The Best Breast


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!



Out to dinner after a breast augmentation and 24 hour recovery- How did an unbelievable patient experience become routine?
March 6, 2009, 6:21 am
Filed under: breast augmentation | Tags:

John B. Tebbetts, M.D.

Chapter 3- Assembling the pieces, defining the scripts, playing it out, and the prize for the patient

Fast forward.  Now almost two years into this effort.  Back to the pig again (if you don’t get it, check out my previous posts, Chapters 1 and 2 of the 24 hour recovery story).  I’d found a couple of (Texican for “two”) prizes that had already improved our surgical efficiency: 1) I redesigned the electrocautery forceps to a needlepoint handswitching version pictured below, and 2) I had learned to control bleeding before it happened and avoid touching ribs and creating bleeding beneath the very sensitive lining over the rib (periosteum).

So far, these two changes alone had reduced our operation time from about 90 minutes to 60 minutes.  It’s amazing how much time is saved when the surgeon doesn’t need to stop to control bleeding that never started (even a pig gets that concept).  A huge side benefit is that tissues are not blood stained inside the implant pocket, the surgeon can see better, has more control, and is less likely to cut even more blood vessels. Everything proceeds much more accurately and efficiently.  Life’s getting better in oink land.

With just a 30 minute reduction in operation times, we immediately noticed that our patients were recovering faster.  Lower doses of narcotics during surgery meant that the patient could awaken faster in recovery, and have less nausea and vomiting.

Another piece fell into place.  While analyzing the hours of video, I began to notice more and more small things, that now I had learned could be big things, especially when several small things were combined.  I noticed in some videos that on the audio, I was breathing harder as I was dissecting the pocket for the implant.  I wondered why.  Then during other surgeries, I noticed that in order to see well inside the pocket, I needed to lift the retractor and overlying tissues up off the ribs.  Easy at first, but more difficult as the case went on, and more difficult on the second side breast compared to the first.  The only thing that could make lifting the retractor more difficult was that the pectoralis muscle being lifted must be getting tighter and resisting.  Enter the discoveries about muscle relaxation.

Let’s forget the pig and get a bit technical for a bit.  I can’t explain the muscle thing without some background information and principles.  Assuring optimal soft tissue coverage over the implant for a patient’s lifetime is the number one priority in breast augmentation, because it prevents uncorrectable deformities such as implant edge visibility and visible rippling.  Assuring optimal (not temporarily adequate) soft tissue cover over an implant usually requires that the surgeon use the pectoralis muscle for partial cover, with a portion of the implant placed behind the pectoralis muscle.  The pectoralis is a strong muscle, and lifting it in the absence of muscle relaxant drugs, although done routinely by many surgeons, causes significant trauma and bruising to the underside of the muscle by the retractor.  Does it matter?  If you’ve ever had a serious muscle bruise, you know how much it hurts and how long it takes to get over it.  Without muscle relaxant medications during surgery, that kind of bruise happens on the underside of the pectoralis muscle virtually every time a surgeon does a breast augmentation with muscle coverage.  As a result, common wisdom is that a subpectoral (placing the implant partially under muscle) augmentation is more painful compared to placing the implant over the muscle–just behind breast tissue.  It that wisdom true?  Not anymore.  With changes in instruments and technique, 85% of our augmentation patients can go out to dinner the evening of their surgery.  But back to the rest of the story. Without optimal muscle coverage, many patients develop uncorrectable deformites as they get older.  Their tissues get thinner, the edges of the implant are visible, and rippling becomes visible, often in the cleavage area.  Ugliness in the land of greatest beauty (I think Socrates said that…Buddy Socrates as I recall).  So I needed to make subpectoral augmentation as pain free as submammary augmentation (not under muscle).   Not to give away the ending, but we did just that.

So why not just give all patients some muscle relaxant medications, relax the pectoralis, save surgeon energy, reduce trauma to the pectoralis, and therefore reduce pain?  The only reason is that many surgeons were taught to perform augmentation using local anesthesia with the patient awake and heavily sedated (you’ve undoubtedly heard the pronouncement that local anesthesia is safer and better than general anesthesia–NOT)  Unfortunately, the muscle relaxants to relax the pectoralis muscle also relax the intercostal muscles and diaphragm, both required to breathe effectively….and breathing effectively is important.  So muscle relaxants cannot be administered to an awake patient under local anesthesia because they would not breathe effectively.

