Sunday, January 29, 2006

Cohesive Gel implants

A few weeks back I promised to continue discussing some of the evolution in contemporary breast reconstruction. Most of that post had to do with past. This one's about the future. The future is the cohesive gel implant with or without a latissimus flap. This is for a couple reasons.

1. As I mentioned earlier, no one is going to subsidize the more labor-intensive reconstructions (ie. TRAM flaps, Free TRAMS, and the various perforator flaps - DIEP,SIEP,Ruben flaps,etc..)

2. The form-stable cohesive gels can look great with very little work, even in patients with thin skin flaps following mastectomy

Seen above is a cut section of the Inamed 410, a textured and anatomic-shaped implant that's fairly far along in the FDA approval process. It uses a silicone gel filler that's cross-linked much more then the traditional gel implants. This gives it the "gummy-bear" feel that patients have described it as.When the shell is cut or ruptures, the filler goes nowhere. This completely eliminates the migratory silicone gel that can cause some local issues in the breast or enlarged axillary lymph nodes. The safety data coming in on the 410 style blows away the currently FDA approved saline and silicone implants already sold. (NOTE: Mentor Corp. also makes a high-cohesive gel, the CPG, which is slightly behind Inamed's 410 in the approval process)

It's been used continuously since 1994 in Europe, and is the most popular style of implant for both reconstructive and cosmetic breast surgery in the world. Surgeons in other countries are amazed at the fact that the United States is still debating about 30 year old implant designs while they've already moved beyond that.

An excellent summary of the 410 cohesive can be found here

Thursday, January 19, 2006

Face transplant debacle

Once again, French Surgeons led by Dr. Jean-Michel Dubernard have managed to set back both science and professional ethics in attempting a poorly planned surgery. Recently the world first "partial" face transplant (consisting of the cheek soft tissue on one side) was performed by his team in Northern France.

If you'll remember, Dr. Dubenard also has the claim to fame of the world's first hand transplant. The common denominator in both case is a rush to be "first" to do a radical surgical procedure while ignoring ethical concerns and half-assed patient selections for his human experimentation.

The first hand transplant was placed on a borderline paroled Kiwi con-artist, Clint Hallam. Predictably this fellow abruptly disappeared from follow up, quit taking his immuno-suppression meds (required to keep his body from rejecting the transplant), and showed up some time later with a dead,mummified hand requiring amputation.

This recent face transplant patient was a young women who reportedly tried to commit suicide with tranquilizer and who face was mauled by a pet dog while she lay unconscious. This alone should have disqualified her from consideration, but did that stop Dr. Dubenard? Of course not.

Well today we see an article that the patient is being non-compliant and has begin smoking, a HUGE risk with a recent microsurgical tissue flap, as nicotine will make the nutrient artery spasm with the flap dying shortly thereafter. Also mentioned from the same article is that fact that a number of previously reported successful hand transplants have failed as patients can't afford their required immunospression drugs or have been non-compliant with their regimines.

These failures only highlight the processes setup at the University of Louisville & the affiliated world-famous Kleinert,Kutz, and Associates hand surgery practice(where I trained) and the Cleveland Clinic which have setup extremely rigorous exclusionary criteria involving not only appropriate physical attributes, but also extensive psychological profiling,testing, and counseling to avoid these problems Dr. Dubenard has predictably encountered. In fact, Dr. Dubenard's team essentially high-jacked the immunosuppression model designed and developed in Louisville (of which I had a very small part in some of the related bench research) while abandoning any pretense of careful patient screening.

Rob Oliver

Tuesday, January 17, 2006

Breast reconstruction in evolution - part I

Up until about 30 years ago there really was no such thing as breast reconstruction. Flap-based reconstruction was just being conceptualized by pioneers John McGraw, Luis Vasconez , Carl Hartrampf, & John Bostwick. Tissue expander technology was in its infantcy. Microsurgical techniques were primitive. Surgeons trained up until that point had no experience in this area.

In the blink of an eye came Bostwick's Latissimus flap/implant procedure, Carl Hartrampf's TRAM (transverse rectus abdominus myocutaneous) flap, and Radavan's tissue expander reconstruction. Unsatisfactory results from early expander + implant reconstructions led to wide-spread popularity of the TRAM flap. As microsurgery matured "free flaps" (the blood supply to the muscle/skin island is isolated,dived, & sewed back in where the tissue is required) were designed and flourished at many training programs and tertiary hospitals.

Recently, a new reportedly less-morbid variant of the free-TRAM has been advocated by New Orleans surgeon, Bob Allen called the DIEP flap. This procedure involves tracing the small perforating vessels thru the rectus muscle & leaving the rectus muscle behind. Proponents argue that this is the most elegant & least morbid autologous reconstruction available. A number of DIEP-performing plastic surgeons have gone so far as to label the traditional pedicled TRAM obsolete.

What's a patient to do when presented with these complex choices?

I think what's telling is that when a panel of female plastic surgeons recently at the Annual Plastic Surgery Society meeting, the majority of them would NOT select TRAMS for their own reconstruction as first-line reconstruction (expanders were most preferred)and a number of free TRAM/DIEP performing surgeons in the audience expressed doubts over the cosmetic superiority of free flaps over the pedicled TRAM or Latissimus+implant reconstructions.

Friday, January 06, 2006

Silicone Gel's future

There's a lot of interest from patients about silicone gel breast implants. Since the early 1990's there's been an FDA moratorium on unrestricted use of gel implants. To make a long story short, in a political maneuver not support by science, the implants were severely limited to IRB-guided protocols for cosmetic & reconstructive use. Since then, silicone implants have been overwhelmingly shown to be both effective AND safe in trials all over the world. Presently, only the United States & South Korea (which defers to the FDA in many issues) have such restrictions.

Last fall, the FDA advisory panels gave approval recommendations to Mentor Corp. to remove the current restrictions. Game over, right? Well in 2004, Inamed Aesthetics likewise passed the advisory panel only to be shut down later on. (Ignoring the science advisory panel is a VERY rare event BTW)

Funny enough, the implants being considered currently are 20 year old designs. Some people label them "3rd generation" implants. They were designed and are manufactured with QA much better then previous implants. Most of the horror-stories of patients with silicone were "2nd generation" & suffered problems related to the low viscosity of the silicone gel & thin shells that surgeons of that era were asking manufacturers for. From the mid-late 1980's on, implants were made with both good durability and efficacy.

Coming down the pike are the cohesive silicone gels which feature much higher viscosity gel. These are the "Gummy Bear" implants you might hear about. They represent potential advantages of being form-stable (rather then more like a liquid) and impart real shape-defining characteristics to the breast.

Check back soon for a diary with more about the cohesive gels!