BREAKING NEWS: A fairly significant announcement by the USFDA was in the paper today re. silicone gel breast implants (see NYT summary here). Based on testimony and evidence presented, the FDA has finally agreed that the suggestion that patients need routine MRI screening of their implants is no longer one they support. This is bringing the United States into line with the rest of the world on being more pragmatic on the issue and reserving workup for symptomatic patients only.  Recent papers in the surgery literature have been reporting that MRI has been associated with overestimation of rupture rates, particularly when applied to asymptomatic patients. The panel also concluded that no new evidence has been presented to change prior determinations that silicone implants are not causally linked to any known systemic illness.

Rob

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When the USFDA lifted a nearly 2 decade moratorium on the use of silicone gel breast implants for cosmetic surgery indications in 2006, there were two puzzling things added to the product labeling.

1. The use of silicone gel implants should be limited to women >22 years olds.
2. That women should undergo routine MRI screening of their implants for rupture every 2-3 years.

The first instruction re. an age restriction on women 18-22 is patently absurd and is a nod to the "unique" political history of silicone breast implants in the USA. One more thing we thank lawyers for!


The second suggestion re. MRI was always puzzling, particularly as the rupture rate is so low for modern implants through the first decade where the FDA would otherwise be having patients undergo 5 screening MRI's (at year 3,5,7, & 9). This intuitively is throwing money down the drain as the yield is low and violates what most people consider appropriate in a screening test.

New data and review of the literature from the University of Michagan suggest that while MRI is fairly accurate in detecting implant-related problems, it is 14 times more likely to detect them in women with implant-related symptoms than in women without symptoms.It has been concluded that because most women in the studies had symptoms, the true accuracy of MRI for detecting implant-related problems in asymptomatic women is probably much,much lower and calls into question the whole idea about routine screening for rupture. Beyond the issue of accuracy, the authors comment that screening tests are generally performed to detect diseases with serious consequences-whereas the health risks associated with ruptured silicone implants, if any, are still unknown. To date, there is no single systemic disease or illness clearly attributable silicone gel implants despite them being the most studied medical device in the history of medicine.

Hopefully this will lead to the updating of the current FDA labeling for these devices that causes some confusion for patients and adds significant extra expense for no benefit.

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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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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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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Santa Barbara-based Mentor Corp., one of the the largest manufacturers of silicone breast implants, is in the news today with word of a takeover bid by Johnson & Johnson. If you're a shareholder in Mentor, you're going to be making some serious coin today. J&J is paying $31 for each Mentor share, a big 92% premium to Friday's closing price but well off its 52-week high of $40.82 about 11 months ago.

Mentor, and rival Allergan, have been locked in a real dogfight for market share of the American (and world) market in breast implants. Mentor today gets almost 90% of its revenue from breast implants, most of which are sold for cosmetic proposes. To survive, Mentor had been desperately broadening their portfolios to include dermal fillers, a BOTOX alternative ("PurTox") , an Alloderm alternative (NeoForm), and medical grade skin care lines. Their expansion to this point has run right into the teeth of the financial market downturns, and their earnings and stock price had been pummeled to this point. A real interesting transcript of the company's on the record discussions with institutional investors last week seemed kind of defensive. You can read it over at the excellent Seeking Alpha website of financial stories. They sure kept this deal under wraps!

This seems like an excellent opportunity to achieve synergy with some of J&J's research and development capability and distribution networks. It puts them on more equal footing with the large corporate entity Allergan.

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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Capsular contracture, an exaggerated hardening of the tissue around a foreign body, continues to be one of the most stubborn issues to stomp out with breast augmentation and reconstruction surgery. It's also been one of the most difficult things to study in a way that's useful because of a relative lack of a clear understanding of why it happens.

Forming a capsule is a normal physiologic process. It happens around everything your body doesn't recognize as "self" when it's implanted and is mediated by a well established interaction among signaling proteins on cell surfaces and your bodies immune system cells. When this process goes haywire, you get thickening and shortening of the capsule which can become painful and distort the shape of the breast.

