In a not unexpected conclusion, yesterday the United States Food & Drug Administration re-affirmed their 2006 decision to reintroduce silicone gel breast implants into the United States market for cosmetic indications. In statements from the FDA, they explained that no new information has arisen to question the safety or efficacy of the devices for intended use. As has been discussed on Plastic Surgery 101 a number of times, this is not really news and has been accepted world-wide for a number of years now. Hopefully this statement from FDA heralds the availability of the new form stable "gummy bear" silicone implants here in the United States which have been available everywhere else for almost 15+ years.
Breast augmentation remains the most popular cosmetic surgery in the U.S., with nearly 300,000 women undergoing it last year. According to the American Society of Plastic Surgeons (ASPS), more than 70,000 others received implants for breast reconstruction.

The most disappointing finding was that only ~60% percent of women enrolled in a 1,000-patient study of one manufacturers implants are still accounted for after eight years. A larger study of 40,000 women conducted has lost nearly 80 percent of its patients after just three years. Diana Zuckerman of the National Research Center for Women and Families, one of the most prominent (and persistent) anti-implant activists, cried foul and suggested that most medical journals would not publish the studies cited by the FDA because of the missing data. I'd agree with her, but for different reasons. She's implying safety issues exist (which they don't by and large), while I'm more interested in outcome data to understand how to reduce re-operations.

Why the relatively poor follow up in the FDA trials?

Dr. Phillip Haeck, president of the American Society of Plastic Surgeons (ASPS)sums it up saying that, "When women are happy with their implants they tend to feel that a regular follow-up is pointless - it becomes a nuisance and an unnecessary expense". I'd agree 100% with that.

It also begs the question of what exactly are we trying to demonstrate with the FDA follow up studies. There is overwhelming world-wide information that suggests safety at this point. It would be nice to have a little more data on longevity so as to better counsel patients on when to consider routine exchange with prior devices, but as we're on the cusp of a major design change in the polymers that make the implant almost impossible to rupture (the "gummy bear" form stable devices) we're going to quickly lose interest in exhaustively studying older devices. This kind of technology advance has always created problems about making conclusions with medical devices, as you end up comparing apples to implants :) (bad pun alert).

Rob

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Sorry for the long break! We've been busy designing our practice's new web site. It's gonna POP! Stay Tuned.

This post is kind of an "inside baseball" topic about what surgeons look at when we judge our own or others work. One thing I fixate on more and more with cosmetic breast surgery is the position of the inframammary fold (IMF). The IMF (in layman's terms) is an anatomic landmark created by adherence of connective tissue to the chest wall. It defines the inferior border of the anatomic breast, and it's location makes it the most popular place for an incision to place breast implants via the "inframammary" approach.

One of the things I look for in someone I've operated on or whom comes in for revision surgery by another provider is where a prior inframammary scar is. If the scar is stable and in the position it was originally made in then I'm satisfied the surgical dissection was performed well. If the scar is now residing up on the skin of the lower breast, that suggests over release of the native IMF during prior surgery. Once violated, that anatomic border is hard to reliably recreate. Just a little extra attention during surgery can prevent a lot of issues down the road as it relates to this.

Rob

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The New York Times had a story last week (see here) on how expensive orthopedic implants for knees and hips were to replace when they failed. As the cost of the devices themselves (without hospital or physician charges) can run north of $15,000, it can be more then $50K on the price tag when these patients require re-operation for premature failure. Highlighted in the story was the fact that the manufacturers did not expressly provide a warranty for replacement costs of their implants.

Much like these orthopedic devices, patients with breast implants can expect their devices to have to be replaced at some point in their life, either thru device failure or for aesthetic revision issues as their body changes. In contradistinction to the orthopedic companies, both Allergan and Mentor Corp. (whom combined sell 99% of all breast implants in the United States) have offered lifetime replacements on their failed devices for several years now. Allergan in particular has been admirable, as the parent company that makes the implants has been sold twice from it's roots as McGhan medical (later Inamed Corp.). As both Allergan and Johnson & Johnson (owner of Mentor Corp. since 2009) are huge multinationals, it would seem patients with these implants should have a good deal of security of their devices fail for replacement of their implants.

