Building a better breast implant

The advances in the technology of silicone breast implant design and manufacturing have progressed significantly since the original was introduced in the late 1950's. We are now in what's called either the 4th or 5th distinct generation of implants as identified in our literature.

Most of the problems seen in the "implant crisis" of the early 1990's were those of the 2nd generation which had very liquid (non-cohesive) silicone gel fillers with thin shells that had a propensity to "bleed" or leak small amounts of silicone even when intact. The FDA endorsed 3rd/4th generation devices in October which have thicker, more-cohesive gel and thicker shells with coating that radically reduces gel bleeding. The high-cohesive "gummy bear" implants contain even thicker gel filler and are pending US approval while widely used elsewhere.

Saline implants are destined for the historical dustbin and have never been used widely outside of the United States.

Other then the form-stable devices, what are the new areas for improvement in implant science and use? Manufacturers report on electron microscopy of explanted devices suggests that many ruptured implants are ultimately caused from trauma during insertion years prior. That may or may not in fact be true as surgical trauma from removal could be hard to distinguish from preexisting device architecture. This assertion has had the effect of stimulation a great deal of educational efforts on proper techniques for insertion, implant handling, and other technical maneuvers.

A chemist, Dr. Judit Puskas, at the University of Akron, is trying to push the scientific envelope developing implants made of a biorubber called polyisobutylene. This compound purports to be lighter, less likely to rupture and less permeable than silicone implants. A write-up of this can be found here.

An interesting property of these biorubber implants would be the ability to design them to contain and release drugs that could inhibit the growth of the implant capsules, akin to how a drug-coated stents prevent scar tissue from blocking coronary arteries. In fact, polyisobutylene is already used in such stents with little side-effects.

Atlanta Breast Symposium tidbits

I just returned this last weekend from the Atlanta Breast Symposium, one of the annual major meetings in Plastic Surgery. Atlanta is one of the places where many milestone advances in Plastic Surgery came from including flap based reconstructive surgery, the TRAM flap & latissimus breast reconstruction procedures, and endoscopic plastic surgery. At one point in the early-mid 1970's there existed a cadre of talent at Emory University's Plastic Surgery department that will never be rivaled.

A few observations from the meeting:

- the form-stable shaped "gummy bear" implants from Inamed (Inamed 410 implant), Mentor (Mentor CPG implant), & others (Silimed, Euro-Silicone) are going to dramatically affect our results for the better in breast reconstruction surgery. A number of international presenters showed results that cannot be achieved with round "normal" silicone implants as were just approved by the FDA.

- the silicone-istas are ready to pounce on any failure of compliance with the FDA instructions to demand that approval be withdrawn for silicone implants.

- we're struggling with how to address the increasing use of radiation in breast cancer patients when we plan reconstruction. There continues to be wide variability in different cities in who gets radiated and how much the side affects are.

- subglandular implant placement seems poised for a comeback. Contemporary "low bleed" implants appear to have significantly lower chance of capsular contracture as compared to older implants when placed above the muscle.

- using smaller implants continues to be identified as the single most important factor in reducing complications and reoperations.

The tangled web of medical fraud

It's easy to take jabs at trial lawyers and the abuse of the tort system in medical-related topics. What's worse is when physicians facilitate outright fraud involved in these cases. In the United States, several radiologists were fingered in recent years committing wide-spread fraud by collaborating with trial lawyers in the interpretation of chest xrays to certify a persons standing in asbestos and silicosis class-action lawsuits. A New York Times profile of West Virginia doctor, Ray Harron.

Some days, Dr. Harron would review more than 100 X-rays a day, he said during his deposition. He charged $125 an evaluation, but would also charge a flat fee -- perhaps $10,000 -- if he had to travel to a faraway screening site, in California or Hawaii, for example. If he had charged $125 per medical report for the 76,224 claims submitted to the Manville trust, Dr. Harron would have made more than $9.5 million from those claims alone.