There's a couple things we know clearly cause high rates of hard capsules with breast implants:

• post-operative hematoma


• infection around an implant


• a history of breast irradiation


• older silicone devices (1970's-19080's) with high rates of "gel bleed"


• rupture of silicone implants

What's more complex is trying to "reverse engineer" how to prevent capsules. Suggestions to reduce high grade capsule rates have included:

• textured implant surfaces


• placement of the implant underneath the pectoralis muscle


• polyurethane-coated implants


• antibiotic irrigation of the implants during insertion


• the use of contemporary "4th generation" implants with thicker "low bleed" shells and more cohesive fillers


• saline implants

The data on textured implants and position of the implant relative to the muscle have been somewhat mixed. At this point it's hard to definitively say that either make much difference long-term. Polyurethane foam works very well, but it's use in the US is likely DOA in the long-term due to liability issues over a (now debunked)risk of breast cancer. Antibiotic irrigation works well in the short-term, but it's not clear that it could affect capsular contracture years out from surgery.

It's been very interesting to see the performance of the "5th generation" silicone devices in published studies. These are the "gummy bear" implants which are semi-rigid and textured. Whether it's a synergistic effect or what is not clear, but these implants have dramatically lower rates of capsular issues almost a decade out. These devices appear to offer an improved solution to capsular (and rupture) issues and hopefully the FDA will give the green light sometime in 2008 for their US debut.

So what else do we have to offer?

There's a class of drugs used to treat asthma called leukotriene inhibitors (LTI) that has shown some promise in prevention or treatment. The two most common LTI's are Accolate and Singulair. Accolate has a small potential for liver problems and has mostly been avoided in favor of Singulair. Singulair was in the news as it's been alleged to cause suicidal ideation by people suing Merck. (How you prove a negative here is anyone's guess, but call me the skeptic.)

Anyway the genesis of this post was a study I saw in a European journal showing dramatic inhibition of capsule thickening in an animal model using zafirlukast (aka Accolate) which you can see view here). This is the first basic science model I've seen actually showing this idea of LTI's can work. This information gives us another option to discuss in the high risk capsule former which is good!

Rob

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It's always amusing to hear the United States Veteran's Administration (VA) hospital system celebrated by advocates of universal health care as a model system. If you've ever worked in one, you quickly learn it's a quagmire of competing impenetrable bureaucracies with insane regulations relating to everything. These regulations combined with a unionized workforce can make simple things (like taking care of patients for instance) not so simple. Illogical rules and regulations, and the irrational thinking behind them is what we used to call "VA logic".

VA logic has metastasized to private hospitals in the form of rules like the Federal Emergency Medical Treatment and Active Labor Act EMTALA, the Health Insurance Portability and Accountability Act HIPAA , and the growth industry of "nurses with clipboards" (NWC), nurses who aspire to have no patient contact, but serve vague administrative roles in hospitals harassing everyone. Each of these things started off with the best of intentions, but have spiraled out of control and now serve non-contributory bureaucratic roles.

A recent case from the German military comes to mind, where enforcement of an outdated and illogical regulation on cosmetic surgery led to the dismissal of a female soldier from her position after she'd had a breast augmentation surgery. From the report

A 23-year old female recruit who underwent breast implant is appealing to military authorities for reinstatement after she was booted out of army training in Germany for have boob job. Alessija Dorfmann, who has cup D after the operation, claims she was devastated after being kicked out of the army training as it has it been always her dream to be a soldier with a great figure. "And now my fake boobs have cost me my job," said Dorfmann adding she earned the money for the boob job by working as in an OAP's home before joining the army. "I could not stop crying when they told me. I wanted to work as an army medic and help save lives."However, military chiefs have vowed to review the Dorfmann's plight. "The rule that was brought in because of the increased risk of an injury is under review," said Army spokesman Harald Kammerbauer. "It was introduced more than a decade ago and it may be that it is no longer relevant in the modern army. In future we may be prepared to make exceptions."

Dorfmann will, however, apparently be allowed to join the Navy (go figure). With great pain, I will refrain from any jokes about floaties.

The rationale for this old policy doesn't make much sense, particularly if she had her surgery done when she wasn't on active duty or while on vacation. When done well, the down time after breast augmentation can be fairly modest. One of these days, I'll write down some thoughts on my take the evolution of surgical techniques for breast augmentation which I think we'll be interesting for the lay audience here.

