Here are a few things that this plastic surgeon is thankful for……….
Modern Anesthesia. This makes for painless surgery. And the surgeon can take her time to do a really, really nice job. During the Pilgrims’ time, the main qualification for being a surgeon was to be really, really, really fast. Yikes!
The Germ Theory and Antibiotics. Surgery used to mean infection. Now surgical infections are rare. Not rare enough, but rare.
The Bovie. This is the electrical gizmo that seals blood vessels as it cuts. This is why you don’t need a blood transfusion when I do your Mommy Makeover.
Surgical Scrubs. It’s like working all day in my pajamas.
My Dansko Clogs. It’s like working all day in my slippers.
Surgical Loupes. These are my silly looking magnifying glasses that allow me to see important teeny tiny things like nerves and blood vessels. They also come in handy for reading the newspaper when I can’t find my reading glasses.
My Battery Powered LED Surgical Headlight. Now I don’t have to be attached to the light source by a fiberoptic tube (which is how my dog must feel on her leash).
Power Assisted Liposuction a.k.a. PAL. This PAL is a true friend. It makes liposuction so much better for the patient and the surgeon.
My Wonderful Staff and Colleagues. They keep me on my toes.
My Wonderful Patients. They are why I love coming to work!
My Wonderful Husband and Children and Dog and Cat. They make my life complete, especially the cat.
My Freakishly Good Health. I’m 64 and still running, skiing, biking, and playing tennis. I’d like to take full credit for this but really I think I’m just lucky.
Four years ago I sent my twin sons off to college. Last Saturday I help their little sister move into her dorm. And then I cried. A lot.
For those parents doing this for the first time, second, third or fourth time, and for all those lucky youngsters heading off to college, let me share this wonderful essay with you.
Coping with the angst of dropping off your child at college by Kent Hickey.
From the Seattle Times, August 29, 2014.
All around the country freshmen are filling up suitcases for college. Their parents’ heads are filling up too, mostly with “remember when.”
As we prepared to send our first off to college, my mind kept revisiting all those Saturday mornings in parks when our kids were little. They loved to sneak acorns into my pockets and run away laughing as if they had pulled off some grand caper. One day I caught the eye of an older gentleman as he walked by. “Enjoy it while you can,” he said. “This passes fast.”
It has. And that first college drop-off was a big moment for all of us, especially for our daughter, though one likely eclipsed by that even bigger moment when she finally received the highly anticipated and much practiced “Dad’s Wisdom for College” talk.
I found the perfect setting a few days before departure: a car ride to the grocery store, doors locked and vehicle in motion to guard against the inevitable triggering of the daughter’s flight response.
Here it is:
“Introverts draw energy from solitude. Extroverts draw it from company. Know who you are and find your balance.
“Dads are awesome; boys are not. Always do what Dad would think is right. Never do what a boy thinks is right.
“The single most stupid thing done in college is almost always done while drunk. And, while getting high on marijuana may not necessarily lead to doing equally stupid things, it will lead to doing fewer things. Don’t be stupid.
“God has been a friend in your life every day, whether you’ve known it or not. Bring your friend to college with you and spend time with your friend every day.
“You will never really leave your home.”
It’s hard to say what the daughter took from these pearls, especially with all the other messages, often mixed, that young people hear as they prepare to head off for college:
Explore, find yourself; just make sure you earn a marketable degree that guarantees high lifetime earnings. Don’t be afraid to meet new people, but be wary given all those sexual assaults on campuses. Become a lover of learning without obsessing over grades, though they will likely decide your future.
Colleges are now keenly aware of how hard the drop-off is on my generation, the baby boomers. Upon our arrival on campus the daughter was quickly immersed in her orientation. The same experience awaited parents. I’ve never felt so nurtured, or exhausted.
There were days of parent orientation, each session starting with a “Relax, it will all be fine.” Heck, the school’s president even gave out his personal cell number, just in case we needed to chat, and I don’t even think it was fake. When did we become so needy?
