The Best Breast


Inventing the First Form Stable Breast Implant- the Birth of the Style 410 “Gummy Bear”
June 5, 2009, 8:02 pm
Filed under: breast augmentation

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.

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“Awake” Breast Augmentation?? Who Is Asleep at the Wheel?
May 21, 2009, 10:14 pm
Filed under: breast augmentation

by John B. Tebbetts, M.D. 

 At first, I couldn’t believe what I was seeing and hearing– in 2009, surgeon ads for “AWAKE BREAST AUGMENTATION” — and some of the ads from physicians who are not even plastic surgeons!  I thought I had seen every wrinkle of advertising in order to sell something old as something new,  resurrecting outmoded practices and techniques that failed to deliver optimal outcomes and recovery thirty years ago–and then trying to repackage and sell them to today’s prospective patients.  But seeing promotions for “awake augmentation”, I realize that marketing gimmicks never cease, and that uninformed patients may never know what can be if someone doesn’t tell them the truth about what is.

 

How do I know what is suboptimal with respect to the concepts and techniques of “awake” breast augmentation?  Because “awake” breast augmentation is how we did breast augmentations 30 years ago when I first started my practice.  It wasn’t optimal then, that’s why science has redefined what is possible for breast augmentation patients–and “awake” breast augmentation is not optimal for patients today.

 

“Awake” breast augmentation is not new or better.  Patients are not fully “awake”–the term “awake” can be misleading.  “Awake” patients are heavily sedated in order to allow a surgeon to perform augmentation with injected local anesthesia.  While some of the concepts of “awake” augmentation may sound appealing in marketing materials, ads, and commercials, let’s look at the facts–medically related facts first:

 

  • Not a single, valid scientific study exists to prove that “awake” augmentation patients can recover as quickly, have as few complications, and have as few reoperations in the future as patients who have been treated with more advanced techniques and processe that use state of the art general anesthesia.  “Awake” augmentation is a marketing gimmick that promotes old practices and does not offer patients the most rapid recovery possible.
  • “Awake”/sedated is not safer than asleep with optimal general anesthesia.  More about that later.
  • The total amounts of anesthetic drugs administered to “awake” or sedated patients are much greater compared to the amounts administered with more state of the art anesthesia protocols, because the numbing effect of local anesthetic injected into tissues is painful on injection, and no amount of local anesthetic alone is adequate to allow a surgeon to perform an optimal breast augmentation.  More drugs means more side effects and a slower recovery–especially nausea, vomiting, and constipation.  More drugs means more potential for drug related complications.
  • While being narcotized and sleepy after surgery may sound good compared to being out to dinner that night, it isn’t.  Scientific studies have conclusively shown that rapid recovery correlates directly with low complication rates and the lowest reoperation rates in the future.
  • “Awake” patients cannot be afforded the protection of an endotracheal tube (a tube that seals the windpipe and protects against potential death from aspiration, a rare but dangerous aesthetic complication.  In fact, heavy sedation can actually increase risks of aspiration by impairing reflexes that guard against aspiration.  And when a surgeon tells you that endotracheal tubes cause a sore throat, know the facts.  With optimal anesthesia techniques, less than 10% of our patients experience a sore throat, and if they do, it’s gone in less than 8 hours.  End of the day, which is worse, a sore throat, or a potentially increased death risk from aspiration?
  • “Awake” or sedated patients experience more bleeding and more trauma to their tissues during the operation, based on our 30 year clinical experience and published data.  More bleeding, even if stopped, means a greater risk of capsular contracture or hard breast that may require more reoperations.  More trauma to tissues also increases risks of capsular contracture, and dramatically increases the amount of pain a patient experiences after surgery.  A patient who can be up and out to dinner or shopping the evening of surgery has had much less bleeding and tissue trauma, or she couldn’t be up and out.  And rapid recovery patients have the lowest published rates of reoperations in the most respected scientific literature.
  • “Awake” or sedated patients cannot receive optimal muscle relaxant medications during surgery.  No muscle relaxants means that the pectoralis muscle on the chest is much tighter, resulting in more trauma by instruments in order for the surgeon to expose the area of subpectoral pocket dissection.  More trauma, more pain, longer recovery, and more risk of capsular contracture from traumatized tissues.  A sedated, “awake” patient means that the surgeon has less optimal visualization and less optimal control of the details of the operation compared to an optimally anesthetized and relaxed patient.
  • It is more difficult for anesthesia personnel to control blood pressure in a sedated patient compared to a patient with general anesthesia.  If the blood pressure rises, bleeding increases, the surgeon cannot see optimally, the operation is prolonged unnecessarily to stop the bleeding, and the risks of capsular contracture increase following augmentation.
  • Every potential compromise and risk described previously for “awake” augmentation is substantially reduced or eliminated when surgeons use scientifically verified, peer reviewed and published techniques for state-of-the-art augmentation using optimal general anesthesia.