Nurses get breast implants fairly frequently and are usually able to return to work within a week with only mild restrictions. Most breast augmentations in Europe are now done using textured form-stable silicone ("gummy bear") anatomic implants placed over the muscle, which has much less recovery time then the submuscular (partially under the pec muscle) placement that we do more here in the United States (another good topic for another day). Those kind of implants are so solid that they literally cannot physically rupture, although they can "fracture". If this woman was not in a front line position, it's fairly ridiculous to assert she's endangered herself or increased her risk of injury by her surgery.

As an interesting aside, while looking for some information on German nursing, I came across this old World War II propaganda poster from Great Britain which was trying to stir passion among the Brits over the German nurses' reputation for not treating captured wound allied soldiers.

P.S. Warning - Don't do an image search on Google using the term "German nurse" with children or your spouse around, as apparently there is a thriving porn-fetish industry around the theme :)

P.S.S. "French nurse" image searches are even more risque as you end up with both nurses and French maids ;)


Rob

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I got a couple emails and posts about the last entry here on Plastic Surgery 101 on the lawsuit over breast reduction asking some questions about the cost of these procedures. Particularly, people (me included) feel this woman's lawsuit is sympathetic but feel the cost difference is indeed something that should be factored in, especially as it's over 15 years out from her original surgery.

A colleague pointed out some of the long-term costs associated with implants that you don't necessarily have with autologous (your own tissue) reconstruction (ie. need for replacing ruptured implants or the need for revision surgery for capsular contracture).

Here's my take.......

Trying to figure out the actual costs & morbidity of surgical procedures is difficult. There are tremendous variables all playing into this. A number of studies have compared the cost of different reconstructions at their institutions and come to different conclusions on long term costs. Implant based reconstruction is clearly cheaper up front, but over the course of many years (and further revision surgeries) this evens out assuming no major complications from flap-based surgery. These studies have never addressed scenarios like the one involved in this lawsuit.

It becomes silly at some point to try to translate the cost of these surgeries at a place like MD-Anderson or Sloan-Kettering Memorial (the most well-known cancer centers in the country) to how much it costs to do the surgery in some non super-tertiary center. Length of stay, routine post-op care, and operating times in these papers are all over the place and most Plastic Surgeons reading these analysis just don't believe the numbers reported (or at least don't believe those numbers are reproducible at their hospital).

In this case consider the up-front costs of the two proposed surgeries:

1. An hour-long outpatient bilateral implant exchange/minor revision prob. has a true cost (not what you'd seen on charges to an insurance company) between $5-10,000. I say "true cost" as I know what it would cost to do this as a cosmetic case where all fees are out in the open. For comparison of what an implant costs (not the surgery fee, but the price tag for just a single device): a saline implant is ~ $300, a traditional silicone implant is about $850, and the not currently available Inamed 410 "gummy bear" implant will be almost $1100

2. a traditional bilateral pedicled (where you keep the blood vessel attached) TRAM flap is a surgery that would likely take 5-7 hours for one surgeon to do and require closer to a week in the hospital. Charges for this might run closer to $100,000. Associated with harvesting both rectus muscles is a fair incidence of abdominal wall hernias requiring future surgery.

3. a microsurgical bilateral "free" DIEP flap could take 10 hours of surgery depending upon the difficulty of the microsurgery, require ICU admission for flap monitoring post-op, require a week in the hospital, and bring a bill over $150,000. This procedure spares the muscle harvest of a TRAM at the expense of a longer and more complex surgery with higher rates of flap loss.

Implant reconstruction brings some "legacy costs" which autologous reconstruction does not. Now modern implants life-expectancy is still a moving target, but 15 years is a reasonable expectation. (The gummy-bear implants still pending approval may extend that life-span indefinitely). Worse-case scenario, a young or middle aged-woman might have to have her implants exchanged 2-3 times over the course of her life. Reoperations from hardening (capsular contracture) are also going to add some number of reoperations to this figure.

From my crude estimate of costs in this case, even though immediate implant-based reconstruction may be more expensive in some cost-analysis decades out from surgery (when reoperation costs are figured in) then doing a TRAM or DIEP at the time of mastectomy, you can imagine that the costs in this particular scenario will never make sense from a cost perspective, especially when the system has already been hit once with the first reconstruction cost. It's for this reason I find it most compelling to expect the patient to self-finance part of this when other less expensive options are available.

Rob

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"I'll boost your boobs or go bust!"