My folks, who were of the World War II and Korean War generation, drove me from our home in Kalamazoo, Mich., to Marquette University in Milwaukee 35 years ago. We had one stop along the way, at the Mars Cheese Castle in Kenosha, went straight to my dorm upon arrival and quickly deposited the contents of one suitcase in my room.
Then Mom gave me a tearful hug, Dad an awkward handshake. Right after I moved in, they moved on. No dayslong orientation for them, and hardly one for me. My first lesson was given that very night by two sailors who tried to mug me when I got lost in an alley behind some dorms. I ran away and hid in a dumpster. A passing grade, if not a very courageous one.
Yes, a lot has changed, but one thing hasn’t. That drop-off moment is just really hard.
Right after the final goodbye the daughter gently slipped an acorn into my hand. I’m glad I had already said all that I wanted to say. I couldn’t talk anymore.
Kent Hickey is president of Seattle Preparatory School.
Thanks for reading! Dr. Lisa Lynn Sowder
i would be honored if you followed me on Instagram @sowdermd and @breastimplantsanity.
This is a question posted by a patient on RealSelf. She’s a lady in her 50’s with 11 year old anatomic Allergan Style 410 implants. She has typical menopausal symptoms and does not think her implants are causing her night sweats, mild brain fog or hot flashes. She’s heard about BIA-ALCL and wants to know if she should have her implants removed. The photos she submitted show an absolutely beautiful long term result and the rest of her looks pretty awesome too. She’s obviously either biologically privileged or she’s a gym rat or maybe both. She’s very lean. She doesn’t have enough fat for a meaningful fat transfer. Her breast volume is mostly implant. She loves her implants but she is scared. What should she do?
So let’s be rational about the advice we give her based on what we know about BIA-ALCL. First of all, she cares about her appearance. Will she look good after explant? IMHO, no. She will be very, very small breasted. If she’s okay with that, fine. But I don’t think she will be okay with it.
What are the odds that she will get BIA-ALCL? The latest numbers coming out of Dr. Mark Clemen’s work at MD Anderson estimate the chance of her developing BIA-ALCL is about 1 in 3000. What about the chances of her DYING from BIA-ALCL? Well, with increased awareness, early diagnosis and proper treatment, those chances are approaching ZERO. I cannot rationally recommend she part ways with her awesome and great looking implants for those odds.
Now let’s look at breast cancer. What are the odds? Well, about 1 in 8 or 9 women will be diagnosed with breast cancer. The cure rate for breast cancer is much lower that the 90% plus cure rate for early diagnosed and properly treated BIA-ALCL. Do we recommend bilateral prophylactic mastectomy for your average patient with average breast cancer odds? Of course we don’t. Women should be freaking out about the fact that they have breasts instead of the fact that they have textured breast implants! And this post is in no way dismissing the suffering and, yes, death of patients with delayed diagnosis and/or treatment of BIA-ALCL. These numbers mean nothing to someone who has died or lost a loved one BIA-ALCL. We now know so much more about the etiology, diagnosis, prevention and treatment of this really weird malignancy.
So this is what I would advise this lady if she were my best friend or sister: Her implants are getting up there in years. I would get them removed and replaced with smooth, round cohesive gel implants. With her anatomy she will look fine with round implants. It’s been demonstrated very well that anatomic implants offer almost zero benefit over round implants in patients with normal anatomy. If her surgeon finds seroma fluid or capsule nodules, he/she should do a capsulectomy and send the fluid and capsules for examination. If the capsule is smooth and thin and unremarkable, he/she can just adjust the implant pocket if necessary to accommodate the new implant and leave the existing capsule in place.
And then she needs yearly exams and regular mammograms based on her breast cancer risk.
Thanks for reading and I would be honored if you followed me on Instagram @sowdermd and @breastimplantsanity. Dr. Lisa Lynn Sowder
I get a lot of requests from breast implant illness patients to do an en bloc resection of their implants and the surrounding implant capsule. The term en bloc refers to a procedure that removes the structure in question in one piece or all together. This term is used most commonly in cancer surgery where a tumor is removed in its entirety without actually cutting into the tumor itself. Except in cases of BIA-ALCL, implant capsules are not cancer.
