Newsline 2004 January – Breast Implants in the News

Welcome to our January email Update.

First of all, a very happy New Year to all of our friends and patients. We hope that your Holiday Season has been as pleasant as ours. As usual, December is a very busy month for us at the Center with so many people hoping to take advantage of the time off to have Cosmetic Surgery.

BREAST IMPLANTS IN THE NEWS

This month’s Newsletter is again devoted to the issue of breast implants. As most of you are probably aware, the FDA Advisory Committee recommended to the Agency that silicone gel filled implants be approved for use. In a rather surprising statement following this recommendation, the Chairman of the Advisory Committee subsequently stated that he personally disagreed with the recommendation. Since the Chairman holds a non voting position on the Committee, his opinion was not a part of the overall vote, but obviously represented a significant objection to the majority opinion of the Committee.

This week, the FDA officially announced that it had rejected the advice of the Committee and had turned down the application of Inamed Corporation to distribute gel filled breast implants in the United States. Gel filled implants continue to be available throughout most of the world, but in the United States, patients are restricted to saline filled implants except in unusual conditions.

My personal opinion is that the FDA is being overly restrictive, yet at the same time, I feel that if the gel filled implants were released, I would continue to advise my patients to select saline implants. My opinion is based on the fact that while I still am firmly convinced that saline is safer, I do not feel that the risk from gel is so great that patients should not have the right to make that choice for themselves.

Gel filled implants were used for many years and while there is no denying that more problems occurred that were originally anticipated, they did not represent the health treat that radical consumer advocates and lawyers suggested. For the most part, unanticipated problems represented higher than anticipated incidence of firmness and leakage. For the most part, these problems could be corrected with additional surgery.

Dr. David Feigal, Director of the Center for Devices and Radiological Health at the FDA, stated that the Agency felt that there was not enough information regarding why ruptures occur and what happens when they do. He also expressed the opinion that longer term studies were required related to these issues as well more information related to any possible relationship to connective tissue disorders.

While it is quite unusual for the FDA to ignore the recommendation of its advisory committees, Dr. Feigal pointed out that approximately 10% of applications are rejected after a vote of approval from the Advisory Panel.

SPRING LEADS TO THOUGHTS OF BODY CONTOURING

Spring is right around the corner and we are already seeing an increase in the number of consultations for body contouring procedures such as breast augmentation, liposuction and tummy tuck.

Last year seemed to be a big year of tummy tuck procedures. We have seen some refinements in technique that have helped to improve the safety and effectiveness of this operation. While still a major procedure, newer techniques help to minimize the extent of the surgical dissection which further reduces the incidence of wound healing complications. Additionally, the use of the pain pump discussed in a previous issue has been a big help in reducing recovery time.

The pain pump is a device that provides for the continued infustion of a local anesthetic into the surgical wound for a few days following surgery. A small catheter allows for a precisely measured safe dosage of the drug. The catheter is subsequently removed when the device is no longer needed. We have been quite impressed with the effectiveness of the pain pump and our patients have certainly confirmed its effectiveness.

Remember however, that in spite of the fact that patients are usually back to near normal activity within a few days of most cosmetic surgery, the final results require much longer periods of time so it certainly pays to plan ahead. Don’t expect to be in that new bathing suit a week or so after liposuction or wearing that new bikini a week after breast augmentation.

That’s it for this month. We appreciate your interest and welcome your suggestions.

That’s it for this month. As always, we appreciate your feed back.

Sincerely,

Howard A. Tobin, M.D., F. A. C. S.
www.newlook.org

For general information: askdena@newlook.org or n41gt@newlook.org