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

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

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

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

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

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

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

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

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

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

Rob

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

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

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

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

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

4. Can touch-up grafts be successfully done?

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

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

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

Rob

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

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


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

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

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

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

Do you?



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


Rob

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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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