The photo below shows an en bloc resection of two ruptured breast implants and the surrounding capsule. In cases like this, doing an en bloc makes a lot of sense in that it prevents any spillage of silicone and makes for a much cleaner explant. Fortunately it is cases like this where an en bloc is usually doable. The thick, nasty and calcified capsule often just peels away from the adjacent breast tissue, muscle and chest wall without causing any collateral damage. Doing a clean and slick case like this is what surgeons live for and believe me, I wish every explant would go just like this!
But……….it is not always possible to do an en bloc resection. Sometimes the capsule is very, very thin and fragile (sort of like a wet Kleenex) and it is not possible remove it unbroken. Sometimes the capsule is very adherent to adjacent structures such as breast tissue, ribs and chest muscle. It is just not worth the damage to those normal structures to get an en bloc resection. Sometimes, with implants under the muscle, the patient is at risk for a collapsed lung when trying to peel a very adherent capsule from the rib cage. In cases like this, the capsule can be removed with curettage. And sometimes, with really large implants or those put in though the axilla (arm pit), the upper part of the capsule cannot be visualized with the implant in the way. And if I cannot see it, I will not cut it. In those cases, I remove the implant and then am able to safely remove the capsule. I am very careful about minimizing or, in most cases, eliminating spillage of any leaking gel.
I am aware that the breast implant illness community is obsessed with en bloc capsulectomy. I’m not sure why because for clean, intact implants, there is no compelling reason to do an en bloc, except maybe to show off and promote oneself, and yes, I am guilty of that! Many patients are lead to believe that there is some sort of evil humor or miasma that exists in the space between the intact and clean implant and capsule. The space (which is actually what we call a potential space because it contains nothing) contains nothing!
It is really easy to pontificate for a potentially dangerous procedure when one has zero responsibility for any downside. Who is responsible for harm to the patient – the surgeon holding the sharp instruments or the social media pundit?
And I am also aware that there are surgeons out there who guarantee an en bloc, every implant, every time. I honesty don’t know how they can. I also provide a guarantee… I’ll do my best.
Thanks for reading! Dr. Lisa Lynn Sowder
I would be honored if you followed me on Instagram @sowdermd and @breastimplantsanity.
Seattle Plastic Surgeon goes back, way back to Match Day 1983.
I remember the excitement of MATCH DAY like it was yesterday.
Every March, fourth year medical students across the United States convene to receive and open a small white envelope that has a huge influence on their future. The information contained in this white envelope is where they “matched” for post-graduate training.
The Match System works like this: As a fourth year student, you apply to a dozen or so residency programs and if asked, go for an interviews at these programs. Then you rank the programs in decending order of fabulous to surely miserable and everything in between. And the residency directors rank all of the applicants in decending order of incredible to surely a disaster. An all knowing computer takes these rankings and matches the applicants with the programs. Supposedly, the applicants’ wish list has more weight than the residency programs’ but I bet that students are still advised NOT to list any program that makes them want to chew glass instead of go there.
This is a momentous day. This Match determines where you will live and train for anywhere from 3 – 8 years, who will become your BFFs, often whom you will marry, where you will eventually live and how you will practice your specialty. Every fourth year medical student wants a great residency experience both academically and socially.
Okay, enough about that and more about me. I matched at my 2nd of 10 choices, the University of Utah and, as a skiier and a woman, was thrilled. Of course Utah has the BEST SNOW ON EARTH and the University of Utah had a lot of women in their general surgery program, even back then.
I ended up spending 6 years in Salt Lake City, 5 years as a general surgery resident and 1 year working in the Intermountain Burn Unit. My years there made a man out of me (even though I’m a girl). I came away from Utah feeling I could handle just about anything that walked in through the emergency room door. I also came away from Utah in fantastic physical condition (the altitude makes for a strong cardio-pulmonay system), with many, many lifelong friends and a deep love and appreciation for deep, dry powder snow and Mormons (really).
