British biotechnology firm AorTech is moving towards clinical trials of what it says are “next generation” breast implants that are less prone to leaking and rupturing and feel more natural.
Elast-Eon implants could take 10 percent of the $600-million-a-year global market, Chief Executive Frank Maguire told Reuters on Friday following a meeting with the U.S. Food and Drug Administration.
“The take-away from the meeting is we’re on the right track,” said Maguire. “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.”
Breast implants have been around since the 1960s but have been dogged by controversy since the 1990s. Critics say silicones often leak from the gel-filled devices, causing cancer and neurological diseases.
As a result, some 90 percent of the U.S. market uses saline-filled implants. Scientists have been working on cross-linking the molecules in silicone-gel implants to prevent leaching, but their texture has become increasingly firm.
“Now they’re too firm,” said Maguire. “And saline implants are like bags of water.”
Trials of implants filled with peanut oil and soy-bean oil have come to nothing, he said.
“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,” said Maguire. “And we can move back into the softer range that more naturally simulates breast tissue.”
He said he was confident of finding a partner company for clinical trials.