These implant companies do not however cover all other costs associated with the replacement of the devices, but have come up with a fairly generous standard program matched by both Mentor & Allergan

• 10 years of guaranteed financial assistance
• Up to $1200 in out-of-pocket expenses for surgical fees, operating room and anesthesia expenses not covered by insurance
• Silicone filled and saline filled breast implants are both covered
• Lifetime product replacement
• Automatic enrollment at the time of your original surgery

Now as a breast implant is relative expensive to design and test clinically, but inexpensive to manufacture by the unit, it's easy to see how these companies can absorb the cost. I don't know exactly their margin per device, but I think it's $600-700+ per silicone implant they sell.

Rob

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A really, really tacky billboard campaign in rural Wisconsin by a wannabe made me immediately think to quote the Will Ferrel character, Ron Burgundy, from the movie "Anchorman",


"Stay classy, Wisconsin!"








Tasteful advertising! Does it surprise anyone that this Doctor promoting plastic surgery is not actually a Plastic Surgeon? Well at least he's a surgeon which is not the case with all these cases. Of note, this yahoo was recently fined (see here) closed to $20,000 for Medicare billing fraud.


Remember to always look for a board-certified Plastic Surgeon when you're considering cosmetic surgery. You can inquire here on the American Board of Plastic Surgery website.

Rob

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As the plastic surgeons of the United States await approval of Allergan's style 410 breast implant (aka "the gummy bear" implant), I frequently get questions from patients about when this device will be approved.

The short answer is "I don't know!"

The approval of medical devices of all sorts has been heavily politicized. After a number of recent high profile issues with prescription drugs, cardiac pacemakers, and vascular stents (devices used to prop open clogged blood vessels or fix aneurysms), the FDA is under the microscope. Caught up in all this is the fate of the next generation of breast implant devices, for which the FDA has been sitting on the manufacturers approval applications for nearly 3 years.

For some context, "form stable" implants like Allergan's 410 have been used clinically around the world for over 15 years. In clinical trials (like this)they have an unparalleled safety record for this kind of medical device, and offer both superior durability and a reduction in every single kind of indexed complication (pain, capsular contracture, rippling, rupture, etc...) after cosmetic and reconstructive breast surgery that we observe and track.

Allergan's Style 410 implant:


The NY Times reported earlier in April (here)on the ongoing reexamination of "legacy" devices that were exempted prior to the late 1970's from review as they were already being used. Silicone and saline breast implants actually already went through this review by the FDA in the early 1990's and eventually emerged with a clean bill of health. The only reason the newer implants have to go thru this process at all is the higher cohesiveness of the silicone polymer exceeds some artificial cut-off that would make them fall under the existing approval. This illogical rationale has cost tens of millions of dollars to companies and delayed patients access to improved devices.

As to the fate of the 410 implant, my understanding is that the FDA is satisfied with the safety and clinical efficacy of the implants and is negotiating on the final labeling to be included with the product. Apparently, surgeons will be required to attend an instructional course prior to being given access to the device (even someone like me who actually used these devices as a resident and fellow during clinical trials). We are hopeful that the ongoing activity signals approval is immanent this quarter!


Rob

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From NBC comes this story:

"Yvonne Jean Pampellonne, 30, allegedly used a fraudulent identity to pay for liposuction and a breast implant exchange, according to the Huntington Beach Police Department. The total cost of the surgeries is valued at more than $12,000.

The Laguna Niguel woman is accused of opening a line of credit in someone else's name in September 2008, having the procedures and then never showing up for any follow-up appointments, police said."

The plastic surgeon who'd been defrauded for cost of the procedure apparently didn't take this lying down. They hadn't yet disposed of the patients old breast implants (which were exchanged during the procedure) when the fraud was discovered. They used the serial number imprinted on the old implants to track her down to her previous surgeon's office, and identified her via photos from the other office. I love it!

If you would like to "friend" Ms. Pampallone on MySpace, her profile can be found here. Apparently Ms. Pampallone was unfamiliar with myfreeimplants.com as she might have saved herself a multiple felony convictions.

Rob

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Just like when your wife or girlfriend asks "Do I look fat in this?", it is surely the deadliest of traps when a cosmetic surgery patient asks you the open-ended "What do YOU think I need done?". Most Plastic Surgeons know not to take the bait with this question, but rather tease more out of the patient about what is concerning them.

A careless phrase or suggestion can produce both anger and anguish to a patient. I still think I'm getting pain from a voodoo doll for my inadvertent pointing out a "witch's chin" deformity to a patient (Long story, read here to get up to speed).

