Silicone implants have been off the market for more than a decade, but last year the FDA gave its stamp of approval to a new generation of silicone implants — implants that are not yet available to the public.
The FDA never banned silicone breast implants, but when the government restricted their use for cosmetic purposes, most women were limited to saline implants.
As part of a clinical trial, some doctors continued to offer silicone to those who qualified.
“Before it became a controversy, the silicone was 98 percent of what plastic surgeons used. And the reason was simple: The saline device was an inferior device. It has a lot of problems with visible wrinkles and did not give as natural a feeling breast,” Dr. John Baeke said.
As part of a clinical trial, some women chose a new cohesive silicone gel implant.
If a conventional silicone implant ruptures — the kind no longer available for cosmetic use — the gel oozes out. With the new cohesive gel, often described as having the consistency of a very soft gummy bear — it holds its shape, even after cutting it with scissors.
An FDA advisory committee has now signed off on the safety of silicone implants, but they are still not available to the general public. Baeke blames bureaucracy.
Despite the delays, Baeke said he’s convinced silicone breast implants will again be available to the general public. He predicts by the middle of next year, but still encourages patients to do their homework.