Breast implant technology moves slowly in this country, and that is mostly a good thing. The FDA’s premarket approval pathway demands years of clinical trial data before a device reaches an American operating room. Genuinely new options are rare, which is exactly how it should be for something a woman will carry in her body for a decade or more.
In the fall of 2024, one arrived. The FDA approved the Motiva SmoothSilk Round and Motiva SmoothSilk Ergonomix implants for primary and revision breast augmentation, the first new silicone gel breast implant to clear the agency’s full premarket approval process in more than ten years. Unlike most new devices, this one did not arrive untested. Motiva has been used internationally since 2010, with roughly four million implants distributed across more than eighty countries. The approval came with a long real-world track record behind it rather than a hopeful one.
I’m board-certified by the American Board of Plastic Surgery and I practice here in Newport Coast. We recently brought Motiva into the practice.
I don’t adopt new devices early. I waited for the American data, and then waited a little longer to watch how these implants behaved outside of clinical trials. What ultimately brought me in was a specific patient I see constantly in this practice: slender, athletic, not much native breast tissue, wanting more shape without the overly “fake” look. That patient has always forced a compromise, enough firmness to hold a reliable shape, at the cost of a result that can read as an implant on a thin frame. The Ergonomix gel behaves differently under the hand and in motion, and the shell is thin enough to place through a smaller incision. Motiva didn’t replace what I was already doing well. It widened what I’m able to offer.
The US approval covers primary and revision augmentation in women 22 and older, which is the FDA’s standard threshold for all silicone gel devices. In the American trial supporting approval, the rate of significant capsular contracture was 0.5 percent at three years among first-time augmentation patients. Capsular contracture, scar tissue tightening around an implant, has historically been the most common reason a woman returns for a second operation. A number that low is meaningful in this category.
There are two options, and the difference is the gel inside.
The Round uses a firmer, more form-stable gel that holds its shape regardless of position, so the upper breast stays full standing or lying down. Patients who want visible fullness tend to land there.
The Ergonomix uses a softer gel that responds to gravity more the way breast tissue does. Standing, it settles into a sloped, teardrop-like contour. Lying down, it spreads and rounds out. One clarification, because the word teardrop causes confusion: this is still a round implant. The shift in shape comes from how the gel moves, not from a pre-formed anatomical shell.
Both gels are highly cohesive, holding together as a single mass rather than moving freely inside the shell.
Neither implant is better. They produce different looks, and the right answer depends on your tissue, your dimensions, and what you actually want.
Which brings me to what matters more than any of the above. A better implant does not make the surgeon’s judgment less important. The technology changed. The planning didn’t.
Sizing is the part patients most want settled in the first ten minutes, and the part I most refuse to rush. I don’t start with a number of cc’s. I start with your chest base width, soft-tissue thickness, nipple position, and the asymmetry you already have and probably haven’t noticed. Those measurements narrow the field to a handful of implants before preference ever enters the room. Then we try them on, and I tell you what each one will look like in five years, not just in five weeks.
What I steer first-time patients away from is straightforward. Choosing a size from a photograph of a stranger’s body. Going as large as the tissue will technically tolerate. Treating the decision as permanent. Implants are durable, not eternal, and planning for that from the beginning is part of doing this well.
A few things I talk patients out of, every single week. Bringing in a photo of someone else’s result and asking for that. In reality, the photo is useful, but it becomes a starting conversation, not an order form. Going bigger than your tissue can comfortably carry. That decision looks great in the mirror at six weeks, but starts causing problems at year three. And treating this like a one-time transaction. It isn’t. The newest 6th generation implants are durable, not eternal.
One rule I don’t bend, no matter why someone’s sitting in my chair. Every patient 35 and older gets a mammogram before I’ll operate. I’ve had that catch cancer in women who came in purely for cosmetic reasons, with zero symptoms and no family history flagging anything. They came in for a consultation about implants and left with a diagnosis that likely saved their life.
What hasn’t moved in my career is the goal. Enhance, don’t alter. A patient should look like a better version of herself, not like she visited a plastic surgeon. Refreshed, not rebuilt. The results I’m proudest of are the ones nobody can quite place, they just know she looks good.
If you’re considering augmentation, see a board-certified plastic surgeon who examines you, asks what you actually want, and tells you honestly what your anatomy will and won’t support. The implant is the easy part of that conversation.
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