Women with silicone breast implants may be at increased risk for a number of rare adverse outcomes according to the study in the Annals of Surgery.
"We report on the analysis of the largest studies to date on the safety of silicone breast implants," - says Mark W. Clemens from the University of Texas. Cancer Center. MD Anderson in Houston. "We use the important information about the incidence of complications and rare associations with systemic harm. These data give women important safety information about silicone breast implants to have realistic expectations and help them to choose what is suitable." On the basis of the database, approved by FDA «postapproval», the analysis is the largest study of breast implant results to date.
In the early 1990s, FDA banned the use of silicone implants in response to public concerns about the health risks, including cancer, connective tissue diseases, and autoimmune diseases. Subsequent studies have found no association between breast implants and these diseases. In 2006, the FDA approved silicone gel implants from two manufacturers (Allergan and Mentor Corp), according to which manufacturers conduct large studies postpodtverzhdeniya (LPAS) to monitor long-term results in terms of health and safety.
"In spite of the abundant data collection and open public access, LPAS database has not yet been analyzed and not reported," - said Dr. Clemens. The researchers analyzed data on nearly 100,000 patients enrolled in LPAS in the period from 2007 to 2009-10. More than 80,000 patients received silicone implants; others received implants are filled with sterile saline.
Seventy-two percent of patients underwent primary breast augmentation, 15 percent - Auditing increase of 10 percent - primary breast reconstruction, and three percent - reconstruction procedures. Large size of the database allowed the researchers to assess the risk of rare adverse outcomes.
Women receiving silicone implants are at increased risk of disease compared with other women exists. Elevated risks include three conditions classified as autoimmune or rheumatologic disorder: Sjogren's syndrome, the risk of which is eight times higher than in women without silicone breast; scleroderma - a sevenfold increase in risk; and rheumatoid arthritis, about six times increased risk.
Silicone implants have also been linked with a 4.5-fold increased risk of stillbirth, but not a significant increase in the risk of miscarriage. The 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. The database included only one case associated with the implant anaplastic large celllymphoma - a rare but serious type of cancer, previously associated with breast implants.
Compared with implants filled with saline, silicone implants have also been associated with a higher risk of certain surgical complications. These include capsular contracture (scarring around the implant), which occurred at a rate of 5.0% with silicone implants versus 2.8% with saline-filled implants. Capsular contracture has occurred in 7.2% of primary breast augmentation procedures and were the most common cause reoperation in this group.
The researchers emphasize that their findings are inconclusive because of limitations inherent in the use of databases postapproval, including the lack of complete information about the patient and the individual data on the follow-up.
"In order to eliminate the remaining uncertainties in the evidence base, it is important that these data are analyzed impartially" - wrote Dr. Clemens et al. "It is the duty of the community of plastic surgeons to provide definitive proof of the risks associated with breast implants."