And then there was Match Day for plastic surgery. Again I snagged my 2nd choice, the University of Cincinnati. I loved the program and training but it was a bit of culture and climate shock for me. I even took up golfing which was about the only outdoor activity available. I learned to love fireflies, the Ohio River, badass thunderstorms, cicadas and the way the humidity turned my naturally wavy hair into a Brillo Pad. I never learned to love Skyline Chile which involves spaghetti noodles and cinnamon.
And now I am living in my home state, Washington in my dream city, Seattle. But I so cherish those years away. They expanded my world view while giving me great surgical training and some interesting ex-boyfriends.
So I hope every fourth year student matches at one of their top ranked programs and some 36 years hence, looks back on their residency program with as much fondness as I do.
Thanks for reading. I would be honored if you followed me on Instagram @sowdermd and @breastimplantsanity. Dr. Lisa Lynn Sowder
This Friday one of my favorite drives on the planet will cease to exist. I know it’s silly to be attached to stretch of asphalt and concrete but I’m going to really, really miss the Alaskan Way Viaduct. For those of you who do not live in the Seattle area, the Viaduct is a big ugly, noisy and dirty double decker monster of a highway that is a blight on Seattle’s waterfront. But when I’m shifting my Minicooper into 5th gear on this monster, I feel like I’m flying through a magical landscape with a bursting young city on one side and a busy and beautiful waterfront on the other. On a clear day I feel like I could roll down the window and reach out to touch the Olympic Mountains to the west. It has the best damn view in Seattle and this view is available to anyone in a car or bus.
But alas, all good things must end, at least that’s the party line. This Friday night, barriers will go up, connections will be made to the deep bore tunnel that took many years to drill, and in a month, the big machines will come in to tear the Viaduct down. Over the next few years, Seattle’s waterfront will explode with new developments and I’m sure it will be awesome but I’m going to miss that big ugly magical asphalt ride.
Tomorrow, after work, I’m going to take one last ride and say goodbye. I’m sure I won’t be the only one.
Thanks for reading and I’d be honored if you followed me on Instagram @sowdermd and @breastimplantsanity. Dr. Lisa Lynn Sowder
Looking for the perfect gift this holiday season? That perfect gift may just be a plastic surgical procedure. Here are a few tips if you are considering this most thoughtful and personal of presents.
Only consider this if your loved one has confided in you that he/she is considering “doing something” or that he/she just wishes that he/she could just “get rid of this ______(fill in the blank)”. Remember, it’s about him/her, not about you.
Make sure the lucky recipient is a good candidate for surgery. Good candidates for surgery are in good heath (physically and mentally) and are in a socially stable place in their life. If in doubt, shoot me an email and I can probably make an educated guess. Do not, I repeat, do not give the gift of liposuction as a substitute for weight loss. Need convincing that doing so is a bad idea? Check out my blogs on obesity.
Make sure that you can afford the surgery! You wouldn’t want to have to back out because of sticker shock. I have a lot of ball park prices posted on my web site. Or feel free to shoot me an email and I can give you a financial idea of how much this could set you back.
Make sure that lucky guy/gal will be able to take enough time off of work and/or household duties to recover. It’s misery to try to get back to work too soon. You want your gift to be a positive experience. I have recovery times listed for most procedures on my web site. Or shoot me an email.
Make sure you have nice package to present. You can’t wrap up a tummy tuck or eyelid lift, but you can wrap up something they might love to wear or use after all the discomfort and bruising is gone. Maybe something sassy fromHanky Pankyfor that mommy makeover patient or a pair of beautiful Firefly earrings for that eyelid lift patient. Or for that dude of yours, how about a nice pair of Ethica boxer briefs You can include one of my practice brochures and a procedure brochure. Oh, I can just hear the shrieks of joy now!
And just think, your gift of plastic surgery will last years, even decades. You and your loved one will be enjoying the benefits much longer than a new car or television or laptop. Do the math. It could end up being a great value as well as a great gift!
