The IDEAL IMPLANT was approved by the FDA in November of 2014 but has only had limited availability until recently. Initially, only the 120 plastic surgeons who were investors in the company had access. They are now starting to release it to more board certified plastic surgeons.
This implant has a profile similar to a high-profile implant. They are said to have the easy ability to detect a rupture like a saline implant, with a more natural in feel like a silicone gel implant . The IDEAL IMPLANT may be “ideal” for you if you are concerned about silent rupture of silicone gel implants but did not like the less natural feel of traditional saline implants. They are more natural in feel than saline but still not quite as soft as silicone.
About Silicone Implants
In general, my patients that want the most natural feel are still choosing silicone implants. The most common implant used in the country is a round, smooth silicone gel implant. The FDA has shown silicone to be safe and effective but recommends in their labeling instructions that you get an MRI three years after surgery and every two years thereafter to check for a rupture.
One analysis in 2014 in the Archives of Plastic Surgery found that silent ruptures occurred in 9-12 percent of cases eight years after implantation. In a silent rupture, the outer shell of the implant can rupture, but the cohesive gel stays inside the scar tissue capsule that has formed around the implant. So, there may be no visible or palpable change in the breast. Is it harmful? No. In the short run, not much is seen. Over years the silicone can cause some irritation of the local capsule and thickening, but if we know the implant is ruptured we generally like to replace it.
A recent survey of 300 patients by Allergan showed that 52% of patients were fearful of silent ruptures, with 45% being concerned that, despite the science and FDA saying silicone gel is safe and effective, it is still a foreign substance, and 34% of patients having a fear of silicone altogether.
About Saline Implants
A saline implant has the advantage of being much easier to tell if it has leaked. You can look in the mirror and tell if it is intact. When it leaks, the saline is absorbed and the shell goes flat. In 2014, the American Society for Aesthetic plastic surgery reported that 20% of breast augmentations used saline implants. However, they do not feel as natural as silicone implants. Some patients describe them as being like a water balloon, and they are prone to palpable and visible rippling and wrinkles.
The Rise of the IDEAL IMPLANT
So, the IDEAL structure saline implant will be a good option for some patients that like the idea of a more natural feel than saline with the advantages of being easier to detect a rupture. The IDEAL IMPLANT has two chambers, and if one leaks it will lose volume that is harmlessly absorbed by the body. If I had to predict, I would guess that the majority of patients will still use silicone gel implants, prioritizing the natural feel. However, I believe an increasing number of ideal structured saline implants will be used in patients that are concerned about silent rupture but didn’t like the feel of the traditional saline implant. It is great to have another choice to offer to our patients.
The makers of the IDEAL IMPLANT are a small company, and warranty concerns are valid- but I would be surprised if they are not purchased by one of the larger main implant companies in the future. The six-year data shows a lower failure rate that the other silicone and saline implants currently on the market, including the highly cohesive “gummy bear” implants. The patient study will not be finished until 2019, so we don’t have 10-year data yet to compare to 10-year follow-up with other implants, but the six-year data looks good.
If you’d like to learn more, please contact us today!