Vanity Fair magazine put this to the test when they had a writer go "undercover" on three consults for cosmetic surgery. (The article can be viewed here). One with a Manhattan Plastic Surgeon (whom I've actually heard of), one with an ENT trained "cosmetic surgeon" (who notably was sanctioned for defrauding Medicare in 2003 - Don't these people use Google?), and one osteopathic (a DO as opposed to an MD degree) surgeon who'd trained in an osteopathic plastic surgery residency.

Note: There is really nothing about Plastic Surgery as a discipline that is related to osteopathic tenants. As the mystical snake-oil aspects of osteopathic medicine, like manipulation, have largely been shed from their curriculum, a DO and MD education is now practically similar. As there are only a handful of DO plastic surgery programs, I'm assuming this guy would have been an intelligent guy and good resident to get a position. End of editorial!

The writer's first consult was with the Plastic Surgeon, who came off really, really, really cheesy.

"Now the doctor and I stand in front of the floor-length mirror while he deconstructs the “before” me. “As a Caucasian woman, you probably—if you were doing lipo—would want this brought down,” he says, pointing to my “banana rolls”—his clever name for the part of my rear end that peeks from beneath my underwear lining. “And again, you know, in jeans, to most people … on white women, you guys like to get this down. And we like to see it down.” I gulp, realizing that I’ll never be able to eat my favorite fruit again without thinking of my own ass....

Back in the Upper East Side exam room, Dr. R******* pinches me from shoulders to knees before concluding: “You look absolutely nice, but, even if I were a blind guy and put my hands here”—he seizes my sides—“there are little lumps. This could be brought down just to give you a little bit better of a curve.” These lumps, I learn, are my “waist wads.” To his credit, Dr. R******* does note that my “waist wads” are “borderline.” But, he says, “I’ve done supermodels with much less than this. To them it was important. To each his own.”

He prefaces his conclusion with a hypothetical scenario: “I think if I were a single plastic surgeon, which I’m not, riding around in my Corvette, which I don’t, my license plate would read full c. O.K.? That would be my license plate. So that’s what I would think, in general, is the Promised Land of Breasts for most people.”

OMFG. Is this guy for real? I'll give him the benefit of the doubt that some of his comments were selectively edited, but I cannot imagine most of his peers would consider that language and tone very professional. Pushing services, as opposed to passive advice, is not how most experienced surgeons would teach their residents to act. I know we weren't. There was a well known surgeon in Louisville who was notorious for telling women at social events that that they needed a face lift. The funny thing was that on a number of occasions this surgeon had actually already done a face lift on that patient and just failed to recognize both the patient and his work. Open mouth, insert foot!

The other two consults described were actually much tamer and more professional IMO except for the part where the ENT's office manager offers to show off her implants to the prospective client. Chez tacky! Props to young Dr. Joseph A. Racanelli D.O., who despite being the least experienced, gave the most appropriate response to the honey trap offered by Vanity Fair.

Rob

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One thing that patients frequently ask about when considering undergoing breast augmentation is how much pain and discomfort they'll experience. I think in general, the pain is directly correlated to the surgical technique.

If you could find a video of breast augmentation circa 1975, you'd see a set of instruments like this used:

Those hockey-stick shaped devices are called "Dingman breast dissectors" (after Dr. Reed Dingman, former chief of plastic surgery at Michigan in the 1960's-70's). Basically, they're a lever to mechanically dissect a pocket to place an breast implant into. Breast augmentation in that era consisted of making an incision, shoving one of these instruments in, tearing a pocket out bluntly, and holding pressure until the patient quit bleeding. Sounds great, huh?

Blood around an implant, as we know, is a potent stimulator of capsular contraction, and techniques like this combined with silicone implants of that era probably precipitated many (with a capital M) cases of hardening breast. There is no way to predictably minimize bleeding with blunt dissection, and it should be largely avoided in breast augmentation except when gently refining a previously dissected pocket.

Believe it or not, there are still some surgeons who use that kind of technique when they place implants thru the armpit (transaxillary approach) and belly button ("TUBA" technique). Evidence based medicine and the refinements in surgical techniques described by surgeons like John Tebbetts, Pat Maxwell, and others have clearly shown us ways to get better results, with less bleeding, less inflammation, and softer breasts over the long term.

The key to safe and excellent plastic surgery is precision and planning. As the apocryphal "7 P's" quote from the British military goes:
"Prior Planning and Preparation Prevents Piss Poor Performance". This is particularly true as it relates to long term outcomes from breast augmentation surgery.

Anyway......

