and included more than 500 women who had the IDEAL Implant for primary breast augmentation or replacement of existing breast augmentation implants.
The follow-up is over 5 years. Based on the safety profile and positive results in the clinical trial, the FDA and Health Canada approved the IDEAL Implant in November 2014. The clinical trial also evaluated satisfaction with the outcome of the procedure, and the results included:
Patient-reported satisfaction with the outcome was high:
- 94.3% of women who had primary breast augmentations
- 90.6% of women who had replacement breast augmentations
Surgeon-reported satisfaction with the outcome was also high:
- 95.9% of women who had primary breast augmentations
- 91.7% of women who had replacement breast augmentations
The clinical trial breast implants were made by the clinical trial manufacturer in Montana in 2009. Almost all deflations were due to early assembly defects. Because of this, manufacturing was moved in 2010 to a large, experienced, FDA-inspected manufacturer in California, which is where the commercial breast implants are manufactured today.
The FDA noted that the early manufacturing defects were addressed at the commercial manufacturing site with improved process controls and inspections.
Jenny Eden: To close, the vast majority of women getting breast implants opt for silicone instead of saline. What would you say to women who haven’t considered saline?
Dr. Hamas: Before they choose their implant, they should do a side-by-side comparison of the IDEAL Implant to the silicone gel implant. It is unlike the original saline implant and has a completely natural feel.
My sincere thanks and congratulations goes to Dr. Robert Hamas! I can't imagine the excitement that he must have seeing an idea that started way back in 1992 come to fruition. :-)