 

So much for the science and medical reasons why “awake” isn’t optimal for patients.  Now let’s consider the logic and legal considerations:

  • It is illegal for any patient to make informed consent decisions while under the influence of drugs–especially when those drugs are sedatives and narcotics administered by her surgeon.  So where is the logic, and how legally defensible is it for an “awake” patient to make any decision or have any input about her operation while the operation is in progress?
  • While it may sound appealing for a patient, friend, or significant other to provide input about breast size or other considerations during surgery, all decisions should be made by the patient and the surgeon prior to the operation, not while the patient is under the influence of drugs, and never by anyone other than the patient.
  • Making good decisions is demanding before surgery for a fully awake and optimally educated patient.  No decision that a patient may make or input the patient may provide while under the influence of sedative and narcotic medications is optimal compared to a fully educated and fully awake patient.
  •  Educated patients rarely choose surgical alternatives that do not offer the most control for the surgeon, safety for the patient, and the least risk of complications, reoperations, or permanent tissue compromises or deformities.  “Awake” breast augmentation compromises optimal surgeon performance in many ways (read on).
  • To avoid permanent and uncorrectable damage to patients’ tissues, decisions about breast or implant size should be based on precise tissue measurements that are different for each patient.  Those measurements and scientifically proved decision processes should than be used to plan breast and implant size before going to the operating room.  History proves the high reoperation rates and uncorrectable tissue compromises and deformities that can result when patient or surgeon ignore tissue measurements and make decisions without optimal planning.  And history also proves the massive differences in patient recovery, outcomes, and reoperation rates when size decisions are made in the operating room based on visual opinions.

 

“Awake” breast augmentation prompts the question of who is asleep at the wheel—the surgeon, the patient, or both?  Why would a surgeon promote 30 year old practices that do not offer patients the best chance for the most rapid recovery and best outcome?  Why would a surgeon not want to learn, implement, and deliver what has been shown scientifically to be best for patients, instead of marketing what may be easier and require less knowledge of state-of-the-art processes?  And why would patients want to subject themselves to less than the best chance for an optimal recovery and the least risk of complications, reoperations, or uncorrectable deformites?   Why not make the effort to learn what is available, what is scientifically verified and state-of-the-art, and be out to dinner the evening of surgery with the least documented risks of problems in the future?

 

Just for the record, let’s put credibility and track record on the line for all to see–money where the mouth is.  I am more than ready and willing to compare the recovery and outcomes we deliver on a routine basis to any surgeon or surgeons’ results or data who promotes “Awake Breast Augmentation.”  Our outcomes and recovery is a matter of record in the most respected peer reviewed professional journal in plastic surgery.  And our patients’ recovery, results, and long-term reoperation rates are documented in those articles and in live surgery venues observed by hundreds of surgeons.  The scientific articles are HERE, and video documentation of our patient recovery is HERE.]

 

“Awake” breast augmentation is asleep at the wheel.



Traveling for 24 Hour Recovery…….How does it work?
April 26, 2009, 3:01 pm
Filed under: breast augmentation

 By Terrye Tebbetts

 

The processes of 24 Hour Recovery have enabled us to make traveling to have a breast augmentation procedure done a true reality.  24 Hour Recovery changes the nature of the operation and its immediate post operative complications and rates of complication so that you can travel with confidence.

 

The first step is to read The Best Breast 2. By reading this book, you will get a sense of our philosophies and personalities and a sense of confidence in our care.  Although you will never feel 100% comfortable until you have met Dr. Tebbetts during your consult, you will already know what he stands for and how he will take care of you.