To take advantage of the huge benefits of muscle relaxants, patients must have general anesthesia and should have an endotracheal tube (a tube that inserts into the windpipe and seals it with a balloon) for optimal safety.  Many surgeons still believe today  that patients operated with local anesthesia and sedation awaken more rapidly and recover more rapidly compared to patients who have general anesthesia.  Not only is that belief not true–it has been scientifically disproved beyond a reasonable doubt by our published scientific studies and others.  Two other objections to general anesthesia–it costs more (also not true when efficiency is optimal), and patients sometimes experience a minor sore throat for a few hours after surgery from the endotracheal tube (less than 2% of our patients, because we also optimize tube sizes and insertion techniques).  Bottom line?  It is categorically impossible to deliver the most state-of-the-art breast augmentation, including surgeon control, accuracy, patient safety, patient recovery experience, patient recovery time, and time to return to normal activities without using general anesthesia and muscle relaxants.  Our studies conclusively prove that fact.

Relaxing the pectoralis was a huge benefit.  Less trauma to the pectoralis, less pain, better visualization and control for the surgeon, less bleeding, less pain again, more efficient operation…you get the picture.  Now we’re gaining multiples from our bricklayer, Mr. Gilbreth’s principles.  We’ve already improved efficiency by about 30% by our instrument and technique changes alone.  Now it’s time to really apply what we learned from the video motion studies.

I began with a list–a really long list–of every step in the augmentation procedure that I could define from the videos.  Then I turned this list into a table, with the list of steps in the left column, and a separate column to the right of the list for each person in the operating room- anesthesia person, circulating nurse, instrument nurse, surgical assistant, and surgeon.  For each step, I then defined what each person should be doing during that step.  This was a very long and detailed process that generated what I chose to call a surgical script.  The first complete script was almost 100 typed pages in length.

Surgeons learn in an apprenticeship education model.  We learn from a mentor (another surgeon) by watching the surgeon perform his craft, and we then perform the craft on our own.  Surgeons tend to think in a specific solution for a problem manner:  given a specific surgical problem, most surgeons have learned and apply a single solution (most often used) to address the problem.  In business, things are different.  Virtually all successful businesses use Total Quality Management (TQM) and process engineering models that focus on processes, not on existing solutions, emphasizing the manner in which things are done (processes) to arrive at innovative solutions.  What did he say?  Here it is:  surgeons think in a surgeon box, usually solution based thinking.  Few surgeons apply TQM and process engineering principles to micro examine each process in surgery–from patient education, to assessment, to planning, to each micro move during the operation, and through every step of recovery.  That’s exactly what I intended to do with breast augmentation, and at this point, I’m more than two years and hundreds of hours into the project.  Why?  Because by now I realized that solutions just produce a solution.  Every improving processes guarantee ever improving solutions, not a single solution.

Next, we began to apply principles of motion and time study and process engineering.  Without going into great detail about process engineering principles, a few key things are important.  I had a list of steps (processes).  Process engineering uses methods of analysis to take each process, and the processes collectively, and refine those processes to create more efficiency.  Simplistically, process engineering helps define which processes are really necessary, and discards all unnecessary processes, steps, and motions.  Then it takes the processes that remain, and asks several questions:

1) Is this process really necessary?  If not, discard it (even if you thought it was necessary before)

2) Can the number of steps in this process be reduced?  Can steps be eliminated without every compromising the quality of the product?  If so, eliminate steps that are unnecessary.

3) Can two or more processes or steps be combined to eliminate duplication of steps or motions, without compromising quality?  If so, do it

4)  In assembly models (very similar to surgery, with repetitive steps in each surgery), for each step in a process, can the length and number of motions be reduced?  Sometimes it’s as simple as moving the instrument tray closer to the surgeon.  Sometimes it means teaching a surgeon to use both hands at once to perform different tasks in the same area.  Or something simple like the surgeon picking up an instrument instead of another person picking it up and handing it to the surgeon–always keeping the instrument in exactly the same location so that the surgeon doesn’t even need to look away from the operative field to pick up the instrument.  The list is endless, and improvement never stops.  It’s only a matter of devoting the commitment and time to repeat the process of looking closer at everything with an open mind.

Over six months of work (fitted in between practice and family), and I reduced the 100+ page script to 21 pages (ultimately 15 pages at last count).  Now I had the practice sheet.  Yep.  Practice.  Alone and with my surgical team.  Mock operations, where we had the scripts on a laptop with someone reading each step (actually a series of steps), and everyone performing the specific tasks and motion listed on the scripts.  Kind of like choreography, I suppose, though I know little about choreography.  If you feel terminally compulsive, you can read or download the scripts here [need to upload scripts and add links].

