Breast augmentation has been around for a long time already, although in the past, the procedure wasn’t always approved by the FDA (Food and Drug Administration) in America. In more recent times, a law was passed which requires all foods, drinks, medical supplies, drugs and etc. to be approved by the FDA before they are made available to the public. Of course, because this law wasn’t always in place, the very early breast implants were being used without any form of approval, and then even when the law was passed, those products which had already been manufactured where excluded. In other words, they were grandfathered; meaning doctors could continue using implants without the need for approval, providing the said implants were manufactured before the law came into effect.
Towards the end of the 1980′s many silicone breast implants were taken off the market. This happened when the FDA scrapped the grandfather clause due to several rumors regarding medical complications caused by these implants. Even though “grandfathered” silicone implants were pulled off the market, saline filled implants were still permitted. Because saline is very similar to fluid which occurs naturally in the body, these implants were deemed to be safe.
Several years after the silicone implants were pulled, and after a considerable amount of research had been done, they were eventually approved by the FDA and once again allowed onto the market. With that said, the FDA has imposed strict regulations regarding the use of them.
For example, while saline filled implants can be used in women over the age of 18, the silicone implants can only be used in women over the age of 22. The FDA introduced these age restrictions because they felt that women below these ages were not yet fully capable of making decisions which could essentially affect them for life.
At present, only Mentor and Allergan have been approved to manufacture saline and silicone implants. These are the only two manufacturers to have been given the green light. While the FDA gave approval for saline filled implants in the year 2000, it wasn’t until 2006 that the silicone implants got the stamp of approval.
There are currently studies underway regarding a new “Gummy Bear” implant. These basically utilize silicone with a thicker consistency than the traditional silicone implants, and because of this, it is believed they’ll be safer should they rupture. How long it will take before these get FDA approval is anyone’s guess.
Clinical research is still ongoing with regards to both the saline implants and the silicone implants in order to establish whether or not they will have any negative long term effects. So far, the implants which have FDA approval are deemed to be safe, but one needs to bear in mind that any medical procedure comes with certain risks.
Risks involving breast augmentation include the following:
* Loss of nipple sensitivity
* Asymmetry
* Inability to breastfeed
* Scarring
* Rupture
* Infection
Any woman who is considering breast augmentation should always consult a duly qualified and board register cosmetic surgeon in order to discuss the various options available, and also the associated risks involved.