 

Then you and I will visit by phone (we may ask you to send photos of your breasts taken from neck to waist, standing with your hands on your hips – front view and each complete lateral).  During this patient ed consult we will map out your choices and preferences, be sure you are comfortable and understand how the consult time with Dr. Tebbetts will be spent, and how the surgery is done – what 24 Hour Recovery really is and your part in fulfilling it and of course, be sure that you understand the pros and cons associated with the surgery. 

 

Since Dr. Tebbetts’ 24 Hour Recovery (see the papers that Dr. Tebbetts published in Plastic and Reconstructive Surgery Journal on our website under the resources section) processes allow us to send you home from the Surgery Center with no bras, straps, bandages, drains, pain pumps or pain pills, there is very little maintenance for you to do – all you have to do is be normal – move normally and resume normal activity.  By resuming normal routines, 24 Hour Recovery, allows you to feel confident and excited about your choices and having this operation, instead of feeling sick and disabled for 2 weeks which is the norm!  And in the process of experiencing a true 24 Hour Recovery, you will be able to reduce your risks of capsular contracture (scar tissue development around the implant).  Having read the book, you will know that you have an adjustment period right after surgery.  A time when you will have tingles, shooting pains, one breast that ‘talks” to you more than the other, one that is higher than the other.  You will know that it takes 6 – 8 weeks for them to soften and settle and at least 9 – 12 months before sensation issues normalize.  You will know that your new twins will be lovingly known as “them” for a while!  You will call me and say “They are doing this” or “They are doing that” but you know with out a doubt that all of this adjusting is normal – you are just getting used to them and they are getting used to you.  Again, having read the book, you have knowledge and knowledge is powerful and comforting as you are living through this experience.

 

There are basically two post operative complications that are not just simply adjustments.  They are very rare in our practice and if they happen  - you will know it -  you will not have to wonder.  If they happen it will be with in 4 – 6 weeks of the surgery, so not a long time to have to worry about it.  If it happens, one breast will be SIGNIFICANTLY larger than the other one – not kinda – but enormous.  If it is warm, red and you have a fever over 102 – it is infected.  After reading the book, you will know our rates and how we educated our patients to deal with this risk.  This is the only risk that can really truly make you sick and we don’t take it lightly.  If you have a huge breast that just appears immediately and you are in excruciating pain – then we have a post op bleed or hematoma.  Again, if you have read the book, you know what causes it and what helps reduce the risk of this happening and if it happens what would we do if you are from out of town.  Prevention precautions pre op and post op will be explained to you and discussed in detail so that we can make every possible effort to avoid these complications.  And to be sure you have a comfort level about them before and after you travel.

 

Once you decide to travel to Texas, we have a lot of work to do.  We can help you arrange labs, mammograms and EKG’s (if appropriate by age).  We have several hotels that we work with that provide our patients with discounted rates.  We have a fantastic travel agent if you need help making flight and car arrangements.  We have a nursing service that would be happy to arrange one of their aides to provide transportation to and from our Center on the day of surgery and stay with you during your 2 hour nap if you have to travel alone (a lot of times the Hubby has to stay home with the kids!).  Rest assured, we have done this many times and will help you make this an easy and relaxed experience! 

 

Once we have done our work by phone and email in preparation for your visit, you would see Dr.  Tebbetts on a Thursday, have surgery Friday, be seen for follow up on Saturday morning and then you are free to go home whenever you feel like it. 

 

See, once you have read the book, then you know what we know and all of this can come together very nicely, allowing you to achieve the desired changes in your breasts while reducing the risks of re-operation (from a national rate of 25% to ours of 3%) and you get a nice weekend in Dallas to boot (cowboy boot that is!).

 

We have had the privilege of patients traveling from all over – here is just a small sampling of where they have traveled from to have a 24 Hour Recovery ~

Washington State

Kentucky

New York State

Virginia

Arizona

New Mexico

Colorado

Oklahoma

Ohio

Louisiana

Florida

Illinois

Maine

North Carolina

Georgia

New Jersey

Utah

Montana

From overseas – England and Germany

And Texas is so big, some who travel from with in it to Dallas feel like they have traveled out of state!

Austin, San Antonio, Houston, Midland, Wichita Falls, Corpus Christie, Brownsville, Longview, Tyler, Odessa



Welcome Back Mrs. Karen Taylor!!!
April 19, 2009, 9:06 pm
Filed under: Uncategorized

After a very (very, very) long two week absence, the best patient coordinator in the world of plastic surgery returns to our office tomorrow as Mrs. Karen Elizabeth Taylor.  