The results were astounding.  The convoluted pig story/fairy tale was actually happening.  By turning off all our time wasting habits, in less than 3 months after the scripts were complete, our operative times decreased from 60 minutes to 30 minutes or less- a two thirds improvement in efficiency from our starting point.  We were like pigs in a pile of acorns/prizes.  But the best was yet to come.

To this point, almost three years into the project, my focus had been entirely on making our surgical processes more efficient.  That included timing each event from the time the patient arrived until the time the patient left our surgical facility, using bar coded events and a wireless scanner on each patient’s chart.  Good data doesn’t lie.  I began to see things in the data that I could hardly believe!  By gathering data using different drug combinations and doses, we had dramatically reduced total doses of narcotics to less than 1/6 of our starting levels.  By defining each step in anesthesia with specific steps in the operation (all timed), and then integrating our anesthesia script with our surgical scripts, I couldn’t believe what I was seeing, and neither could any of my very experienced personnel.

Patients were awake, moving, laughing, with minimal discomfort in less than 20 minutes following surgery.  They could hold their arms above their head and do arm raises within 30 minutes!  In over 600 patients, the total time from start of their breast augmentation to discharge home from the surgery center averaged 78 minutes!  Once home, no nausea, no vomiting, no constipation.  Up and out didn’t mean hurling–it meant getting up and going out to dinner!  All confirmed by independent observers and visiting surgeons.  The year was 2001.

There were other hurdles.  My entire team had to struggle with letting go our preconceptions- things like: patients should not move their arms or lift early to avoid bleeding; bandages and drains are necessary; tubes and pain pumps are necessary to relieve pain; narcotics are necessary. As we did away with all the unnecessary contraptions and drugs, our patients continued to amaze us with their recovery.  Without bandages, drain tubes, special bras, and narcotics, when we’d call the evening of surgery to check on patients, a majority were not at home.  When we learned to get their cell phone numbers, we found that many were out shopping or at a movie.  Unbelievable.  More acorns.

Then the first of two final prizes.  Improving efficiency had redefined patient recovery.  One morning while seeing follow up patients, I said to Terrye, “I’m totally amazed at most of these aug patients.  Virtually every patient I talk to tells me she was back at full activity within a couple of days”  Terrye’s reply: “A couple of days?  You must be kidding.  When you started all this, we started keeping up with patients’ activity levels, and when they resumed activities. Here’s the book (a massive 3 ring binder) with the results documented on our phone call forms.  Over 95% of the patients you’ve operated on since beginning this project have returned to full, normal activity within 24 hours.”  Although I was in the middle of the action the entire time, being a typical surgeon, I didn’t see what was right in front of me. While dramatically improving our efficiency, we had completely redefined the patient’s experience and recovery in breast augmentation.  I still didn’t believe it until I compiled all the data and had it reviewed independently.

I had never been more excited in my professional life, but I knew that the majority of surgeons would never believe what we were doing.  Our processes needed to be peer reviewed and published, and only in the most respected and rigorously peer reviewed journal in plastic surgery.  That finally happened in the January, 2002 issue of Plastic and Reconstructive Surgery Journal.  If you’re interested in even more detail, the two parts of the publication are here and here on our website.  If you’re really curious, you can even read the detailed operative scripts here and here ***[to be uploaded and links added].   Why two scripts?  Well, after doing all of this for the inframammary (under the breast incision) approach, I did it all again for the axillary (in the armpit incision) approach.  It was easier the second time around, but only required about 20% less time).

I knew that writing the scientific paper and publishing it would not be enough.  Honestly, we began to continually hear more and more behind the back naysayer surgeon comments like, “Yeah, it may become  published, but I still don’t believe it.”  I never took that personally, because as I write this today, I still find it difficult to believe, even though we deliver even better today.

The ultimate test of the skill and composure of a surgeon is hard to define, but in our specialty, many surgeons would agree that live surgery is one good measuring tool. Live surgery means performing surgery in an operating room filled with lights and cameras with a fiberoptic or satellite link to an auditorium where large numbers of surgeons sit and watch on a massive screen–all the while asking the operating surgeon questions, and enjoying watching their colleagues face challenges when they operate in a strange environment with personnel who are not their routine personnel (no doubt it’s a closet gladiator mentality).  Of all live surgery symposia in the world, the most challenging, in my opinion, is the Baker-Gordon Symposium in Miami.

