Journal backpedaling on platinum article with silicone breast implants

It looks like the editors of the journal Analytical Chemistry are distancing themselves from the controversial May article where researchers claimed to identify the presence of previously undocumented toxic Platinum radicals in patients with silicone breast implants. A summary from today can be read here. Catherine Fenselau, the associate editor who handled the manuscript, says, “The manuscript went through a full review and, as the associate editor who handled it, I am ultimately responsible for the review process. In hindsight, there now seem to be strong arguments that the science in the paper was probably flawed.”

This should come as little surprise as the conclusions and methods of the researchers were controversial when the article was accepted for publication. A number of chemists pointed out that the conditions to produce the unstable oxidative platinum radicals could not exist outside carefully controlled laboratory conditions.

Thomas Lane, a senior chemist with Dow Corning Corp., was quoted as
saying that “the facts are just not right.”


Michael Brook, a silicone expert from McMaster University (Canada), said the data and conclusions are “hard, if not impossible, to accept.” (Note: Dr. Brook has been a consultant to Inamed Corp. on their breast implant presentations).

Steven Pollack of FDA’s Center for Devices and Radiological Health/Office of Science and Engineering Laboratories.“The general sense we have from the science that is available is that the platinum is in its zero-valence state as released from the implant. We have no other evidence to say that it is in any other form, other than this paper, [in] which we find the science is questionable,”

These platinum states are so inherently unstable that they spontaneously revert to less reactive(and benign)conditions.

If you'll remember from a previous post on this (see below), the FDA did not agree with the findings of the paper in question and quite boldly dismissed it on the record. The activists were once again ahead of the curve here grasping for any maneuver to influence this issue. I think this points towards how wary people should be in accepting papers, even from journals as prestigious in their field as Analytic Chemistry or Plastic Surgery, when bold discoveries in controversial fields appear in the literature that dispute current understanding.


Tags
plastic surgery
silicone
breast implant
platinum

US Senate panel backs FDA moves on breast implants

More developments in the pending reintroducing of silicone breast implants for primary cosmetic indications. If you recall, both major US manufacturers received approvable letters from the FDA Advisory panel in 2005 and action on these has been pending by the FDA. In the interim negotiations between industry & the FDA have been ongoing over what kind of post-market surveillance and education for surgeons would be mandated, it is these negotiations which have been slow but apparently very close to completion.

Watching the debate develop for close to 15 years on this you can see the shift from concerns by the FDA over cancer and auto-immune disease (which have been settled to most people's satisfaction) to issues re. local complications, rupture rates, and efforts that can be implemented to reduce the instances of those complications. A change in policy re. implants would put the USA in line with the world scientific consensus on the safety of these devices.

This progression towards reintroduction has the political groups lobbying against this in crisis mode. There have been a sequence of desperate claims in recent years, each of which they feel would require indefinite delay in consideration of the device. In years past this was autoimmune disease potential, which has been repeatedly reviewed in the negative. Two large long-term cancer follow ups reported in this year without association. Alleged toxic effects of the platinum catalyst used in manufacturing process were dismissed by the FDA last month.

A number of allegations by these activists, essentially arguing flows in the process of how the FDA considered the devices, was reviewed by a Senate Panel and reported on Friday. It involved a review of the advisory panel proceedings and some various claims of corporate malfeasance by industry.


Once again, the hopes of the silicone-istas were dashed by the outcome of a another review. Claims by activists of improprieties surrounding the government's conditional approval of silicone gel-filled breast implants were largely unsubstantiated, according to the results of a Senate investigation released Friday.

The panel focused on 10 allegations but found only one that was substantiated: a member of a 2005 FDA advisory panel on plastic surgery devices did solicit money from a company owned by Inamed to produce educational materials on the use of silicone implants in breast cancer reconstruction. That relationship was properly disclosed to the FDA and did not violate any laws or regulations, but did present the appearance of a conflict of interest to some of the complaintants.


Tags
plastic surgery
silicone
breast implant

Bra Science

A very interesting thing you (or at least guys) don't often think about are bras.


In 1863, Luman L Chapman patented a corset substitute with breast puffs and shoulder-brace straps that tied in back. Seen below, this was the first bra, although the term 'brassiere' was not introduced for similar garments for another forty years.


The bra size of a woman is determined by measuring around the body, just under the arms, and above the breasts. The "cup size", a concept introduce in the 1920's, is determined by measuring around the body, at the point where the breasts stick out the most. Subtract the bra size from that measurement. If the difference is 0, the cup size is AA. If it is one inch, the cup size is A. If it is two inches, the cup size is B. If it is three inches, the cup size is C. If it is four inches, the cup size is D. If it is five inches, the cup size is DD. If it is six inches, the cup size is DDD or F. There can be tremendous variations in what a cup size is between different bra manufacturers.