It's a bold claim, but British bra-maker Emma Clark has come up with an interesting line of bras and swimwear to one-up the Wonderbra for non-surgical cleavage control under the banner of Max-Cleavage. Using a clever selection of gel padded (as opposed to foam) bras, swimsuits, and blouses Ms. Clark has created some real buzz in the fashion industry.

Dissatisfied with the trusty Wonderbra which she says,“In my experience, they simply push up what little bust you do have to the middle of your chest and leave this void at the side." That's an interesting and astute observation.

Another bra is being marketed specifically for the post breast augmentation breast under the pretentious label, "Le Mystere No 9". I've never really thought about a need for this, but they make the point that

"Augmented breasts often have more projection and wider cleavage than natural breasts. Because breast implants are ideal for women with narrower rib cages, high profile implants require more depth in the bra cup. The center gore of traditional bras is too narrow for breast implants and causes poor fitting and loss of support."

I'm not quite sure if I buy this logic the way I think about breast augmentation. The "width" of cleavage is determined by the attachments of the underside of skin to the peri-osteal tissue covering sternum (breast bone) and is also defined somewhat by the medial attachments of the pectoralis major muscle when implants are in the sub-muscular position. Implants themselves do not make cleavage wider unless the lateral dissection is overdone, stretched, or expanded from the contraction of the pectoralis major muscle. Saline implants in the sub-muscular position are notorious for gradual lateral drift.

I tell patients to be wary when asking about whether or not your can narrow one's cleavage. You certainly can do it, but it is an ill-advised manuever. Once those natural attachments are lost, control of the space around an implant can slip out of your control. Uncorrectable deformities, including synmastia, the"uniboob" deformity, can result from over aggressive dissection towards the midline, particularly when the implants are in an "over the muscle" (subglandular) position. Pictured at right is a patient with synmastia.

Rob

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I've featured a couple of unusual things over the last year which have reportedly caused implants to rupture. Who can forget the the implant that deflected rocket shrapnel , the implant's acting as an airbag, or the images of the Marlin harpooning the fisher-woman on video last year?

I'm not sure I believe this at face value, but there's a story in China that reports a woman's saline breast implant was punctured by a Hornet sting.

From the China Post

Dr. Tseng Ting-chang said a 31-year-old woman who received breast implants three years ago visited his clinic early this week complaining that one of her breasts had deflated after a hornet sting a couple of days before. The woman said the incident took place while she was riding a scooter in the countryside,whilst wearing a low-cut dress.

She took the sting in stride at first, but later was astonished to find that one of her breasts had shrunk a couple of days later. Dr. Tseng said he found saline from the woman's breast implant had leaked, apparently due to the hornet's sting. He said the woman had to undergo surgery to reconstruct her breast. Noting that the woman is quite thin and has little fat tissue under her skin, the doctor said it is possible the hornet's sting could have pierced the saline-filled sack, which is touted as being able to withstand pressure of up to 200 kilograms per square centimeter.

Must have been one of these Japanese "Yak Killer" hornets (native to Japan & Asia)which can be over 2 inches long and possess acidic venom which can dissolve human tissue ,and is strong enough to "kill a Yak" according to local folk-lore. See "Hornet's From Hell" at National Geographic. The venom is notably painful and was described by one entomologist who been stung as being akin to "a hot nail through my leg". An estimated 40 deaths annually come from these stings in Asia.


Below is a 9600x magnifiction of a hornet stinger on Electron microscopy.


For an interesting blog featuring unusual bugs check out this. It's cooler then it sounds!



Now a woman's skin flaps after mastectomy and implant reconstruction can be thinned out from tissue expansion, particularly in thin women who have little residual subcutaneous fat. Most implant reconstructions have the implant placed beneath the pectoralis major muscle, which can add up to 1 cm thick padding. Assuming the average male hornet (unlike the average male human) doesn't exaggerate the size of his stinger, they tend to run about 6-8 mm long according to my homework. It would take a forceful sting to reach a submuscular implant, and even then I'm not sure it would be able to actually pierce it.



Rob

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The image at right is by artist Sheila Chambers entitled "Before Suicide"

It's funny the way the media seizes on medical issues sometimes. In late July, another analysis of suicide rates among breast augmentation patients was published and it generated enough attention to percolate thru most media services. This study was (I think) the 5th or 6th epidemiological study in the literature flagging breast augmentation as a risk factor for suicide. I wrote about this before here & here, discussing this issue in context to what we do know.


