The Best Breast 2

Cohesive Confusion – the State of the Gummy Bear implant AKA Allergan Style 410

An editorial by Terrye Tebbetts

In the early 1990's when the FDA pulled silicone implants off the market due to safety concerns, there was only one basic type of silicone implant - round, smooth or textured, liquid gel (from here on referred to as "conventional gel"). At that time the state of implants was very clear to patients. Silicone was bad, Saline was good.

For the next 16 years, women basically had two implant choices ~ round smooth, or textured, saline or textured anatomic (shaped) saline. Silicone implants became available again under restricted studies somewhere along the way and were primarily used for secondary (women who already had conventional gels that needed to be replaced) and reconstructive cases and only with surgeons enrolled in the study.

In 2000, Inamed, which is now Allergan, was allowed to start a study in the US on a product it had launched in Europe in the early 1990's - the Style 410, cohesive gel implant. John B. Tebbetts, M.D. designed this implant, along with its saline counter part, the 468, in late 1980's and introduced the Style 410 in Europe in the early 1990's - a tour of 8 countries - operating and teaching surgeons in each country how to use a shaped, form stable implant.

As an interesting side note, the first silicone breasts implants were designed by fellow Texans, Frank Gerow and Thomas Cronin in the 1960's. There has not been a new, different, design or development in breast implants since then (recreations and modifications don't count). Now almost 50 years later after much research and development, ironically, another Texan, John B. Tebbetts, M.D., changes the world of breast implants with the Style 410 breast implant.

Enrollment in the Style 410 study was limited to begin with and required a 10 year commitment from the patient to agree to follow up, providing long term data to the FDA. There were only a handful of surgeons that were Investigators in the study at that time.

In December of 2006, Dr. Tebbetts paper, Achieving a zero percent reoperation rate at 3 years in a 50-consecutive case augmentation mammaplasty PMA Study. Plast. Reconstr. Surg. 118(6): 1453-1457, was published demonstrating how truly revolutionary this new implant and the new surgical processes that it inspired can be.

Just one month before this paper was released, November of 2006, the FDA allowed the conventional gel implants back on the market with the proviso that surgeons inform patients that the FDA still believes there is a silent rupture risk with this implant and that patients should have periodic MRI's through out the life of their implants. This event caused quite a frenzy as you can imagine! Silicone was back - but what KIND of silicone???? Was it new? Was it different? Surely if the FDA was approving it, it was new and improved, right?

The concept of new and improved, gave the entire plastic/cosmetic surgery industry a chance to muddy the waters - to blur the lines. All of the sudden, these conventional gels reentered the markets with names like Memory gel, and Cohesive gel and there in lies the confusion. It is back. It must be new. It must be different - it even has a new name! May be it's even the Gummy Bear implant!!! The cloud of confusion just kept getting growing and looming over patients as they try to determine what's what.

It's just like trying to pin down cup size! Because there is no clear standard of definition for it, there is no way to get a definitive answer -- cohesive gels were now traveling down that same path.

So to help you understand, here's my take on the current state of the Cohesive Confusion and the Gummy Bear implant:

The Allergan style 410 is still only available under study. Only 150 surgeons in the US currently participate in this study. The style 410 is the implant that women and patients often refer to as the Gummy Bear implant because of its more form stable silicone gel. In our book, The Best Breast 2, Dr. Tebbetts cuts a wedge out of the 410 and the photo shows the gel's consistency and that it remains in its shell. Chapter 5 of the book, goes into great detail on all of the device options and choices. If you are offered the a true Gummy Bear implant, you will be asked to fill out tons of study paper work and informed of your responsibilities of being in the study.

Allergan is not the only manufacturer with an implant under study. The Mentor CPG is also being studied as a more cohesive product and it too is shaped. Silimed is also participating in a PMA study in the US with its version of a more cohesive gel implant. But again, if you are truly getting a more form stable, or cohesive product you will be asked to enroll in a study.

Conventional gel implants are available to every surgeon and patient with out any special paperwork. Conventional Gels are round and either smooth or textured. When you look at the FDA PMA data, even though, they have a silent rupture issue, their data is showing up the Saline data hands down!

Patients should ask to see the type of implant they are getting and ask for the manufacturers implant information - most have a consent book or material that tells you all about the product. - so that you truly understand which implant you are buying in to.

As the new form stable, truly cohesive, or Gummy Bear (whatever you want to call them) implants emerge out of controlled studies and into the mass markets, there will be challenges. You see, these implants, currently, are all shaped - not round. Using a shaped implant requires a different preoperative planning approach and surgical technique to ensure optimal results with the implants. Too bad so much of the plastic surgery industry shunned using shaped implants during the saline era. But it just makes since, new products need new techniques. These techniques are what brought about 24 Hour Recovery for Dr. Tebbetts. With an improved product, came improved surgical techniques that allow us to routinely return our patients to full, normal activity in just 24 Hours.

At this time, we have almost 8 years of follow up in the Allergan Style 410 study. The current industry buzz is that the new implant should be approaching a time when all women - all patients - will have this implant as an option or choice when considering breast augmentation very soon. But still, to get a "Gummy Bear" implant now, you must seek an surgeon that is an investigator in the FDA PMA studies.

I hope this little history lesson will help clear up a little of the cohesive confusion!