Posted by 
Women receiving silicone breast implants may be at increased risk of several rare adverse outcomes compared to the general population. The researchers analyzed data on nearly 100,000 patients enrolled in the LPAS between 2007 and 2009-10. More than 80,000 patients received silicone implants; the rest received implants filled with sterile saline solution.
Seventy-two percent of the patients underwent primary breast augmentation, 15 percent had revision augmentation, 10 percent had primary breast reconstruction, and three percent had revision reconstruction procedures. The large size of the database enabled researchers to assess the risk of rare adverse outcomes.
Women receiving silicone implants were at increased risk of several rare harms compared to the general population. The elevated risks included three conditions classified as autoimmune or rheumatologic disorders: Sjogren’s syndrome, with a risk about eight times higher than in the general population; scleroderma, a seven-fold increase in risk; and rheumatoid arthritis, about a six-fold increase in risk.
Silicone implants were also associated with a 4.5-fold increase in the risk of stillbirth, but no significant increase in the risk of miscarriage. Risk of melanoma, a serious type of skin cancer, was nearly four times higher in women with silicone implants. There was no significant association with the risk of suicide, which had been suggested by a previous study. The database included just one case of breast implant-associated anaplastic large cell lymphoma-a rare but serious type of cancer previously linked to breast implants.
Compared to saline-filled implants, silicone implants were also linked to a higher risk of some surgical complications. These included capsular contracture (scarring around the implant), which occurred at a rate of 5.0 percent with silicone implants versus 2.8 percent with saline-filled implants. Capsular contracture occurred in 7.2 percent of primary breast augmentation procedures, and was the most common reason for reoperation in this group.
While certain rare harms appeared to be more common in women with silicone implants, absolute rates of these adverse outcomes were low. The researchers emphasize that their results are inconclusive, due to limitations inherent in the use of postapproval databases including the lack of complete patient information and individual follow-up data. Plastic surgery community’s duty to provide definitive evidence for the risks associated with breast implants.