Since silicone gel breast implants have been re-introduced for patient use in late 2006, they rapidly have become the preferred implant for many breast augmentations. Yet, despite FDA-approval, many patients (even relatively young ones) understandably ask about their safety. In my Indianapolis plastic surgery practice, I routinuely tell patients that they are perfectly safe and would not be FDA-approved if it were not so. However, a more detailed explanation of that general statement is detailed below.
In 1997, the Department of Health and Human Services began one of the most extensive research studies in medical history by appointing the Institute of Medicine of the National Academy of Science (IOM) to examine potential complications during or after breast implant surgery. The committee included members of the medical, scientific and educational communities with experience in radiology, women’s health, neurology, oncology, silicone chemistry, rheumatology, immunology, epidemiology internal medicine and plastic surgery. After reviewing years of evidence and research concerning silicone gel-filled breast implants, the IOM found that health problems such as connective tissue illnesses, cancer, and neurological diseases are no more common in women with breast implants than in women without implants.
Furthermore, reviews of research and medical studies on silicone breast implants shows that breast cancer is no more common in women with silicone breast implants than in those without. The American Academy of Pediatrics concluded in September 2001 that the evidence currently does not justify classifying silicone breast implants as a contraindication to breastfeeding. Epidemiological investigations have not found any increased risk of adverse health outcome in children born to women with silicone breast implants.
Since the early 1990s, a number of independent comprehensive reviews have examined studies concerning links between silicone gel breast implants and systemic diseases. The consensus of these reviews is that there is no clear evidence of a causal link between the implantation of silicone breast implants and systemic disease. In the 1990s, thousands of women claimed that they had become ill from their implants. Some studies around that time have suggested that these health symptoms of women with implants may improve when their implants are removed. As studies have been done which followed women with implants for a longer period of time, more data have become available on the likelihood of these autoimmune symptoms. Several large studies in Denmark found implant recipients no more likely to be diagnosed with an increased incidence of classic auto-immune symptoms as compared to women of the same age in the general population and that musculoskeletal symptoms were generally lower among women with implants compared with women with other cosmetic surgery and women in the general population.
Several studies have established that women who elect to undergo breast augmentation or other plastic surgery tend to be healthier and more affluent than the general population, prior to surgery and afterwards. A large study with long-term follow-up of nearly 25,000 Canadian women with implants reported that breast implants do not increase the risk of death in women.
In 2001 a study suggested an increase in fibromyalgia among women with extracapsular silicone gel leakage, compared to women whose implants were not broken or leaking outside the capsule. This association has not been repeated in a number of related studies and the FDA concluded the weight of the epidemiological evidence published in the literature does not support an association between fibromyalgia and breast implants.
In conclusion, every previous medical fear about the dangers of silicone gel breast implants has never been substantiated by further study and review. Over ten years of exhaustive studies has failed to find any reason for women to be concerned about receiving silicone gel breast implants.
Dr. Barry Eppley