New Breast Implant Set for Trials
October 29, 2004 -- A British firm has announced plans to develop breast implants using a synthetic biomaterial which it claims will make them safer and feel more natural.
Scottish-based AorTech said on Friday they were preparing to begin clinical trials of their "next generation" Elast-Eon implants following a recent meeting with the U.S. Food and Drug Administration.
"The take-away from the meeting is we're on the right track," AorTech chief executive Frank Maguire told Reuters.
"It makes all the sense in the world to move ahead and take it to the stage where we're ready for clinical trials. This is the next generation."
Elast-Eon was designed at the Commonwealth Scientific and Industrial Research Organization (CSIRO) in Melbourne, Australia, as a biostable material for use in life-critical medical devices such cardiovascular implants.
But AorTech said it hoped Elast-Eon would help them break into a global market in breast implants estimated to be worth $600 million a year.
Tear-resistant, flexible and blood-compatible, the material offers a more durable and resilient alternative to silicone or silicone gel.
Silicone implants, which were first developed in the 1960s, were taken off the market in the U.S. in 1993 due to concerns over their safety.
Critics claim silicone often leaks from the gel-filled devices, causing cancer and neurological diseases.
As a result more than 90 percent of the U.S. market now uses saline-filled implants. To prevent leaching and rupturing, breast implants have become increasingly firm, while trials with peanut oil and soy-bean oil have failed to produce a satisfactory alternative.
In January the U.S. Food and Drug Administration rejected a manufacturer's request to restore silicone breast implants to the market.
"Now they're too firm," said Maguire. "And saline implants are like bags of water.
"Elast-Eon is a very clean material that is free of the silicone oil that has been leaching out of gel-filled devices for the past 20 to 30 years. And we can move back into the softer range that more naturally simulates breast tissue."
AorTech said Elast-Eon was also more compatible with imaging technology used in tumor screening.
Earlier this year the Journal of the American Medical Association published research which claimed that breast implants made it harder for doctors to interpret mammograms.