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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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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The Star (UK) reports (here) on a plaintiff from the 1980's class action lawsuit against Dow-Corning involving silicone breast implants who finally received her share of the remaining settlement for a grand total of £207 ($304.50 USD at today's exchange rate).

It's hard to believe that elements of the 2nd or 3rd biggest "whale" of American class action lawsuits are still in existence. I call it 2nd or 3rd because asbestos and tobacco suits have dwarfed it now in overall compensation (Don't even get me started on the claims that smokers had no idea they could get addicted to cigarettes or get lung cancer!). The shenanigans of the trial bar in our country cultivating these proceedings does not reflect well on our legal system.

The person in the Star article had what sounds like subcutaneous mastectomies for painful breast cysts and reconstruction with silicone implants. She's attributed multiple and diffuse symptoms to the fact she had silicone breast implants in. (Keep in mind, large databases of women around the world with implants have failed to demonstrate an increase in any common rheumatologic symptom.)

She was among thousands of women from the USA and Europe who took action against the company claiming their health had been damaged after their silicone breast implants leaked or caused immune system reactions.

Now more than a decade of waiting the cases have finally been settled.

"It is an insult, they might as well have given us nothing at all," said Shirley. Women were originally expected to received thousands of pounds in compensation when the action was first launched. But Dow Corning, which did not admit liability in the legal case, went into bankruptcy and the amount of compensation available fell.

Well, if you believe the overwhelming world scientific consensus (see here) that has shown no linkage of any identifiable disease to breast implants , you might make the argument she received £207 too much. What's most striking is to consider how much the handful of class action plaintiff's lawyers literally stole from investors of Dow Corning (hundreds of millions of dollars) and how little claimants received some 20 years later.

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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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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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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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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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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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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There's a great primer (for those interested) that can be read here at Plastic Surgery Products Magazine on how surgeons approach and analyze all the processes and steps that go into getting the best results and least complications with breast augmentation procedures.

It's written by my friend and mentor, Dr. Pat Maxwell, who knows as much on this subject as anyone on the planet. I think it's worth paying particular attention to his description of "biodimensional" principles, a now wide taught concept he pioneered. Another interesting thing Dr. Maxwell outlines is to look back at the sequential stages in implant development to see what went wrong (thin shell/thin gel designs in the 1970's) all the way to the sophisticated manufacturing of current and future devices. The engineering and computer modeling of implant designs is indeed impressive.

First Generation (1962-1970)
Thick, two-piece shell
Smooth surface with Dacron fixation patches
Anatomically shaped(teardrop)
Viscous silicone gel
Second Generation (1970-1982)
Thin, slightly permeable shell
Smooth surface (no Dacron patches)
Less viscous silicone gel
Third Generation (1982-1992)
Thick, strong, low-bleed shell
Smooth surface
Round shape
More viscous silicone gel
Fourth Generation (1993-present)
Thick, strong, low-bleed shell
Smooth and textured surfaces
Round and anatomically shaped
More viscous (cohesive) silicone gel
Fifth Generation (1993-present)
Thick, strong, low-bleed shell
Smooth and textured surfaces
Round and diverse anatomical shapes
Enhanced cohesive and form-stable silicone gel
* In accordance with technical parameters established by the ASTM.

Fifth generation devices will hopefully be available late this year or early 2008. While not useful in all scenarios, they offer significant advantages in breast reconstruction and in primary (initial) breast augmentation procedures.

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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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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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As Reagan famously said to Carter in one of the 1979 presidential debates, "There you go again!"

Uber-liberal congresswoman, Rep. Rosa DeLauro (D-CT) (pictured at right), recently reintroduced her "FDA Scientific Fairness for Women Act" in the US Congress legislative docket. If you'll recall, last year Rep. DeLauro went out of her way (read here) to try and bully the FDA into ignoring both their own expert panels and unanimous international consensus when the final stages of FDA bureaucracy was being reached on reintroducing silicone breast implants (SBI) for cosmetic surgery indications in 2006. Now that Democrats have replaced Republicans as the crooks in charge and she has some actual political power, she apparently misses the irony when she claims her bill would take politics out of the FDA approval process?????

If passed, the bill would rescind the 2006 FDA approval for SBI's and create an impossible gordian knot standard for ever proving safety to her satisfaction. Keep in mind, the next generation of cohesive gel ("gummy bears") implants (which aren't even being debated about in this issue yet) are sitting poised for approval and would be even further from clinical use despite strong evidence of their superior performance and rupture rate data to currently used devices ("4th generation" implants).