The take home message is that more atraumatic technique produces less pain and controlled dissection of the space for the implant under direct vision increases precision and decreases bleeding. We're getting to the point where there are few technical steps to be discovered that will decrease pain much more. Most of available improvement involves intercostal nerve blocks with local anesthetics (which last 6-8 hours), disposable external pulsed electromagnetic field generators (PEMF) (like those made by Ivivi or ActiPatch), or indwelling pain pumps which trickle a local anesthetic in the breast pocket for 2-3 days. They all work, but have limitations due to duration (nerve blocks), external device requirements and costs(PEMF), or potential contamination of the implant from the skin (pain pumps).

I'm currently involved in some phase III FDA trials with breast augmentation on a long-acting local anesthetic that may solve all these problems. It involves bonding a local anesthetic to a fatty lipid molecule which serves to make a very effective sustained release drug. Where normally this drug (marcaine) might last 6-8 hours, when bound to this carrier molecule it lasts up to 3 days.

That is a game changer in post operative pain control IMO. It gives both proven efficacy with long action and no external devices/catheters to pay for. Our most recent patients we've done have have used nothing but tylenol for post-op for pain control, which is pretty amazing for sub-muscular implants.



Study Recruitment for Depo-bupivicaine FDA clinical trial:

Rob

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There are several distinct types of ways we classify breast implants.

• silicone or saline filled


• round or anatomic shaped


• smooth surfaced or textured

For the material and shape issues, there clearly are performance characteristics that differ. As to the issue of the implant shell surface, it gets a little more confusing.

The routine use of rough or textured surfaces on breast implants in the prevention of capsular contracture has been debated for nearly 20 years.
In the early 1980's we first read in the literature that the surface texture of an implant is an important variable in determining the soft-tissue response to an implant's capsule surface and experiments suggested that texturing resulted in tissue ingrowth and adherence to the implant surface.

These observations were first made with polyurethane-coated breast implants which had rough surfaces and almost no observed capsular contractures in patients with breast implants. Texturing was then quickly translated to contemporary silastic (silicone rubber) covered implants, but whether or not the same effect was maintained has been a little murky.

If (a big if) there's a protective effect from texturing, the best data I've seen suggests that it's gone as you get closer to a decade out during surgery. If I had to guess why that's so, I'd say that reflects the ruptures starting to show up in those 4th generation implants at a decade out.

It's kind of interesting to see the split between the United States and the rest of the world on this issue. Our singular experience with saline implants from 1990-2006 led many surgeons to abandon textured implants for smooth round devices as they're less likely to show visible wrinkles or ripples thru the skin. The "velcro-like" effect of the implant on it's surrounding tissue causes these ripples when the implant shifts. The rest of the world has a strong preference for textured devices as they never went through dealing with the limitations of saline implants. Philosophically, those doctors made the decision that they're willing to accept more rippling as a trade off for (possibly) less capsular contracture (implant hardening).

I personally am kind of ambivalent on this. Being an American-trained surgeon, I saw mostly round smooth implants placed partially under the pectoralis muscle during my residency. Over time, I've come to believe there's a role for "subfascial" implant techniques(over the muscle, but under the muscle fascia) with smooth implants. Looking ahead, I think we're poised to see a lot of plastic surgeons getting reacquainted with textured implants with the new shaped "gummy bear" implants which are all textured to help prevent rotation of the implant in the body.

Rob

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One of the peculiarities of the USFDA process during silicone implant reintroduction in 2006 was the labeling on the devices recommending routine MRI surveillance of implants for rupture. When you step back and look at the proceedings and "unique" American history with breast implants, you can see that this was more a political concession to the anti-implant activist lobby then evidence-based medicine.

The FDA labeling currently suggests MRI's at 3 years post op and then every 2 years subsequently. It will be interesting with the coming form stable "gummy bear" implants whether or not this recomendation is still maintained.



Why 3 years for the first MRI?

That was the first data point with any ruptures reported in the FDA data during clinical trials. While there will be a certain failure rate associated with any manufactured device, it's likely that early failures of silicone devices were from missed trauma to the implant during insertion. Education courses on proper techniques for implant handling and insertion in recent years have emphasized ways to minimize this risk by suggesting larger incisions for gentler introduction and better visualization during closure.


But does it make sense to do this?

Clearly it does not. On this point, there's pretty much international agreement (USFDA excepted).

We've actually got a pretty good handle on rupture rates of 4th generation implants (conventional devices used for the last 15 years or so) up thru a decade, where it's pegged around 6-8% at 10 years based in two pretty solid studies on single devices by the two major implant makers Mentor & Allergan. If you take that and work backwards from the FDA recommendation, you're doing up to 4 MRI's during the first decade where the rupture rate is either almost nonexistent (years 3-7) or in the low single digits (year 9).



