A new study regarding breast implants draws new conclusions about their overall effect on health. But according to many in the plastic surgery community, the study isn’t the full story.
Published in the Annals of Plastic Surgery, the paper—authored by plastic surgeons at University of Texas MD Anderson Cancer Center—uses data from close to 100,000 breast implant patients and is the largest study of silicone gel implants since 2006. It concludes that breast implants are associated with higher incidence of certain medical conditions: “Compared with normative data, silicone implants are associated with higher rates of Sjogren syndrome, scleroderma, rheumatoid arthritis, stillbirth and melanoma. The research is drawn from a secondary analysis of data gathered from an FDA database of large post-approval studies.
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“This is our best data to date,” says senior investigator and Houston plastic surgeon Mark Clemens, MD. “Common complications, such as rupture, scar development, and infection, were confirmed, but the risks continue to accumulate over the lifetime of a breast implant.” He points out that “researchers found that silicone implants had an association with some disease such as cancers or autoimmune disease; but no causative relationship was found.”
Some surgeons, however, fear that readers will come away from the study with the conclusion that breast implants cause melanoma and other health concerns. “The article doesn’t follow good scientific logic,” says La Jolla, CA Robert Singer, MD. “This is a retrospective study that combines different reports from different manufacturers with a very poor follow-up as far as compliance of patients coming back to their physicians’ offices to be evaluated.” That means that patients didn’t return to their doctor after surgery or dropped off in check-up visits after a few years. Adds Dr. Singer, “The follow-up or compliance rate is very low, so the vast majority of patients who don’t follow up or comply probably are having no problems.”
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The authors acknowledges this potential difficulty with the data: “There is significant attrition in follow-up,” the study reads. “…Overall compliance is poor.” Still, Dr. Singer and his fellow surgeons worry readers will read the conclusions without a comprehensive understanding of the methods used to gather the research.
One such conclusion is an “increased rate of… melanoma, greater than double the general population.” For Dr. Singer, it’s difficult to make that conclusion in light of inconsistencies with the data. “[The paper] doesn’t take into account that people who have implants may be living a more active lifestyle, out in the sun more, out in the beach more, and how does that compare with the normal population?” he asks.
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Eugene, OR plastic surgeon Mark Jewell, MD is concerned about the accuracy of drawing conclusions by piecing together results from different studies that used different methods to report outcome. “There have been other studies that have been published in the scientific literature that were more elegant in design, used better statistical methods to analyze data, and concluded that breast implants were safe,” he says.
Chicago plastic surgeon Laurie Casas, MD says the way the study is presented misleads the reader. “It’s self-reported data. You have to have conclusive evidence to make that particular statement. You can’t say that breast implants cause melanoma because a few women in a post-approval study have melanoma. All you can say is ‘these are the list of things that happened to these women that had breast implants,’” she says, echoing Dr. Singer’s wish that the study had compared their own results to larger statistics. “Self reported symptoms by patients do not in many cases constitute a medical diagnosis of an actual disease.”
Dr. Singer’s final word is a reminder that “plastic surgeons are interested in health of their patients. I know I, and all of my ethical colleagues, would not be doing this procedure if we didn’t feel it was safe.”
For his part, Dr. Clemens seems to feel the same way. “The conclusions provide women with information to discuss with their doctor when making a decision about breast implants,” he says. “Plastic surgeons at MD Anderson continue to provide breast implants as a safe option for our patients, but we want women to be aware of the both the rare and common risks.”
According to the Star Tribune, the Food and Drug Administration plans to hold a meeting early next year to discuss the latest data on breast implant safety, including this study. No date for the meeting has been announced.