Alexander cuts the Gordian Knot, by Jean-Simon Berthélemy (1743–1811)

Rep. DeLauro and the fringe cadre of anti-implant activists she associates with, live in a parallel bizarro-world universe in which SBI weren't (according to the FDA) the most extensively studied medical device in the history of the world. In contra-distinction to information contained in the text of the bill, we arguably know more and have more data about how SBI's (or silicone in any device for that matter) behave then any other implantable material in existence. Within the last few years, we have more then half a dozen studies (also here, here, here, here, & here) turning in outcome data on patients approaching two decades out in some cases from surgery with implants similar to what's currently manufactured.

In point of fact, there are already existing FDA clinical trials collection long-term outcome data on the issues Rep. DeLauro is demanding answers to. However, the activists she has allied herself with have no wish to actually let prospective information continue to accrue and be analyzed (We already have mountains of retrospective data on these issues which do not support their POV) . They are so convinced that SBI are toxic that they will use any means neccessary to achieve their political agenda.

There are legitimate issues still to be better characterized with SBI's

1. What's the rupture rate in modern implants beyond a decade? (we have a good idea at around a decade it's ~ 6-8% with contemporary devices)



2. How do you reduce reoperations relating to complications (not cosmetic issues)?



3. Are there things we can do to reliably reduce capsular contracture (hardening of the implant)?



4. What is an evidenced-based way to recommend MRI studies to screen for rupture? (Currently the FDA's "cover their ass" position of frequent MRI's is illogical)



5. Is the superior performance of 5th generation cohesive gel SBI's compelling enough to abandon older device styles? (softer, round, & smooth surfaced)

Rob

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New York Times columnist, Natasha Singer, features an overview of the issue of MRI surveillance of silicone breast implants in her style/health column on Friday. I read Natasha's columns frequently, especially when they mention me :)

I think the title "Implants Are Back, and So Is Debate." is a little misleading to someone who didn't read the story. The debate, in this case, is not in re. to safety but rather about how, when, & why we should be doing serial MRI's after implantation.

It's pretty clear that no one is embracing the non-binding FDA recommendations about MRI's after implantation, and if you know anything about the data on this topic and observe practice patterns/standards of care world-wide, you can see that the FDA position is more political CYA then evidence based medicine. Health Canada (the Canadian FDA equivalent) so much as said so when they released the last of their token restrictions one months prior to the United States.

One thing mentioned in the story which I've never heard of was the investigation of radio frequency (RFID) tags made by Novalert to be embedded in implants to warn of potential rupture. Unless these add only pennies to the cost of the device or obviate the need for MRI's, I see a lot of potential barriers to it being used (especially outside the USA).

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On this day April 16,1992 the FDA started the groundwork for what would ultimately be the reintroduction of silicone gel breast implants (SBI) when they relaxed the outright prohibition that had been hastily introduced shortly before and started some of the early clinical trials that would provide data for further review.

It was nearly 15 years later this past October when they finally (officially) concluded that they were likely mistaken and reintroduced SBI's. We're now part of the international consensus of over 60 countries where this has been the decision by the respective health regulatory agencies overseeing this in other countries.

I found this January 1992 editorial from Reason Magazine (click to read) which is an interesting window into the mindset and arguments flying around at that time. Many of the philosophical issues are the same now as then. It's interesting that the author of this was spot on in warning that (at that time) pending epidemiological studies might not corroberate the claims being asserted in lawsuits. Since then an avalanche of literature has done just that.

In its letter to the Food and Drug Administration requesting a ban on the implants, the advocacy group Public Citizen repeatedly emphasized the frivolous nature of cosmetic surgery: "Because approximately 80 percent of these devices have been used for breast augmentation, as opposed to reconstructive purposes, the overwhelming 'public need,' not the public health need, for these devices is the psychological benefit of having more perfect or larger breasts . . . . We do not accept that the psychological needs of women, who seek breast augmentation, are legitimate public health needs within the meaning of the {Food, Drug and Cosmetic} Act."

The notion that breast augmentation is simply wrong undergirds much of the hostility to the procedure. In her widely discussed book, "The Beauty Myth," Naomi Wolf characterizes breast augmentation as "sexual mutilation." And Public Citizen declares in a press release, "The widespread use of silicone gel implants for surgery that is purely cosmetic is a particularly egregious aspect of the issue."

Take the claim that silicone breast implants cause scleroderma, a connective-tissue disorder that leads to a painful tightening of the skin. To lead in to its program on the implant controversy, "Nightline" featured a woman who had had a breast implant and who had later developed scleroderma. Reporter Judy Muller told viewers that the woman's doctor "believes the disease was caused by silicone leaking from the breast implants."

