Here is an article I wrote that is more academic than usual but it explains how silicone breast implants (yes ladies, cohesive gel too!) can affect health. However, I think you will be relieved to know my findings…
Silicone Breast Implants—Health vs. Vanity
Author: Erica Grenci
For years the scientific and medical communities endeavoured to create a product that would act as a sustainable breast implant for women. For purposes of breast reconstruction following a mastectomy, to correct distortion, or to enlarge for cosmetic enhancement, there was a demand for a functional product that would replicate the real thing. Many attempts were made with a variety of materials; however, it wasn’t until scientists at Dow Corning offered silicone materials to two plastic surgeons from Texas that the first promising silicone breast implant was developed. The first trial patient was in 1962, and only 2 years later the product was widely marketed, enticing thousands of women to undergo the implant procedure. At this time medical devices were not under regulation by the FDA and thus lacked sufficient medical research to testify to its safety. In 1974 approval of medical devices was designated to be under the control of the FDA, which now was required to review all pre-existing products. After 30 years of use, silicone implants were banned in 1992 to the general public due to lack of evidence that would address potential risk factors.
So what is silicone? Elemental silicon comprises 28% of the earth’s crust by mass, making it the most abundant element on earth and is essential in bone formation as well as mineralization (Carlisle, 1984). As silicone, silicon-oxygen chains with organic side groups combine to form a family of synthetic polymers that are widely used in a variety of medical products (Teuber, 1994). In an extremely pure form called dimethylsiloxane (see diagram #1), silicone is modified into the medical grade breast implant that is still extensively used today (Brody, 2009). Specifically, this silicone polymer is one of the least bioreactive materials being used for medical devices and is extensively present in the environment, making its presence in our bodies not uncommon. However, it is important to distinguish the variety of compounds in which silicone exists (although only slightly in the form of dimethylsiloxane) and the possibility of the body reacting to varying configurations. “Biologically, medical-grade silicones invoke a straightforward, nonspecific foreign body response, resulting in typical macrophage invasion, giant cell formation, and eventual scarring.” (Brody, 2009). What had challenged the medical community in 1992 was the need for evidence to demonstrate that the silicone breast implant was safe for its ever-growing patient base.
What had been an initial concern were the occurrences of implant rupture as well as the diffusion of silicone through the walls of the implant shell. As discussed by Brody (2009), the implant gel consists of a 3-dimensional mesh-like molecule with a mix of oils bound to its matrix. In fact, it is the oil portion of the matrix that ‘bleeds through’ the implant. Since silicone is hydrophobic, the element remains attached to the implant surface without being transported throughout the body or affecting any organs. As time passes, a few molecules may be picked up by marcrophages and even fewer reach the lymph nodes. Also, in the case of implant rupture, the silicone is confined within the surgical pocket of the scar envelope (Brody, 2009). Evidence regarding the interaction of implant-derived silicone with the body provided the foundation for optimism surrounding implant safety, however, further examination still needed to be conducted.
Since the moratorium on silicone breast implants a vast amount of research was undertaken to uncover the health effects it poses to an individual. Fortunately, for its widespread patient database, no correlation could be demonstrated that indicated a harmful outcome to its recipient. Of the many illnesses tested for, silicone implants were not linked to connective tissue disease (Nyren et al. 1998; Sanchez-Guerrero et al. 1995) nor were they linked to malignancies, “women with silicone breast implants are not at an increased risk for primary or recurrent breast cancer or other tumors.” (Handel et al. 2006). Also contrary to what was previously thought, there was lack of association between silicone breast implants and immune disease of any systemic illness (Handel et al. 2006). Seemingly, what once had fuelled widespread concern is not actually cause for much worry at all. Interestingly, a study that measured mortality rates among women who received silicone breast implants for cosmetic purposes found that they had lower mortality rates than the general population (Villeneuve, 2006). Further alleviating concern, it was reported that due to the indigestibility of silicone filler, it is safe for women with silicone breast implants to breast-feed their children (Bondurant et al., 2010). The silicone used for breast implants is insoluble in biological fluids and additionally, the widespread presence of silicon compounds in the environment and our bodies lends to its harmlessness.
Despite its reported safety, silicone implants are not without side effects. A complication known as capsular contracture is a potential adverse effect of silicone implants; however, its cause is a result of the natural process of scar formation that occurs after there is a separation of tissue, not from the silicone product itself (Gampper et al. 2007). Varying in degree that is dependent on the individual, capsular contracture is “the production of firmness, pain, and distortion that arises when the scar envelope shrinks and squeezes the implant” (Brody, 2009). Moreover, “the incidence of symptomatic capsular contracture does not diminish after 1 or 2 years. The longer the implants are in place, the greater the risk for developing contracture” (Handel et al. 2006). Alongside occasions of reoperation, capsular contracture is the most common complication associated with silicone breast implants and is low in severity, followed by others that are also cause for moderate concern (See chart #1); specifically, implant rupture, breast pain, swelling, malposition of implant, nipple complications, scarring, hematoma, asymmetry, loss of sensation, rippling, implant visibility, fluid accumulation, drooping of the breasts, and delayed wound healing (Bondurant et al., 2010).
Since the first generation of implants in the 1960s, steps have been taken to redesign implants to reduce the incidence of capsular contracture and the leakage of silicone filler. The viscous silicone gel that would seep out through the implant shell has been largely eliminated as have the frequency of occasions of shell rupture. Implants today are manufactured with a semi-solid silicone gel filler and the implant shell is coated with an elastomer, which is a polymer with the property of elasticity (Handel et al. 2006). They are also offered in several textures and shapes: round, tapered, and natural, smooth or textured (see image #1). These evolvements have provided increased success rates to women undergoing implant surgery for both cosmetic enhancement and reconstruction. Also, in spite of local complications and a 30% reoperation rate, patient satisfaction remains high (Handel et al. 2006). Just in the United States alone over 6 million women have received breast implants in past years and the numbers are rising at an exponential rate (Brody, 2009). According to the American Society of Aesthetic Plastic Surgery, in 2008 approximately 355,671 women underwent breast augmentation, a 350% increase from the previous year (see Table #2). Thus, it appears that breast implants have made their mark in spite of previous alarms challenging their safety. In the case of silicone implants, it appears that health triumphs along with vanity.
So now in English… silicone breast implants are just fine!
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15, 2011 from National Academy Press, Institute of Medicine: http://www.nap.edu/catalog/9602.
Brody, G.S (2009). Breast implants, safety and efficacy of silicone. Retrieved March 15, 2011 from
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