Silicone Breast Implants and the FDA
Over the years, there has been a great deal of confusion regarding the safety of silicone gel breast implants. Are they safe in the event of a rupture? Do they cause CTDs? Many people still don’t know the whole story on silicone gel implants.
In 1992, the FDA removed silicone gel breast implants from the market amid a media-fueled health scare that had no scientific basis. The rumor was that silicone gel implants caused connective tissue disorders, which typically occur in cases where foreign matter has entered the body.
Just two years after the ban, in 1994 the Mayo clinic found “no association between breast implants and the connective-tissue disease and other disorders.” Nonetheless, class action lawsuits were filed and implant manufacturers were driven out of business.
In 2006, after volumes of research had debunked the CTD hypothesis, the FDA lifted the restrictions on silicone gel breast implants. Fortunately, research and development wasn’t significantly hindered by the ban and we are now fortunate to have several choices in advanced silicone gel breast implants.
The latest breast implant offerings from Mentor and Natrelle are superior to those used by plastic surgeons in the past. Each company has their own gel formula that is able to maintain its integrity and inhibit silicone leakage, while still remaining highly pliable. Both manufacturers also offer excellent warranties for their products.
Advantages
- Natural appearance and consistency
- Lighter than saline breast implants
- Not prone to visible rippling
Disadvantages
- More expensive than saline breast implants
- Non-adjustable volume, requiring longer incision
- Patient must be at least 22 yrs old, per FDA regulation