ANALYSIS OF 100,000 PATIENTS SHOWS SILICONE IMPLANTS ASSOCIATED WITH CERTAIN SYSTEMIC DISEASES
Do you remember when the FDA lifted a 14-year ban on silicone implants in November 2006? At that time, the FDA and the Institute of Medicine based its decision to lift the ban on silicone implants on a number of small studies in the US and Europe; the studies, for the most part, were sponsored by implant manufacturers. That long-lasting moratorium resulted in thousands of lawsuits resulting in the bankruptcy of Dow Corning. Today over 300,000 cosmetic breast augmentations and 100,000 breast reconstructions that utilize implants are performed yearly in the US.
The authors of “Breast Implant Long-term Outcomes”, published last month in the Annals of Surgery, studied a prospectively collected database called LPAS (large postapproval studies) that had not previously been analyzed. The database totaled 99,993 patients and included data from Allergan’s 41,342 silicone implant patients and 15,646 saline implant patients. In addition, Mentor had also enrolled 41,975 silicone implant patients and 1030 saline implant patients. Seventy-two percent had primary augmentation and 15% were revisions.
Systemic harms were reported only for silicone-gel implants and not for saline implants. Diagnoses were made using a standard incidence ratio (SIR), the ratio of observed number of cases to the expected number of cases. Diseases that occurred over 2 times the general population included Sjogren syndrome (SIR 8.14), scleroderma (SIR 7.0), rheumatoid arthritis (SIR 5.96) and melanoma (SIR 3.71). Diseases with less than a SIR of 2.0 but with statistically significant associations included overall cancer incidence, neurological disorders, multiple sclerosis, and myositis. Interestingly, there were decreased rates of fibromyalgia and lung cancer. Unexpectedly, the rate of stillbirths (SIR 4.5) was more than double the general population; although there were statistically significant decreased rates of birth defects and congenital malformations.
The weakness of this study is that the diseases were self-reported. Yet the near 100,000 patients renders the study robust.
So from 1992 to 2006 silicone gel implants were taken off the market in the US because of reports of systemic disease possibly implant related. Now, over 14 years since the end of the moratorium, the question again arises as to whether certain systemic harms are resulting from the use of gel implants. Plastic surgeons, if not all surgeons who are asked about silicone implants, will again need to inform their patients about the possible systemic diseases associated with silicone gel implants.
As Yogi Berra once said "It's deja vu all over again".