The History of Silicone

Written by Board Certified Plastic Surgeon Nima Naghshineh, MD, FACS on July 8th, 2020.

---

Silicone breast implants have a very long and complex history dating back decades into the 70s and 80s. I have selected some excerpts from a well written article from Plastic and Reconstructive Surgery journal that will hopefully summarize much of it…

“In the 1980s, as consumer concern regarding silicone breast implant safety grew, the U.S. Food and Drug Administration’s new surveillance system began to identify local complications associated with silicone implants in addition to several published case reports that described an association between cancer and connective tissue disorders in patients with these devices…”

“Ultimately, in 1992, the U.S. Food and Drug Administration determined that silicone implant manufacturers had not provided enough data to adequately address consumer concerns, and silicone implants were removed from the market… Since their return, there has been ongoing extensive research concerning their safety…”

Cancer

“Between 1999 and 2005, multiple independent scientific review boards concluded that there is no excess risk of cancer of any type in women with silicone breast implants…” However, recent large studies showed that patients with silicone implants were “1.54 times more likely to develop a cancer diagnosis”. But is important to note that the “difference is likely attributable to both selection bias and lack of cancer diagnosis validation…[and] there are multiple epidemiological studies in the literature that found that women with breast implants have different patient demographics and lifestyle and/or reproductive characteristics compared with the general population that may explain these findings.”

BIA-ALCL (anaplastic large cell lymphoma)

“Reports from the scientific community have suggested a possible link between… (ALCL) and breast implants… [with] an incidence that varies between one in 3800 and one in 30,000 -100,000 women with breast prostheses per year... In 2011, the U.S. Food and Drug Administration published a safety communication stating that ‘women with breast implants may have a very small but increased risk of developing ALCL in the scar capsule adjacent to an implant.’” And readers should recognize that “textured silicone implants continue to be responsible for the overwhelming risk”

Connective Tissue Disease

“In the 1980s and early 1990s, anecdotal reports of connective tissue disorders in women with breast implants were first published. Through 2004, data from all but one study unanimously concluded that there is no association between breast implants and connective tissue disease” In fact, through 2011 the vast majority of data showed no association. However, “recently, the largest and most comprehensive epidemiological study of patient safety… of nearly 100,000 patients over a 7-year follow-up period [showed] that there were multiple connective tissue disorders for which diagnoses exceeded double that of the general population”. A review article and a large analysis of several data also showed an association between “silicone breast implants and autoimmune/rheumatic disorders, Sjögren syndrome, systemic sclerosis, and sarcoidosis.” However, it should be noted that these results are not without bias and don’t actually show a cause and effect relationship but they do raise questions and show the need for further evaluation.