Ideal Structured Saline Implants

Types of Breast Implants – Saline and Silicone-Gel Filled Implants, “Gummy-Bear” or Form-Stable gel implants

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Gel or “silicone gel” filled implants have become the frequent choice of women considering breast augmentation since the FDA released them for all women over the age of 22. This is because they are soft, feel very natural, and much less likely to be visible through the skin. Unlike regular saline implants, they do not have that “ripply” feeling at the bottom or side of the breast in women who have little soft tissue of their own to cover them. They are an ideal implant in terms of feel, for thin women, for this reason.

However, there is now a saline-filled implant that feels like a gel implant. If you were to feel it under a thin cloth, side by side with a gel implant, particularly a high-profile gel implant, you would have difficulty telling the difference. This implant is called the Ideal implant, and more information can be found at Idealimplant.com.

This implant is now available in my practice. It’s use is only available to the clinical investigators who took part in the FDA approval process, and plastic surgeons who have invested in the company. My disclaimer is that I am an investor in the company because I wanted to make this implant available to my patients.

The Ideal saline implant does not feel wrinkly or bouncy or ripply like the usual saline implant. It was developed by a plastic surgeon, Dr. Robert Hamas, MD, of Dallas and has received FDA approval as of October, 2014. It is available as of September, 2015 for plastic surgeons to offer to their patients, but only a small number of plastic surgeons in the Bay Area have the ability to offer it to their patients. Our practice is one of them.

The Ideal implant has several internal shells, and two compartments to hold saline, one in front, and one in back. The one in back is filled to a fixed volume for that implant size, and the one in front can be filled within a range. Between the two compartments are multiple internal shells with perforations in them that allow saline to flow. This arrangement makes the implant soft to the touch without wrinkling. Compared to a regular saline implant that bounces when dropped on a surface, the Ideal saline implant behaves identically to a gel implant; both do not bounce.

Why consider a new saline implant that feels like gel? Why not just use gel? While no implant is perfect, gel implants require an MRI in most cases to know if they are ruptured. That is why it is called “silent rupture” when referring to the phenomenon in gel implants.  Usually the patient does not know there is a leak. The  FDA initially recommended that women check their gel implants for silent rupture at three years and every three years thereafter. Memorial-Sloan Kettering Hospital published a study suggesting that the initial rupture rate was low enough that it made sense to wait up to six or seven years, Nevertheless the FDA recommendation has not been altered.

The FDA has published 10 year follow-up results of post-implant rupture rates as determined by MRI, in the group of women who agreed to be part of this long-term study. All manufacturers, Mentor, Allergan and Sientra were required to participate as a condition of having their implants on the market for breast augmentation.

FDA Update on the Safety of Silicone Gel-Filled Breast Implants

The ten-year cumulative incidence of silicone gel implant rupture in this report was 10.1% for Allergan Natrelle; 13.6% for Mentor at eight years; 17.7% for Allergan 410 anatomic form-stable gel (gummy bear).

Health Canada, January 2014, reported that the ten-year rupture rate for Mentor gel implants was 24.2%.

So despite the excellent track record of gel implants, and the satisfaction of women who have them and enjoy their natural feel, there is the question of silent rupture and the fact that women will in most cases not know they have a gel implant rupture unless they get an MRI.

For those women who would like a saline implant because they know that when it ruptures, it will get smaller and they will know it has ruptured, the uncertainty would be removed. Saline is harmless and is absorbed by the body. Because the Ideal implant has two compartments containing saline, a leak would not result in full deflation, making it less of an urgent matter to get the implant replaced.

Women who might have wanted to have the security of knowing when their implant was leaking, but were not willing to accept the trade-offs of more firmness, more wrinkling or rippling or shell visibility through thin skin, might be more willing to consider a saline implant if there was one that felt like a gel implant.  This is the reason that the Ideal implant was developed.

It’s place among implant choices is for those women who want a natural-feeling breast implant, the feel of gel, but not the uncertainty of knowing if their implant is ruptured without getting an MRI, as is the case for gel.

Because the long-term rupture rates for gel implants are turning out to be so much higher than they were thought to be in the first five years, the Ideal implant which costs about the same as a gel implant, is now available as an alternative.

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