On Saturday, April 11, 2009, Karen and Scott tied the knot in one of the most beautiful settings I have ever seen.  They choose to marry in there home town area of Southern Maryland and now I definitley know why.  Southern Maryland

Site of Wedding BlissThe quaintness, the colonial history, the beauty of the water all made for a perfect setting for about 200 of their closest friends and family to witness this very special event in their lives. 

 

The Dancing Taylors

 

 

 

 

 

 

 

 

 

 

 

 

Congratulations Karen and Scott and Welcome Back to Texas!!!



Commitment, Sharing, Challenges, and Advancement
April 15, 2009, 12:19 am
Filed under: Uncategorized

Some of life’s most interesting and rewarding opportunities to learn and improve are the result of other people’s commitment and their willingness to share. 

 

Jean Keene was that kind of person.  Jean, known to nature lovers and photographers worldwide as the “Eagle Lady”, was born in Minnesota, grew up on a dairy farm in Minnesota, and first worked as a rodeo trick rider.  Following a riding injury, she worked as a professional truck driver hauling cattle, and in 1977, drove a motor home from Minnesota to Alaska.  She parked her motor home near  the end of the Homer Spit in Homer, Alaska, and worked as a foreman in a fish processing plant.

 

Soon after arriving in Homer, Jean noticed bald eagles on the beach of Kachemak Bay adjacent to the Homer Spit Campground.  Having fed songbirds for years, Jean began bringing fish parts from the processing facility, and began feeding bald eagles near her motor home.  For three decades, Jean fed up to 200 eagles daily an estimated 500 lbs. of fish daily during the late winter and early spring until the eagles departed with the influx of tourists to the area.

 

 

 

trip1

 

Jean’s eagle feeding was not without controversy.  Some environmentalists felt that eagles were harmed as a result of their proximity to people.  Some believed that other bird populations in the area suffered as a result of the eagles, and others including some Homer residents, claimed that the eagles caused car accidents, and even were a threat to their small animal pets.  Although many of these claims were undocumented, the Homer City Council ultimately passed an ordinance banning the feeding of eagles within the city limits, but granted Jean rights to continue feeding until 2010.  Jean passed away in her house adjacent to her motor home on January 13, 2009  with her eagles nearby.  The house and her truck were funded largely by donations from a group of photographers who Jean had befriended and who made frequent pilgrimages to photograph the eagles.

 

Read more about Jean’s life and her challenges here.

 

How does Jean Keene’s story relate to us?  Beginning during  my teenage years, I developed an avid interest in photography.  Due to a lack of financial resources, my photography equipment was extremely limited during my medical school, residency, and early years in practice, but my interest in visual images has grown progressively.   My love of all things outdoors and critters of all kinds that live there made wildlife photography something I couldn’t do without.  Fortunately, I am blessed with a wife and daughter who share my love of animals, and support my indulgences.

 

When I learned that Jean had passed away, and knew of her story, I made a short notice trip to Homer to have one last chance to photograph one of the world’s largest concentrations of bald eagles.  The images in this video of Homer, the Homer Spit, the Grewingk Glacier directly across Kachemak Bay (visible from Homer), and the eagles were taken over a two day period that I’ll never forget.  I have worked diligently for many years to improve my photographic skills, helped by many committed photographers who despite their own priorities, were willing to spend time to share their knowledge to help me learn.

 

 

The opportunity to see and photograph these magnificent birds in a close up and personal setting would likely have never happened were it not for Jean Keene.  Despite any objections by groups or individuals (in my opinion often based on unproved or self-serving motives that I nevertheless respect), I am grateful to Jean and those who have supported her for this unique opportunity.  For many years, I have photographed eagles in the wild, and despite my best efforts, I have never been able to be close enough to fully appreciate the beauty of bald eagles and the magnificent mechanics of their flight.  As I sat on the beach in 20 degree weather with a 25 knot howling wind and blowing snow photographing the eagles on the Homer spit, it occurred to me that the things I respect most about Jean are things that Terrye and I believe in strongly–commitment, sharing, and facing challenges head on in order to advance.

