As a breast surgeon, perhaps the most common question I am asked is whether silicone implants are safe. Over the past 3 decades the controversies around silicone and associated media coverage have led to confusion amongst patients. Here, I offer a brief history of the silicone implant and evidence-based answers to commonly asked questions.
The first silicone gel implants became available in the early 1960s. These implants had a weak outer shell and a liquid inner gel. The weak shell led to a high number of implant ruptures, which caused women to wonder if the leaking silicone could cause systemic health problems. In 1976, with the passage of the Medical Device Amendments Act, the Food & Drug Administration gained authority over regulation of silicone implants. The Panel decided that there was a lack of evidence supporting the safety of silicone and in 1992 silicone implants were pulled off the market.
By 1992 there were a number of case series in the literature describing women with silicone implants and autoimmune diseases such as scleroderma and rheumatoid arthritis. But there were no studies that could answer whether the silicone was causing these diseases. In 1994 a study out of the Mayo clinic published in the New England Journal of Medicine showed no association between silicone implants and autoimmune disease.
A Danish study that looked at autoimmune disease in 2761 women with breast implants and 8807 comparison subjects who underwent breast reduction surgery found that compared with general population rates, there was no significant increase in the incidence of any autoimmune diseases in either the implant or comparison groups, after a follow-up time of 13.4 years.
The only finding of a relationship between autoimmune disease and breast implants comes from a single study of female health professionals. This study found a small increased risk of self-reported autoimmune disease overall among women with breast implants. Compared with women without implants, the relative risk for any self-reported autoimmune disease was very small. This study used outcome data that were self-reported by female health professionals in a mailed questionnaire. In a subsequent medical record validation of these data by the same research group, evidence of over-reporting of disease by the subjects was observed, as only 22.7% of self-reported cases could be confirmed using medical charts.
As large studies showed no increased risk of systemic disease, and new implants provided stronger outer shells and more cohesive inner gel, the FDA approved the reintroduction of silicone implants onto the market in 2006 and are now widely used for both breast reconstruction and breast augmentation surgery.
Common Patient Questions
What is the risk of rupture of a silicone implant?
A 2014 study showed that by 10 years the overall implant rupture rate is 7.7% as studied using MRI imaging. My approach is to see my breast augmentation patients every year for the rest of their lives to check for any evidence of rupture.
Is there an increased risk of breast cancer with silicone implants?
In the same study new diagnoses of breast cancer in breast augmentation patients were less than 1%. There were no instances of the implant interfering with mammography. Based on current studies there is no evidence that implants either increase or decrease the risk of breast cancer as shown in this Canadian study published in the New England Journal of Medicine.
Are there risks of any cancer with silicone implants?
The FDA has identified a possible association between breast implants and the development of anaplastic large cell lymphoma (ALCL), a rare type of non-Hodgkin’s lymphoma. ALCL is not cancer of the breast tissue, but instead starts in the scar that develops around an implant. In total, the agency is aware of approximately 60 cases of ALCL in women with breast implants. This is a very small fraction of the 5-10 million women who have received breast implants worldwide. So far the majority of cases are associated with textured implants.
Do I need to get my implants replaced every 10 years?
A common misconception is that breast implants need to be replaced routinely. This idea keeps many women from getting a procedure they want because they are worried about future surgeries. However, breast implants can last longer than you may think. When it comes to the “lifespan” of implants, there are no guarantees. Some will last a lifetime. On average, 35% of women will need a reoperation within the first 10 years after augmentation. However, we do not routinely replace implants if there are no complications. 65% of women will be living with their original implants at 10 years and should continue to be followed by their surgeon every year.
Do I need routine MRI imaging?
When the FDA approved the use of silicone implants in November of 2006 one of their recommendations was to obtain an MRI every 2-3 years to detect any evidence of a rupture. The key word is "recommend" and not require. I follow my patients yearly and if there is any concern I obtain an MRI, however I do not recommend routine imaging.
Is there a warranty on implants?
Implant companies differ in their warranties, but in general if there is a rupture of the implant it will be replaced by the company free of charge. Some surgical costs may also be covered.
Is silicone better than saline?
This has not yet been studied in breast augmentation patients. However breast reconstruction patients show a clear preference for silicone as shown in one of my studies from 2010. Generally silicone feels more natural than saline.