These kind of hyped stories about breast implants inevitably generate questions from patients in the week or two after they break. They're also siezed upon by activists in the breast implant debate as a priori evidence that implants are evil, predictably generating a slew of implausible theories about how breast implants must be causing ______ (cancer, autoimmune disease, suicide, global warming, etc.....)


In the July Annals of Plastic Surgery published a Swedish study titled, "Excess Mortality From Suicide and Other External Causes of Death Among Women With Cosmetic Breast Implants". Almost 3,527 women out of Sweden were followed from as far as forty plus years ago (1965-1993), and what was observed was that there's an increased risk of suicide in women, especially 10 years after the implant surgery.

How big are the numbers we're talking about? Of 175 deaths among study participants, 24 were suicides which was something like twice the expected 12 if you assume that this group was similar to the population as a whole. However, this group of patients is clearly NOT representative of the larger pool of women for risk factors for suicide. In fact, one researcher working "backwards" from suicide rates towards known risk factors suggested that in fact an expected 5x increase in suicide rates should have been observed and speculated that the surgery had actually lowered observed rates of suicide. I don't buy that neccessarily, but it's an interesting hypothesis.

So what are the problems with trying too read much into this if you're asserting some causal relationship?

1. The group of patients and cultural norms in 2007 are arguably different from a group of patients nearly 30-40 years ago. As surgery has become more "democratized" (ie. more people can afford it) and plastic surgery is more mainstream, I'd bet you'll see a dilution effect somewhat down the line as the % of high risk patients shrinks relative to the numbers undergoing the procedure.


2. These databases from (mostly) western Europe don't include patients who were implanted for breast cancer reconstruction or who had surgery done by non plastic surgeons. We have not observed increased rates of suicides in implant breast reconstructions.


3. The largest one of these kind of studies saw differences in suicide rate disappear when the control group was other cosmetic surgery patients rather then the population as a whole.


4. Several dozen large studies have failed to establish any clear mechanism for breast implants causing systemic disease. The United States, Canada, Great Britain, and the European Union have all reaffirmed their positions on this in the last 18 months.


5. These studies weren't designed to prospectively study suicide rates and offer few clues as to the nature of the relationship between breast implants and suicide.

Like several other studies in this area, they found problems with an increased number of women who were substance abusers, alcoholics and had underlying depression. In fact, they found almost a 3x greater rate of deaths attributed to alcohol or substance abuse, or attributed to accidents or injuries that could have been associated with alcohol or drug use.

What's a plausible "wild card" in the mix? Body dysmorphic disorder (BDD). Defined as a preoccupation with a slight or imagined defect in appearance that leads to significant psychological distress, BDD has been found in up to 5%–15% of all cosmetic surgery patients. These patients bring rates of suicidal ideation and suicide attempts that are 10x higher (or more) to the table.

Meredith Vieira discussed the study on the Today show last week with NBC's chief medical editor Dr. Nancy Snyderman who had an excellent summary of this study and how it's applied in day to day practice,

"Now, is this great science? No. Is there sort of an implied link? Maybe. But I don't think this is an indictment of plastic surgery and certainly not breast implants. It may be that if you'd roll back to the '60s when doctors really started doing a lot of these, they weren't screening patients so well. And if a woman has unrealistic expectations or she's psychiatrically not sound, she's not a good surgical candidate. And I think in 2007, you'll have doctors screen plastic surgery patients much differently than they did 30 or 40 years ago...

Good surgeons say no because they don't want problem patients on the back end. If you have a patient with unrealistic expectations, you're going to have a patient who will be unhappy with you forever and ever. And no surgical fee is worth that. So you look at the good--the good plastic surgeons, they're always trying to get the temperature of patients and what they expect, and they'll tell patients no"

Rob

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Instant Karma meet one John O'Quinn, attorney-at-law of Houston, TX. Mr. O'Quinn is best know as the shake-down artist who fleeced several implant manufacturers in the 1990's for a billion dollars +(USD) over the since dismissed claims of diseases allegedly caused by silicone breast implants. O'Quinn's total attorney fees while his firm represented the plaintiffs was over $260 million.