Bra's took a huge step in pop culture, when eccentric billionare, Howard Hughes, developed the cantilevered bra to better show off Jane Russell's cleavage in the movie 'The Outlaw'



Who can forget the taboo-breaking image from the 1999 Women's World Cup Soccer final, when American, Brandi Chastain, "spontaneously" celebrated The United States defeat of China by mugging Nike's line of women's underwear to millions.


As it turns out, there's a lot of R&D involved in making bras better, especially in the area of high performance sports bras. Just as with running shoes, they now take video analysis of women with different breast sizes running to analyze areas for design improvement. On stop motion video each breast makes a figure eight type motion with the breasts themselves receiving a considerable amount of torque, tension, and acceleration/deceleration with each stride. Research has shown up to 56% of women experience breast pain when exercising as an average sized breast can move close to 5 inches on the chest wall, which can be reduced 50% with a good sports bra. Over time, permanent stretching of the supporting elements (Coopers' ligaments) may result in an accelerated drooping of the breasts.


I learned reading about this a couple of interesting factoids (which I'll relay in case you're ever on Jeopardy):

- The first sports-bra (the "Jogbra") was originally designed by two women, from two jockstraps sewn together (one of the women who conceived it is now a Vermont state senator of all things)

- Sports-bras are a $400 million dollar a year business

- Murals from Sicily in the 3rd-4th century shown women exercising in gymnasiums wearing something resembling a sports bra



Tags
plastic surgery
bra
breast

Now I've been drunk, but.....

For a disturbing news story for the male audience....

A 30 year old Latvian man strongly under the influence of alcohol, made a bet with his friend for 1 000 lats ($1 800) that he would cut off his penis.... and then did it! This "flick of the switch" required a six hour microsurgical operation by Plastic Surgeons to reattach. It will be a number of months (if the replantation works) before his doctor will be able to reassess his recovery of sensation. (Peripheral nerves regenerate at just under 1mm/day under ideal conditions BTW)

Those Latvians really know how to party! Remind me never to pass out drunk around that crowd.


Tags
plastic surgery
Latvia

Bad celeb breast surgery on display

As I've mentioned before, some of the sites featuring celebrity plastic surgery are guilty pleasures. I saw two good examples of complications in high-profile women (the names are unimportant) that are a little instructive.



I just saw this celeb photo recently with perhaps about as visible a capsule irregularity from breast implants as you will see (especially in public). What can you do for something like this? To camouflage this you need COVERAGE, COVERAGE, & more COVERAGE.

1. Change this (presumably) subglandular implant to below the pectoral muscle to give more soft tissue coverage
2. Switch from saline to silicone implants (which "ripples" less)
3. Use a spacer like Alloderm (a cadaver skin product, see earlier post on one stage breast reconstruction) if a site change is impossible
4. Consider a smaller implant & capsulectetomy
5. Preferably use a form-stable cohesive gel implant like the Inamed 410



This public nipple slip is a slightly different problem that can be described in mathematical terms.

Periareolar mastopexy + big implants - good tissue quality = Franken-nipple

How do you fix this?

You're going to have to start all over here with a complete redo of the mastopexy while downsizing the implants. Depending upon her skin quality you may no longer be able to get away with just a peri-areolar incision and may have to take this vertical or a full inverted-T incision. I've seen a lot of bad scars from these full peri-areolar mastopexies under tension. If you don't close with a permanent suture, or close it slightly oval-shaped you can get some really unsatisfactory nipples which are stretched, irregular, or both (as this picture shows).

There's a really nice trick I was taught by Dr. Pat Maxwell called a "pinwheel" which is a modification of how you close this incision in a circle with permanent sutures. It makes all the difference in the world for predictability. However, the inherent competing interests of augmentation-mastopexy operations makes many authorities recommend against doing them routinely.

Tags
plastic surgery
silicone
breast implant
celebrity
cosmetic surgery

Loose lips sink practices

For someone who considers himself a "surgeon to the stars", Dr. Anthony Griffin, really went out of his way to alienate potential clients.In this interview, Dr. Griffin ruthlessly went off on a number of celebrity features in a flippant way that reflects fairly poorly on himself.


plastic surgery
celebrity
dr. 90210
cosmetic surgery

CATFIGHT! CATFIGHT!

Funny story involving an onstage fight between two strippers who got into in an argument on stage with a third. In the midst of the action, one upped the ante and stabbed another with a broken wine glass, creating a weapon that punctured the woman’s right breast and ruptured her implant.