HAPPY SHOPPING AND THANKS FOR READING! Dr. Lisa Lynn Sowder
I would be honored if you followed me on Instagram @sowdermd and @breastimplantsanity.
Over the years, I have done a bajillion implant revision cases. This comes with the territory of being in practice many years (27 years and counting as of this blog post!) and also with showing and voicing an interest in revisional surgery. Implant revision is a fact of life. Breast implants are not life time devices and in general what goes in must eventually come out. Here a primer on the vocabulary of breast implant revision. Your surgeon may throw around these terms. Make sure you understand what he/she is saying and ask for clarification if you need to. Here goes:
Capsule: The scar tissue that forms around the implant. This happens with ALL implants. It’s a normal response to a “foreign body”. Yes, breast implants (like all non-biologic implants) are a foreign body.
Capsular contracture: The presence of a tight and often thick and sometimes calcified capsule. This results in a “hard implant”. This is abnormal scarring.
Implant pocket: The space where the implant resides. In cases of submuscular implants, the pocket is between the pectoralis major and the rib cage. In cases of subglandular implants, the pocket is between the breast gland and the pectoralis major. Sometimes a change in the implant pocket is advised for implant revision.
Implant malposition: Implants that are too high, too low, too medial or too lateral. This is most often corrected by modifying the implant pocket.
Bottoming out: A condition that occurs when the implant settles too low and/or is too loose.
Inframammary fold (IMF): The crease under the breast that is densely attached to the chest wall. The IMF tends to go back to where it was before implants after implant removal.
Double bubble: A condition that occurs when the implant falls below the inframammary fold. This is often accompanied by a crease along the lower breast at the level of the native inframammary fold or the edge of the pectoralis muscle.
Waterfall deformity: A condition that occurs when the implant stays put but the breast sags as it ages and falls over the implant.
Synmastia a.k.a. unaboob: Implants that are too close together. This looks really weird and is very, very hard to fix.
The gap: The space over the sternum that separates the breast. Sometimes the patients anatomy will result in a wider gap than she desires. Trying to close the gap can result in really lateral nipples or the dreaded unaboob. See above.
Capsulotomy: Cutting open the layer of scar tissue either to loosen it up or to change the position of the implant. This can sometimes be done with a local anesthetic.
Capsulectomy: Cutting out the capsule. This always requires a general anesthetic. This can be very difficult.
Capsulorrhaphy: Putting stitches into the capsule to either tighten it up and/or to raise the implant. This usually requires a general anesthetic.
En bloc capsulectomy: Removing the implant capsule with the implant without opening the capsule. This is the preferred method for removing a ruptured silicone gel implant. This is not always technically possible.
Acellular dermal matrix (ADM) and surgical mesh: A sheet of collagen or other substance that controls position of the implant and may prevent recurrent capsular contracture. Alloderm and Strattice are two of the ADMs I have used. I have also used Seri surgical mesh. Think of these as an internal bra, a very, very expensive internal bra.
Perfect symmetry: Not possible but we try.
Touch-up: This term best used when referring to make-up application. I try to avoid this term when it comes to breast implants. It implies that it’s easy and it’s never easy.
Revision: This term best used when referring to repeat surgery on a breast with an implant.
So there you have it. Now you can translate what your surgeon has told you needs to be done. And again, if you don’t understand make him/her go over it again until you do understand. Tell them Dr. Sowder told you to do so. Thanks for reading and I would be honored if you followed me on Instagram @sowdermd and @breastimplantsanity.
Recently I received this email from a former breast implant illness patient. I am sharing it with her permission but she has asked me to protect her identity. I will call her Celeste because I love that name. I have made no changes except for correcting a few typos.
