I was asked this great question through Google Plus-
“Hi Dr. Kim, what’s your take on silicone implant leaks?”
Uhm, let me get my professor hat on, and start to lecture. Drink some caffeine if you need help staying awake.
In general, there are a couple of things to remember about silicone breast implant leaks, or the lack thereof. The FDA reapproved silicone breast implants in November 2006, so the newer filler material is good to great.
- History of Silicone Breast Implants
- Age of Silicone Breast Implant
- What is a “gummy bear”, “memory gel”, or “cohesive gel” silicone breast implant?
- What does the FDA have to say about all of this?
History of Silicone Breast Implants
Silicone breast implants were invented in the 1960’s by plastic surgeons in Houston, TX. Without torturing you with geeky details, and to make the overall history more melodramatic, one of my fave movies was made by HBO about early breast implants- “Breast Men”, starring David Schwimmer and Chris Cooper.
Factually, it’s correct, but not surprisingly, Hollywood has made it more fun to watch.
Early silicone breast implants were great, since there were very few options at that time for breast cancer patients. However, if the silicone breast envelope failed, the silicone gel would be difficult to remove from the surrounding breast tissue. I have removed the older silicone gel breast implants from several patients, and I have to use special techniques to remove the silicone gel, because it’s difficult to separate from normal breast and chest wall tissue.
Not all silicone breast implants, even pre-1992, fail. However, every medical device, including old and current breast implants, have a known failure rate, and generally, you need to remove and replace any breast implant that’s not working like it’s supposed to.
There were concerns about auto-immune disorders and silicone breast implants, but it seems like significant, major problems with early silicone breast implants and the causation of auto immune disorders has not been linked in really large meta-analyses of patients with breast implants. I’m basing these sentences on my plastic surgery knowledge of bio medical statistics, patient studies with a larger“n” value, pooled studies, and “P values”. (This entire paragraph is very controversial, so I’m sure I’ll get a lot of comments from haters, but at least try to be civil and not use vulgar language!)
With continued problems with the early silicone breast implants, the FDA banned silicone breast implants in 1992. The FDA re-approved silicone breast implants for reconstructive surgery in the early 2000’s, but only under special patient groups of studies. (FYI- I was an investigator in those studies). The FDA re-approved silicone breast implants for cosmetic use, and easier access, in November 2006.
Age of Silicone Breast Implant
Silicone breast implants made after November 2006 use silicone gel inside that sticks to itself- and thus sticks to itself, even if the envelope of the breast implant is not intact. I have a photo of a cut breast implant on my website, and basically, cutting out a piece from a silicone breast implant reveals that it’s not oozy, like pre-1992 breast implants.
What is a “gummy bear”, “memory gel”, or “cohesive gel” silicone breast implant?
These are marketing or non-medical terms for silicone gel implants that are cohesive, or self-sticking. The FDA has not approved the latest generation of silicone gel breast implants, which have better cohesive properties and more breast shapes. If the newer models are approved, then breast reconstructive patients and cosmetic breast patients will have even more options for breast enhancement. Also, especially in breast augmentation, there will be better sizing, width, and volume options available.
What does the FDA have to say about all of this?
The FDA is carefully and closely monitoring silicone gel breast implants in the US. They want better long-term follow-up studies of patients, and I recently wrote a blog post on their latest committee meeting on it.
So, given current technology, studies, and future follow-up, silicone gel breast implants seem to have more cohesive gel inside of them that allows more stickiness to itself, and little to no stickiness and reaction to surrounding breast and chest tissue.
So, a long answer to a short question- are you still awake? If so, please leave comments below.