The Motiva 6th Generation Breast Implant has arrived in New Jersey

Motiva Breast Implants – What’s the excitement all about?

You may have heard about a new breast implant on the market.  Surgeons have been waiting for this device for years and they are now FDA approved in the United States.

Worldwide these breast implants have been used in over 80 countries and with over 4 million implants placed they are not new to plastic surgeons in the world, just in the United States!

These implants have been called “6^th generation” breast implants.  What exactly does that mean?   I will briefly review the history of implants:

• 1^st generation: Various products have been used to augment the breast before there were real implants.  Breasts were injected with ground rubber, liquid silicone, ox cartilage, glass and various other substances before Houston plastic surgeons Frank Gerow and Thomas Cronin produced the first shelled, silicone gel filled implants in 1961.  This implant was used until the early 1970s but was plagued with high capsular contracture rates (scarring around the implants) and high leakage rates.
• 2^nd Generation: The second generation of breast implants had thinner shells and no longer used dacron patches.  They had a softer silicone gel in an attempt to provide a softer result.
• 3^rd Generation: Thicker shells and softer silicone gels became a stimulus for fear in the 1980s as when these implants leaked the silicone could more easily diffuse into the body.  These implants became the focus of the FDA and in 1992 the moratorium on silicone gel breast implants started.  This lasted until the 4^th generation of implants were approved by the FDA in 2006.
• 4^th Generation: Stronger shells and a more cohesive silicone are the hallmarks of these breast implants.  The stronger more cross-linked silicone gels maintain their shape when cut and thus the silicone is less prone to oozing out of the shell when there is a leak.
• 5^th Generation: These are similar to 4^th generation but with a thicker, more cohesive gel. They are often referred to as “Gummy Bear” implants as when the implant is cut in two pieces it maintains its shape like the candy gummy bear. 

What are the differences in these new implants and why are they being called 6^th generation?

The first major difference is the shell of the implants.  Many different implant shells have been used over the years.  The basic options have been smooth or textured, and in the textured variety there are various coarseness levels just as sandpaper has various different grits.  The problem with textured breast implants is that over years of use some patients developed breast implant-associated anaplastic large cell lymphoma (BIA-ALCL).  This lymphoma has been most often associated with one type of implant which was taken off the market by the FDA in 2019.  This aggressive texturing is believed to lead to chronic inflammation triggering multiple conditions including double capsules, late seromas, and BIA-ALCL.  BIA-ALCL and breast implant associated squamous cell carcinoma (BIA-SCC) have been one of the biggest fears for surgeons contemplating different types of implants.

The Motiva implant has a shell that is unique and required a new category to be designated by the FDA.  The implant shell has been named SmoothSilk® as it is a smooth, uniform surface with a 4 nanometer biocompatible imprinting.  The surface is so finely textured that it feels smooth and silky.  Studies show that the body reacts well to this shell leading to very little inflammation and thin, soft capsules.   This implant shell has been shown to enhance interactions with the body leading to low capsular contracture rates which in the FDA approval studies was less than 1 percent.  In addition there have been zero cases of BIA-ALCL or BIA-SCC associated with this SmoothSilk® shell worldwide.  This shell was classified as smooth by the International Organization for Standardization (ISO) but in the United States has been given a new category known as SmoothSilk®.

Another major difference is what is known as TrueMonobloc® Shell.  Establishment Labs carefully designed this implant to have a gel/shell/patch system that interacts as one solid unit.  The gel, patch and shell all have the same rheologic characteristics allowing for a beautifully soft, natural shape and feel.  You might ask, what is rheology?  There are four important characteristics of the gel’s rheology.  The silicone has been designed by Motiva to have a low viscosity or low resistance to flow.  This makes it very soft.  The elasticity measures how quickly it returns to its normal shape and is engineered to be high.  Giving the gel a high viscoelasticity properties allows adaptability to forces such as gravity.   Finally the cohesivity level measures how tightly the gel holds together when stretched or manipulated.  This highly cohesive implant resists breaking up when stretched or manipulated.  There has certainly been a tremendous amount of engineering that went into selecting and refining such a highly advanced TrueMonobloc® Shell system.

A final safety factor designed into the implant is the BlueSeal® barrier.  This is an additional colored layer under the shell which prevents silicones from passing through and is a visual indicator of an intact barrier.  This is visible to the surgeon as a final safety check for the integrity of each implant. 

In the studies submitted to the FDA for approval of the Motiva breast implants the rates of leakage and capsular contracture are significantly lower than previous generations of implants.  The leakage rate of 0.6% and capsular contracture rate of 0.5% is very low.  I would note that this was only 451 patients in their primary augmentation group and data is only 3 years of follow up so I believe these percentages will clearly go up with longer term data.  That being said worldwide data continues to show very low rates and this is promising for the next generation of implant.  14 year safety data shows consistently low capsular contracture, rupture, and infection rates!    Worldwide data has shown no cases of BIA-ALCL and this is of course promising.  Had there been any confirmed cases I suspect the FDA would have been much more reluctant to approve the new surface type and as a surgeon I would not use it. 

Another exciting aspect of these implants is that there are both round and teardrop versions available.  The round one gives more upper pole fullness as do all traditional round implants.  The teardrop “Ergonomix” implant has a different gel that moves more in a standing position so that the implant appears round when lying down but when standing up takes a more natural upper pole shape.

 

The physical characteristics of this new Motiva implant will allow placement in a subfascial or subglandular plane for many women where this would not have been a good option with previous implants.   If a woman is very lean the 5^th generation implants still appeared quite round and obvious and could still ripple.  That being said many women are simply not great candidates for submuscular implants given their levels of physical activity or body type.  Many surgeons will likely change their approaches to augmentation pocket location based on the availability of this new generation of implant.  This will allow for better outcomes in both the short and long term.   Given the abundance of safety data and scientific evidence that clearly demonstrates the biocompatibility of the shell I am excited to watch how breast augmentation surgery changes over the next few years. 

I started using these implants in my practice in November 2024 as the first surgeon in New Jersey to use them outside of surgeons in the FDA studies.   I am very impressed with the early results.  Time will tell if all breast implants shift to these new devices or if certain patients will continue to benefit more from one brand than another as is my current practice.  I encourage any patient seeking breast enhancement to learn about these new implants and about all of her options in these exciting times for plastic surgery!