Muller did not inform viewers that there is no epidemiological evidence to back up that diagnosis. To tell whether there is indeed a connection between implants and scleroderma-like disorders would require a large sample of women who had received implants, whose medical histories were well-documented and whose symptoms were unambiguous. Such evidence may be forthcoming, although a May 1991 literature search under the auspices of the American Medical Association turned up only 28 women who had developed connective-tissue disorders after receiving silicone gel implants. For now, it is scientifically incorrect to say that implants cause such auto-immune diseases.

To such arguments, implant opponents reply by pointing to scleroderma victims. See, they say, it happened to this woman. She had an implant and now she has a disease. Post hoc, ergo propter hoc. The statistical standards of proof on which epidemiologists rely do not make for powerful journalism. And they run counter to the case-oriented culture of clinical practice.

In evaluating the safety of breast implants, the FDA and the courts should view the evidence rationally, with an eye toward real epidemiological proof rather than emotional claims. Regulators should seek to inform women of risks, not deprive them of choices. And those women who do want the freedom to make informed choices must take responsibility for the consequences, rather than going to court later to demand compensation for bad outcomes. Above all, the FDA should avoid taking refuge in extremist, paternalistic views of what women should be and what women should want.

A couple of other Reason Magazine articles about breast implants can be read here, here, and here

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There's another paper today challenging conventional wisdom on how effective screening studies are in the prevention of breast disease. In this instance it's computer-aided detection (CAD) mammograms, which were billed as a way to increase the effectiveness of interpreting mammograms. It uses advanced image recognition software to screen for abnormalities. Despite little data, this technolopgy was quickly adopted. Many mammography centers adopted this technology and were incentivized by medicare with additional payments ( ~ $20 per study) to use CAD. Note: When you do thousands of mamograms a year, this $20 per study can be serious money in someone's budget

CAD is apparently more sensitive then humans to abnormalities, but less able to distinguish malignant from benign. It also tends to identify a number of ductal carcinmona in situ (DCIS) lesions, which if left undiscovered may never turn into invasive breast cancer (aka. "real" breast cancer). Much like small prostate cancers in males, where many would die with it rather then from it, we as yet have no predictable way of tell patients that nothing will come of it and are forced to offer more aggressive surgical and medical treatments and their associated morbidity.




This report is the mirror image of the other large counter-intuitive finding we saw recently with screening CT scans for lung cancer. (ie. we find more disease but don't improve outcomes about death from cancer, while actually increasing morbidity and anxiety for patients.

While I'm off on this I'd like to dovetail on imaging studies for breast implants. With the 2006 FDA approval for silicone gel breast implants came a recommendation for routine screening by MRI of all implant patients starting 3 years post-op then every 2 years. This illogical and unenforceable (and unfunded) suggestion is surely going to widely ignored by patients and I'm not sure I'd blame them. For the period which would encompass the first 2 MRI's (five years out) the rupture rate of an implant in augmentation patients of "regular" silicone implants is likely under 1-2% while after 4 MRI's (10 years out)it's likely only 6 or 8%.

What drove this recommendation by the FDA? Most point to the highly charged political environment that still exists in America over this. One month prior to the FDA approval, Canada released the last of it's token restrictions on the devices and commented that while MRI screening was discussed, routine use was not evidence-based medicine. What do other countries do? They image implants selectively and usually start with ultrasound and reserve MRI for equivocal findings. As consequences of rupture tend to be confined to the breast and we know many woman may go years or decades with asymptomatic rupture, this is the position that makes the most sense to me. If you were to start MRI screen in asymptomatic women it would make sense to do this at 10-12 years when you sit and crunch the numbers.


The form-stable cohesive gel implants from Inamed
(picture below), Mentor, & other companies will make this topic be revisited when they are likely (you never know with the politics of the FDA)approved for general use later this year. When you have a device like Inamed's 410 implant with rupture rates so low as there are no data points to even do projections on rupture rates will the unsound MRI recommendation be attached to it as well? Keep in mind there has also been an issue of a number of false positive MRI's read out with the Inamed 410 and some of the dual-lumen devices (part saline-part silicone)in some of their clinical trials as they look somewhat different on MRI

Stay tuned!

Rob Oliver Jr. MD
www.oliverplasticsurgery.com

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Found a thought-provoking editorial in The American magazine, titled "Second Thoughts on Breasts." which summarizes some of the history of regulatory issues with silicone implants. The effects of this on the corporation and employees of Dow Corning(which was sued out of existence)are touched upon nicely. It's ironic that if Dow had waited about 15 months (when the first of the large studies not finding links between silicone and disease was published by the Mayo Clinic) they would have not had to pay a dime of the multi-multi billion dollar settlement.

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