The FDA met for two days at the end of August to discuss and review the safety of silicone gel breast implants. In November 2006, almost five years ago, silicone gel implants were released back on to the American market for general use. The FDA demanded at that time that MRI evaluations be recommended for every patient, regardless of whether or not she was having any problems, at 3 years and then every 2 years.
This has been a major source of difficulty in my NJ breast implant practice. When I meet with a lady in consultation for breast implants I review what I consider to be the 3 major differences between saline and silicone implants. First of all, silicone feels more natural than saline. They also have less wrinkling or rippling but I consider this as one thought. Issue two is safety. Despite being one of the most studied medical devices in the history of the United States, people still worry about safety. They were taken off of the market because we just didn’t know if they were safe. Now we have an abundance of true scientific evidence demonstrating their safety. That being said, some ladies still simply worry about them. The biggest issue is long term detection of leaks. What I explain to patients is that it is often very hard to detect silicone gel leaks. This is why the FDA recommended MRI in 2006. The problem with MRI is that they are a nuisance, they are embarrassing for many women, they are expensive, and they sometimes overcall “possible” leaks.
The FDA concluded at the end of the sessions that the MRI recommendation should likely be ended. Many news outlets have reported this although official notification of any change has not been proclaimed. Many plastic surgeons already do not recommend this. In my practice I have recommended this to each and every silicone gel patient since they were released back onto the market in 2006 and it has unfortunately discouraged many ladies from choosing silicone. I have not seen the official notifications from the FDA that physicians should stop making this recommendation but it is likely just around the corner and would be a very good change. For now, MRI recommendations will continue until the FDA mandated package labeling changes however patient education will certainly include these discussions.