You guessed it.  Put up or shut up.  Off to Miami, our turn in the operating room, more than 600 surgeons in attendance.  But that wasn’t the real test.  I promised the audience that for the first time in the history of any live surgery symposium in plastic surgery (to my knowledge it still is), we would commit before surgery to allow the patient to be videotaped throughout the evening of her surgery–with time code on the videotape verifying the exact times following surgery that each event occurred–good or bad, for better or worse.  A single case in a strange environment is poor odds with an upside down spread if you’re a gambler, but it needed to be done.  Thankfully, we had a great patient and the augmentation procedure went well.

 

24_aug

 

The pictures, clips from the videotapes on the evening of surgery spoke for themselves- at the symposium, and later in the scientific publication.  Attendee surgeons saw the entire videotape, and saw the patient the next morning as she was walking along the beach before boarding a plane for home.  Three hours after surgery, in the top left photo, the patient is blow drying her hair after a shower; top right, 4 hours after surgery she is eating a dinner of raw oysters (yep, the real deal) at a restaurant in Coconut Grove; lower left, 5 and a half hours after surgery she is shopping at Victoria’s Secret in Coconut Grove, and contrary to postop instructions, in the lower right photo, about 6 hours following surgery, she is dancing at a nightclub in the Grove.

Talk about pigs finding acorns.  We can show patient recovery videos today that cut these times in half, but I don’t think I’ll ever forget the first time I looked at this patient’s video, knowing that good or bad, I had to show it the Baker Gordon Symposium attendees.  I was sweating in spots other than the palms.

While we started focused on efficiency, the best prize in the whole story so far was the prize for our patients- an unprecedented improvement in patient recovery and a redefined patient experience.  But the naysayers didn’t stop.  Now the surgeon naysayers (and it still persists today, and I still don’t take it personally) focused on, “Well, there is no way that a breast augmentation can be done that fast and be done well.  If the patient gets a better long-term result by taking more time in the operating room, then all that Tebbetts has done is put on a show.  What patients really want and need is the best long-term outcome.”

End of the story–last prize, and as the naysayers suggest–the most important prize–patient outcomes.  What about long term patient outcomes?  What about reoperation rates?  Does more efficient surgery and faster recovery mean better for patients, or does it mean worse.  Opinions are many, and opinions are just opinions.  Peer reviewed, scientifically valid data is unbiased, scientifically tested and verified, scrutinized by expert surgeon peers, and in studies performed under FDA scrutiny with independent supervision is what counts–what distinguishes science from opinions.  Scientific, hard data separates the men from the boys–for good or for bad.

In our peer reviewed and published studies in the most respected journal in plastic surgery, in 1664 patients followed for up to 7 years, our overall reoperation rate was 3%.  In FDA studies with similar implants with a large number of surgeon investigators, average overall surgeon reoperation rate averaged 25% at the same 7 year follow up  .  Average patient experience–a 25% reoperation rate; our patient experience–a 3% reoperation rate–more than 800% better.  Some surgeons didn’t care for those numbers, so there had to be yet another naysayer theory–that our studies were not as rigorously supervised compared to independently monitored FDA studies.

Okay, still nothing personal–let’s find out how our processes and our patients would do in an FDA study–a prospective study in which the first 50 patients we enrolled in the 410 implant PMA study were followed for the first 3 years of the study. At 3 years, the average patient reoperation rate in the study was 12.5% for all surgeon investigators in augmentation.  Our reoperation rate in our first 50 patients at three years was 0%–yes, that’s zero percent.  Not a single patient had a reoperation at 3 years–something that has never been done in the history of FDA studies of breast implants, and a patient outcome/reoperation level that has never been published in the history of breast augmentation in an independently monitored study.

More efficient surgery and refined surgical processes deliver a redefined patient experience and recovery.  More efficient IS better–no matter how you look at it.

I realize the online incorrectness of shouting with capital letters, but I really don’t care and I’m going to do it anyway….because it’s that important for patients.  If you take nothing else away, remember this:

THE PROCESSES THAT PRODUCE FASTER RECOVERY ARE THE VERY PROCESSES THAT REDUCE COMPLICATIONS, REDUCE REOPERATION RATES, AND PREDICTABLY DELIVER IMPROVED PATIENT OUTCOMES.  Case closed.  End of story.

Postscript:

What about the pig?  Well, the pig is still rootin’ around…still lookin’ for that next acorn/prize.  Tryin’ to figure (by now I hope you speak pig and Texican) out how to find more acorns in less time with less rootin’—cause the pig, though wiser, still wants to do better.  Stay tuned…the pig is likely to return another day.