The FDA released a 63-page report on the safety of silicone gel-implants, commenting that the risks of the implants were well enough understood that patients could make a well-informed decision. Still, however, there are issues that women who have silicone gel-implants should know about, or if they are considering them, should be aware of. This is in contrast to saline filled breast implants- that do not have these issues.
Silicone gel implants are not a lifetime implant says the FDA
Many remember how silicon breast implants were removed from the market in 1992 as a result of some poorly done studies linking the leaking liquid silicon to Lupus, arthritis type illness, and other connective disease issues. In 2006 the FDA approved two brands of silicone gel implants for women over 22.
The good news is that the studies found no association between the silicone implants and connective tissue disease (Lupus, arthritis, etc) but did find a “very small” increased risk of a large cell lymphoma.
The most frequent complications included implant rupture, capsular contracture, wrinkling, asymmetry, scarring, pain, and infection and ultimate implant removal. The complications increased with time. “The longer a woman has silicone gel-filled breast implants, the more likely she is to experience local complications or adverse outcomes. As many as 1 in five primary augmentation patients and 1 in 2 primary reconstruction patients require implant removal within 10 years of implantation.”
On the other hand, woman who had implants had high levels of satisfaction with their body image “shape, feel and size of their implants.”
The FDA recommended that women with silicone gel-filled breast implants undergo MRI screening for silent ruptures at 3 years post-implantation and every 2 years thereafter. This does not apply to women who have saline filled implants – they do not need to have the MRI studies. In follow up- the FDA has changed that- please see the video
It is also noted that the implant is not a “lifetime device,” that “the longer you have your implants, the more likely it will be for you to have them removed.” Still, most women will need to have them replaced about every ten years.
Note that the studies for the silicone gel implants are on going, so new data may emerge with time. The FDA was critical of both companies involved because of low number of women in the study groups – apparently Johnson and Johnson and Allergan did not pay the people for this study or the physicians to follow it.