I love this quote in the article "Justice Deborah A. Satanove was told that the attackers had become perturbed with the stripper’s ‘arrogant demeanor and disposition’."

I got a chuckle over this as I saw a similar scenario during residency where two dancers got into in the dressing room with a nail file. One of them showed up in the trauma bay with about a dozen stab wounds from the nail file, including one of her implants.

Health court hearings

The debate over establishing Health Courts (special courts to handle medical injury disputes) began late last month in Washington. This bill, the Fair and Reliable Medical Justice Act was introduced by Senators Baucus(MT) & Enzi (WY). I briefly touched upon the Health Court concept a few weeks back discussion some tort reform/medical malpractice issues (see- "Man bites dog...")

A number of the nations top hospitals have volunteered to be pilot programs including Duke University, Emory, University of Miami, Johns Hopkins, New York-Presbyterian(The University Hospital of Columbia and Cornell), & Yale.

More discussions are scheduled today starting at 9:30am est and can be streamed here

Single stage breast reconstruction

It's nice to see some main stream media articles on things like breast reconstruction rather then Dr. 90210 or Nip/Tuck. This article elaborates on single stage breast reconstruction with implants. The novel concept of this is to combine a subcutaneous mastectomy (where the nipple isn't removed) with the use a product called Alloderm to help control the shape and pocket of an implant when immediate breast reconstruction is attempted.

Alloderm comes from human skin harvested from the back of organ donors. It is processed to remove markers (antigens) that would cause you body's immune system to identify it as foreign and 'reject' it. It has found utility in hernia operations, reconstructive surgery, nasal operations, and some redo cosmetic breast surgeries where there is thin tissue coverage over an implant.

The advantage of this is that it would remove the need (hopefully) for operations to exchange a tissue expander (temporary implant that stretches the skin). The downside of this is that the skin may retract unpredictably after this type of mastectomy and still require revisions. This has been the reason that immediate implant reconstruction hasn't been widely adopted. Alloderm allows greater control of the shape and more freedom to release the pectoralis muscle at the bottom.

Will this be effective? I'm not so sure. My impression is that you will be sacrificing the aesthetic result in many cases to avoid a second operation, which may in fact be unavoidable in many cases. I'm sure willing to try this on people who are interested, as I've already embraced the advantage of nipple-sparing mastectomies.

Regulating medi spas and office plastic surgery

Florida has recently passed a law increasing oversite requirements in the booming medi-spa business. The spa industry has grown an average of 38% in the last year alone, according to The Spa Association's 2005 study, making it the third largest leisure industry in the United States. Medi-spa's generally are clinic environments offering some of the less invasive treatments like fillers, BOTOX, micro-dermabrasion, light chemical peels, laser hair removal, and some of the non-ablative skin treatments intensed pulsed light, Thermage, etc...).

The increasing market for these services has driven a number of entrepreneurs into operating these medi-spas. Many of these were initially opened by Physicians with little or no background in the treatments they were offering. It was very common for ER docs or Family Practicioners to suddenlyredefinee themselves as providers of "Aesthetic Medicine" or whatever they called themselves. Increasingly, a number of industryinterestss have moved into this and establishing franchises paying some random Doctor to 'pimp' hislicensee out in order to operate.

The stumbling block with this industry is that Physicians are not cheap labor. Up until now, many of these services were being delivered by nurses or even simply employees with no advanced degrees. Oversite was notoriously nonexistentt by the medical directors at these spas. There have been reports of some nurse practicioners who have been particularly egregious in opening their own place sans supervision.

After a number of adverse outcomes with "safe" technologies (peels, fillers, & IPL) legislators have gotten involved.The American Society for Dermatologic Surgery found that half of its 2400 members reported an increase in complications in the past year from laser procedures performed by non-medical personnel.

• Virginia man, age 20: Coast Guard cadet died of allergic reaction to drugs given to him before a laser hair removal treatment according to the WashingtonPost.com.
• Shiri Berg, age 22, North Carolina: North Carolina State student died of a lidocaine overdose, a common numbing cream applied to the skin before a laser hair removal treatment.
• Terri Bowling, age 36, Pennsylvania: Deep second degree burns on legs from laser hair removal procedure performed by a spa technician. The actual photo is seen below.




This is what just played out in Florida. The loose oversite requirements that were flouted before, are now requiring the direct supervising physician to be board eligible or board certified in dermatology or Plastic Surgery. Behind sciencesnces, there was furious lobbying by some of the manufacturers of various lasers & related devices. This type of law has the potentialsignificantlyntly cut into their market for sales of their equipment.