 

Like Jean–we don’t focus on objectors and detractors.  Our focus is all about patients.  Every priority begins with our patients–assuring every patient the best opportunity for knowledge, good decisions, the most state-of-the-art surgery, the most rapid and carefree recovery, and the least risk of reoperations or risks to their tissue in the future.  An unblinking commitment to those priorities, regardless of the challenges, has enabled us to deliver a completely redefined experience for breast augmentation patients.  Our track record is open for comparison to any other surgeon worldwide.

 

We are committed to continually develop new techniques to deliver better for patients, and committed to sharing what we’ve learned and developed with our colleagues for the benefit of all patients.  We have published and shared scientifically verified, peer reviewed data and processes in the most respected professional journal in our specialty, and have demonstrated unequivocally that specific processes of patient education, tissue based implant selection, and surgical techniques can routinely deliver out to dinner augmentation, 24-hour recovery, and the lowest  reoperation rates ever published from an FDA PMA study–objectors and detractors persist.

 

Challenges are unavoidable, but they not distract us from patient priorities.  We have and will continue to deal aggressively with challenges to assure what’s best for patients.  Commitment, sharing, and dealing with challenges is what has enabled us to deliver an unparalleled level of recovery and outcomes for our patients.  The same approach enabled Jean Keene to realize her priorities and provide a path for others, like me, to learn and grow.

 

Rest in peace, Jean.  Many of us will think of you every time they see an eagle.  It’s not about the naysayers; it’s about the eagles.

 



It’s Official, the NY Times agrees ~ Cups Size is NOT a Reliable Measurement!
April 9, 2009, 7:46 pm
Filed under: breast augmentation

by Terrye Tebbetts

Finally, some national recognition of my soap box rants regarding the unreliablity of bra cup sizes!  As I have said many times, there is no standard of measurement for cup size in the fashion world and there is certainly no MEDICAL, CLINICAL definition for cup size.  So how can patients and surgeons keep planning breast augmentation surgeries based on something that doesn’t exist?

In the New York Times today, Laura M. Holson writes, “While clothes designers have whittled down dress sizes so that even a musclebound woman can wiggle into a size 2, brassiere makers are defying fashion convention by selling bras with bigger cup sizes. These days, many women (to their shock or glee) are finding that DD is becoming the new C.”  This article quotes manufacturers like Wacoal America and retailers like Bare Necessities, who all agree, “Simply put, a woman who wears a 36A is also likely to fit into a 34 B or a 32 C”.  Acknowledging that cup sizes and how bras are fitted can vary so much should really be a wake up call to all women who are thinking about getting breast implants.

The biggest problem with planning breast augmenation surgeries using things like the Rice Test, sizers, photos of others or cup size is that none of those methods take into account the actual breast envelope you are going to operate on.  Respecting your breast tissue is the key to a natural result, that hopefully, will age gracefully with you and cause you the least risk of reoperation long term.

 

Operations need objectivity.  The High Five System of measurement which was published by Dr. John Tebbetts, allows surgeons to plan the operation based on objective numbers.  A key concept is that a properly chosen breast implant does not force tissues to where they have never been or were never inteded to go.  An optimum implant either optimally fills the space present or stretches tissues no further than they are likely to stretch with a pregnancy.

When the size of an implant is chosen by the patient’s own breast tissue, then the patient will have the comfort of knowing it will never be too big and it is respecting her tissues.   What cup size she ends up being …..who knows?  Who cares?  The size will vary depending on where she shops and what mood she is in at the time.  She will get to have fun with shopping and figuring that out what cup sizes she can wear when she is about 3 months post op ~ after the implants “drop and fluff” as they say on the breast forums!  Cup size will vary, but the safety of her breast augmentation and her breast implants will be secure if objectivity is used to plan the operation.

 

 

 

 



Cohesive Confusion – the State of the Gummy Bear implant
April 4, 2009, 2:19 pm
Filed under: breast augmentation

 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!



Fibrocystic Breast Disease and Capsular Contracture??
April 2, 2009, 6:34 pm
Filed under: breast augmentation

by Terrye Tebbetts

Here is a question I recieved this week – I hope the discussion of the cause and prevention of capsular contracture – scar tissue  that can develop around the breast implant will be helpful to you.  The national rate of CC with silicone breast implants is 36% – Dr. John Tebbetts’ internal practice rate is 1.5%!  We may not be able to prevent it completely, but there are certainly proactive things that can be done to help reduce the risk of reoperation due to CC.

