Sunday, December 12, 2010

Silicone Breast Implants ~ Are they LEGAL?

When the FDA allowed silicone filled breast implants back on the market in November of 2006, they did so with a few caveats - 1.  You must be 22 years old to receive a breast implant, 2.  The FDA recommends that you have an MRI every three years to check the integrity of the shell of the implant or detect silent ruptures 3.  The only FDA approved silicone breast implants are round, memory or cohesive gel implants made by Mentor and Allergan (the "gummy bear" shaped implants manufactured by any company are not legally available except under FDA controlled studies).


Ok, so like any government agency, the FDA is just doing it's job and trying to keep the public safe.  Their jurisdiction is over food, drug and medical devices - not over the people who prescribe them (surgeons) or choose to use them (patients).  They cannot enforce good decision making - only the access we have.


So, the FDA is saying there needs to be an age limit on who can have a breast implant.  Good for them - I think surgeons should say that too!  When you choose to have a breast implant - it's not like getting new colored contacts or purple streaks in your hair or even like having Botox injected!  All of these cosmetic changes are TEMPORARY!  When you choose to have a breast implant implanted into your body - you are changing your body forever - for your life time.  And you are committing yourself to all of the maintanence that comes with it.......for your life time.


The very least we can do as responsible medical professionals, is try to help each patient, regardless of age, understand the committment and the pro and cons of each and every preoperative surgical decision that is made - becasue the better those decisions are, the better and longer the result will last.


Nothing last forever and that certainly applies to a breast implant device.  However, the decisions you and your surgeon make BEFORE surgery should be in an effort to make it last as long as possible for you.  For example, the number one reason for reoperation with a breast implant is SIZE - either they are not big enough and they want more (booby greed) or they get them so big to begin with that then they are faced with all the problems of the excess weight the implants cause over time - sagging, bottoming out, traction rippling.  So by simply employing scientificly proven clinical methods like The High Five System to determine size, the surgeon and patient can drastically decrease the risk of reoperation due to size exchange - - but they have to think past "cup size" first!


So, no, the FDA can't tell us how to use implants, but they can certainly control access and in this case - -the age issue - - they are trying to save us from ourselves.  Wait, young ladies, at least until you are 22 so that you have access to all of the best products and devices.  And while you are waiting, please read and gather and research as much information as possible so that when you go in for your consultations, you are prepared.  Your consultations with surgeons about breast implants, can only be as good as your questions, which will only improve as your knowledge base improves as well.