Whether you're screening an asymptomatic population for ruptured implants, colon cancer, breast cancer, or aortic aneurysms there's trade offs between costs and risk reduction. For tests to be effective for screening, they must satisfy both criteria. For a number of cancers, screening tests often fail this goal.

Take screening mammograms or breast self-exams for instance to detect breast cancer. In non-selected groups of women, both cancer detection modalities increase both cost and morbidity from unnecessary procedures without materially affecting death rates from breast cancer (arguably the whole point of screening). It's been persuasively argued when reviewing the data, that screening mammograms can be deferred to age 50 for low risk women (as opposed to the current recommendation for age 40) and perhaps discontinued altogether for women in their 70's with no affect whatsoever on breast cancer death rates. BTW, this same pattern of "dodgy logic" of routine screening also exists in regards to male prostate cancer and lung cancer screening in smokers.

Anyway, back to implants......

At the end of the day it's just hard to support screening implants for rupture in asymptomatic patients on either a cost basis or benefit basis. As it's been established that ruptured silicone implants (silent or otherwise) do not appear to correlate with systemic illness, the clear benefit of screening asymptomatic women is hard to establish. A team of doctor's from the world famous Sloan-Kettering Memorial Cancer Center agreed with this sentiment in a recent paper, Silicone Breast Implants and Magnetic Resonance Imaging Screening for Rupture: Do U.S. Food and Drug Administration Recommendations Reflect an Evidence-Based Practice Approach to Patient Care?


Rob

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* Image at right spoofed from The Onion

One of the most serious claims in the class action lawsuits against Dow Corning Corp. during the "silicone crisis" involving breast implants in the late 1980's was that silicone breast implants caused breast cancer and/or delays in diagnosis of breast cancer. Despite there being no evidence for it actually happening, these were reasonable questions to ask. Over the last 20 years, we've been flooded with data that has been reassuring on these issues.

Implants do make conventional mammograms harder to interpret by their "shadow", but the increased ease of doing manual exams by having the implant to push against to feel lesions compensates a great degree. An MRI mammogram can be used to supplement mammograms when needed for better imaging for screening.

One of the more interesting findings in several of the large series of women with implants was the observation of significantly lower (almost 40%) rates of breast cancer in the implant group versus a control population of women without implants. The intuitive reason for this has been that these women with implants were a self-selected (rather then "randomly selected") group who were likely to be healthier and have less breast tissue, which both should lowered their expected rates.

To really sort out a true "expected rate" for breast cancer, you'd have to do some herculean effort of better characterizing the individual risks with a tool like one of the "Gail Model's" of the study participants, which is almost impossible in such large trials. The suggestion that the presence of implants themselves was protective wasn't really taken seriously. There could however, be something that makes us look at this issue a little closer.

I came across a pre-publication in the journal Aesthetic Plastic Surgery entitled, "Breast Implants as a Preventive Factor" describing the differential temperature seen on thermography (a imaging technique that shows temperature) from experimental rats with silicone implants placed and the resultant affect that had on local circulating hormone levels and cellular abnormalities (both of which were decreased in the implant group). Now this was only an animal model mind you, but it immediately occurred to me that maybe part of that effect we were seeing was from this phenomena. Interesting stuff!

rob

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Little did Duke University plastic surgeon, Dr. Michael Zenn, know what he was in for in a recent Q&A guest appearance in the Freakonomics Blog column in the New York Times. Out of about 20 questions on a range of subjects he responded to, he made the "mistake" of accurately discussing a single innocuous question about breast implants.

Q: Would you endorse cohesive gel instead of silicone due to the concern over safety issues of silicone? Or do you believe that was all just hoopla? Is it true that breast implants should be redone every 5 to 10 years?

A: Today’s breast implant options are saline or silicone. Saline implants are a silicone shell filled with salt water, silicone implants are a silicone shell filled with cohesive gel. Both implants are equally safe, both have the same safety profile.
The Institute of Medicine found that much of the concerns were hoopla — except for the problems that they both have: rupture, scarring, and infection. Most plastic surgeons and patients will tell you silicone just feels better. Implants are replaced when one of the above problems occurs

Skip down to the comments section and you'd think he was advocating beating your wife as nearly 5 out of every 6 comments are by breast implant "survivors" wailing alternately on his intelligence, character, and ethics. Ah, the wonders of the Internet to organize like-minded partisans into rapid response teams!