Celeste: I read your blog post on breast implant illness and it literally brought tears to my eyes. Tears of joy!!!! Back up three or four years ago when my life was in shambles – emotionally abusive husband, stressed out to the max at work, sex hormones had crashed, possible thyroid issue…..but yet my family physician said I was fine according to my lab tests. I wasn’t able to see what my ex husband and stress were doing to my body at the time and so I was bound and determined to find an answer. Then I found it – the BII group on Facebook. I had found my answer so I thought. Went through the surgery and wow none of my symptoms got better! It wasn’t until my divorce was final and I was able to relax and started taking a low dose thyroid medicine and got my estrogen back to a normal level that I started to feel normal again. Long story short, I miss my implants like crazy and want them back. I’m soooooo happy to see a plastic surgeon standing behind her beliefs! I totally think it wasn’t my implants at all and more stress and hormone related. I guess I’m going to be the first trial case to see what happens. lol. Thanks for the blog. I really enjoyed it.
Me: I am very glad you are feeling better after getting your life in order and getting good medical care. Sorry about your implants, though. Have you shared your experience with the Facebook group? I am just curious.
Celeste: Hahahah. To spare myself the verbal attacking that would come with it, I have not. All of my friends have implants – a good mixture of saline and silicone, and none of them have issues. I even have one older friend who has had her saline implants for 20+ years to the point one ruptured and still no issues. I don’t want to fight with 18,000+ desperate women who are looking for an answer to their issues when in reality it is probably what you said, the general human condition and life itself. My mom has a lot of allergies and it is possible that my body reacted to my silicone implants (second set), but it took several years for me to feel bad. So, doubtful in my opinion. I had my saline implants for six years with no issues. The issues of general fatigue were once again a result of stress and being on birth control most likely. When I got my silicone implants I went off birth control and my stress was at an all time high. Perfect storm imo. But we shall see what happens. I’m torn on what to get again. I loved how my silicone looked and felt, but still have a slight fear that maybe just maybe it was my body reacting to the silicone (doubtful)……
I’m sure that group has attacked you. It’s like the blind leading the blind and defintely a herd mentality. I can’t bash them too much because three years ago I was one of them – desperate for an answer……and I’m a research scientist, so no dummy either ….. I was just that desperate to feel better.
Me: Is there any advice you would give women who like their implants but think they have breast implant illness?
Celeste: Oh geez this is a hard one. There is so much misinformation out there that if it seems pretty far fetched, it probably is.
I lived with my symptoms for years and even had my best friend, who is also my family physician, tell me that I was super stressed and THAT was my problem. The funny thing I have learned about stress in our society is that it starts out small and slow and that becomes the new normal. Then a little more stress gets added on, then that is the new normal. The cycle continues to repeat itself until something or someone stops it. In my case I got my second set of implants (silicone), stopped birth control causing my hormones to crash because I was basically dependent on it, major stress in my marriage, and I was studying for my board exams. And I was the silly one sitting in my doctor’s office telling her that I wasn’t stressed, but yet I couldn’t sleep, felt tired and heavy all the time, my weight was increasing quickly, etc. I went on like this for six years! I’m a little stubborn, ha! Removing my implants helped momentarily because allI could do was sit around and relax. That should’ve been my huge red flag. But nope, I missed it, lol. It wasn’t until just recently that all the pieces started coming together. My hormones are finally at normal levels, my stress is down, my divorce was final two weeks ago. I am finally relaxing and it feels good! I’m still going to the gym and doing strenuous weight lifting and from time to time when I don’t get enough sleep because I’m enjoying life too much and burning the candle at both ends, guess what????? My symptoms start to come back!
For me I’m skeptical that the millions of women that have implants are walking around like zombies (basically what I felt like). I was barely functioning – getting out of bed was difficult, but I didn’t want to lose my job so every morning was a struggle and a pep talk to do it one more day. And what about all the celebrities that have butt implants, chin implants, cheek implants, pec implants (men) – all silicone. I suppose one could argue that those are different than breast implants in chemical consistency, but why aren’t they feeling awful???? I’m more of a believer of an inflammatory response to implants that are too big for the body and overtime the body starts to reject them. My last set were DD and way too big imo. I’m naturally an A, so that is a big difference. And what about all the women in the bikini industry – models and competitors??? They are fine. I’m not saying breast implants are 100% safe, but causing issues almost a decade later is something that I’m not too sure on. My implants came out looking brand new with a thin capsule and no other issues. It is interesting though, the doc that took mine out says he’s seen some stuff that he just can’t explain and the lab can’t identify what it is……so maybe there is truth to it????
