ParfumGigi@aol.com
1 février, 2007 00:09
Health — Breast implant idea full of promise
AKRON, Ohio — Nearly 350,000 women received breast implants last year in the United States. And nearly all of them will eventually suffer the same side effect — scar tissue that forms a capsule around the implants, in some cases leading to ruptures, leaks or deformity, as well as additional surgeries.
But Judit Puskas believes many of these problems could be avoided.
Puskas, a professor of polymer science at the University of Akron, is trying to develop a new type of breast implant made of biorubber polyisobutylene, which would be lighter, less likely to rupture and less permeable than silicone implants.
The biorubber implants would also have the ability to release drugs that could inhibit the growth of the scarlike capsules, much like drug-coated stents prevent scar tissue from blocking arteries.
For now, Puskas is waiting to hear whether the National Science Foundation will fund an 11-year, $10 million proposal to produce and test the new implants.
If that funding comes through, it would be a new direction in federal research.
"My real awakening and motivation for this project is that the [National Institutes of Health] does not support any project — zero — for alternative materials for breast implants," Puskas said. "It's silicone and silicone only. There is nothing else."
Last year, the U.S. Food and Drug Administration lifted a 14-year ban on silicone breast implants, saying that "rigorous scientific review" shows that the risks, benefits and labeling of implants allow women and their doctors to make informed decisions. It found "no convincing evidence" that silicone implants lead to connective tissue disease or cancer.
Puskas said that determination is missing the broader problem. "The real problem is the capsule formation around the implant," she said. "It actually happens to 100 percent of women over time."
Summa Health System, the Cleveland Clinic, Tulane University, the Michigan Nanotechnology Institute for Medicine and Biological Sciences, and Nano Copoeia Inc. of St. Paul, Minn., are supporting the grant request, Puskas said.
If the grant is funded, Summa's role would be to test the biorubber to determine if it's more compatible with the human body than silicone, said Stephen Schmidt, Summa's director of surgical research.
"There's good reason to suggest it would be," he said, explaining that the biorubber in Puskas' project is similar to that being used in stents made by Boston Scientific. The biorubber has also been approved by the FDA for use in an artificial pancreas.
If the grant money comes through, the first year of the project would focus on creating a prototype and testing its mechanical and chemical properties. In the second year, the implant would be tested in the lab and in animals, with the goal of presenting the device for clinical trials.
According to the American Society of Plastic Surgeons, breast augmentation was the most popular surgical cosmetic procedure in 2005, with 291,000 women choosing breast implants. Another 58,000 women received breast implants as part of breast reconstruction surgery.
However, a large number of women had to have their implants removed — about 40,000 in 2005 and 51,000 in 2004.
Given such statistics, Puskas said, it's obvious that there's a need for research into different implant materials.
In fact, she said, "I find it offensive that nobody else is working on it."
— By Tracy Wheeler, Akron Beacon Journal
