The Best Breast

It all began two decades ago. And it all began and ended with one priority–the same priority today–how we can take the best care of our patients. We constantly receive questions from patients and the media about how we invented and developed the world’s first highly cohesive, near form stable, anatomic breast implant–the Style 410. It’s an interesting story.

In the early 1980’s patients that I was treating early in my practice had their initial breast augmentation years earlier by other surgeons. A significant number later experienced ruptured implants, often accompanied by severe capsular contracture. The reason? Misplaced priorities and suboptimal implants. In the late 1970’s and early 1980’s, many surgeons and patients insisted (as some who are poorly informed still insist today) that breast implants should have thin shells, very liquid silicone gel filler, and be under filled with gel to make them feel as natural as possible.

Natural? No breast implant is “natural”. Misplaced priorites by patients and surgeons–prioritizing “naturalness” above durability and safety– encouraged manufacturers to make breast implant products that had 3 distinct problems:

1) Shell folding and shell failure- thin shells that lacked optimal durability and experienced shell folding, fatigue, and failure– the result of underfilling the shell to make the implant feel softer.
2) Gel bleed- the minimally cohesive or more liquid gel could “bleed through” or escape from the thin shells in minimal amounts that are often not even visible to the surgeon
3) Gel migration- when the thin, under filled implant shells failed, the less cohesive, more liquid silicone gel was more likely to migrate outside the capsule and into adjacent tissues in larger amounts that could cause inflammation or lumps in adjacent tissues.

These three clearly distinct problems were apparent to me in 1985. I thought we could do better for patients. How to get there? Start with the basics:

1) Put a greater amount of filler in each shell size to minimize risks of shell folding and shell fold failure, thereby increasing implant durability and life span, and decreasing the number of reoperations for implant failure. Placing more fill in a round implant, however, made the implant excessively round, unnatural, and firm, and was not appealing to anyone. The solution was to change the shape of the implant to a more anatomic shape that would allow adequate fill to minimize shell collapse and folding while creating an optimal aesthetic result.
2) Make the gel filler much more cohesive to minimize gel bleed and more importantly, minimize risks of gel migration if shell failure occurred. The gel needed to be highly cohesive so that it would not only adhere tightly to itself without the shell being present, and the gel and shell needed to be designed to minimize escape of even tiny amounts of silicone gel.
These basic design improvements evolved from observing the deficiencies of implants in the 1980’s and addressing those deficiencies. With the help of Dan Carlisle, his bioengineers, and the folks at McGhan Medical Corporation, over a four year period, we designed and developed several generations of prototype implants. These new designs incorporated three specific new characteristics:

1) An anatomically shaped implant shell (not really “teardrop” as the commonly used term implies) with a barrier coating that minimizes gel bleed or escape of small molecules of silicone gel from the shell
2) Increased gel fill volumes that minimized implant shell collapse and folding with the implant in the upright position
3) A highly cohesive silicone gel filler, nearly form stable, that held its shape in the laboratory even when the shell was stripped off the implant or when a wedge was cut out of the implant. This highly cohesive gel has been compared to the consistency of “gummy bear” candies, and the term “gummy bear”, though highly unscientific, has been used to describe the implant.

In 1993, the Style 410, textured, anatomic, highly cohesive (near form stable) silicone gel implant was complete, tested, and ready for submission for FDA studies in the United States. Unfortunately, the track record of the older generation implants and the complications that patients were experiencing prompted the FDA and then commissioner Dr. David Kessler, to ban silicone gel implants for breast augmentation in the United States. Rather than ban the specific types of implants that appeared to be causing the problems, the FDA globally banned all silicone gel implants for breast augmentation–ignoring the availability for testing of a dramatically different type of silicone gel implant. At the same time, the FDA illogically continued to allow use of the same, older generation implants for breast reconstruction, while banning testing of any new types of silicone gel filled implants.

Unable to complete clinical testing of the Style 410 in the United States, we turned to our friends and colleagues in Europe, where the new devices were not banned. We were graciously hosted by many European colleagues who invited us to operate with them in their hospitals and surgical facilities and who assisted us in following patients who chose the new Style 410 implant.
The very best implant does not determine a patient’s outcome in breast augmentation. Decisions determine outcomes, and the best decisions require knowledge. For the first time in the history of breast augmentation, we insisted on a comprehensive education program for surgeons to learn how to optimally use the new implants, and for the first time in history, a breast implant manufacturer responded. McGhan Medical Corporation funded the most comprehensive surgeon education program ever undertaken, and it began across Europe.
In 1995, we took our entire surgical team, all of our own surgical instruments, and ancillary equipment, and began an extensive surgical education “tour” of Europe. Beginning in Amsterdam and Eindhoven in the Netherlands, we lectured extensively and performed live operations for surgeon attendees and observers in Eindhoven (the Netherlands) Dusseldorf, Berlin, Madrid, Barcelona, Paris, and London. At each location, selected surgeons attended intensive lectures and operative planning sessions, and then observed as we performed augmentations using the new implant in live surgery settings. The tour was exhaustive (and exhausting), but was an incredible experience as we shared our knowledge of the implant and the processes for its optimal use with our colleague friends and their patients.

The reception of the 410 in Europe was unparalleled for any breast implant design in history. Seeing the results and the much lower complication rates associated with the new device and the new processes for breast augmentation, surgeons and patients rapidly made the 410 the most commonly used anatomic breast implant in Europe. More importantly, patients and surgeon colleagues helped accumulate and publish 15 years of critically important data that confirm the safety and efficacy of the 410 compared to all other implants–making the Style 410 the most comprehensively studied implant design in history prior to FDA approval in the United States.

During the ban of silicone gel implants in the United States, we designed a similar anatomically shaped implant that could be filled with saline–the Style 468 textured, anatomic, saline filled implant. The Style 468, in our published scientific studies, has delivered patient outcomes and complication and reoperation rates that have been unmatched for saline implants in the scientific literature. Nevertheless, no saline implant has ever been able to match the durability and device failure rates of the Style 410 cohesive gel implant. Saline filled implants have an inherently higher failure rate compared to silicone gel filled implants. One reason is the presence of a valve on saline implants to allow surgeons to fill the device, and a valve is one more device that can fail.

The Style 410 “gummy bear” implant is now in its eighth year of FDA supervised investigation (and with 15 years of data from Europe). The FDA approved the older type of round silicone gel implants (responsive gel..meaning less cohesive gel) with only three years of data. The obvious question is, “Why has the FDA not formally approved the 410, and when will they do so?” The question is even more perplexing when current data shows that the 410 has a 75% lower capsular contracture rate compared to the older type of silicone gel implants the FDA has already approved, and has unprecedented low failure rates.

The answers to these questions appear to be much more political than scientific. There has been significant turnover at the FDA, and sources within the FDA have been quoted as saying that it’s just not the optimal political time to be approving another silicone gel breast implant. Unfortunately, that means that women who could be choosing an implant product that has been scientifically proved to be superior are being denied that choice. The only women who can currently choose the 410 in the United States must enroll in the FDA study, and enrollment is limited.

So that’s the story of the invention and development of the 410 “gummy bear” breast implant. The good news is that for the first time in the history of breast augmentation, a series of patients [insert hyperlink to zero reop paper] within an FDA PMA study experienced a zero percent reoperation rate at three years follow up. The challenge is overcoming politics to enable more patients to have that device as a choice when they consider breast augmentation.

For more information visit The Best Breast – Your resource for breast augmentation and cohesive breast implants.