With all that being said, I think my biggest piece of advise is know that the mind is very powerful and when you are desperate for an answer, almost anything can be made to fit the given scenario. I wasn’t able to take a step back and evaluate my life and see that the problems I was having were self inflicted. Stress, abuse, lack of sleep, etc. had nothing to do with my implants. After years of living like this, my body was burned out and literally quitting on me. What it needed was lots of TLC! I’m still happy I got my implants removed. That set was too big, but I wish I would’ve swapped them out for a smaller set like my first set of implants. At this point I do miss my implants enough that I’m willing to risk that I’m completely wrong about all this and get implants again……..
So there you have it. Another side of the breast implant illness conundrum.
Thanks for reading and I would be honored if you followed me on Instagram @breastimplantsanity and @sowdermd. Dr. Lisa Lynn Sowder
In a previous blog post bemoaning the difficulty of good follow-up in clinical research I sort of place most of the blame on patients who blow off the follow-up once they have their desired implants. This was my experience with the implant study I participated in many years ago. I had an 80% follow-up at 5 years (which was really, really high) mostly because I pestered patients relentlessly to come back for their follow-up exams. I have taken a bit of flack (especially from the breast implant illness activists) for my blame-the-patient stance but now there is a recent study out that supports my politically incorrect opinion. Check this out. It seems if you pay the patient big bucks to show up they do! This study has an astounding 94.9% and 96.7% follow-up compliance at 5 years. The study has another 5 years to go and my guess is that given the size of the monetary award, those numbers will also be very high.
“Maybe I will show up for my follow-up.”
Novel Approach for Maximizing Follow-Up in Cosmetic Surgery Clinical Trials: The Ideal Implant Core Trial Experience
Mueller, Melissa A. M.D.; Nichter, Larry S. M.D.; Hamas, Robert S. M.D.
Background: High follow-up rates are critical for robust research with minimal bias, and are particularly important for breast implant Core Studies seeking U.S. Food and Drug Administration approval. The Core Study for IDEAL IMPLANT, the most recently U.S. Food and Drug Administration–approved breast implant, used a novel incentive payment model to achieve higher follow-up rates than in previous breast implant trials.
Methods: At enrollment, $3500 was deposited into an independent, irrevocable trust for each of the 502 subjects and invested in a diversified portfolio. If a follow-up visit is missed, the subject is exited from the study and compensated for completed visits, but the remainder of her share of the funds stay in the trust. At the conclusion of the 10-year study, the trust will be divided among those subjects who completed all required follow-up visits. For primary and revision augmentation cohorts, the U.S. Food and Drug Administration published follow-up rates from Core Studies were compared for all currently available breast implants.
Results: Five-year follow-up rates for the IDEAL IMPLANT Core Study are higher for both primary augmentation and revision augmentation cohorts (94.9 percent and 96.7 percent, respectively) when compared to all other trials that have used U.S. Food and Drug Administration standardized follow-up reporting (MemoryShape, Allergan 410, and Sientra Core Studies).
Conclusions: This trial demonstrates the utility of a novel incentive strategy to maximize follow-up in cosmetic surgery patients. This strategy may benefit future cosmetic surgery trials and perhaps any prospective research trial by providing more complete data.
CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, IV.
Hey, thanks for reading and I really thank Drs. Mueller, Nichter and Hamas for this awesome article. And my hat is really off to Dr. Robert Hamas who not only thought up the idea of the Ideal implant but actually brought it to market. And Ideal only sells its implants to surgeons certified by the American Board of Plastic Surgery. That means if your surgeon is using an Ideal implant, he/she is actually a real honest to goodness plastic surgeon, not just poseur.
And I would be honored if you followed me on Instagram @sowdermd and @breastimplantsanity. Dr. Lisa Lynn Sowder