Most disturbing, though, was another finding by the judge. ''When Dr. Harron first examined 1,807 plaintiffs' X-rays for asbestos litigation,'' Judge Jack wrote, ''he found them all to be consistent only with asbestosis and not with silicosis.'' But after re-examining X-rays of the same 1,807 people ''for silica litigation, Dr. Harron found evidence of silicosis in every case.''

The diagnoses ''were manufactured for money,'' the judge wrote last summer in an opinion that sent some claims back to state courts and imposed sanctions on one of the plaintiff firms. ''The record does not reveal who originally devised this scheme, but it is clear that the lawyers, doctors and screening companies were all willing participants,'' Judge Jack wrote.

Back in the late 80's and early 1990's a number of doctor's made windfalls on the fears of breast implant patients by repeatedly testifying for money in court about the ills of silicone gel implants (which as we know was later found to unsubstantiated).

It seems like the lawyers in other countries were inspired by our example, as has played out in Great Britain.

In an explosive article in The Lancet (Britain's equivalent of the New England Journal of Medicine) back in 1998, an article was published by surgeon, Andrew Wakefield, associating certain vaccines with autism. This article caused the vaccination rate in the U.K. to fall by almost 1/3 and set of a world-wide ripple of lawsuits against vaccine manufacturers. It later was revealed that Dr. Wakefield received more then $50,000 from lawyers supporting this research which he argued was a donation to the hospital and not to him.

It turns out that aside from that sum of money which has been known about for years, recent investigative reporting has discovered he personally was receiving far greater sums directly from plaintiffs lawyers in excess of $500,000 USD with a number of friends and associates also being paid.

ANDREW WAKEFIELD, the former surgeon whose campaign linking the MMR vaccine with autism caused a collapse in immunisation rates, was paid more than £400,000 by lawyers trying to prove that the vaccine was unsafe.

The payments, unearthed by The Sunday Times, were part of £3.4m distributed from the legal aid fund to doctors and scientists who had been recruited to support a now failed lawsuit against vaccine manufacturers.

Critics this weekend voiced amazement at the sums, which they said created a clear conflict of interest and were the “financial engine” behind a worldwide alarm over the triple measles, mumps and rubella shot.

Dr Evan Harris, Liberal Democrat MP for Oxford West and Abingdon remarked “This lawsuit was an industry, and an industry peddling what turned out to be a myth.”

On a positive related note is this recent article in Business Week "How business trounced the trial lawyers"

Is there evidence to support the use of exotic skin care products in Plastic Surgery and Dermatology?

One of the fastest growing areas in Cosmetic Medicine for the last decade has been the steady growth in new skin care treatments. Much like lasers, Intense Pulsed Light (IPL), Thermage, Chemical Peels, and other devices which purport to rejuvenate the skin, doctors and patients are marketed hundreds of products which claim to have reinvented the wheel of skin care.

Some of these products cost hundreds of dollars and can involve treatment regimens so complex as to beg the question of who in fact has enough time to perform them. A syndicated New York Times article "The Cosmetics Restriction Diet" touches upon an interesting revolt against this by some doctors who are asking "Where's the beef?".

The article can be read by clicking here

“You have to think of cosmetics as decorative and hygienic, not as things that are going to change your skin,” said Dr. Coleman, who is a clinical professor of dermatology at Tulane University Health Sciences Center in New Orleans. “A $200 cream may have better perfume or packaging, but as far as it moisturizing your skin better than a $10 cream, it probably won’t.”

A study of wrinkle creams published last month by Consumer Reports concluded that there was no correlation between price and effectiveness. The study, which tested nine brands of wrinkle creams over 12 weeks, also concluded that none of the products reduced the depth of wrinkles by more than 10 percent, an amount “barely visible to the naked eye.”

I tend to agree somewhat with some of the sentiments that skin-care is being made too deliberately complex. A gentle cleanser and sun-screen form the basis most people need to start from. I do however think that Retin-A (and related products) and topical anti-oxidants got a little short shrift in the story. We do know that both of those can have significant positive effects in general.

As to how much is enough? I have no idea. There is no way to intelligently cut thru the crap of marketing, and most existing and new products have little objective analysis of results. In fact there is little incentive for manufacturers to submit their products for that kind of scrutiny.