It seems like a only quarter of a billion dollars was not enough for counselor O'Quinn, who was stung Friday with a judgement for (with interest) nearly $60 million dollars for defrauding his clients with irregular (and undeclared) attorney fees as well as bogus and phantom expense reports.

O'Quinn was a particularly nauseating player in the late "silicone crisis" phantom menace that was driven to ridiculous heights by O'Quinn et. al. To this day his breezy attitude toward the truth (or as best we understand the truth on breast implants) represents the worst stereotypes of the American trial lawyer., ie. "Never let truth get in the way of a class action payday".

In lawsuits against the since bankrupted Dow Corning, O'Quinn made ridiculous leaps of logic during arguments with an over the top closing statement urging jurors to ignore the science and instead rely on “common sense, circumstantial evidence,” and post hoc ergo propter hoc (If "x" happened it must be from "y") reasoning. America, being the home of jackpot justice, rewarded these lawyers with staggering wealth.

From the Houston Chronicle:

An arbitration panel Thursday ordered O'Quinn to pay at least $35.7 million to more than 3,000 former breast implant litigation clients for collecting improper fees. The award includes $10.7 million in improper fees and a $25 million
penalty, the panel said.

The 3,000-plus women joined in a 1999 lawsuit claiming O'Quinn took funds from their settlements for group charges they had not agreed to pay. One of their lawyers estimated that with interest and lawyer fees, O'Quinn could pay up to $60 million out of his estimated $263.4 million in fees from the implant litigation.

$60 million, huh. Couldn't happen to a nicer guy.

Rob

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MyFreeImplants.com just completed a promotion at the Erotica-LA convention, a sexuality and lifestyle exposition, which culminated with its second annual free boob job giveaway. Much like the contest in Florida we discussed in the April post here, " Does it make sense for an E.R. Doctor to do your breast surgery?", the "plastic surgeon" doing the breast augmentation is also in fact not even a plastic surgeon at all. (I guess things are "improving" in that unlike the former episode, this doctor at least trained partially in some kind of surgical residency)

The surgeon, "Dr. S", in this instance is not a Plastic Surgeon by training and apparently is not even board-certified by any board recognized by the American Board of Medical Specialties (ABMS) . You'd have a hard time knowing that by the somewhat deceptive way many physicians like this market their practice (I don't mean that perjoratively directed at "Dr. S." BTW) . When looking on the Internet or thru the Yellow Pages, these doctors will call themselves Plastic Surgeons or the catch-all "cosmetic surgeon", and pay to have themselves listed in directories of real Plastic Surgery physicians.

If you see someone with a lot of "board certifications" next to their name but not The American Board of Surgery/Plastic Surgery (ABPS) or membership in the Amer. Society of Plastic Surgeons (ASPS), they aren't a Plastic Surgeon in most instances. Most egregious are ones like the obnoxious American Academy of Cosmetic Surgery which were created out of thin air and are not recognized by the ABPS or ABMS (the gold-standard organization for credentialing physicians) and do nothing more then to confuse patients.

Rob

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There's a column on Slate.com "True Believers: Why there's no dispelling the myth that vaccines cause autism." that's kind of interesting.

At right, a parody MAD magazine cover by blogger Bev Harp pokes fun at those who believe vaccines cause autism.

If you're not familiar with that controversy, the short version is that there was a contention that a mercury-based preservative (thimerosol) used previously in the Mumps-Measles-Rubella (MMR) vaccine was responsible for making children develop autism.

This past week concluded a 12-day hearing before the US Court of Federal Claims. The hearings largely confirmed the scientific consensus that there's no connection between autism & thimerosol. A story in the Washington Post summarizes thishere.

With the medical literature surrounding mercury poisoning reviewed in the hearing (which has never shown autistic-like effects), the dose are often 100's to 1000's of times higher than what someone would receive in the MMR vaccines. A number of large epidemiological studies have shown no link to either MMR or other thimerosal-containing medicines.

From the Slate.com article:

People who study irrational beliefs have a variety of ways of explaining why we cling to them. In rational choice theory, what appear to be crazy choices are actually rational, in that they maximize an individual's benefit—or at least make him or her feel good.