Q: Question on fibrocystic breasts
Hi Dr. Tebbetts, I have some questions re; fibrocystic breasts. I have very lumpy breasts with a
tendency towards cysts. Taking vitamin E helps somewhat. I am worried if this might result in CC, I’m
also worried the lumpy and hardened breast tissue I have will make the implant placement more
difficult. I’m hoping to have my augmentation via belly button incision. Thanks in advance for your
response!!

.

Terrye Tebbetts:
First, please know, I am not a surgeon, just married to one for the last 18 years! Dr. Tebbetts and I
wrote The Best Breast 2 together to help educate patients -he does the surgery, I do the patient
education and recovery care!

As for your question, most of us have some form of Fibrocystic disease whether we know it or not.
Stress, caffeine, hormones etc can make it seem worse at times. But in our experience, Fibrocystic
changes should not limit you from having an implant. Be sure you have a pre-op mammogram done if
you are over 30 and that it is clean and good.

Scar tissue formation around the breast is the most unpredictable complication we have in this
operation -it depends primarily on 3 things -how each patient heals around a wound, the type of
implant (filler and shell surface), and how the surgery is done. One of the neatest things we
discovered when we wrote the second edition of the book is that the better recovery we provide for
patients -the 24 Hour Recovery -is also showing us lower capsular contracture rates! Our internal
rate is 1.5 % -national with silicone implants is about 36%!!! We know keeping blood out of the
pocket is critical -that is why there are 2 chapters in the book about recovery -you MUST learn about
what your recovery will be like BEFORE you choose your surgeon -what recovery is like will tell you
what is going on in the operating room!!

And as for your incision choice -I would highly encourage you to read the incision location section in
your new book I will send you (just send your name and address as instructed in my post above).
Most TransUmbilical incisions are done blind and blunt -no way you can keep a dry -precisely
dissected pocket due to location and instrumentation issues.

Read it carefully and please let me know if you have any further questions!

Response:

This was very helpful-thank you!



The Problem with Rice, Cups, Photos and Sizers
April 2, 2009, 6:03 pm
Filed under: breast augmentation

by Terrye Tebbetts

Last week when I did a Q&A session on www.implantinfo.com , I missed a very important follow up question to the Rice Test comment that I made, I am sorry that I can’t tell at this point who posted it, so I am posting my response to you all.

The biggest problem I have with planning breast augmenation surgeries using things like the Rice Test, sizers, photos of others or cup size is that none of those methods take into account the actual breast envelope you are going to operate on.  Respecting your breast tissue is the key to a natural result, that hopefully, will age gracefully with you and cause you the least risk of reoperation long term.

The only way to know how much each breast envelope will hold is to measure it.  Now a measurement, is not a measurement is not a measurement.  You have to not only measure the breast but apply the measurments to a formula that tells you the volume the breast will hold.  This is the High Five System that Dr. John  Tebbetts published in our national journal Plastic and Reconstructive Surgery.  This system basically gives the surgeon a formula to figure out the empty area of the inside of your breast envelope. 

When you know this number, it allows you to simply fill the empty space – end result – - you only BETTER!  You look fantastic and everyone has to wonder why you look so good – - not whisper behind your back “Boob job!”.

A key concept is that a properly chosen breast implant does not force tissues to where they have never been or were never inteded to go.

An optimum implant either optimally fills the space present or stretches tissues no further than they are likely to stretch with a pregnancy.

If you don’t put enough in a breast, it is empty in the upper portion, if you put too much then it begins to buldge in the upper portion (looking more and more like a grapefruit).  So there really isn’t a RANGE of sizes for each breast – if the result you are after is one of Ideal Fill or a natural appearing breast.  There is a really good illustration of this on page 69 in The Best Breast 2 book – it is also available on our homepage at www.thebestbreast.com under articles.



Allergan Style 410 Update
March 22, 2009, 1:03 pm
Filed under: breast augmentation

Well, I have been telling all of you that we would keep you posted on the availablity of the 410 form stable implant via this blog – so here’s your first status report.

We just received word that the study will continue at least through April.  This puts us in the same situation we have been in for the last 8 years – limited spots per month and local patients.

On the bright side, at least they are still available and under the study parameters there are some benefits.  So if you want a 410, are local to the Dallas area and want to be part of the study – -let us know quickly so that Karen can request a spot for you!