Much like the autism vaccine conspiracy theorists, the breast implant siliconistas come off looking out of touch with such reflexive outrage on command, particularly when you recognize the kind of heavy duty microsurgical and reconstructive surgery practice that Dr. Zenn is known for at Duke. He's one of the good guys for Pete's sake!

There's intelligent reasons to object to breast augmentation surgery, but claiming it caused symptom or disease "X,Y,Z...." is a dead horse that's been buried several times over! For a refresher see here and here to recap the comprehensive 2007 landmark review.

Rob

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Computer game publisher Funcom had to do some fixing of their popular online mulitplayer game when apparently a recent update of the game's software code left the female characters suddenly "breast deficient".

The MMORPG Age of Conan: Hyborian Adventures features partially nude female character models. Based on the original stories by Robert E. Howard and brought to the big screen in 1982 by Gov. Arnold Schwarzenegger, the game takes place in the fantasy world of Hyboria, which combines fantasy elements with strong sexuality.

This issue has caused controversy all over nerd-dom with hundreds of messages left by players demanding Funcom bring their boobs back. Seen below is a pair of images whose player felt like they'd had a mastectomy.

"Funcom can confirm that some of the female models in the game have had the size of their breasts changed. This is due to an unintended change in data that was introduced in an earlier patch, data which controls the so-called morph values associated with character models and the size of their respective body parts. We are working on a fix for this and your breasts should be back to normal soon. The plastic surgeons of Hyboria apologize for the inconvenience."

Well at least they have a sense of humor about it!

Rob

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I like to say that unlike most blogs by plastic surgeons, Plastic Surgery 101 really isn't about me, but today's post is actually about me.

I was asked by the editor of Plastic Surgery Products (PSP) magazine, an industry trade journal, to come up with something interesting to write about for his magazine. One of the questions that I'm always thinking about is "What are the things we do that really cause long term problems and how can I avoid that?".

Spending time as a fellow working with the world's best re-operative breast surgeon (for my money), Nashville's Dr. Pat Maxwell, really gave me a different kind of respect for some of the long term sequalla we can produce with cosmetic and reconstructive breast surgeries. There's a famous quote (attributed to former Houston Oilers coach Bum Phillips) about Alabama football coach Paul "Bear" Bryant, that he could "Take his'n and beat your'n, and then take your'n and beat his'n.". Well Pat could do the same with some of the most unfavorable or difficult to treat scenarios in breast surgery that you can imagine.

Anyway, I've kind of gotten an interest in this kind of patient and put some of my understanding and thinking on these issues down for PSP in an article entitled "Solid Strategies in Revisional Breast Surgery" which you can read here.

Thanks to editor Jeff Frentzen for the opportunity to contribute, however Jeff, I'm going to demand the cover story next time :)

Ok now back to posts definately "not about me".

Rob

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If it wasn't so predictable it would be funny.

Newsweek magazine ran a vanilla story about breast implants called "Chest Right" which was an overview safety/educational guide for laypeople on some issues re. breast augmentation surgery. It's a very conservative piece and touches on a few important factors like choosing a qualified surgeon, complications, follow up, silicone vs. saline devices, etc.... It quotes the presidents of the two major Plastic Surgery organizations and one of the more well-known female Plastic Surgeons, all of whom are reputable and all of whom have extensive track records of championing patient safety issues. In summary, a very mainstream and respectful treatment of the issue.

Skip to the reader comments however, and you see breathless condemnation of the story by a number of the crusaders that populate the handful of web bulletin boards promoting the idea that a giant medical-industrial conspiracy exists to hide the truth from unsuspecting women about links of implants to every known medical condition and psychiatric disorder known to man. Readers of Plastic Surgery 101 know that there is pretty overwhelming international consensus that breast implants have been vindicated over and over in this regard in the medical literature (read here).

Now implants have their own issues, namely capsular contracture and surveillance for rupture, but we appear poised to make signifigant progress on these issues with the 5th generation form stable silicone implants seemingly poised for approval. Both the major manufacturers, Allergan & Mentor, have arranged for inservices this spring for their product reps on these devices. To me this suggests they've already heard thru the back channels that FDA approval is imminent and are getting ready for a new marketing push. You'd think with the improved performance data on these devices, the people upset over existing implants would be encouraging the FDA to act. On the contrary they're determined to push the FDA to rescind access to all breast implant devices (silicone and saline).