Blaming vaccines can promise benefits. Victory in a lawsuit is an obvious one, especially for middle-class parents struggling to care for and educate their unruly and unresponsive kids. Another apparent benefit is the notion, espoused by a network of alternative-medical practitioners and supplement pushers, that if vaccines are the cause, the damage can be repaired, the child made whole. In the homes of autistic children it is not unusual to find cabinets filled with 40 different vitamins and supplements, along with casein-free, gluten-free foods, antibiotics, and other drugs and potions. Each is designed to fix an aspect of the "damage" that vaccines or other "toxins" caused.

In reality, autism has no cure, nor even a clearly defined cause. Science takes its time and often provides no definitive answers. That isn't medicine that's easy to swallow.....Another explanation for the refusal to face facts is what cognitive scientists call confirmation bias.

Systems of belief such as religion and even scientific paradigms can lock their adherents into confirmation biases. And then tidbits of fact or gossip appear over the Internet to shore them up. There's a point of no return beyond which it's very hard to change one's views about an important subject.

Then, too, the material in discussion is highly technical and specialized, and most parents aren't truly able to determine which conclusions are reasonable. So they go with their gut, or the zeitgeist message that it makes more sense to trust the "little guy"—the maverick scientist, the alt-med practitioner—than established medicine and public health. "History tells us that a lot of ground-breaking discoveries are made by mavericks who don't follow the mainstream," says Laidler. "What is often left out is that most of the mavericks are just plain wrong. They laughed at Galileo and Edison, but they also laughed at Bozo the Clown and Don Knotts."
.....Joined together on the Internet, these actors create a climate of opinion that functions as an echo chamber for conspiracy dittoheads.

The activist community in the breast implant debate is an obvious parallel to this. There's tremendously compelling science not confirming their contentions of related illness, but there still exists heart-felt conviction by these women that their breast implants caused their medical conditions.

A whole counter-culture of "implant survivor" support groups and websites have come up and are filled with anecdotes outlining their beliefs. On display are often desperate stories of depression and swapped tales of homeopathic voodoo-like potions to "detoxify" them of silicone, platinum, mold, etc... The reactions on display, like the parents of some autism patients, seek to point the finger at someone who must be responsible for their illness. This may have been a legitimate question in the late 1980's, but we long since know this to not likely be true with silicone or saline breast implants.

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I'm on vacation this week which is why I've been so productive with the blog.

I saw this on FOX-News, but it's been picked up by the DrudgeReport as well. Entrepreneurs in New York have come up with "drive-thru" clinics to give BOTOX to walk-in clients. While this is convenient, I think this is a somewhat troubling trend.

Allergan, the parent multi-national conglomerate, who owns BOTOX, the Lap-Band weight loss surgical device, Juvederm skin filler, and other products has taken a page from the pharmaceutical industry in how they market. Allergan bought Inamed Corp. in 2006 to also become the world's largest breast implant maker and are now arguably the world's premier cosmetic medicine complany.

To these corporations, Doctors are an inconvenient middleman in their product distribution systems. Big pharma realized this years ago by slashing their budget for detailing physicians & concentrating it on print and media ads directed at consumers. What they want is for people to show up asking for their drug by name when they go to the doctor.

Allergan has thrust out it's formidable marketing team with huge media pushes for BOTOX & Juvederm (their hyaluronic acid filler aimed at knocking off market-leader Restylane), with TV ads on Grey's Anatomy and other popular shows featuring actress Virginia Madsen (co-conspirator Tony Youn mentioned this here last month).

From the Orange County Register, in an article titled "Allergan rethinks marketing of Botox, implants."

In its new breast-implant campaign, for example, Allergan's marketers imply that implants are artful, like designer clothing. Even though implants are basically plastic bags filled with silicone or saline solution, Allergan portrays them as sources of power, freedom, individuality and self-confidence.

That's a big change from last year, when Allergan bought Santa Barbara-based Inamed and its breast implants for $3.2 billion. Then, the implants were labeled "Style 68," "Style 101," etc.

The old labels were cold and clinical, so Allergan is giving them a new identity that sounds natural, feminine and artful. In a new marketing campaign, they're the "Natrelle collection of breast implants."

Write this down: Expect to see lots of feisty press releases from the anti-breast implant crowd over this for the wrong reasons (ie. a non-demonstrable auto-immune disease risk). The underlying concept of direct-marketing this type of surgery makes me uncomfortable as it will further trivialize what is an operation and aftercare that is anything but simple.

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