FDA disputes study that suggests breast implants may put women at risk for rare diseases
The Food and Drug Administration is disputing a recent study that suggested women with silicone breast implants are at higher risk for certain rare diseases.
The agency cites methodology problems with the study, and has called a meeting for next year to review all available data.
The research is from one of the top cancer centers in the country: MD Anderson in Texas.
"Some of the rare diseases that we saw were lupus, Sjogren's, autoimmune diseases that have been previously shown," said Dr. Mark Clemens.
Dr. Clemens reviewed data from women with smooth, silicone implants from two manufacturers -- the only companies in existence where data was available at the time of the study.
He reiterated the FDA says implants are safe. But according to the study, one group of patients had illnesses like rheumatoid arthritis and melanoma twice as frequently as the general population.
"Silicone implants were associated with common diseases and some rare diseases,” said Dr. Clemens. “It wasn't possible to say who was most at risk but this is important information for physicians to know because if they do encounter one of these very rare occurrences, that they anticipate it and they know how to send the patient for further evaluation."
The study was published recently in the journal "annals of surgery."