Rob

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Sorry for no posts since last week, but I've just returned back from the 2008 Atlanta Breast Symposium. Like I mentioned last year, Atlanta is kind of the "spiritual home" for plastic surgery of the breast in America, and this meeting is kind of the premier forum for discussing issues re. to breast surgery.

Lots of things buzzing around my head which I'll be writing about soon!

Expect forthcoming writings on:

• fat grafting of the breast
• controversies in breast reconstruction
• technical and safety advances
• the pending approval of form-stable "gummy bear" implants

Cheers!

Rob

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Today's entry is kind of an "inside baseball" thought that occured to me reading an article on medicine.

There was a breathless article on the news wire "Participants Left Uninformed in Some Halted Medical Trials" (syndicated from a New York Times story) earlier this week about the fate of patients who were enrolled in clinical trials for devices or drugs that had been discontinued. In many instances these patients (and occasionally their doctor) were apparently unaware of this fact. They used two medical devices as examples - vascular stents used to treat aortic aneurysms and a type of breast implant used in cancer reconstruction.

The stents are a potential big problem in that if they don't perform as designed, the patient will die. The breast implant patients (two women in south Florida) seem to be having much less an urgent issue. From the thumbnail description it sounds like the women were having some degree of capsule pain, which is not terribly uncommon especially in breast reconstruction patients who've been radiated. Capsular contracture is also the way some silicone implant ruptures present.

Implied in the NYT article is the implication that these women are "sitting on a time bomb" with their implants which is really silly and makes the juxtaposition from the stents scenario kind of ridiculous. In this instance, I'm not sure you'd do anything at all different for these women other then checking for rupture. No one would recomend "prophylactic" removal of those implants in the abscence of documented rupture, particularly if the implants were less then 10 years old. We have plenty of information about the treatment of silicone breast implant ruptures, and it's well established that the problems you get are local issues to the chest wall. A capsular contracture or ruptured implant is it's own issue, but to hold it up next to potential life-threatening device failures misses the real serious problems with medical devices and their surveillance.

They don't really go into much detail other then identifying the implant manufacturer, Allergan, and that the particular implant had been discontinued recently (~2005). If I had to guess, it's probably the Inamed "Style 153" implant these women had, which was an anatomically shaped silicone gel device that preceded the more advanced Style 410 "gummy bear" implants. Those implants, which were voluntarily pulled from the market by the manufacturer during their approval process negotiations with FDA for their conventional type of silicone gel breast implants.

The style 153 implant had an innovative "double lumen" core that had an apparent higher failure rate when you studied them on MRI scans (the best test for rupture). Confusing the issue is the resemblance of the double shell for some of the described signs of intracapsular implant rupture which is well described in this full text American Journal of Radiology article. There are a great many surgeons who strongly believe MRI's (or at least the radiologists reading them) have a tendency to over-estimate ruptures, particularly with this specific implant. At the end of the day Inamed made the decision in 2005 to "cut bait" on such a minor product to better their chances of FDA approval for their other products. The style 153 was a good implant for it's time, but it really was just a transitional model to the form-stable devices like the 410.


* Below is an MRI showing the characteristic "double lumen" sign confused for rupture occasionally with style 153 device

Rob

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The November issue of the journal, Annals of Plastic Surgery, features an up to date comprehensive review article on the state of research involving issues of safety surrounding silicone gel breast implants. Researchers from the Vanderbilt University Medical School-Ingram Cancer Center review several hundred related studies to produce this magnum opus. A story interview the lead researchers can be read on the Vandy News Service here.

This "snapshot" is the most thorough review of this topic since the landmark 1999 Institute of Medicine report and addresses the ongoing epidemiology studies thru the Fall of 2007. The body of literature continues to be remarkably consistent in that the weight of the epidemiological evidence does not support a causal association between breast implants and breast or any other type of cancer, definite or atypical connective tissue disease, adverse offspring effects, or neurological diseases.

From lead author, Dr. Joseph McLaughlin,

“Few implantable medical devices have been investigated for safety hazards more extensively than silicone gel-filled breast implants,” said McLaughlin. “For almost three decades researchers around the world have been conducting in-depth studies on the health of women with implants to determine if there are significant health risks. The evidence is clear that implants are not linked to serious disease.”

