Implants anyone?

[Guest guest]

Yet another idea for " new, improved " breast implants!

.. . . Rogene

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http://www.buchtelite.com/2005/1020/news_01.shtml

Implants anyone?

Breast technology ready to go when prof finds funding

by Kopec

News Editor

news@...

University of Akron polymer science professor Judit

Puskas holds the silicone gel implant that is not

approved by the FDA. She wants to use a polymer

material to make them safe.

You don't need to remind Judit Puskas that October

marks the 15th annual Breast Cancer Awareness Month.

The University of Akron polymer science professor has

done more than her part for the cause. Puskas

developed a polymer material to prevent leakage in

breast implants. She received FDA approval last year.

Puskas said 75 percent of women who suffer from breast

cancer choose to have reconstructive surgery or breast

implants.

The problem, she said, is safety.

In an implant filled with silicone gel, the gel leaks

out of its shell over time and spreads throughout the

body.

" It was established that certain women are really

sensitive to silicone, " Puskas said. This leakage has

been linked to health problems such as lupus and

immune system difficulties.

" There is no direct evidence that even though the

silicone might leak to all kinds of places, it was the

cause of those illnesses, " Puskas said. This

controversy led to class action lawsuits against Dow

Corning, the company that produced the silicone gel

implants. The lawsuit caused Dow Corning to go

bankrupt and the FDA to ban the silicone gel.

Currently, the only implant filling approved by the

FDA is saline, a saltwater solution. This solution

also leaks, and eventually needs to be refilled.

Clients also complain that the saline is not as

authentic as the gel.

" It is water inside and they say that it is very

unnatural; the gel is more like the human tissue, "

Puskas said. " The women must sign up for a clinical

trial if they want the silicone gel implant. "

Despite the health problems that have been linked to

implants, the demand is on the rise. In 2000, the

demand for cosmetic implants increased six-fold.

" I was shocked because I thought, oh my God, why is

this? How come no one is researching another material

to replace silicone, " Puskas said.

Puskas said her polymer material may be the solution.

The material currently has applications in cardiology.

It coats a wire mesh that is inserted into the artery,

then blown up like a balloon. Puskas' material

prevents the artery from closing up. Before this

technology, patients had to have open-heart surgery.

Puskas believes this same material can be used to coat

silicone gel to prevent breakage and leakage.

" It looks like the silicone but it is very impermeable

so nothing would go through it, " she said. " We already

know from previous studies that it is bio-compatible. "

With the proper funding, Puskas said she could have an

implant ready for clinical trial in about two years.

" The surgeons I have talked to at the Cleveland Clinic

said they are ready to try it if it gets approval, "

she said.

The only thing holding her back is funding. Puskas has

written a half dozen funding proposals, but she said

breast implants are not a top priority to most

sponsors.

" The funding agencies establish their own priorities

based on input from a lot of advisory groups and their

own planning, " said Kelley, dean of the polymer

science department. " Nonprofit foundations also have

set criteria and lots of competitive proposals. "

Puskas said she gets a positive response whenever she

talks to women's groups about her proposal.

" They say, 'Why don't we do this,' " Puskas said. " It's

because I have no money. " Until her project receives

funding, the breast implant situation will remain in

limbo. " It deserves a chance, " Puskas said.