Silicon Gel Breast Implants

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.

Dr. Terry Simpson About Dr. Terry Simpson
Dr. Terry Simpson received his undergraduate and graduate degrees from the University of Chicago where he spent several years in the Kovler Viral Oncology laboratories doing genetic engineering. He found he liked people more than petri dishes, and went to medical school. Dr. Simpson, a weight loss surgeon is an advocate of culinary medicine. The first surgeon to become certified in Culinary Medicine, he believes teaching people to improve their health through their food and in their kitchen. On the other side of the world, he has been a leading advocate of changing health care to make it more "relationship based," and his efforts awarded his team the Malcolm Baldrige award for healthcare in 2011 for the NUKA system of care in Alaska and in 2013 Dr Simpson won the National Indian Health Board Area Impact Award. A frequent contributor to media outlets discussing health related topics and advances in medicine, he is also a proud dad, husband, author, cook, and surgeon “in that order.” For media inquiries, please visit

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  1. Lynn says:

    I realize that this thread was posted almost a year ago but I have had time since then to find out a bit about this subject. The lymphomas occurred in about 60 women worldwide and millions of women have the implants. The only question is this, isn’t that lymphoma specific to women with implants and does not occur elsewhere or in other people? Also, although there is no proof that diseases such as scleroderma (sp?) are caused by silicone implants (all implants, even saline are silicone on the outside), if a woman develops the disease after reconstruction, is it possible that the disease did develop as a result of the immune response to the foreign body? I mean, since we don’t know where the disease came from, is that a possibility along with all the other possibilities that exist. Currently, I think that the scleroderma rate is approx 3% for implant reconstruction patients which may be somewhat higher than in the general population but I am not up on the latest statistics so don’t take that one to the bank.
    My take on the implant reconstruction issue is that it almost always involves more than one surgery. The fat auto-graft type of reconstruction requires many hours on the operating table and several surgical sites. Sometimes the area that the fat came from will also require later reconstruction. Sometimes the abdominal muscles are weakened which can make coughing difficult. A post-menopausal woman who has implant reconstruction is possibly looking at further surgery in her old age when the implant ages and a young woman may have several revisions over the course of her lifetime as each implant wears out.

  2. thedoc says:

    The large cell lymphoma is real – but the autoimmune is not. Silicone is non-reactive in its solid state. In its liquid state it isn’t

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