An increased suicide rate from patients implanted 20-30 years ago has been the only consistent finding across several large follow-up studies. I've touched on that issue before on Plastic Surgery 101 (read here) on how inferring causation is likely incorrect as epidemiology suggested significantly higher psychiatric co-morbidity among women in those studies from the 1960's to early 1990's (so you'd expect higher suicide rates/attempts). I cannot imagine how you could ever effectively study this subject prospectively, particularly in the United States where medical records aren't centralized. Confusing things even more I'd submit is the recent rise in the United States of pharmacological treatment with mood-altering drugs (Prozac, Daypro, Xanax, anti-depressants, ADHD drugs, weight-loss medicines, etc...) for people who don't have classic or formally diagnosed depressive disorders. I see women (and men) all the time on such medicines prescribed by their family doctor or internist who would not meet strict medical criteria for what they're medicated for.

It would seem to me at this point that the most important issues left to characterize about existing silicone implants would be:

1. Late rupture rates - what can we expect durability-wise at 12-15+ years out?
2. Suicide rates - how to most effectively screen out unstable patients?
   
   

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The Boston Herald last week did a "gee whiz" piece on a dermatologist(!) promising to start performing breast enlargement via fat grafting despite the fact that there is no literature documenting it's either safe or effective. Over the last year I think I've mentioned this idea once or twice commenting on some of the technology evolving to better harvest stem cells from liposuction aspirate.

Irrespective of whether it's appropriate for your average dermatologist to do large volume liposuction (which is required for harvesting the graft material) and go anywhere near your breasts, there's a couple things that are really troubling with this.

1. Is it a good idea to out pleuripotent stem cells in a cancer prone organ like the breast?

2. What's the effect on mammograms from (inevitable) areas of fat necrosis?

3. Does fat grafting and the internal breast tissue scarring/distortion that will result, prohibit conventional techniques for breast surgery from being performed?

4. Can touch-up grafts be successfully done?

5. Can predictable volumes of graft be obtained in a material (fat) who's success rate traditionally hovers around 50%?

6. Has this doctor established an IRB (internal review board) protocol for this kind of human experimentation (which is what this is?)

Call me a cynic, but I find it unlikely that these kind of issues have really crossed the mind of this dermatologist from the rather flip quotes in the newspaper story. Fat grafting of the breast has a role in the armatarium of breast surgery and is being studied, but "cowboy medicine" like this article describes sticks in my craw. Fat grafts for primary breast augmentation is a subject that demands carefully designed multi-site studies.

Rob

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In what I guess passes for peer-reviewed literature in the UK, a London surgeon has proclaimed to have identified the perfect breast. The model mammary has a nipple that points slightly up, and an upper breast pole just a bit smaller than the bottom half. Apparently UK surgeon, Dr. Patrick Mallucci, spent many hours "poring over photos of topless models in lads magazines and tabloid newspapers" to come up with this theory.

While observing the "ideal" (as defined by cultural norms) is an ok way to make some general observations about beauty, I'd take issue that "laddie mags" (STUFF, Maxim, etc....) and pornography are the best reference point. A disporportionate number of models in those mediums have had breast augmentations which changes your whole frame of reference for comparison. The ideal augmented breast should approach the ideal un-augmented breast, which most (don't flame me here) would point to as the symetric nulliparous (prior to childbearing) breast with little ptosis (droop) that possesses some degree of upper pole fullness. This is pretty much what Dr. Mallucci describes, but I take some contention to his methods and conclusions. Most women will never have this kind breast naturally, but "good" breast surgery can move someone closer to it. The ideal breast shouldn't be pointed to one that does not and cannot exist in nature, ie. Baywatch circa 1996.


Who has the "best breast" according to this doctor? The "why exactly am I famous again?" model/singer/personality, Caprice Bourret

And the worst? The world's most famous soccer mom, Victoria (Posh Spice) Beckham

I'd agree that Ms. Beckham's result isn't the best, but thin women have a hard time hiding all but the most modest implants. She would have done better with smaller and narrow implants, and would have been ideal for the anatomically-shaped gumy bear devices (form-stable high cohesive silicone gel devices like the Inamed 410 or Mentor CPG).

But picking 36 year-old Caprice Bourret as the best "natural" breast shape (as described by this doctor in the article)? She's got a classic over-sized, over-round result you get from big implants (again that Baywatch thing). She's claimed in the past not to have had extensive plastic surgery, but I find that implausible.

Do you?



While it may in fact be a result that both earns Ms. Bourret a great deal of attention and be one that many women think they want, it's a setup for multiple future complications. That tissue just won't maintain that result for any length of time.


Rob

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